Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
- Registration Number
- NCT02722837
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
Key
- Any other chronic liver disease
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Clinical hepatic decompensation
- Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SOF/VEL SOF/VEL SOF/VEL 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) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event Up to 12 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4) Posttreatment Week 4 SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) Posttreatment Week 24 SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1 Week 1 Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2 Week 2 Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4 Week 4 Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8 Week 8 Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12 Week 12 Change From Baseline in HCV RNA at Week 1 Baseline (Day 1); Week 1 Change From Baseline in HCV RNA at Week 2 Baseline (Day 1); Week 2 Change From Baseline in HCV RNA at Week 4 Baseline (Day 1); Week 4 Change From Baseline in HCV RNA at Week 8 Baseline (Day 1); Week 8 Change From Baseline in HCV RNA at Week 12 Baseline (Day 1); Week 12 Percentage of Participants With Virologic Failure Up to Posttreatment Week 24 Virologic failure was defined as:
* 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), or
* Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)
Trial Locations
- Locations (15)
Central Research Institute of Epidemiology
🇷🇺Moscow, Russian Federation
First Moscow State Medical University I.M. Sechenov
🇷🇺Moscow, Russian Federation
Limited Liability Company "Clinic Tour"
🇷🇺Moscow, Russian Federation
Sahlgrenska Universitetsjukhuset
🇸🇪Göteborg, Sweden
Kirov Medical Military Academy
🇷🇺Saint Petersburg, Russian Federation
North-Western State Medical University named after I.I. Mechnikov
🇷🇺Saint Petersburg, Russian Federation
Krasnoyarsk Regional Center of AIDS Prevention
🇷🇺Krasnoyarsk, Russian Federation
Central Scientific-Research Institute of Epidemiology
🇷🇺Moscow, Russian Federation
City Clinical Hospital # 24
🇷🇺Moscow, Russian Federation
First Moscow Medical University I.M.Sechenov.
🇷🇺Moscow, Russian Federation
Center for Prevention and Control of AIDS and Infectious Diseases
🇷🇺Saint Petersburg, Russian Federation
Scientific Research Institute of Nutrition
🇷🇺Moscow, Russian Federation
Sklifosovsky Scientific Research Institution of Emergency Care
🇷🇺Moscow, Russian Federation
LLC Medical Company "Hepatolog"
🇷🇺Samara, Russian Federation
Karolinska University Hospital Huddinge
🇸🇪Stockholm, Sweden