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)

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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

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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

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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)

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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)

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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)

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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

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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

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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

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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

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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

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Secondary Outcomes

Description: IL28 gene polymorphism,rs8099917,rs12979860,etc

Measure: IL-28B polymorphism

Time: Baseline

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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

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

Measure: HCV genotype

Time: Baseline

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Description: Co-infection status are analyzed.

Measure: Blood Anti-HCV,HBV Antibody

Time: Baseline

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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

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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

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Description: Fibrosis is analyzed with Fibroscan.

Measure: Fibrosis stage

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

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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

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Description: Electrocardiography is taken to avoid severe side effects.

Measure: Electrocardiography

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

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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

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

Measure: Drug abuse history

Time: Baseline

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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

Time: EoF

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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

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

Time: EoT

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

Time: EoT and EoF

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

Time: EoT and EoF

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

Time: EoT and EoF

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

Time: EoT and EoF

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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

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Secondary Outcomes

Description: IL28 gene polymorphism,rs8099917,rs12979860,etc

Measure: IL-28B polymorphism

Time: Baseline

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

Measure: HCV genotype

Time: Baseline

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

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

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

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Description: Fibrosis is analyzed with Fibroscan.

Measure: Fibrosis stage

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

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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

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Description: Electrocardiography is taken to avoid severe side effects.

Measure: Electrocardiography

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

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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

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

Measure: Drug abuse history

Time: Baseline

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Primary Outcomes

Measure: Change in pocket depth (mm)

Time: 21 days

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Measure: Change in clinical attachment level (mm)

Time: 21 days

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Measure: Change in plaque index (0-3)

Time: 21 days

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

Time: 21 days

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

Time: 21 days

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

Time: 21 days

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

Time: 21 days

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

Time: 21 days

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Measure: Change in gingival index (0-4)

Time: 21 days

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Measure: Composition of the microbiota oral flora

Time: 21 days

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

Time: 21 days

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Secondary Outcomes

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

Time: 35 days

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

Time: 35 days

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Primary Outcomes

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

Time: Baseline

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Secondary Outcomes

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

Time: Baseline

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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

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HP:0012115: Hepatitis

Genes 91

SERPINA1 RFXANK RFXAP SPIB HSD3B7 CD3D MET TP53 PGM1 IL17F IL17RC BLNK CD79A CD247 STAT1 IL21R FOXP3 IL12RB1 KRT8 FASLG ATP7B IGF2R CYP7A1 CD3E TBX19 BTK RFXANK ALMS1 CASP10 ATP7B C1S GUSB XIAP FAS IL17RA PIK3CA IGHM RASGRP1 MMEL1 TTC7A TCF3 CIITA GPR35 PIK3R1 MST1 CIITA AIRE SLC25A15 TPP2 GLIS3 IRF5 XIAP POU2AF1 C4B VPS33B CYP7B1 SKIV2L BTK PIEZO1 RFX5 TTC7A BTK FAS TNPO3 CD40LG CASP8 ATP7A RFXAP SH2D1A VIPAS39 LRRC8A CTNNB1 PDGFRL CLEC7A SHPK TNFSF15 AXIN1 RFX5 APC PRKCD TCF4 AMACR TRAF3IP2 COG8 ITCH CD79B SLC25A15 IGLL1 KRT18 IL12A COG6

Protein Mutations 29

A181V A92T C282Y E62D G1764A H54Y H58C H63D L28M L31M L528M M204I M204V M28L M552I M552V N236T N370S P1028S P58A Q215S Q30H Q54H Q62E Q80K R30H Y93C Y93F Y93H

SNP 20

rs10813831 rs1127354 rs11795404 rs12356193 rs12979860 rs12992677 rs17037122 rs179008 rs2066842 rs2067085 rs2464266 rs3853839 rs41308230 rs4588 rs5743844 rs6592052 rs7041 rs7270101 rs7549785 rs8099917

HP:0000704: Periodontitis

Genes 42

TCIRG1 NOTCH2 TERT NHP2 RTEL1 CAT SLC35C1 ELANE C1S CTSC SRP54 CTSC NOP10 FGF3 PARN AEBP1 PLG COL3A1 OCRL USB1 CTSC TINF2 CTC1 CXCR4 PLG C1R FERMT1 DKC1 FERMT1 GORAB ITGB2 C1R NPM1 ELANE TERC AP3B1 GFI1 WRAP53 COL3A1 CTSC C1S LYST

Protein Mutations 2

C282Y C31G

SNP 8

rs11083519 rs2043211 rs20432111 rs30461 rs4612666 rs679620 rs8099917 rs8105790

HP:0001392: Abnormality of the liver

Genes 1412

PLIN1 CTBP1 CASR BCS1L GLB1 GDF2 SDCCAG8 TCIRG1 MICOS13 RAG1 INSR IFT172 TSC2 CDIN1 IL17F BLNK KCNAB2 FAN1 PHKA2 ARHGAP31 SGSH TSFM STK11 KCNN4 RNASEH2C EPCAM GPC3 RRAS2 OSTM1 CASP10 CC2D2A PDGFRA BRIP1 MOGS SFTPC ASAH1 NDUFAF1 BOLA3 GPR35 LIPE MED25 RAG2 TYMP TTC37 KCNH1 LTBP3 MTRR RNASEH2A PEX1 WDR35 CC2D2A PIEZO1 RHAG TTC7A GPC3 MLH3 FAH NDUFS3 MSH2 AUH IL6 POLG2 ATP7A ALDH7A1 SRD5A3 TRIM32 AXIN1 TCF4 AP1B1 ALG8 RUNX1 SERPINA1 SLC7A7 INS GBA ICOS SETBP1 CFI ALAS2 MYBPC3 SLC35A2 SLC37A4 MRPS16 RPGRIP1 DLD BSCL2 IFT43 PKLR GBA KCNH1 TRNW MRAS PEX12 CIDEC SLX4 PCCA PALB2 PEX10 DHFR OCLN PFKM CASK GLB1 ACADVL COX8A BBS4 TREX1 STX11 AGA POU6F2 ABCG8 TBX19 DAXX HGSNAT CEP290 LIPA MARS1 LRP5 BCS1L SLC25A20 FCGR2A PSMB8 FANCA ARSA CLCN7 MST1 PEX12 TRAPPC11 NCF4 NDUFS6 ARSB CFTR LYST RAG1 TPP2 NBAS FOXF1 UROD F5 ARSA AP1S1 XRCC2 TMEM67 ITCH WDR19 OFD1 UGT1A1 B2M WT1 PDGFRB HYMAI TRAPPC11 UNC13D SRD5A3 SRP54 AGPAT2 TNNI3 TINF2 RHAG HSD17B4 DCLRE1C HSD3B7 NPHP1 ACAT1 ABCA1 PMM2 GTF2IRD1 ND5 IFT80 COG8 UFD1 LETM1 SLC26A4 NDUFS8 NDUFAF3 FANCB SP110 TMEM126B HNRNPA2B1 NPC1 GPIHBP1 DPM3 TSHR RFXANK ICOS LPIN2 FANCM CD3D GPC1 SNX10 LDLR JAK2 ERCC6 POU1F1 COX6B1 TMEM199 PCCA CPT1A LHX4 GPC4 HNF1A HBB GANAB PKHD1 XRCC4 KRT8 TET2 COX14 ATP7B HFE SUMF1 OFD1 DGUOK CD3E ALG13 EXTL3 NCF1 PIK3CA CLIP2 COG6 COMT DCDC2 WDPCP SLC4A1 HLA-DRB1 DPM3 SLC5A5 RMRP GLIS3 PEX26 KCNN4 PLEKHM1 DCDC2 DIS3L2 PEX12 LBR RAB27A TRMT5 NDUFS2 PKLR SMAD4 CALR NDUFV1 APC CFH PEX5 TFAM NEU1 NOTCH1 DMPK DUOX2 HIRA DKC1 BRCA1 ADAR UQCRC2 STEAP3 PCK1 PEX19 IFIH1 DOLK CPLX1 MRPL3 MSH6 PMS1 CTSA APC PKD1 STK11 DYNC2I2 PRSS1 ACADM HBB IGLL1 SOS1 LCAT COG6 STX1A HMGCS2 RNF43 TERT G6PD NSD2 CYTB FBP1 C8ORF37 MKS1 BRCA2 IL2RB PEX2 SLC22A5 TP53 HMGCL MAD2L2 PAX4 IQCB1 WDR19 TMEM67 C11ORF95 FOXP3 IL12RB1 ABCG8 BCS1L TRNL1 PRKCD SLC4A1 TALDO1 HNF1A RAF1 MSH6 TANGO2 ADAMTS13 DYNC2H1 ABCA1 BTK RFXANK ND3 PEX13 C1S NEK1 HK1 TERC NDUFB3 ND6 HBB RPS20 CDKN1C AGA TERC H19 FGA RIT1 PYGL NCF1 CR2 IL2RA MYC ACAD9 MKS1 SLC7A7 CAVIN1 KCNQ1 NFKB2 CLDN1 PEPD MMUT GCK ALG8 PRKCD CTC1 IFT122 PMM2 KRT6A NSMCE2 CDKN2B PALB2 EPB42 NDUFS7 PEX16 SCNN1B HAVCR2 HBA2 ASAH1 RNU4ATAC DHCR7 KMT2E KIT TREX1 SPTB AMACR IL17RC PSAP NAB2 SC5D APC IFT172 DMD EIF2AK3 RECQL4 NGLY1 PEX16 NPHP3 PMS2 PIGM A2ML1 POLG TACO1 LYRM4 SETBP1 CASR ALMS1 ATRX TBX19 GUSB CCDC28B ND3 SLCO2A1 EPB41 CPT2 APOE RNU4ATAC SDHD VHL GCDH B3GLCT CDKN1B PRDM16 BBS5 C4B NEUROG3 ARSA SEC63 HYOU1 NHP2 TNFRSF11A SDHC PRKCSH UROS ATPAF2 PEX13 MSH2 PSAP HESX1 COG4 ALDOB RREB1 DDRGK1 CD40LG IFT140 PEX11B ND1 HNF1B SLC39A8 NPHP3 LMNA CFTR COX10 C1QBP AKR1D1 SMPD1 RFT1 LHX3 PEX3 PC NAGA TMEM216 MMUT BTNL2 ABCG8 TRIM37 SLC25A1 POMC MEN1 USP18 PSAP PEX19 FBN1 NDUFS1 PEX1 TNFRSF13C PDGFB ALG9 LIG4 MKS1 GALNS GBA NAGLU COA8 LMNA MAN2B1 CTSC HMGCL KCNJ11 ANK1 TARS2 TGFBR2 DYNC2I1 KRAS TINF2 FLT1 SLC30A10 SP110 GPD1 SMPD1 ACADL NHLRC2 TRMU HADHA HNF4A FAS PKD1 FANCD2 TPI1 TMEM165 PTPRC TCIRG1 ZIC3 COX10 POLG ADA ABCB4 DMPK PEX2 SEMA4A COG2 POLG2 BAZ1B EXTL3 CYP7B1 ABCD3 UQCRB PCSK9 KRT8 NDUFS4 CTLA4 ASXL1 WT1 LRP5 WDPCP DYNC2LI1 ATP7A EARS2 ASS1 GYPC GCGR GBA MPL CDKN1A DUOXA2 TRIM28 GP1BB CTNNB1 CYP7B1 TGFB1 COA8 HPD CLPB PIK3CA EFL1 BBS12 SBDS CAVIN1 MVK ICOS PAX8 PYGL RAD51 GALT NPHP4 SFTPA2 JAG1 MMUT KIT PEX11B BSCL2 SLCO1B3 FAH PSMB9 SLC17A5 IDUA TRNS1 NFKB1 IFT27 GBA TPO INPP5E STAT1 SDCCAG8 BMPR1A TET2 RAG2 HLA-DRB1 HADHB APC XIAP POLG GNPTAB ESCO2 MS4A1 TTC21B SLC30A10 NAGA ATM NDUFA6 MIF AIRE SEC23B BBS7 UQCRFS1 MPV17 NPHP3 MEFV STXBP2 CBS AKT2 RFX5 CEP164 HMOX1 FH APC GBA RAD51C ACSF3 DIS3L2 KRAS NDUFS4 BTNL2 DNAJC19 LMNA SH2D1A HBA2 ABCB11 ALG1 NDUFA1 TBX1 CHD7 SLC25A15 BBS1 NDUFA11 CD96 ALG9 IL12A TNFRSF13B CD28 MLH1 MPC1 RPGRIP1L JAM3 IL7R LZTR1 APPL1 MECP2 IL2RG PRPS1 CIDEC TG PHKG2 DDOST BBS1 POU1F1 ND4 CNTNAP2 WDR19 PARN EOGT TSC1 TRIM37 PEX10 HMBS CTCF C8ORF37 PRKAR1A NPHP1 SPTA1 GPI DLD KRT18 VCP HELLPAR TRNK FASLG TSHR DYNC2I2 GATA6 GABRD ADK SLC20A2 PIEZO1 AGPAT2 PEX10 PEX6 AKT2 CTLA4 COG4 GALT NDUFB9 CSPP1 PHKA2 HBB ITK RNASEH2A KIF20A CBS SUMF1 APOA1 HLA-DRB1 TRNV MPI CD27 UGT1A1 DPAGT1 SLC25A19 CLCN7 CD46 TNFSF12 PSAP RRAS PLPBP IFT172 WDR19 SLC4A1 LACC1 PDGFRL IFIH1 TRHR GALE TNFSF15 APC NDUFS7 PRKCD PNPLA2 TGFB1 IDUA EFL1 NOS3 LIPA NUBPL SNX14 NHP2 DYNC2LI1 CCDC47 LIMK1 LBR CPT2 PDX1 PSAP HNF1A CPOX FANCL EPB42 TERT CD79A SURF1 SLC22A5 LYZ IL36RN ATP11C ND2 KLF11 COG7 LIG4 ARL6 ELN APOA1 CTSK SPTB RELA DPM2 PRKAR1A ERBB3 PCCB CEP55 TJP2 GBE1 RRM2B ABCC2 UGT1A1 CD81 ATP6V1B2 ZAP70 WRAP53 ADA2 MYRF MRPL44 HAMP EPB41 FGFRL1 KLF1 PHKB CLCA4 SAA1 HADH CP BTK ABCB4 ALG2 TERT NDUFV2 TNNT2 PRKCSH HBG2 ERCC8 PHKG2 PEX6 SPINK1 ACVRL1 TNFSF11 IFT172 ATP8B1 LIPE TNFRSF13B PALLD HLA-B CDKN2A MPV17 FADD GCLC CTLA4 NLRP3 KRT18 NDUFB11 CYBC1 PRSS2 VPS33A CA2 HSD3B7 UGT1A1 MYD88 DOCK6 PEX1 AGL GYS2 DZIP1L MAN2B1 GPC4 TIMMDC1 NDUFAF8 NDUFB10 CLDN1 IL21R TMEM70 FASLG ASL PLAGL1 SMAD4 CYP7A1 LMNA CORIN SLC40A1 AP3D1 PEX1 AGGF1 RPGRIP1L LARS1 NOD2 ARVCF DLL4 BPGM RAG2 KIAA0586 INVS COG1 H19-ICR B9D1 FOXRED1 LRPPRC TGFB1 INPPL1 SKI TNFSF11 XIAP RBPJ VPS33B XPR1 HBG1 ABHD5 UBR1 TRIM28 NDUFAF4 FOS IL2RG NR1H4 HFE F5 CLCN7 FAS GNPTAB RNASEH2B GBA IGF2 TRAF3IP1 PPARG RFXAP UBE2T DHDDS MET GLRX5 VPS45 ATP8B1 APOE ANK1 PEX1 PEX16 PPARG SOS2 SLC2A1 TMEM216 ARSA HADHA CDKN2C NAGS PEX11B PEX6 PCCB TTC21B PEX14 PEX5 MYH9 CAV1 ATP8B1 SPIB PRF1 PEX19 RFC2 ERCC4 IL2RG REST MMAA PEX12 KRT16 CLCN7 NCF2 BBS10 SRP54 IDUA MCCC1 STEAP3 STN1 NSD2 ERCC4 ACOX1 PCK2 BBS9 SDHA LMNA GALK1 NLRP1 SCNN1G BBS2 TCIRG1 PEX6 XK BCS1L CASR SLC25A15 FUCA1 SKIV2L GLB1 JMJD1C COA3 G6PC FERMT3 GNAS HBB STAT6 NEUROD1 LZTFL1 PEX5 TNFRSF13C SCYL1 PKD2 SPTB UCP2 TRIP13 PSAP DNAJB11 BRCA2 NELFA SLC25A13 TBX1 CTRC JAK3 CTNNB1 MYPN IDS SBDS LMNA ITCH BRCA1 PCSK1 CSPP1 WDR35 CCDC115 DPM1 CYBB IDUA HOXD13 TCTN2 CR2 GAA FECH ALMS1 ETFDH JAK2 CARS2 BMP2 ELN GNMT HJV PNPLA6 MKKS AHCY SMPD1 NDUFAF2 COX15 PLEKHM1 GATA6 KCNQ1OT1 LMNB2 RNU4ATAC RMRP ABCB4 DDRGK1 PIK3C2A CAV1 RNASEH2C TMEM67 POLR3A CPT2 IL17RA SF3B1 TRNW TBX1 CPT1A HNF4A MMEL1 DCLRE1C PSMB4 JAK2 CIITA TET2 ARL6 POMC ALG6 TRAF3IP1 PIGS CEP290 STOX1 COX20 IRF5 TMEM67 USP9X INTU GBA NGLY1 MFN2 SPECC1L SEC24C BSCL2 TRMU IARS1 CTNS PEX3 COG2 FAS SLC2A1 H19-ICR TMEM107 HAMP SAR1B FGFR2 HADHB HNF1B PEX2 TRMT10C XYLT1 SLC25A4 FLNC SON TNFRSF1B GPC3 ACADM RAG1 TNFRSF1B CEP120 TTC8 FANCE GBA CYBA CBL UGT1A1 SDHB TERT NPHP3 SCO1 NDUFAF5 HNRNPA1 NOTCH2 MET TMEM67 SPTB PGM1 G6PC3 PEX19 SLC25A13 NOP10 MPI IFT80 SEC63 RFWD3 PDGFRA SPRTN TRNE IGF2R SCNN1A ALG11 CD19 PPARG WDR35 TREX1 PARS2 CPT2 SLC39A4 HADHA LHX1 HBB IGHM TTC7A PET100 ABCA1 HNF4A CPA1 GNE SLC29A3 INSR COG8 HADH RFT1 PEX26 SCARB2 HFE DYNC2I1 GNS APOB PEX5 ACVRL1 SLC25A20 CD19 RRM2B TUFM BSCL2 DCTN4 ABCB11 PEX10 BLK BLVRA CYC1 FANCF HNF1B SAMHD1 PEX26 IFT140 AKR1D1 FGFR2 CFTR CC2D2A BRCA2 MAN2B1 ACOX1 NRAS CEP290 MYORG RFXAP CYP19A1 RHBDF2 HBA1 TTC37 CD28 MCM4 CCND1 FARSB FANCG NPC2 TF RERE NRXN1 IL7R TMEM67 PTRH2 MLXIPL KCNJ11 ALDOB LETM1 ATP6 CYP27A1 PEX12 PLIN1 FANCI RPGRIP1L SLC13A5 HBG2 ABCC8 IKZF1 PEX13 APOE PIGA ZAP70 ABCC2 NRAS NKX2-5 PNPLA2 APOC2 SPTA1 TFR2 KRIT1 NSMCE2 RTEL1 EWSR1 SLCO1B3 ATP6AP1 ND1 SLC11A2 SNX10 PEX26 ABHD5 CBL RPGRIP1L ETFA TNPO3 SLC29A3 NPHP3 PKD2 PEX2 ERCC4 TRNN FBP1 NEK8 LRRC8A IER3IP1 SHPK ACAD9 ADAMTSL2 ABCC8 SLC25A13 MRPS7 TRAF3IP2 RMND1 ADA CEP290 FAN1 FAM111B SLC4A1 LBR VPS33A TANGO2 NOTCH2 DYNC2H1 MLH1 TWNK PEX3 PKHD1 BICC1 RHAG PROP1 GNE ETFB ENG GANAB PEX14 INPP5E SC5D YARS2 RBCK1 GTF2I CD247 MVK CEP83 FLI1 LIPT1 GDF2 BMPER KIF23 ANKS6 CASP10 TSHB XRCC4 MMAB KCNN3 RASA2 CA2 ATP7B DNASE1L3 DHCR7 HJV B9D2 IFNGR1 RASGRP1 PEX6 ANTXR1 CIITA COG5 NPM1 SLC37A4 SLCO1B1 LDLRAP1 SLC25A19 POLG2 ALAS2 SLCO1B1 POU2AF1 DNAJC21 COX4I2 SKIV2L SOX10 SCYL1 MUC5B VPS13A MPL COX15 SLC25A13 WT1 HNF4A TP53 TKFC HEXB LMNA TWNK KLF1 VIPAS39 CYBA ABCG5 SRP54 PAX8 PTPN3 CD79B GATA2 TERC SERPINA1 LPL LONP1 KRT17 SRSF2 PTPN11 CYP27A1 KRAS IYD NCF2 NDUFAF1 FANCC FBXL4 GFM1 DLL4 PEX13 WHCR DNAJC19 NLRP3 GUCY2D TBL2 POLD1 HMBS SLC40A1 PEX14 TREX1 PEPD HBA1 TMPRSS6 RBM8A CEP19 AP1S1 PEX3 ACADVL CDKN1B IGF2 CD70 CEL DPM2 RFX6 DGUOK TCF3 ND2 TNFRSF1A CC2D2A CYBB PIK3R1 IL1RN NOP10 DNAJC21 HADHA LIPA TNFSF12 AP1B1 CDAN1 SDHA LYST BBIP1 NHP2 TMEM231 PEX16 PEX3 IL7R HPGD EIF2AK3 BTK ENG CD55 CASP8 IDUA TKT USB1 ZMPSTE24 KRT6B PTEN CLEC7A SMAD4 BTD KPTN RFX5 BCHE AMACR PEX14 TALDO1 DKC1 ALDOA JAM2 FECH GUSB AP3B1 TET2 JAK2 FUCA1 FDX2 KRAS

Protein Mutations 5

C282Y G20210A H63D I148M V617F

SNP 8

rs12979860 rs2281135 rs2294918 rs58542926 rs641738 rs73049 rs738409 rs8099917