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

NCT04211909 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GS-US-342-5532
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 22

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.

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment

  SVR12 was defined as HCV RNA \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.

  Posttreatment Week 12

• 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 Outcomes (5)

• Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment

  Posttreatment Week 4

• Percentage of Participants With Virologic Failure

  Baseline up to Posttreatment Week 12

• Percentage of Participants With HCV RNA < LLOQ on Treatment

  Week 2, Week 4, Week 8, Week 12

• 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

Study Arms (2)

SOF/VEL

EXPERIMENTAL

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.

Drug: SOF/VEL

SOF/VEL/VOX

EXPERIMENTAL

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.

Drug: SOF/VEL/VOX

Interventions

SOF/VEL DRUG

400/100 mg FDC tablet orally once daily.

Also known as: Epclusa®, GS-7977/GS-5816

SOF/VEL

SOF/VEL/VOX DRUG

400/100/100 mg FDC tablet orally once daily.

Also known as: Vosevi ®, GS-7977/GS-5816/GS-9857

SOF/VEL/VOX

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic HCV infected males and non-pregnant/non-lactating females
• Treatment-naive or treatment-experienced individuals
• Non-cirrhosis or compensated cirrhosis at screening

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (22)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-D, 13620, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Dong-A University Hospital

Busan, 48789, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Chosun University Hospital

Gwangju, 501-717, South Korea

Location

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, 21431, South Korea

Location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Chonbuk National University Hospital

Jeonju, 54907, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

VHS (Veterans Health Service) Medical Center

Seoul, 05368, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea, Seoul Saint Mary's Hospital

Seoul, 06591, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination; sofosbuvir velpatasvir voxilaprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 26, 2019
• Study Start: January 3, 2020
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: October 27, 2021
• Results First Posted: October 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

KR (22)