SNPMiner Trials by Shray Alag


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Report for SNP rs8099917

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 8 clinical trials

Clinical Trials


1 Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

NCT00516321 Hepatitis C, Chronic Drug: eltrombopag Drug: placebo
MeSH:Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO:Hepatitis

There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance.

Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted.

Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.. Number of Par.

Primary Outcomes

Description: Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase.

Measure: Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Secondary Outcomes

Description: Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=90 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.

Measure: Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase

Time: From Baseline up to Week 9 in the OL Phase

Description: In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.

Measure: Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase

Time: From Baseline up to Week 9 in the OL Phase

Description: Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.

Measure: Median Platelet Count at the Indicated Time Points During the OL Phase

Time: OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)

Description: Blood taken from peripheral blood vessels was used for the measurement of platelet counts.

Measure: Median Platelet Count at the Indicated Time Points During the DB Phase

Time: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Description: The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.

Measure: Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.

Measure: Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase

Time: From Baseline up to Week 12

Description: EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.

Measure: Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase

Time: From Baseline up to Week 12

Description: ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.

Measure: Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase

Time: From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3)

Description: Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.

Measure: Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.

Measure: Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.

Measure: Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: The following participants were considered to have discontinued from antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.

Measure: Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.

Measure: Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Measure: Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Measure: Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.

Measure: Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of "abnormal" alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.

Measure: Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase

Time: DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

Description: Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.

Measure: Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase

Time: End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

Description: Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Measure: Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase

Time: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Description: Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Measure: Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase

Time: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Description: The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Measure: Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase

Time: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Description: The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Measure: Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase

Time: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

2 Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

NCT00529568 Hepatitis C, Chronic Drug: eltrombopag Drug: placebo
MeSH:Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO:Hepatitis

There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance.

Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.. Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.],

Primary Outcomes

Description: Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.

Measure: Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Secondary Outcomes

Description: Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.

Measure: Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase

Time: From Baseline up to Week 9 in the OL Phase

Description: In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <100 Gi/L. Participants who achieved platelet counts >=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.

Measure: Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase

Time: From Baseline up to Week 9 in the OL Phase

Description: Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.

Measure: Median Platelet Count at the Indicated Time Points During the OL Phase

Time: OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)

Description: Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.

Measure: Median Platelet Count at the Indicated Time Points During the DB Phase

Time: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Description: The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.

Measure: Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.

Measure: Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment.

Measure: Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.

Measure: Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.

Measure: Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.

Measure: Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.

Measure: Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.

Measure: Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.

Measure: Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Measure: Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS)

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Measure: Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.

Measure: Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication

Time: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Description: Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.

Measure: Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase

Time: DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

Description: Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.

Measure: Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase

Time: End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

Description: Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Measure: Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase

Time: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Description: Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Measure: Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase

Time: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Description: The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Measure: Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase

Time: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Description: The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Measure: Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase

Time: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

3 Study of Parameters of Early Hepatitis C Virus Dynamics for Predicting the Outcome of Standard Interferon Therapy With Chinese Cohort

The purpose of this study is to determine whether the outcome of interferon therapy on HCV infected patients can be early precisely predicted with a novel mathematic method with Chinese population.

NCT01434212 Hepatitis Drug: Interferon Alfa-2b, Ribavirin
MeSH:Hepatitis A Hepatitis C Hepatitis
HPO:Hepatitis

IL28 gene polymorphism,rs8099917,rs12979860,etc.

Primary Outcomes

Description: Blood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.

Measure: Blood HCV RNA Copies

Time: 0h,8h,10h,12h,18h,24h,37h,43h,3d,7d,2w,4w,6w,12w,24w,48w

Secondary Outcomes

Description: IL28 gene polymorphism,rs8099917,rs12979860,etc

Measure: IL-28B polymorphism

Time: Baseline

Description: During the first 3 days, blood samples are collected for PBMC separation and microarray analysis.

Measure: Microarray Analysis of PBMC Gene Expression

Time: Baseline,8h,18h,3d

Description: HCV NS5A is cloned into T vector and sequenced for evolutionary analysis.

Measure: HCV genotype

Time: Baseline

Description: Co-infection status are analyzed.

Measure: Blood Anti-HCV,HBV Antibody

Time: Baseline

Description: Deep sequencing is used for blood serum HCV genome analysis.

Measure: HCV genome sequencing

Time: 0h,8h,10h,12h,18h,24h,37h,43h,3d

Description: ALT AST are assayed to detect the hepatic function.

Measure: Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)

Time: Baseline,4w,6w,12w,24w,48w

Description: Fibrosis is analyzed with Fibroscan.

Measure: Fibrosis stage

Time: Baseline,4w,12w,24w,48w

Description: The distribution and absolute count of the different types of blood cells are assayed.

Measure: Regular blood test

Time: Baseline,4w,12w,24w,48w

Description: Electrocardiography is taken to avoid severe side effects.

Measure: Electrocardiography

Time: Baseline,4w,12w,24w,48w

Description: Patients are asked whether they take alcohol or smoke cigarettes during the therapy period.

Measure: Alcohol ,smoking condition

Time: Baseline,4w,12w,24w,48w

Description: Patients will be asked about their drug usage history.

Measure: Drug abuse history

Time: Baseline

4 An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C

This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.

NCT01675427 Hepatitis C, Chronic Other: Interleukin 28B testing
MeSH:Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO:Hepatitis

Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.. Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive.

Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.. Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced.

Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.. Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive.

Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.. Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced.

Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.. Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive.

Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.. Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced.

Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.. Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive.

Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.. Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced.

Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.. Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive.

Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.. Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced.

Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.. Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive.

Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.. Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced.

Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.. Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive.

Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.. Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced.

Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.. Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive.

Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.. Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced.

Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.. BMI by IL28B Genotype rs8099917: Treatment-Naive.

Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.. BMI by IL28B Genotype rs8099917: Treatment-Experienced.

HCV RNA genotype was obtained from medical records.. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive.

HCV RNA genotype was obtained from medical records.. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced.

Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.. Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive.

Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.. Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced.

Mean ALT ratio was calculated by averaging the values of all participants within each arm.. Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive.

Mean ALT ratio was calculated by averaging the values of all participants within each arm.. Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced.

Mean AST ratio was calculated by averaging the values of all participants within each arm.. Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive.

Mean AST ratio was calculated by averaging the values of all participants within each arm.. Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced.

Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.. Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive.

Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.. Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced.

HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive.

HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced.

HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]).

HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]).

HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]).

HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]).

HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.. Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive.

Participants underwent blood sampling at the Study Visit to determine IL28B genotype.. Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced.

Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype.

Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.. Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype.

Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype.

Primary Outcomes

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype (Genotype 1 [G1], Genotype 2 [G2], Genotype 3 [G3], Genotype 4 [G4], and all other genotypes [Other]) and cirrhosis status ('Cirrhosis/transition to cirrhosis' or 'No cirrhosis') were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.

Measure: Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive

Time: Study Visit 1 (single study visit)

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kilopascals (kPa).

Measure: Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.

Measure: Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.

Measure: Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.

Measure: Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Secondary Outcomes

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

Measure: Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.

Measure: Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.

Measure: Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.

Measure: Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.

Measure: Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.

Measure: Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.

Measure: Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.

Measure: Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.

Measure: Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kilograms (kg).

Measure: Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.

Measure: Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.

Measure: Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.

Measure: Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kilograms per meter-squared (kg/m^2), and mean BMI was calculated by averaging the values of all participants within each arm.

Measure: Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.

Measure: BMI by IL28B Genotype rs12979860: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.

Measure: BMI by IL28B Genotype rs8099917: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.

Measure: BMI by IL28B Genotype rs8099917: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.

Measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.

Measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.

Measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.

Measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 international units per milliliter (log10 IU/mL).

Measure: Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.

Measure: Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.

Measure: Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.

Measure: Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 international units per liter [IU/L] for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.

Measure: Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.

Measure: Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.

Measure: Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.

Measure: Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.

Measure: Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.

Measure: Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.

Measure: Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.

Measure: Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells per liter (10^9 cells/L).

Measure: Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.

Measure: Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.

Measure: Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.

Measure: Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype.

Measure: Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype.

Measure: Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype.

Measure: Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype.

Measure: Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

Measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included rapid virological response (RVR), complete early virological response (cEVR), and partial early virological response (pEVR). RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the lower limit of detection (LLOD) for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'

Measure: Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included RVR, cEVR, and pEVR. RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'

Measure: Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.

Measure: Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.

Measure: Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included sustained virological response (SVR), relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'

Measure: Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included SVR, relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'

Measure: Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 grams per deciliter (g/dL) or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.

Measure: Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 g/dL or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.

Measure: Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.

Measure: Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype

Time: Study Visit 1

Description: Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.

Measure: Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype

Time: Study Visit 1

5 Cross-sectional Multicenter Study Evaluating the IL28B Polymorphism in Patients With HBeAg-negative Chronic Hepatitis B Treated With Pegylated Interferon Alfa-2a in the Course of Peg.Be.Liver Study

This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the predecessor ML18253 study. The study consists of a single visit where eligible patients will undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.

NCT01697501 Hepatitis B, Chronic Other: Interleukin 28B testing
MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis
HPO:Hepatitis

Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF. null.

Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT. null.

Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF.

Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF.

Primary Outcomes

Measure: Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)

Time: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.

Measure: Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF

Time: EoF

Secondary Outcomes

Measure: Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)

Time: EoT, as defined in the predecessor study, was at Week 48 or Week 96

Measure: Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT

Time: EoT

Measure: Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF

Time: EoT and EoF

Measure: Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF

Time: EoT and EoF

Measure: Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF

Time: EoT and EoF

Measure: Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF

Time: EoT and EoF

6 Study of Parameters of Early Hepatitis C Virus Dynamics for Predicting the Outcome of Standard Interferon Therapy With Chinese Cohort (Second Phase)

The purpose of this study is to validate the first round HCV early dynamics discovery within a larger population.

NCT01760148 Hepatitis C, Chronic Liver Diseases Interferon Deficiency Drug: interferon alpha 2b
MeSH:Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases
HPO:Abnormality of the liver Decreased liver function Elevated hepatic transaminase Hepatitis

IL28 gene polymorphism,rs8099917,rs12979860,etc.

Primary Outcomes

Description: Blood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.

Measure: Absolute Blood HCV RNA Copies at designed time points

Time: 0hr,24hr,1wk,2wk,4wk,6wk,12wk,24wk,48wk,72wk

Secondary Outcomes

Description: IL28 gene polymorphism,rs8099917,rs12979860,etc

Measure: IL-28B polymorphism

Time: Baseline

Description: HCV NS5A is cloned into T vector and sequenced for evolutionary analysis.

Measure: HCV genotype

Time: Baseline

Description: ALT AST are assayed to detect the hepatic function.

Measure: Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)

Time: Baseline,4wk,12wk,24wk,48wk

Description: Fibrosis is analyzed with Fibroscan.

Measure: Fibrosis stage

Time: Baseline,4wk,12wk,24wk,48wk

Description: The distribution and absolute count of the different types of blood cells are assayed.

Measure: Regular blood test

Time: Baseline,4wk,12wk,24wk,48wk

Description: Electrocardiography is taken to avoid severe side effects.

Measure: Electrocardiography

Time: Baseline,4wk,12wk,24wk,48wk

Description: Patients are asked whether they take alcohol or smoke cigarettes during the therapy period.

Measure: Alcohol ,smoking condition

Time: Baseline,4wk,12wk,24wk,48wk

Description: Patients will be asked about their drug usage history.

Measure: Drug abuse history

Time: Baseline

7 IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis

A maximum of 220 subjects with a minimum of 25 years will be recruited and examined for this 1-7 visit, up to 35 days research study: Subjects will be genotyped to identify variants of the interleukin-29 (IL29) and interleukin-28B (IL28B) genes and placed in one of the 4 groups: 50 subjects with dominant allelic variants with healthy periodontium, 50 subjects with dominant allelic variants with periodontitis, 50 subjects with IL29 (rs30461) or any of IL28B (rs11083519; rs8105790; rs8099917) single nucleotide polymorphism's (SNP) variants and healthy periodontium, and 50 subjects with IL29 (rs30461) or any of IL28B (rs11083519; rs8105790; rs8099917) SNP variants and periodontitis. Visits will consist of outpatient procedures including oral examinations, oral prophylaxis or periodontal scaling and root planing, collection of gingival crevicular fluid, dental plaque, saliva, and blood samples. Analysis will include salivary DNA isolation and pyrosequencing to determine IL29 and IL28B genotype, mediator analysis of gingival crevicular fluid, dendritic cell differentiation and inflammatory mediator analysis, and whole-genome shotgun sequencing plaque analysis. Clinical outcomes will include measurements of periodontal disease progression and inflammation, such as clinical attachment level (CAL), pocket depth (PD), bleeding on probing (BOP), gingival index (GI), and plaque index (PI). Primary Objective: To determine the impact of IL29 and IL28B SNP variants on periodontal disease expression and local inflammatory response during stent-induced biofilm overgrowth. Secondary Objective: To evaluate in vitro the impact of IL29 and IL28B SNP variants on cell-mediated, innate inflammatory response.

NCT02710903 Periodontitis Procedure: Stent-induced biofilm overgrowth
MeSH:Periodontitis Periodontal Diseases
HPO:Periodontitis

IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis A maximum of 220 subjects with a minimum of 25 years will be recruited and examined for this 1-7 visit, up to 35 days research study: Subjects will be genotyped to identify variants of the interleukin-29 (IL29) and interleukin-28B (IL28B) genes and placed in one of the 4 groups: 50 subjects with dominant allelic variants with healthy periodontium, 50 subjects with dominant allelic variants with periodontitis, 50 subjects with IL29 (rs30461) or any of IL28B (rs11083519; rs8105790; rs8099917) single nucleotide polymorphism's (SNP) variants and healthy periodontium, and 50 subjects with IL29 (rs30461) or any of IL28B (rs11083519; rs8105790; rs8099917) SNP variants and periodontitis.

Primary Outcomes

Measure: Change in pocket depth (mm)

Time: 21 days

Measure: Change in clinical attachment level (mm)

Time: 21 days

Measure: Change in plaque index (0-3)

Time: 21 days

Measure: Change in bleeding on probing (Yes/No)

Time: 21 days

Measure: Change in gingival crevicular fluid interleukin-1 beta (GCF IL-1b)

Time: 21 days

Measure: Change in gingival crevicular fluid prostaglandin E2 (GCF PGE2)

Time: 21 days

Measure: Change in gingival crevicular fluid interleukin-29 (GCF IL-29)

Time: 21 days

Measure: Change in gingival crevicular fluid interleukin-28B (GCF IL-28B)

Time: 21 days

Measure: Change in gingival index (0-4)

Time: 21 days

Measure: Composition of the microbiota oral flora

Time: 21 days

Measure: Change in gingival crevicular fluid interleukin-6 (GCF IL-6)

Time: 21 days

Secondary Outcomes

Measure: Change in interleukin-29 expression in dendritic cells at day 35

Time: 35 days

Measure: Change in interleukin-28B expression in dendritic cells at day 35

Time: 35 days

8 Prevalence of IL28B Polymorphism in Hepatitis C Patients in Singapore and Its Effect on the Outcome of Hepatitis C Treatment

Response to peginterferon and ribavirin treatment in hepatitis C (HCV) depends on viral and host factors. Single nucleotide polypmorphisms (SNP) near to IL28B gene (especially at rs12979860 and rs8099917) are strongly associated with the response to treatment in HCV genotype 1 infection, less so in HCV genotype 2/3 infection. CC genotype in rs12979860 and TT genotype at rs8099917 are associated with good treatment outcome. Asian populations have high prevalence of CC genotype in other studies, which can explain relatively good response to peginterferon/ ribavirin in genotype 1 infection in Asians compared with Caucasians.

NCT03415009 Hepatitis C
MeSH:Hepatitis A Hepatitis C Hepatitis
HPO:Hepatitis

Single nucleotide polypmorphisms (SNP) near to IL28B gene (especially at rs12979860 and rs8099917) are strongly associated with the response to treatment in HCV genotype 1 infection, less so in HCV genotype 2/3 infection.

CC genotype in rs12979860 and TT genotype at rs8099917 are associated with good treatment outcome.

Primary Outcomes

Measure: the prevalence of genetic variants for IL28B SNPs (rs 12979860 and rs 8099917) in HCV patients in Singapore.

Time: Baseline

Secondary Outcomes

Measure: The distribution of the different SNP variants in different ethnic groups (Chinese, Malay, Indian and others)

Time: Baseline

Description: To study the correlation between genetic variants and treatment response

Measure: The association of the genetic variants and the treatment response in patients receiving peg-interferon/ ribavirin therapy.

Time: Baseline


HPO Nodes


HP:0001392: Abnormality of the liver
Genes 1390
SRD5A3 WHCR CSPP1 ATP7A IL2RG MYORG NR1H4 IL17RC PEX1 B9D1 CD40LG TCF4 INSR SKIV2L RRM2B TTC37 HPD PEX11B NEU1 DOCK6 RBPJ CLEC7A RNF43 PSAP HNF1B HSD3B7 VPS33A LIPT1 EFL1 SDHC CEP290 TGFB1 CHD7 TINF2 FOXP3 PRKCD ALG6 CR2 C11ORF95 PTPN3 LACC1 ABCB11 KRT8 PLEKHM1 SETBP1 CASK PEX10 PKLR HADHA GBA TINF2 SLC4A1 AGA HADHA RPS20 IL7R TCIRG1 FLI1 GLIS3 CFI UQCRC2 IL17RA DNASE1L3 TRNK MRPL3 LCAT MPV17 TBX1 PEX11B TMEM70 KLF1 INS HBB NDUFS1 KMT2E HFE FASTKD2 ALG9 CTRC KRT18 SOS1 EIF2AK3 WDR35 PYGL FASLG CORIN BSCL2 ALG8 CD81 TNFSF12 RHAG FAN1 NCF2 LMNB2 ACADM H19 FBP1 GNE TNFRSF1B ND3 RMRP XRCC2 PC SLC29A3 ACOX1 COG8 RHAG SLC30A10 CDKN2B TJP2 COX6B1 SMPD1 SPTB WDR60 CBS RPGRIP1 SRD5A3 RPGRIP1L MLH1 ATP8B1 TRIM37 TMEM67 NHP2 SLC11A2 INPP5E NFKB1 CDKN1A HADHA CA2 ACSF3 H19 POLD1 AP1S1 F5 LYRM4 SLC2A1 KRT6B PCK1 POLG2 SEC24C HNRNPA1 DHDDS ALG13 AKT2 APOA1 B3GLCT GBA MPC1 KRT16 TET2 LDLRAP1 SLCO2A1 ACVRL1 KCNH1 PIGS APC TMEM67 USP9X CAV1 IFT122 TNFSF11 LRPPRC POMC BBIP1 B9D2 PEPD ACAT1 LMNA SPTA1 ACVRL1 GATA6 LPL DIS3L2 GNPTAB PHKG2 TNFRSF1A IDUA KRIT1 SLC25A13 BMP2 GPI SNX10 AKR1D1 BBS1 MED25 APC MAN2B1 MTRR ALAS2 ERCC4 PEX14 PNPLA2 PIEZO1 MVK PEX16 BRCA2 BCS1L SBDS TUFM VPS13A IFT140 SDCCAG8 GBA AMACR PFKM HFE PTPN11 APC INSR NPC1 CTNS TSFM PEX5 IFT172 BRCA1 IFT80 ERCC4 SLC25A13 RFWD3 PSMB4 HBA2 WDR19 ALDOA ELN ATP8B1 JAK2 MPI SMPD1 HMBS TBX1 ABCA1 ICOS UROD DCTN4 DKC1 LIG4 NBAS PEX3 TRNE ACADVL SDHA GPC3 TREX1 PEX10 CAV1 MYC HADHB HGSNAT GBA MMUT PEX26 RAB27A PEX12 PMM2 RREB1 RPGRIP1L CLDN1 MPL UQCRB MRPS16 UGT1A1 WDPCP FANCC HJV PEX13 CARS2 AP1B1 GYS2 PROP1 MRPS7 PEX2 PEPD G6PC MCM4 MMUT COG4 ABCC2 PEX26 HLA-DRB1 PPARG NDUFS7 NPHP1 VIPAS39 ABHD5 SBDS PIGA APOA1 GP1BB EFL1 VCP SLC17A5 COX4I2 GPD1 GPC3 CA2 DDRGK1 NDUFAF1 COG5 PHKA2 TWNK PHKG2 KRAS CYBC1 USP18 TMEM231 SP110 PEX1 CIDEC EOGT MSH2 IL2RB SLC39A8 MEFV TANGO2 FERMT3 ATP7B PDGFRL ATM TTC21B TERT HMGCS2 HOXD13 ENG MYH9 CEL LONP1 FGA SLCO1B3 CYP27A1 MIF DPAGT1 TERT TF CLCN7 TMEM107 CD247 NDUFA6 TRAF3IP2 DNAJC19 APOB SMPD1 CEP290 PRDM16 STK11 ND2 LETM1 ITCH LPIN2 PEX6 CASR SLCO1B1 POLG TPP2 IFT172 ZAP70 CNTNAP2 SKI H19 CYP19A1 ABCG8 PKHD1 CC2D2A CTCF GCGR CD96 PIK3CA GAA PSAP LHX1 PEX2 UBE2T PSAP ND4 PEX6 SLC29A3 TACO1 RNASEH2B POLG2 ZMPSTE24 RELA TMEM67 PCK2 POMC CD79B LBR SRP54 AKR1D1 SLC39A4 SC5D RPGRIP1L PLPBP SPTA1 RERE NKX2-5 NDUFS4 FAH CC2D2A COX20 GATA6 TERT TRAPPC11 ARSA HBA1 FANCL RFX5 PEX14 HNF1A FUCA1 OCLN DCDC2 TPI1 GUCY2D PSAP NSD2 PIK3C2A STAT6 CEP19 TERC SF3B1 NDUFS6 COG6 ACADL HADH RRAS POU2AF1 NOD2 CLIP2 NDUFV1 ERCC8 PEX5 HBB NPHP3 CAVIN1 PSMB9 RFXAP TCF3 NRXN1 FECH CP GFM1 GYPC CTSC SLCO1B3 CD28 NOTCH2 GNS HAMP CDAN1 CEP120 C1QBP ADAR CEP290 POLG2 HBG2 TIMMDC1 PARN EIF2AK3 RHAG ALDOB TNFRSF13C IL21R TRMT10C RFXANK BMPR1A STX11 CD27 CASP8 DHCR7 SGSH SLC25A19 HNF1A CSPP1 BBS12 RFT1 NLRP3 USB1 TRIP13 TMEM67 IDUA PMS1 CPT2 SLC25A20 RFXAP ADA HSD3B7 RAG2 WDR35 RMRP PCSK1 PRSS1 KCNQ1 FDX2 NDUFS8 CEP290 ND1 CCDC115 NGLY1 LMNA WDR60 FANCA MSH6 TMPRSS6 POU6F2 IL2RG NCF1 NSD2 STEAP3 INTU ADAMTSL2 SON PIK3CA FANCM LDLR KCNJ11 CLDN1 DLD TNFSF11 ABCA1 PIEZO1 ARHGAP31 RBM8A SLC13A5 NOTCH2 PEX6 EPCAM MEN1 KRAS TRIM32 PEX14 DUOX2 PDGFRB HBB UBR1 PEX13 RAG1 ABCC2 CIDEC TBX19 SDHA APC ARL6 XIAP RASGRP1 TCIRG1 SMAD4 NHLRC2 ALG1 BRCA2 POU1F1 ND5 DLL4 NDUFB11 TNFRSF11A HLA-B GTF2I EPB42 CTRC SLC22A5 PEX1 IL2RA RNU4ATAC SLC37A4 BCS1L BCHE KCNJ11 LMNA TFR2 TREX1 GUSB BTNL2 TRAF3IP1 SLX4 TNFRSF13B CYBA UGT1A1 DNAJB11 KCNN3 DKC1 PEX3 VPS45 APOE SCO1 GPR35 TBX1 CR2 ATP6 PRKCD JAK2 CTNNB1 HESX1 NPHP1 LMNA APOE FANCI LYST TET2 PEX13 TP53 NUBPL TRAF3IP1 CCDC47 PDX1 TANGO2 TTC8 LYST AP1B1 RNASEH2A MUC5B IL17F SERPINA1 PEX6 FAN1 PKLR NPHP3 C1S NPHP4 FBN1 UGT1A1 KRT18 CYP7B1 CIITA GPC3 HADH HJV KPTN XYLT1 PEX16 CYP7B1 APC UGT1A1 CPT1A BBS5 PALLD CTC1 NSMCE2 FADD TTC7A BCS1L FARSB DDRGK1 NPHP3 IFNGR1 CFTR PEX16 XRCC4 FGFR2 HNF4A MPV17 GALT SLC25A1 ACADM ALG9 KLF11 MLH3 CLCN7 IGLL1 UGT1A1 CLPB GBA TALDO1 KRT8 BTD ARSA PLAGL1 HK1 ALG2 DPM2 C8ORF37 DMD SLC40A1 SLC26A4 G6PD GALK1 AGPAT2 PEX5 PDGFRA SLC40A1 IL2RG IYD KLF1 WT1 BBS10 ATP7A RNASEH2C SRP54 ABCC8 PEX13 DYNC2H1 SLC20A2 ESCO2 GPC4 PAX8 CLCA4 C4B PCCB COG8 ABCB4 XK TNFSF15 APPL1 HEXB CPT2 PEX6 XPR1 CTSA IER3IP1 ACOX1 B2M TNFRSF1B YARS2 DCLRE1C HYMAI SCARB2 CD70 BSCL2 AHCY LYZ SPINK1 SOX10 IDUA ABCC8 GABRD WT1 FASLG ERCC6 FOXF1 STOX1 TBX19 CTBP1 DPM1 ATP8B1 PEX12 BSCL2 ENG UCP2 PKD2 RNU4ATAC FGFR2 SCYL1 COG7 DAXX MST1 PSMB8 BLVRA GPIHBP1 HADHA NELFA SURF1 TNFSF12 GPC4 SMAD4 PEX19 GNAS TRMU COX10 ALAS2 NAGA DOLK PEX2 NHP2 MCCC1 TRIM28 DHFR DNAJC21 CTSK SETBP1 PEX3 WDR19 NAB2 DPM3 RECQL4 MVK RFT1 LZTR1 G6PC3 ANK1 CDKN1C STN1 KRAS PALB2 SEMA4A EPB42 UFD1 NHP2 LIPE RIT1 RNASEH2A DCDC2 FGFRL1 HNRNPA2B1 STEAP3 PARS2 DNAJC21 LHX3 TG DCLRE1C HMGCL DIS3L2 FOS VPS33B TMEM199 BRCA2 RBCK1 HELLPAR NFKB2 CASR LMNA NOP10 SFTPA2 XRCC4 PAX4 JMJD1C RAF1 CD46 PALB2 RAG2 DGUOK COX8A ND3 CFTR FANCE ICOS RMND1 RFX6 NDUFS7 IL12A LIG4 KIF23 SCYL1 NDUFS2 HLA-DRB1 FAS NCF1 ARSB MKS1 SLC25A20 RAD51 EWSR1 ALMS1 GALE PEX26 TSC1 MMAA SLC4A1 KRT17 PAX8 ABCA1 PEX19 ZIC3 ADA2 EPB41 SERPINA1 CFTR NPHP3 MOGS FBP1 FANCD2 LBR TNPO3 SLC25A4 ATP11C LRP5 TSHR NEK1 CCND1 MET VHL ABCG8 IDUA TRMU WDR34 ABCB4 SPECC1L ERCC4 DYNC2H1 MKS1 GLB1 ASAH1 ATP6V1B2 SLC25A13 NEUROG3 ND1 TCIRG1 HSD17B4 CDKN1B LRP5 STK11 IL1RN COG1 NRAS ND6 GBA BTK AMACR ETFA ND2 PPARG FLT1 COMT DGUOK CD19 PRPS1 GBA HADHB POU1F1 DLD MKKS SEC63 TRMT5 TGFBR2 GBA HMGCL SLC4A1 HBB TRNS1 MRPL44 DDOST PCCA ABCB4 LIPA ABCD3 LIPE GATA2 BTK REST SUMF1 FUCA1 PEX3 AGGF1 PEX14 RAG1 UROS ANKS6 KCNN4 SDHD PTEN TREX1 TSHB APOC2 SLC2A1 GLB1 CDKN1B CPA1 ASL HMBS IL36RN KIT INPPL1 HYOU1 TRIM37 HPGD ELN PEX19 TGFB1 CBS CYP27A1 RAG2 TGFB1 PSAP MMUT COX10 COX15 KCNN4 CYBB HMOX1 H19-ICR NDUFA11 PLIN1 DYNC2LI1 NDUFAF2 TERC MAD2L2 NDUFB9 MSH6 KRAS CD3E FOXRED1 CD19 HBG2 TRNV PCCA HNF1A KIT WRAP53 GCLC C8ORF37 COX14 ACAD9 GNMT TREX1 ATP6AP1 RFC2 HNF4A CD3D SLC25A13 PEX12 TMEM67 TERC CTLA4 TRNN CDKN2A LMNA BCS1L IDS MET IL7R CDKN2C TSHR PLIN1 PET100 GPC1 CPT1A HNF1B NLRC4 BRCA1 PEX3 DPM3 JAM3 GNPTAB TRNW DLL4 JAK3 IFT140 MICOS13 DNAJC19 PNPLA2 PRF1 NAGA CEP55 SC5D PIGM PMM2 GALT BBS7 HLA-DRB1 ITK PRKCD NDUFAF4 BBS2 LIPA NGLY1 IDUA HAVCR2 IQCB1 MFN2 NOS3 SUMF1 BBS9 NDUFAF1 MYBPC3 SLC30A10 PEX26 PEX10 EPB41 KCNAB2 ACADVL GUSB CPT2 AGPAT2 HBB POLG ETFDH NRAS PEX16 GLRX5 LRRC8A COA8 OSTM1 LIMK1 NLRP3 TBL2 LZTFL1 FH CPOX CEP164 PNPLA6 SLC37A4 SPTB ABCB11 TWNK SFTPC ALDH7A1 INPP5E HBA1 ATPAF2 SHPK ICOS SLCO1B1 FCGR2A SPRTN FBXL4 MARS1 ALG11 TMEM67 KIAA0586 CPT2 IL7R NDUFS3 RASA2 ACAD9 AUH TKT ATP7B NSMCE2 RHBDF2 OFD1 CLCN7 IFIH1 JAK2 WT1 DZIP1L HIRA DPM2 PRKCSH GNE NCF2 SLC25A19 ARSA TFAM COX15 COG2 CEP83 SNX14 KCNH1 NEK8 BBS1 NDUFAF3 PSAP CD79A BRIP1 SEC63 ADAMTS13 ANTXR1 IGF2 FANCF PDGFRA BLNK ALG8 WDR19 PEX10 TMEM126B TPO TALDO1 FAS PDGFB CLCN7 DHCR7 BMPER IFT172 PCCB TP53 CTLA4 SDCCAG8 GCK NOTCH1 PTRH2 ADA NCF4 SLC35A2 SMAD4 STAT1 TTC37 GDF2 TMEM165 IL12RB1 RFXANK IRF5 NDUFAF5 TNFRSF13B PEX12 TRAPPC11 INVS CALR TRHR SPINK1 CD28 MECP2 SEC23B AGL ABCG8 CIITA WDR19 HBG1 GALNS OFD1 TMEM216 CC2D2A ABHD5 PEX2 LARS1 TTC21B GCDH RPGRIP1L STX1A IGF2R IGF2 BTK LIPA TRNL1 MKS1 COG2 SLC25A15 PKD1 CC2D2A TNFRSF13C SLC4A1 SP110 CASP10 ATRX PKHD1 PRKCSH HNF1B SKIV2L SOS2 KRT6A PIK3R1 TARS2 RRAS2 RTEL1 POLG TCTN2 CD55 GBE1 CCDC28B PRKAR1A SLC7A7 CYTB IFT27 NPC2 BSCL2 NDUFB10 COG4 SDHB SAA1 AP3D1 ITCH SLC5A5 PRSS1 SAR1B PEX11B RAG1 GDF2 ALMS1 F5 PMS2 COA8 GBA HBB TSC2 CASP10 CASR EXTL3 LETM1 NDUFS4 HAMP DYNC2LI1 TRIM28 PHKB PSMB8 RAD51C AKT2 ARVCF SH2D1A DUOXA2 ZAP70 LHX4 C15ORF41 RNU4ATAC POLR3A HNF4A AGA RNASEH2C TYMP IFT172 MYD88 JAG1 APOE LTBP3 ASAH1 NPM1 COG6 IKZF1 PHKA2 SLC7A7 CYBA HFE GLB1 NLRP1 CBL RFX5 MS4A1 HNF4A BBS4 ARSA NAGLU BTNL2 FAM111B PLEKHM1 DMPK AIRE BPGM MLXIPL FANCG EARS2 WDR35 SAMHD1 PGM1 AP1S1 AXIN1 LMNA ALDOB ADK PRSS2 KCNQ1OT1 HBA2 CAVIN1 BLK SNX10 PPARG RRM2B CYP7A1 IFT80 BAZ1B CTLA4 FAH SLC25A15 NEUROD1 PEX1 NDUFV2 PEX5 SLC22A5 MLH1 FANCB WDR34 CPLX1 IARS1 WDPCP EXTL3 TMEM216 TERT BOLA3 XIAP MYRF CTNNB1 CYBB SPTB GANAB NPHP3 NAGS CYC1 TTC7A NOP10 MSH2 APC UNC13D TRNW JAK2 MMEL1 MMAB IGHM MPI IFT43 MRAS NDUFB3 PCSK9 FAS STXBP2 ANK1 CFH PTPRC LBR SPIB VPS33A IL6 TET2 ASS1 NDUFA1 FECH ABCG5 MPL GTF2IRD1 PEX12 AP3B1 IFIH1 ETFB PEX19 PEX1 PRKAR1A ERBB3 A2ML1