Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
- Registration Number
- NCT02671500
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) 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
- 375
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
- HCV treatment-naive or treatment-experienced
- Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)
Key
- Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non HCV etiology
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
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 FDC 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 HCV RNA < LLOQ On Treatment Weeks 1, 2, 4, 6, 8, 10, and 12 Change From Baseline in HCV RNA Baseline and up to Week 12 Percentage of Participants With Overall Virologic Failure Up to Posttreatment Week 24 Virologic failure was defined as: (1) 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) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Percentage of Participants With SVR 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 SVR at 24 Weeks After Discontinuation of Therapy (SVR24) Posttreatment Week 24 SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Trial Locations
- Locations (38)
Bach Mai Hospital
🇻🇳Hanoi, Vietnam
Hospital Tengku Ampuan Afzan
🇲🇾Pahang, Malaysia
National University Hospital
🇸🇬Singapore, Singapore
Singapore General Hospital
🇸🇬Singapore, Singapore
Maharaj Nakhon Chiangmai Hospital
🇹🇭Chiang Mai, Thailand
Shanghai Public Health Clinical Center
🇨🇳Hongkou, Shanghai, China
Beijing Friendship Hospital Affiliate of Capital Medical University
🇨🇳Beijing, China
The First Hospital of Jilin University
🇨🇳Jilin, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Ramathibodi Hospital Mahidol University
🇹🇭Bangkok, Thailand
Siriraj Hospital
🇹🇭Bankok, Thailand
People's Hospital 115
🇻🇳Ho Chi Minh City, Vietnam
Peking University People's Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Shanghai Ruijin Hospital
🇨🇳Huangpu, Shanghai, China
Xiangyan Hospital, Central South University
🇨🇳Changsha, Hunan, China
Tongji Hospital Affiliated to Tongji Medicine University
🇨🇳Wuhan, Hubei, China
Jinan Infectious Disease Hospital
🇨🇳Jinan, China
National Hospital for Tropical Disease
🇻🇳Hanoi, Vietnam
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Shanghai Renji Hospital
🇨🇳Shanghai, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Guangzhou Eighth People's Hospital
🇨🇳Guangdong, China
Shengjing Hospital of China Medical University
🇨🇳Liaoning, China
The 3rd Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Songklanagarind Hospital
🇹🇭Songkla, Thailand
The People's Hospital of Hainan Province
🇨🇳Hainan, China
The 2nd Xiangya Hospital of Central South University
🇨🇳Hunan, China
The Second Hospital of Nanjing
🇨🇳Jiangsu, China
University of Malaya
🇲🇾Kuala Lumpur, Malaysia
The First Affiliated Hospital of NanChang University
🇨🇳Nanchang, China
Henan Province People's Hospital
🇨🇳Zhengzhou, China
Chulalongkorn Hospital
🇹🇭Bangkok, Thailand
Beijing Ditan Hospital
🇨🇳Chaoyang, Beijing, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Ho Chi Minh City Hospital for Tropical Diseasees
🇻🇳Ho Chi Minh, Vietnam
Peking University First Hospital
🇨🇳Beijing, China