Hepatitis C, Chronic
Conditions
Keywords
Hepatitis C, HCV, Chronic Hepatitis C
Brief summary
The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
Interventions
DRUGSofosbuvir
Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily
DRUGRBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUGPEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate * Naive to previous HCV treatment
Exclusion criteria
* Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab * History of any other clinically significant chronic liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) | Post-treatment Week 24 | SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug. |
| Percentage of Participants Who Experienced Adverse Events | Baseline (Day 1) to post-treatment Day 30 | Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HCV RNA at Week 4 | Baseline (Day 1) to Week 4 | — |
| Change in HCV RNA at Week 8 | Baseline (Day 1) to Week 8 | — |
| Change in HCV RNA at Week 12 | Baseline (Day 1) to Week 12 | — |
| Percentage of Participants With HCV RNA < LOD at Week 2 | Week 2 | — |
| Percentage of Participants With HCV RNA Below < LOD at Week 4 | Week 4 | — |
| Percentage of Participants With HCV RNA Below < LOD at Week 8 | Week 8 | — |
| Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) | Post-treatment Week 12 | SVR12 was defined as HCV RNA \< LOD 12 weeks after the last dose of study drug. |
| Percentage of Participants With HCV RNA Below < LOD at Week 24 | Week 24 | — |
| Percentage of Participants With ALT Normalization at Week 12 | Baseline (Day 1) to Week 12 | ALT normalization was defined as ALT \> ULN at baseline and ALT ≤ ULN at Week 12. |
| Percentage of Participants With ALT Normalization at Week 24 | Baseline (Day 1) to Week 24 | ALT normalization was defined as ALT \> ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24. |
| Percentage of Participants With ALT Normalization at Post-treatment Week 4 | Baseline (Day 1) to Post-treatment Week 4 | ALT normalization was defined as ALT \> ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4. |
| Percentage of Participants With Virologic Failure During Treatment | Baseline (Day 1) to Week 24 | Virologic failure was defined as either * HCV RNA ≥ 15 IU/mL after having previously had HCV RNA \< 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough); * \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or * HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse) Baseline was Day 1 for all groups. |
| Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). | End of treatment to Post-treatment Week 24 | Viral relapse was defined as HCV RNA \< 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement. |
| Percentage of Participants With HCV RNA Below < LOD at Week 12 | Week 12 | — |
| Change in HCV RNA at Week 2 | Baseline (Day 1) to Week 2 | — |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled in a total of 42 study sites in the United States. The first participant was screened on 23 March 2011. The last participant observation was on 27 August 2012.
Pre-assignment details
589 participants were screened and 332 were randomized and treated, and comprise the Safety Analysis Set.
Participants by arm
| Arm | Count |
|---|---|
| SOF+PEG+RBV 12 Weeks Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | 52 |
| SOF+PEG+RBV 24 Weeks Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | 125 |
| SOF+PEG+RBV 12 Week/Rerandomization Group Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. | 155 |
| Total | 332 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Rerandomization Treatment Period | Lost to Follow-up | 0 | 0 | 0 | 5 | 3 |
| Rerandomization Treatment Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 |
| Sofosbuvir+PEG+RBV Treatment Period | Adverse Event | 1 | 2 | 0 | 0 | 0 |
| Sofosbuvir+PEG+RBV Treatment Period | Lost to Follow-up | 2 | 8 | 2 | 0 | 0 |
| Sofosbuvir+PEG+RBV Treatment Period | Subject Moved Out of State | 0 | 1 | 0 | 0 | 0 |
| Sofosbuvir+PEG+RBV Treatment Period | Subject Was Incarcerated | 0 | 1 | 0 | 0 | 0 |
| Sofosbuvir+PEG+RBV Treatment Period | Withdrawal by Subject | 1 | 1 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | SOF+PEG+RBV 12 Weeks | SOF+PEG+RBV 24 Weeks | SOF+PEG+RBV 12 Week/Rerandomization Group |
|---|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 10.7 | 51 years STANDARD_DEVIATION 9.8 | 50 years STANDARD_DEVIATION 11 | 50 years STANDARD_DEVIATION 10.8 |
| Alanine Aminotransferase (ALT) | 79.8 U/L STANDARD_DEVIATION 66.98 | 80.5 U/L STANDARD_DEVIATION 71.61 | 83.7 U/L STANDARD_DEVIATION 77.18 | 76.4 U/L STANDARD_DEVIATION 55.91 |
| ALT Category ≤ 1.5 × the upper limit of the normal range (ULN) | 239 participants | 37 participants | 87 participants | 115 participants |
| ALT Category > 1.5 × ULN | 93 participants | 15 participants | 38 participants | 40 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 67 Participants | 10 Participants | 26 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 265 Participants | 42 Participants | 99 Participants | 124 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HCV RNA | 6.4 log10 copies/mL STANDARD_DEVIATION 0.75 | 6.5 log10 copies/mL STANDARD_DEVIATION 0.66 | 6.3 log10 copies/mL STANDARD_DEVIATION 0.73 | 6.4 log10 copies/mL STANDARD_DEVIATION 0.79 |
| HCV RNA Category < 800,000 IU/mL | 68 participants | 7 participants | 33 participants | 28 participants |
| HCV RNA Category > 800,000 IU/mL | 264 participants | 45 participants | 92 participants | 127 participants |
| Hepatitis C Virus (HCV) genotype Genotype 1a | 241 participants | 40 participants | 85 participants | 116 participants |
| Hepatitis C Virus (HCV) genotype Genotype 1b | 75 participants | 12 participants | 24 participants | 39 participants |
| Hepatitis C Virus (HCV) genotype Genotype 4 | 11 participants | 0 participants | 11 participants | 0 participants |
| Hepatitis C Virus (HCV) genotype Genotype 6 | 2 participants | 0 participants | 2 participants | 0 participants |
| Hepatitis C Virus (HCV) genotype Genotype 6e | 2 participants | 0 participants | 2 participants | 0 participants |
| Hepatitis C Virus (HCV) genotype Genotype 6o | 1 participants | 0 participants | 1 participants | 0 participants |
| IL28b Genotype CC | 88 participants | 13 participants | 36 participants | 39 participants |
| IL28b Genotype CT | 184 participants | 33 participants | 63 participants | 88 participants |
| IL28b Genotype TT | 60 participants | 6 participants | 26 participants | 28 participants |
| Liver Biopsy Fibrosis Score Bridging Fibrosis | 47 participants | 7 participants | 17 participants | 23 participants |
| Liver Biopsy Fibrosis Score Missing | 14 participants | 0 participants | 1 participants | 13 participants |
| Liver Biopsy Fibrosis Score None or Minimal Fibrosis | 43 participants | 9 participants | 14 participants | 20 participants |
| Liver Biopsy Fibrosis Score Portal Fibrosis | 228 participants | 36 participants | 93 participants | 99 participants |
| Race/Ethnicity, Customized Black | 35 participants | 2 participants | 17 participants | 16 participants |
| Race/Ethnicity, Customized Not Black | 297 participants | 50 participants | 108 participants | 139 participants |
| Sex: Female, Male Female | 118 Participants | 17 Participants | 52 Participants | 49 Participants |
| Sex: Female, Male Male | 214 Participants | 35 Participants | 73 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 52 | 121 / 125 | 153 / 155 |
| serious Total, serious adverse events | 2 / 52 | 6 / 125 | 4 / 155 |
Outcome results
Primary
Percentage of Participants Who Experienced Adverse Events
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Time frame: Baseline (Day 1) to post-treatment Day 30
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants Who Experienced Adverse Events | AE leading to drug discontinuation | 5.8 percentage of participants |
| SOF+PEG+RBV 12 Weeks | Percentage of Participants Who Experienced Adverse Events | Any AE | 98.1 percentage of participants |
| SOF+PEG+RBV 12 Weeks | Percentage of Participants Who Experienced Adverse Events | Serious AE | 3.8 percentage of participants |
| SOF+PEG+RBV 12 Weeks | Percentage of Participants Who Experienced Adverse Events | Drug-related AE | 96.2 percentage of participants |
| SOF+PEG+RBV 12 Weeks | Percentage of Participants Who Experienced Adverse Events | Grade 3 or higher AE | 15.4 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants Who Experienced Adverse Events | AE leading to drug discontinuation | 16.0 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants Who Experienced Adverse Events | Grade 3 or higher AE | 17.6 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants Who Experienced Adverse Events | Drug-related AE | 94.4 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants Who Experienced Adverse Events | Serious AE | 4.8 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants Who Experienced Adverse Events | Any AE | 96.8 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Grade 3 or higher AE | 14.2 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Any AE | 98.7 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Drug-related AE | 97.4 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | AE leading to drug discontinuation | 4.5 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Serious AE | 2.6 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Serious AE | 2.7 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Any AE | 98.7 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | AE leading to drug discontinuation | 5.3 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Grade 3 or higher AE | 14.7 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Drug-related AE | 98.7 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Grade 3 or higher AE | 13.3 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | AE leading to drug discontinuation | 4.0 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Any AE | 100.0 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Serious AE | 2.7 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants Who Experienced Adverse Events | Drug-related AE | 97.3 percentage of participants |
Primary
Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug.
Time frame: Post-treatment Week 24
Population: Participants in the Safety Analysis Set (participants who were randomized and received at least 1 dose of study drug) with genotype 1 and who had available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) | 90.4 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) | 92.7 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) | 91.0 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) | 93.3 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) | 94.7 percentage of participants |
Comparison: The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL). Only participants with genotype 1 were included in the comparison due to the fact that participants with genotype 4 and 6 were only enrolled in the SOF+PEG+RBV 24 weeks group.p-value: 0.7795% CI: [-12.2, 9.4]Cochran-Mantel-Haenszel
Comparison: The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL).p-value: 0.9395% CI: [-10.8, 9.9]Cochran-Mantel-Haenszel
Secondary
Change in HCV RNA at Week 12
Time frame: Baseline (Day 1) to Week 12
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF+PEG+RBV 12 Weeks | Change in HCV RNA at Week 12 | -5.36 log10 IU/mL | Standard Deviation 0.616 |
| SOF+PEG+RBV 24 Weeks | Change in HCV RNA at Week 12 | -5.20 log10 IU/mL | Standard Deviation 0.719 |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Change in HCV RNA at Week 12 | -5.25 log10 IU/mL | Standard Deviation 0.791 |
Secondary
Change in HCV RNA at Week 2
Time frame: Baseline (Day 1) to Week 2
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF+PEG+RBV 12 Weeks | Change in HCV RNA at Week 2 | -5.12 log10 IU/mL | Standard Deviation 0.66 |
| SOF+PEG+RBV 24 Weeks | Change in HCV RNA at Week 2 | -5.07 log10 IU/mL | Standard Deviation 0.701 |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Change in HCV RNA at Week 2 | -5.13 log10 IU/mL | Standard Deviation 0.768 |
Secondary
Change in HCV RNA at Week 4
Time frame: Baseline (Day 1) to Week 4
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF+PEG+RBV 12 Weeks | Change in HCV RNA at Week 4 | -5.33 log10 IU/mL | Standard Deviation 0.649 |
| SOF+PEG+RBV 24 Weeks | Change in HCV RNA at Week 4 | -5.19 log10 IU/mL | Standard Deviation 0.733 |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Change in HCV RNA at Week 4 | -5.24 log10 IU/mL | Standard Deviation 0.785 |
Secondary
Change in HCV RNA at Week 8
Time frame: Baseline (Day 1) to Week 8
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF+PEG+RBV 12 Weeks | Change in HCV RNA at Week 8 | -5.34 log10 IU/mL | Standard Deviation 0.635 |
| SOF+PEG+RBV 24 Weeks | Change in HCV RNA at Week 8 | -5.17 log10 IU/mL | Standard Deviation 0.74 |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Change in HCV RNA at Week 8 | -5.25 log10 IU/mL | Standard Deviation 0.789 |
Secondary
Percentage of Participants With ALT Normalization at Post-treatment Week 4
ALT normalization was defined as ALT \> ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.
Time frame: Baseline (Day 1) to Post-treatment Week 4
Population: Participants in the Safety Analysis Set with ALT \> ULN at baseline and with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With ALT Normalization at Post-treatment Week 4 | 89.5 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With ALT Normalization at Post-treatment Week 4 | 87.2 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With ALT Normalization at Post-treatment Week 4 | 95.2 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants With ALT Normalization at Post-treatment Week 4 | 91.7 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants With ALT Normalization at Post-treatment Week 4 | 100.0 percentage of participants |
Secondary
Percentage of Participants With ALT Normalization at Week 12
ALT normalization was defined as ALT \> ULN at baseline and ALT ≤ ULN at Week 12.
Time frame: Baseline (Day 1) to Week 12
Population: Participants in the Safety Analysis Set with ALT \> ULN at baseline and with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With ALT Normalization at Week 12 | 78.3 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With ALT Normalization at Week 12 | 76.6 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With ALT Normalization at Week 12 | 67.6 percentage of participants |
Secondary
Percentage of Participants With ALT Normalization at Week 24
ALT normalization was defined as ALT \> ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.
Time frame: Baseline (Day 1) to Week 24
Population: Participants in the Safety Analysis Set with ALT \> ULN at baseline and with available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With ALT Normalization at Week 24 | 78.9 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With ALT Normalization at Week 24 | 94.3 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants With ALT Normalization at Week 24 | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA Below < LOD at Week 12
Time frame: Week 12
Population: Participants in the Safety Analysis Set with Available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With HCV RNA Below < LOD at Week 12 | 100.0 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With HCV RNA Below < LOD at Week 12 | 100.0 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With HCV RNA Below < LOD at Week 12 | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA Below < LOD at Week 24
Time frame: Week 24
Population: Participants in the Safety Analysis Set with Available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With HCV RNA Below < LOD at Week 24 | 100.0 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With HCV RNA Below < LOD at Week 24 | 100.0 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants With HCV RNA Below < LOD at Week 24 | 98.6 percentage of participants |
Secondary
Percentage of Participants With HCV RNA Below < LOD at Week 4
Time frame: Week 4
Population: Participants in the Safety Analysis Set with Available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With HCV RNA Below < LOD at Week 4 | 98.0 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With HCV RNA Below < LOD at Week 4 | 100.0 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With HCV RNA Below < LOD at Week 4 | 98.7 percentage of participants |
Secondary
Percentage of Participants With HCV RNA Below < LOD at Week 8
Time frame: Week 8
Population: Participants in the Safety Analysis Set with Available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With HCV RNA Below < LOD at Week 8 | 100.0 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With HCV RNA Below < LOD at Week 8 | 100.0 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With HCV RNA Below < LOD at Week 8 | 99.3 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LOD at Week 2
Time frame: Week 2
Population: Participants in the Safety Analysis Set with Available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With HCV RNA < LOD at Week 2 | 68.6 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With HCV RNA < LOD at Week 2 | 85.5 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With HCV RNA < LOD at Week 2 | 77.1 percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
SVR12 was defined as HCV RNA \< LOD 12 weeks after the last dose of study drug.
Time frame: Post-treatment Week 12
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) | 90.4 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) | 92.0 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) | 91.0 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) | 93.3 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) | 94.7 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure During Treatment
Virologic failure was defined as either * HCV RNA ≥ 15 IU/mL after having previously had HCV RNA \< 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough); * \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or * HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse) Baseline was Day 1 for all groups.
Time frame: Baseline (Day 1) to Week 24
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With Virologic Failure During Treatment | Viral breakthrough | 0.0 percentage of participants |
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With Virologic Failure During Treatment | Non-response | 0.0 percentage of participants |
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With Virologic Failure During Treatment | Viral rebound | 0.0 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With Virologic Failure During Treatment | Viral rebound | 0.0 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With Virologic Failure During Treatment | Viral breakthrough | 0.0 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With Virologic Failure During Treatment | Non-response | 0.0 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With Virologic Failure During Treatment | Viral rebound | 0.0 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With Virologic Failure During Treatment | Viral breakthrough | 0.0 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With Virologic Failure During Treatment | Non-response | 0.0 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants With Virologic Failure During Treatment | Viral breakthrough | 0.0 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants With Virologic Failure During Treatment | Non-response | 0.0 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants With Virologic Failure During Treatment | Viral rebound | 0.0 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants With Virologic Failure During Treatment | Viral rebound | 0.0 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants With Virologic Failure During Treatment | Viral breakthrough | 0.0 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants With Virologic Failure During Treatment | Non-response | 0.0 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).
Viral relapse was defined as HCV RNA \< 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.
Time frame: End of treatment to Post-treatment Week 24
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks | Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). | 5.9 percentage of participants |
| SOF+PEG+RBV 24 Weeks | Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). | 1.6 percentage of participants |
| SOF+PEG+RBV 12 Week/Rerandomization Group | Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). | 3.9 percentage of participants |
| SOF Rerandomization Group | Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). | 2.7 percentage of participants |
| SOF+RBV Rerandomization Group | Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). | 2.7 percentage of participants |