Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
- Registration Number
- NCT04211909
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
- Chronic HCV infected males and non-pregnant/non-lactating females
- Treatment-naive or treatment-experienced individuals
- Non-cirrhosis or compensated cirrhosis at screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF/VEL/VOX SOF/VEL/VOX Participants with chronic HCV infection (genotype 1), who are treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least 4 weeks duration will receive SOF/VEL/VOX for 12 weeks. SOF/VEL SOF/VEL Participants with chronic HCV infection (genotype 1 or 2), who are treatment-naive or treatment-experienced with interferon (IFN)-based treatments will receive SOF/VEL for 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment Posttreatment Week 12 SVR12 was defined as HCV RNA \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event First dose date up to 12 weeks plus 30 days
- Secondary Outcome Measures
Name Time Method Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment Posttreatment Week 4 SVR4 was defined as HCV RNA \< LLOQ (i.e.15 IU/mL) 4 weeks after stopping study treatment.
Percentage of Participants With Virologic Failure Baseline up to Posttreatment Week 12 Virologic failure was defined as:
On-treatment virologic failure:
* Breakthrough (HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment, confirmed with 2 consecutive values), 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 visitPercentage of Participants With HCV RNA < LLOQ on Treatment Week 2, Week 4, Week 8, Week 12 LLOQ was 15 IU/mL.
Change From Baseline in HCV RNA Baseline, Week 2, Week 4, Week 8, Week 12 Number of Participants With Alanine Aminotransferase (ALT) Normalization Baseline, Week 2, Week 4, Week 8, Week 12 Number of participants with ALT normalization, defined as ALT \> upper limit of normal (ULN) (ULN = 43 U/L) at baseline and ALT ≤ ULN, at each visit was presented.
Trial Locations
- Locations (22)
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
The Catholic University of Korea, Seoul Saint Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-D, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
VHS (Veterans Health Service) Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of