Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536313
• Other study ID #: GS-US-367-1871
• Status: Completed
• Phase: Phase 2
• Start date: July 29, 2015
• Est. completion date: June 28, 2016

Study information

• Verified date: August 2017
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 28, 2016
• Est. primary completion date: March 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Individuals with chronic HCV genotype 1 infection

• Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response

• Absence of cirrhosis or presence of compensated cirrhosis

• Screening laboratory values within defined thresholds

• Must use specific contraceptive methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

• Co-infection with HIV or hepatitis B virus (HBV)

• Current or prior history of clinical hepatic decompensation

• Chronic use of systemic immunosuppressive agents

• History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol

• Pregnant or a nursing female

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

Drug:
• SOF/VEL/VOX
400/100/100 mg FDC tablet administered orally once daily with food
• RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and = 75 kg = 1200 mg)

Locations

Country	Name	City	State
United States	The Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lawitz E, Poordad F, Wells J, Hyland RH, Yang Y, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Landaverde C, Gutierrez J. High Efficacy of Sofosbuvir/Velpatasvir/GS-9857 With or Without Ribavirin for 12 Weeks in Direct Acting Antiviral-Experienced Patients With Genotype 1 HCV Infection [Presentation PS021]. J Hepatol 2016; 64: S146.

Lawitz E, Poordad F, Wells J, Hyland RH, Yang Y, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Landaverde C, Gutierrez J. Sofosbuvir-velpatasvir-voxilaprevir with or without ribavirin in direct-acting antiviral-experienced patients with genotype 1 hepatitis C virus. Hepatology. 2017 Jun;65(6):1803-1809. doi: 10.1002/hep.29130. Epub 2017 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)	SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event		Up to 12 weeks
Secondary	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.	Posttreatment Weeks 4 and 24
Secondary	Percentage of Participants With HCV RNA < LLOQ on Treatment		Weeks 1, 2, 4, 8 and 12
Secondary	HCV RNA Change From Baseline/Day 1 Through Week 12		Weeks 1, 2, 4, 8, and 12
Secondary	Percentage of Participants With Virologic Failure	Virologic failure is defined as: 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); Virologic relapse: Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.	Up to Posttreatment Week 24