Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
- Registration Number
- NCT01858766
- 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, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 379
- Chronic HCV infection
- Body mass index (BMI) ≥ 18 kg/m^2
- HCV RNA ≥ 10000 IU/mL at screening
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
- Must not have cirrhosis
- 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
- Prior treatment of HCV with interferon or ribavirin
- 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 12 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg 12 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 100 mg 12 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg 12 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 25 mg 12 Weeks (GT2/4/5/6) SOF Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg 12 Weeks (GT2/4/5/6) VEL Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 100 mg 12 Weeks (GT2/4/5/6) SOF Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg 12 Weeks (GT3) SOF Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 100 mg 12 Weeks (GT3) VEL Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 25 mg 8 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks. SOF+VEL 25 mg 8 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 100 mg 12 Weeks (GT2/4/5/6) VEL Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks. SOF+VEL 25 mg 12 Weeks (GT3) SOF Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg 12 Weeks (GT3) VEL Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 100 mg 8 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks. SOF+VEL 100 mg 8 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT1) SOF Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT1) VEL Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. SOF+VEL 25 mg 8 Weeks (GT2) SOF Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks. SOF+VEL 25 mg 8 Weeks (GT2) VEL Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT2) SOF Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT2) VEL Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 100 mg 8 Weeks (GT2) SOF Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks. SOF+VEL 100 mg 8 Weeks (GT2) VEL Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT2) SOF Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT2) VEL Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT1) RBV Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT1) RBV Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. SOF+VEL 25 mg + RBV 8 Weeks (GT2) RBV Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. SOF+VEL 100 mg + RBV 8 Weeks (GT2) RBV Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event Up to 12 weeks 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.
- 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.
Related Research Topics
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Trial Locations
- Locations (51)
UCSD
🇺🇸La Jolla, California, United States
University of California San Diego Medical Center
🇺🇸La Jolla, California, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Ruane Peter J MD Incorporated
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Huntington Medical Research Institutes Liver Center
🇺🇸Pasadena, California, United States
Kaiser Permanente Medical Grp
🇺🇸San Diego, California, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
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