Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
- Registration Number
- NCT01808248
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- Infection with genotype 2 or 3 HCV infection
- Cirrhosis determination
- Individual is treatment-experienced
- Screening laboratory values within defined thresholds
- Individual has not been treated with any investigational drug or device within 30 days of the Screening visit
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
- Prior exposure to a direct-acting antiviral drug targeting the HCV NS5B polymerase
- Pregnant or nursing female or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the study protocol
- Excessive alcohol ingestion or significant drug abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SOF+PEG+RBV SOF Participants will receive SOF+PEG+RBV for 12 weeks. SOF+PEG+RBV RBV Participants will receive SOF+PEG+RBV for 12 weeks. SOF+PEG+RBV PEG Participants will receive SOF+PEG+RBV for 12 weeks.
- Primary Outcome Measures
Name Time Method 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, \< 15 IU/mL) at 12 weeks after stopping study treatment.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) Up to 12 weeks The percentage of participants discontinuing any study drug due to an adverse event was summarized.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Experiencing Viral Relapse Up to Posttreatment Week 24 Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
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 12 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
Trial Locations
- Locations (1)
Alamo Medical Research
🇺🇸San Antonio, Texas, United States