Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

Hepatitis C Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909804
• Other study ID #: GS-US-342-0109
• Status: Completed
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: August 2014

Study information

• Verified date: July 2016
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Body mass index (BMI) = 18 kg/m^2

• HCV RNA = 10000 IU/mL at screening

• Prior treatment failure to a regimen including interferon with or without RBV

• HCV genotype 1 or 3

• Chronic HCV infection

• Cirrhosis determination

• Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

• Current or prior history of clinically significant illness other than HCV

• Screening ECG with clinically significant abnormalities

• Prior exposure to HCV specific direct acting antiviral agent

• Pregnant or nursing female or male with pregnant female partner

• Chronic liver disease of non-HCV etiology

• Hepatitis B

• Active drug abuse

• Use of any prohibited concomitant medications

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• SOF
400 mg tablet administered orally once daily
• VEL
Tablet administered orally once daily
• RBV
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  Puerto Rico, 

References & Publications (2)

Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, et al. High Efficacy of Treatment with Sofosbuvir+GS-5816±Ribavirin for 12 Weeks in Treatment-Experienced Patients with Genotype 1 or 3 HCV Infection [Abstract 197]. American Association for

Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Rabinovitz M, Towner WJ, Gane EJ, Stedman CA, Reddy KR, Roberts SK. Sofosbuvir Plus Velpatasvir Combination Therapy for Tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was 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 Any Study Drug 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 were 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 Virologic Failure	Virologic failure was 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