Hepatitis C, Human Immunodeficiency Virus
Conditions
Keywords
Hepatitis C, Chronic, HCV, HIV, Human Immunodeficiency Virus, Co-Infected
Brief summary
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.
Interventions
DRUGSOF
Sofosbuvir (SOF) 400 mg tablet administered 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)
Sponsors
Gilead Sciences
Study design
Allocation
NON_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 * Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection * HCV RNA \> 1 x 10\^4 IU/mL at screening * Infection with HCV genotype 1, 2 or 3 as determined at screening * HIV-1 infection confirmed with positive ELISA or Western blot at screening * Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV. * Confirmation of chronic HCV infection * Ability to determine presence/absence of cirrhosis. * HIV antiretroviral therapy (ARV) criteria of one of the following: * ARV untreated with a CD4 T-cell count \> 500 cells/mm\^3 * On a stable, protocol-approved, ARV for \> 8 weeks prior to screening with a CD4 T-cell count \> 200 cells/mm\^3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the screening visit * Approved HIV antiretroviral medications based on drug interaction studies * Not been treated with any investigational drug or device within 30 days of the screening visit * Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV * Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV * Must be of generally good health as determined by the investigator. * Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)
Exclusion criteria
* Non-genotype 1/2/3 or mixed genotype at screening * Genotype 1 with prior treatment for HCV * Poor control with ARV regimen * Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase * Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis) * A new AIDS-defining condition diagnosed within 30 days prior to screening * Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to baseline * Infection with hepatitis B virus (HBV) * Contraindication to RBV therapy * Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent \> 10 mg/day) * History of solid organ transplantation or malignancy diagnosed or treated within 5 years * Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. |
| Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | Up to 24 weeks | The percentage of participants discontinuing any study drug due to an adverse event was summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HCV RNA at Week 2 | Baseline; Week 2 | — |
| Change From Baseline in HCV RNA at Week 4 | Baseline; Week 4 | — |
| Change From Baseline in HCV RNA at Week 6 | Baseline; Week 6 | — |
| Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | Posttreatment Weeks 4 and 24 | SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. |
| Percentage of Participants Experiencing On-treatment Virologic Failure | Up to 24 weeks | On-treatment virologic failure was defined as: 1. Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 2. Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment |
| Percentage of Participants Experiencing Viral Relapse | Up to Posttreatment Week 24 | Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR. |
| Change From Baseline in HCV RNA at Week 8 | Baseline; Week 8 | — |
| Change From Baseline in HCV RNA at Week 1 | Baseline; Week 1 | — |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled at a total of 34 study sites in the United States. The first participant was screened on 20 July 2012. The last participant observation occurred on 10 February 2014.
Pre-assignment details
330 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| SOF+RBV 12 Wk GT 2 TN SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2) | 26 |
| SOF+RBV 12 Wk GT 3 TN SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3) | 42 |
| SOF+RBV 24 Wk GT 2 TE SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2) | 24 |
| SOF+RBV 24 Wk GT 3 TE SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3) | 17 |
| SOF+RBV 24 Wk GT 1 TN SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) | 114 |
| Total | 223 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Efficacy Failure | 1 | 12 | 0 | 1 | 24 |
| Overall Study | Enrolled but not treated | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 3 | 1 | 1 | 2 |
| Overall Study | Subject Withdrew Consent | 2 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | SOF+RBV 24 Wk GT 1 TN | SOF+RBV 24 Wk GT 3 TE | SOF+RBV 24 Wk GT 2 TE | SOF+RBV 12 Wk GT 3 TN | SOF+RBV 12 Wk GT 2 TN |
|---|---|---|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 8.7 | 48 years STANDARD_DEVIATION 8.4 | 54 years STANDARD_DEVIATION 7 | 54 years STANDARD_DEVIATION 4.9 | 48 years STANDARD_DEVIATION 9.6 | 51 years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants | 25 Participants | 5 Participants | 5 Participants | 11 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 169 Participants | 89 Participants | 12 Participants | 19 Participants | 31 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HCV Genotype Genotype 1 | 114 participants | 114 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| HCV Genotype Genotype 2 | 50 participants | 0 participants | 0 participants | 24 participants | 0 participants | 26 participants |
| HCV Genotype Genotype 3 | 59 participants | 0 participants | 17 participants | 0 participants | 42 participants | 0 participants |
| HCV RNA Category < 6 log10 IU/mL | 50 participants | 22 participants | 2 participants | 5 participants | 15 participants | 6 participants |
| HCV RNA Category ≥ 6 log10 IU/mL | 173 participants | 92 participants | 15 participants | 19 participants | 27 participants | 20 participants |
| HCV RNA (log10 IU/mL) | 6.5 log10 IU/mL STANDARD_DEVIATION 0.75 | 6.6 log10 IU/mL STANDARD_DEVIATION 0.83 | 6.4 log10 IU/mL STANDARD_DEVIATION 0.47 | 6.5 log10 IU/mL STANDARD_DEVIATION 0.82 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.59 | 6.5 log10 IU/mL STANDARD_DEVIATION 0.59 |
| IL28b Status CC | 75 participants | 30 participants | 10 participants | 10 participants | 15 participants | 10 participants |
| IL28b Status CT | 111 participants | 57 participants | 7 participants | 10 participants | 22 participants | 15 participants |
| IL28b Status Missing | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| IL28b Status TT | 36 participants | 26 participants | 0 participants | 4 participants | 5 participants | 1 participants |
| Liver Cirrhosis No | 201 participants | 109 participants | 11 participants | 20 participants | 36 participants | 25 participants |
| Liver Cirrhosis Yes | 22 participants | 5 participants | 6 participants | 4 participants | 6 participants | 1 participants |
| Race/Ethnicity, Customized American Indian/Alaska Native/First Nations | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 1 participants | 0 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 52 participants | 37 participants | 1 participants | 6 participants | 2 participants | 6 participants |
| Race/Ethnicity, Customized Hawaiian or Other Pacific Islander | 2 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other | 9 participants | 5 participants | 0 participants | 0 participants | 3 participants | 1 participants |
| Race/Ethnicity, Customized White | 156 participants | 70 participants | 15 participants | 17 participants | 36 participants | 18 participants |
| Sex: Female, Male Female | 38 Participants | 21 Participants | 3 Participants | 1 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 185 Participants | 93 Participants | 14 Participants | 23 Participants | 34 Participants | 21 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 | 57 / 68 | 37 / 41 | 106 / 114 |
| serious Total, serious adverse events | 5 / 68 | 1 / 41 | 8 / 114 |
Outcome results
Primary
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Time frame: Up to 24 weeks
Population: Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+RBV 12 Wk GT 2 TN | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | 4.4 percentage of participants |
| SOF+RBV 12 Wk GT 3 TN | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | 2.4 percentage of participants |
| SOF+RBV 24 Wk GT 2 TE | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | 2.6 percentage of participants |
Primary
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Population: Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+RBV 12 Wk GT 2 TN | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | 88.5 percentage of participants |
| SOF+RBV 12 Wk GT 3 TN | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | 66.7 percentage of participants |
| SOF+RBV 24 Wk GT 2 TE | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | 91.7 percentage of participants |
| SOF+RBV 24 Wk GT 3 TE | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | 94.1 percentage of participants |
| SOF+RBV 24 Wk GT 1 TN | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | 76.3 percentage of participants |
Secondary
Change From Baseline in HCV RNA at Week 1
Time frame: Baseline; Week 1
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF+RBV 12 Wk GT 2 TN | Change From Baseline in HCV RNA at Week 1 | -4.69 log10 IU/mL | Standard Deviation 0.471 |
| SOF+RBV 12 Wk GT 3 TN | Change From Baseline in HCV RNA at Week 1 | -4.52 log10 IU/mL | Standard Deviation 0.464 |
| SOF+RBV 24 Wk GT 2 TE | Change From Baseline in HCV RNA at Week 1 | -4.63 log10 IU/mL | Standard Deviation 0.68 |
| SOF+RBV 24 Wk GT 3 TE | Change From Baseline in HCV RNA at Week 1 | -4.78 log10 IU/mL | Standard Deviation 0.354 |
| SOF+RBV 24 Wk GT 1 TN | Change From Baseline in HCV RNA at Week 1 | -4.42 log10 IU/mL | Standard Deviation 0.958 |
Secondary
Change From Baseline in HCV RNA at Week 2
Time frame: Baseline; Week 2
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF+RBV 12 Wk GT 2 TN | Change From Baseline in HCV RNA at Week 2 | -5.11 log10 IU/mL | Standard Deviation 0.574 |
| SOF+RBV 12 Wk GT 3 TN | Change From Baseline in HCV RNA at Week 2 | -4.84 log10 IU/mL | Standard Deviation 0.579 |
| SOF+RBV 24 Wk GT 2 TE | Change From Baseline in HCV RNA at Week 2 | -5.15 log10 IU/mL | Standard Deviation 0.813 |
| SOF+RBV 24 Wk GT 3 TE | Change From Baseline in HCV RNA at Week 2 | -5.06 log10 IU/mL | Standard Deviation 0.467 |
| SOF+RBV 24 Wk GT 1 TN | Change From Baseline in HCV RNA at Week 2 | -5.00 log10 IU/mL | Standard Deviation 0.829 |
Secondary
Change From Baseline in HCV RNA at Week 4
Time frame: Baseline; Week 4
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF+RBV 12 Wk GT 2 TN | Change From Baseline in HCV RNA at Week 4 | -5.04 log10 IU/mL | Standard Deviation 0.71 |
| SOF+RBV 12 Wk GT 3 TN | Change From Baseline in HCV RNA at Week 4 | -4.86 log10 IU/mL | Standard Deviation 0.602 |
| SOF+RBV 24 Wk GT 2 TE | Change From Baseline in HCV RNA at Week 4 | -5.16 log10 IU/mL | Standard Deviation 0.82 |
| SOF+RBV 24 Wk GT 3 TE | Change From Baseline in HCV RNA at Week 4 | -5.06 log10 IU/mL | Standard Deviation 0.467 |
| SOF+RBV 24 Wk GT 1 TN | Change From Baseline in HCV RNA at Week 4 | -5.12 log10 IU/mL | Standard Deviation 0.957 |
Secondary
Change From Baseline in HCV RNA at Week 6
Time frame: Baseline; Week 6
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF+RBV 12 Wk GT 2 TN | Change From Baseline in HCV RNA at Week 6 | -5.13 log10 IU/mL | Standard Deviation 0.593 |
| SOF+RBV 12 Wk GT 3 TN | Change From Baseline in HCV RNA at Week 6 | -4.86 log10 IU/mL | Standard Deviation 0.602 |
| SOF+RBV 24 Wk GT 2 TE | Change From Baseline in HCV RNA at Week 6 | -5.16 log10 IU/mL | Standard Deviation 0.82 |
| SOF+RBV 24 Wk GT 3 TE | Change From Baseline in HCV RNA at Week 6 | -5.06 log10 IU/mL | Standard Deviation 0.467 |
| SOF+RBV 24 Wk GT 1 TN | Change From Baseline in HCV RNA at Week 6 | -5.20 log10 IU/mL | Standard Deviation 0.785 |
Secondary
Change From Baseline in HCV RNA at Week 8
Time frame: Baseline; Week 8
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOF+RBV 12 Wk GT 2 TN | Change From Baseline in HCV RNA at Week 8 | -5.13 log10 IU/mL | Standard Deviation 0.593 |
| SOF+RBV 12 Wk GT 3 TN | Change From Baseline in HCV RNA at Week 8 | -4.83 log10 IU/mL | Standard Deviation 0.589 |
| SOF+RBV 24 Wk GT 2 TE | Change From Baseline in HCV RNA at Week 8 | -5.16 log10 IU/mL | Standard Deviation 0.82 |
| SOF+RBV 24 Wk GT 3 TE | Change From Baseline in HCV RNA at Week 8 | -5.06 log10 IU/mL | Standard Deviation 0.467 |
| SOF+RBV 24 Wk GT 1 TN | Change From Baseline in HCV RNA at Week 8 | -5.20 log10 IU/mL | Standard Deviation 0.785 |
Secondary
Percentage of Participants Experiencing On-treatment Virologic Failure
On-treatment virologic failure was defined as: 1. Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 2. Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
Time frame: Up to 24 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+RBV 12 Wk GT 2 TN | Percentage of Participants Experiencing On-treatment Virologic Failure | 3.8 percentage of participants |
| SOF+RBV 12 Wk GT 3 TN | Percentage of Participants Experiencing On-treatment Virologic Failure | 0 percentage of participants |
| SOF+RBV 24 Wk GT 2 TE | Percentage of Participants Experiencing On-treatment Virologic Failure | 0 percentage of participants |
| SOF+RBV 24 Wk GT 3 TE | Percentage of Participants Experiencing On-treatment Virologic Failure | 0 percentage of participants |
| SOF+RBV 24 Wk GT 1 TN | Percentage of Participants Experiencing On-treatment Virologic Failure | 0.9 percentage of participants |
Secondary
Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR.
Time frame: Up to Posttreatment Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+RBV 12 Wk GT 2 TN | Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
| SOF+RBV 12 Wk GT 3 TN | Percentage of Participants Experiencing Viral Relapse | 28.6 percentage of participants |
| SOF+RBV 24 Wk GT 2 TE | Percentage of Participants Experiencing Viral Relapse | 4.2 percentage of participants |
| SOF+RBV 24 Wk GT 3 TE | Percentage of Participants Experiencing Viral Relapse | 5.9 percentage of participants |
| SOF+RBV 24 Wk GT 1 TN | Percentage of Participants Experiencing Viral Relapse | 22.1 percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Time frame: Posttreatment Weeks 4 and 24
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF+RBV 12 Wk GT 2 TN | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 88.5 percentage of participants |
| SOF+RBV 12 Wk GT 2 TN | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 88.5 percentage of participants |
| SOF+RBV 12 Wk GT 3 TN | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 66.7 percentage of participants |
| SOF+RBV 12 Wk GT 3 TN | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 71.4 percentage of participants |
| SOF+RBV 24 Wk GT 2 TE | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 95.8 percentage of participants |
| SOF+RBV 24 Wk GT 2 TE | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 91.7 percentage of participants |
| SOF+RBV 24 Wk GT 3 TE | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 94.1 percentage of participants |
| SOF+RBV 24 Wk GT 3 TE | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 88.2 percentage of participants |
| SOF+RBV 24 Wk GT 1 TN | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 75.4 percentage of participants |
| SOF+RBV 24 Wk GT 1 TN | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 80.7 percentage of participants |