Hepatitis C Virus Infection
Conditions
Keywords
Sofosbuvir, Velpatasvir, SOF/VEL, GS-5816, Hepatitis C, HCV, Cirrhosis, Genotype 3
Brief summary
The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.
Interventions
DRUGSOF
400 mg tablet administered orally once daily
DRUGRBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUGSOF/VEL
400/100 mg FDC tablet administered orally once daily
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
* Willing and able to provide written informed consent * HCV RNA ≥ 10\^4 IU/mL * HCV genotype 3 * Chronic HCV infection (≥ 6 months) * Females of childbearing potential must have a negative serum pregnancy test * Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Exclusion criteria
* Current or prior history of clinically-significant illness (other than HCV) that may interfere with subject treatment, assessment or compliance with the protocol * Screening ECG with clinically significant abnormalities * Laboratory results outside of acceptable ranges at Screening * Pregnant or nursing female or male with pregnant female partner * Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis) * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 24 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | Posttreatment Weeks 4 and 24 | SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug. |
| Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | — |
| Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | — |
| Percentage of Participants With Virologic Failure | Up to Posttreatment Week 24 | Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit. |
Countries
Australia, Canada, France, Germany, Italy, New Zealand, Puerto Rico, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Australia, North America, Europe, and New Zealand. The first participant was screened on 14 July 2014. The last study visit occurred on 15 December 2015.
Pre-assignment details
652 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| SOF/VEL 12 Weeks SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks | 277 |
| SOF+RBV 24 Weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks | 275 |
| Total | 552 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 5 |
| Overall Study | Death | 0 | 3 |
| Overall Study | Lack of Efficacy | 9 | 30 |
| Overall Study | Lost to Follow-up | 8 | 8 |
| Overall Study | Randomized but Never Treated | 1 | 5 |
| Overall Study | Withdrew Consent | 2 | 5 |
Baseline characteristics
| Characteristic | SOF+RBV 24 Weeks | Total | SOF/VEL 12 Weeks |
|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 10 | 50 years STANDARD_DEVIATION 10.2 | 49 years STANDARD_DEVIATION 10.4 |
| Cirrhosis Status Missing | 5 participants | 5 participants | 0 participants |
| Cirrhosis Status No | 187 participants | 384 participants | 197 participants |
| Cirrhosis Status Yes | 83 participants | 163 participants | 80 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 22 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 263 Participants | 529 Participants | 266 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| HCV Genotype Genotype 3a | 250 participants | 515 participants | 265 participants |
| HCV Genotype Genotype 3b | 5 participants | 7 participants | 2 participants |
| HCV Genotype Genotype 3h | 2 participants | 2 participants | 0 participants |
| HCV Genotype Genotype 3k | 0 participants | 1 participants | 1 participants |
| HCV Genotype Genotype 3 (No Confirmed Subtype) | 18 participants | 27 participants | 9 participants |
| HCV RNA | 6.3 log10 IU/mL STANDARD_DEVIATION 0.71 | 6.3 log10 IU/mL STANDARD_DEVIATION 0.72 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.72 |
| HCV RNA Category < 800,000 IU/mL | 81 participants | 167 participants | 86 participants |
| HCV RNA Category ≥ 800,000 IU/mL | 194 participants | 385 participants | 191 participants |
| IL28b Status CC | 111 participants | 216 participants | 105 participants |
| IL28b Status CT | 133 participants | 281 participants | 148 participants |
| IL28b Status TT | 31 participants | 55 participants | 24 participants |
| Prior HCV Treatment Experience Treatment-Experienced | 71 participants | 142 participants | 71 participants |
| Prior HCV Treatment Experience Treatment-Naive | 204 participants | 410 participants | 206 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 participants | 4 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 29 participants | 52 participants | 23 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants | 4 participants | 3 participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Not Disclosed | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 239 participants | 489 participants | 250 participants |
| Region of Enrollment Australia | 44 participants | 93 participants | 49 participants |
| Region of Enrollment Canada | 18 participants | 33 participants | 15 participants |
| Region of Enrollment France | 52 participants | 100 participants | 48 participants |
| Region of Enrollment Germany | 35 participants | 66 participants | 31 participants |
| Region of Enrollment Italy | 11 participants | 18 participants | 7 participants |
| Region of Enrollment New Zealand | 8 participants | 17 participants | 9 participants |
| Region of Enrollment United Kingdom | 47 participants | 105 participants | 58 participants |
| Region of Enrollment United States | 60 participants | 120 participants | 60 participants |
| Sex: Female, Male Female | 101 Participants | 208 Participants | 107 Participants |
| Sex: Female, Male Male | 174 Participants | 344 Participants | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 216 / 277 | 243 / 275 |
| serious Total, serious adverse events | 6 / 277 | 15 / 275 |
Outcome results
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 3.3 percentage of participants |
Primary
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Population: Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL 12 Weeks | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 95.3 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 80.7 percentage of participants |
95% CI: [9.2, 19.6]
Comparison: If the lower bound of 95% CI on the difference was \> -10%, the p-value tested for the superiority of SOF/VEL for 12 weeks over SOF+RBV for 24 weeks. Superiority was demonstrated if the two-sided p-value is less than 0.05.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Time frame: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF/VEL 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 1 (SOF/VEL: N =272; SOF+RBV: N =268) | -4.26 log10 IU/mL | Standard Deviation 0.644 |
| SOF/VEL 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 2 (SOF/VEL: N =274; SOF+RBV: N =272) | -4.82 log10 IU/mL | Standard Deviation 0.769 |
| SOF/VEL 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 4 (SOF/VEL: N =276; SOF+RBV: N =270) | -5.02 log10 IU/mL | Standard Deviation 0.776 |
| SOF/VEL 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 6 (SOF/VEL: N =275; SOF+RBV: N =269) | -5.06 log10 IU/mL | Standard Deviation 0.718 |
| SOF/VEL 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 8 (SOF/VEL: N =276; SOF+RBV: N =269) | -5.07 log10 IU/mL | Standard Deviation 0.728 |
| SOF/VEL 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 10 (SOF/VEL: N =276; SOF+RBV: N =267) | -5.07 log10 IU/mL | Standard Deviation 0.723 |
| SOF/VEL 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 12 (SOF/VEL: N =275; SOF+RBV: N =264) | -5.08 log10 IU/mL | Standard Deviation 0.721 |
| SOF/VEL 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 16 (SOF/VEL: N = 0; SOF+RBV: N = 262) | NA log10 IU/mL | — |
| SOF/VEL 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 20 (SOF/VEL: N = 0; SOF+RBV: N = 259) | NA log10 IU/mL | — |
| SOF/VEL 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 24 (SOF/VEL: N = 0; SOF+RBV: N = 255) | NA log10 IU/mL | — |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 16 (SOF/VEL: N = 0; SOF+RBV: N = 262) | -5.11 log10 IU/mL | Standard Deviation 0.765 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 1 (SOF/VEL: N =272; SOF+RBV: N =268) | -4.16 log10 IU/mL | Standard Deviation 0.64 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 10 (SOF/VEL: N =276; SOF+RBV: N =267) | -5.14 log10 IU/mL | Standard Deviation 0.71 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 2 (SOF/VEL: N =274; SOF+RBV: N =272) | -4.79 log10 IU/mL | Standard Deviation 0.702 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 24 (SOF/VEL: N = 0; SOF+RBV: N = 255) | -5.14 log10 IU/mL | Standard Deviation 0.715 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 4 (SOF/VEL: N =276; SOF+RBV: N =270) | -5.09 log10 IU/mL | Standard Deviation 0.699 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 12 (SOF/VEL: N =275; SOF+RBV: N =264) | -5.14 log10 IU/mL | Standard Deviation 0.711 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 6 (SOF/VEL: N =275; SOF+RBV: N =269) | -5.13 log10 IU/mL | Standard Deviation 0.712 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 20 (SOF/VEL: N = 0; SOF+RBV: N = 259) | -5.14 log10 IU/mL | Standard Deviation 0.715 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Wk 8 (SOF/VEL: N =276; SOF+RBV: N =269) | -5.13 log10 IU/mL | Standard Deviation 0.712 |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 12 (SOF/VEL: N = 275; SOF+RBV: N = 265) | 100.0 percentage of participants |
| SOF/VEL 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 16 (SOF/VEL: N = 0; SOF+RBV: N = 262) | NA percentage of participants |
| SOF/VEL 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 20 (SOF/VEL: N = 0; SOF+RBV: N = 260) | NA percentage of participants |
| SOF/VEL 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 24 (SOF/VEL: N = 0; SOF+RBV: N = 255) | NA percentage of participants |
| SOF/VEL 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 1 (SOF/VEL: N = 277; SOF+RBV: N = 275) | 18.4 percentage of participants |
| SOF/VEL 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 2 (SOF/VEL: N = 276; SOF+RBV: N = 274) | 62.0 percentage of participants |
| SOF/VEL 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 4 (SOF/VEL: N = 276; SOF+RBV: N = 272) | 91.7 percentage of participants |
| SOF/VEL 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 6 (SOF/VEL: N = 276; SOF+RBV: N = 269) | 96.7 percentage of participants |
| SOF/VEL 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 8 (SOF/VEL: N = 276; SOF+RBV: N = 269) | 99.6 percentage of participants |
| SOF/VEL 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 10 (SOF/VEL: N = 276; SOF+RBV: N = 268) | 100.0 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 6 (SOF/VEL: N = 276; SOF+RBV: N = 269) | 98.9 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 12 (SOF/VEL: N = 275; SOF+RBV: N = 265) | 99.6 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 2 (SOF/VEL: N = 276; SOF+RBV: N = 274) | 50.0 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 16 (SOF/VEL: N = 0; SOF+RBV: N = 262) | 98.9 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 10 (SOF/VEL: N = 276; SOF+RBV: N = 268) | 99.3 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 20 (SOF/VEL: N = 0; SOF+RBV: N = 260) | 99.6 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 4 (SOF/VEL: N = 276; SOF+RBV: N = 272) | 88.2 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 24 (SOF/VEL: N = 0; SOF+RBV: N = 255) | 100.0 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 8 (SOF/VEL: N = 276; SOF+RBV: N = 269) | 99.3 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Week 1 (SOF/VEL: N = 277; SOF+RBV: N = 275) | 17.5 percentage of participants |
Secondary
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug.
Time frame: Posttreatment Weeks 4 and 24
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL 12 Weeks | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 96.8 percentage of participants |
| SOF/VEL 12 Weeks | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 95.3 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 82.2 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 80.7 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Time frame: Up to Posttreatment Week 24
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL 12 Weeks | Percentage of Participants With Virologic Failure | 4.0 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With Virologic Failure | 14.2 percentage of participants |