Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
- Registration Number
- NCT01909804
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 323
Inclusion Criteria
- Body mass index (BMI) ≥ 18 kg/m^2
- HCV RNA ≥ 10000 IU/mL at screening
- Prior treatment failure to a regimen including interferon with or without RBV
- HCV genotype 1 or 3
- Chronic HCV infection
- Cirrhosis determination
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
- Current or prior history of clinically significant illness other than HCV
- Screening ECG with clinically significant abnormalities
- Prior exposure to HCV specific direct acting antiviral agent
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of non-HCV etiology
- Hepatitis B
- Active drug abuse
- Use of any prohibited concomitant medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF+VEL 25 mg (GT3) without cirrhosis SOF Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25mg+RBV (GT3) without cirrhosis SOF Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. SOF+VEL 25mg+RBV (GT3) without cirrhosis VEL Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. SOF+VEL 100 mg (GT3) with cirrhosis SOF Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 25mg+RBV (GT3) without cirrhosis RBV Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. SOF+VEL 100 mg (GT3) without cirrhosis SOF Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg (GT3) with cirrhosis VEL Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg (GT3) without cirrhosis VEL Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg+RBV (GT3) without cirrhosis SOF Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. SOF+VEL 100 mg+RBV (GT3) without cirrhosis VEL Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. SOF+VEL 100 mg+RBV (GT3) without cirrhosis RBV Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. SOF+VEL 25 mg (GT3) with cirrhosis SOF Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg (GT3) with cirrhosis VEL Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg+RBV (GT3) with cirrhosis SOF Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. SOF+VEL 100 mg+RBV (GT3) with cirrhosis SOF Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. SOF+VEL 100 mg+RBV (GT3) with cirrhosis VEL Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. SOF+VEL 100 mg+RBV (GT3) with cirrhosis RBV Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. SOF+VEL 25 mg (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg+RBV (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks. SOF+VEL 25 mg+RBV (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks. SOF+VEL 25 mg+RBV (GT1) RBV Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks. SOF+VEL 100 mg (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg+RBV (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks. SOF+VEL 100 mg+RBV (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks. SOF+VEL 25 mg+RBV (GT3) with cirrhosis RBV Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. SOF+VEL 100 mg+RBV (GT1) RBV Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.
- Primary Outcome Measures
Name Time Method 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 12 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
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.