Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults 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-Naive Subjects With Chronic HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858766
• Other study ID #: GS-US-342-0102
• Status: Completed
• Phase: Phase 2
• Start date: April 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, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• 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:

• Chronic HCV infection

• Body mass index (BMI) = 18 kg/m^2

• HCV RNA = 10000 IU/mL at screening

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

• Must not have cirrhosis

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

• Prior treatment of HCV with interferon or ribavirin

• 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
Puerto Rico	Fundacion de Investigacion de Diego	Santurce
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	Asheville Gastroenterology Associates, P.A.	Asheville	North Carolina
United States	Center For Hepatitis C/Atlanta Medical Center	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Mercy Medical Ctr	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Methodist Transplant Physicians	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Metropolitan Research	Fairfax	Virginia
United States	INOVA Institute of Research & Education	Falls Church	Virginia
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	University of Florida Center for Clinical Trials Research	Gainesville	Florida
United States	Gastro One	Germantown	Tennessee
United States	ID Care	Hillsborough	New Jersey
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Indianapolis Gastroenterology & Hepatology, Inc.- ARC	Indianapolis	Indiana
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	UCSD	La Jolla	California
United States	University of California San Diego Medical Center	La Jolla	California
United States	North Shore/Long Island Jewish PRIME	Lake Success	New York
United States	VA Long Beach Healthcare System	Long Beach	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Los Angeles Medical Center	Los Angeles	California
United States	National Research Institute	Los Angeles	California
United States	Ruane Peter J MD Incorporated	Los Angeles	California
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	University of Miami	Miami	Florida
United States	Nashville Gastrointestinal Specialists Inc.	Nashville	Tennessee
United States	Weill Cornell Medical College-New York Presbyterian Hospital	New York	New York
United States	The Liver Institute of Virginia	Newport News	Virginia
United States	Digestive and Liver Disease Specialists, Ltd.	Norfolk	Virginia
United States	Orlando Immunology Center	Orlando	Florida
United States	Huntington Medical Research Institutes Liver Center	Pasadena	California
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	UPMC Center For Liver Diseases	Pittsburgh	Pennsylvania
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	University Gastroenterology	Providence	Rhode Island
United States	Alamo Medical Research, LTD d/b/a American Research Corporation	San Antonio	Texas
United States	Kaiser Permanente Medical Grp	San Diego	California
United States	Medical Associates Research Group, Inc.	San Diego	California
United States	Kaiser Permante	San Francisco	California
United States	Southwest C.A.R.E. Center	Santa Fe	New Mexico
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	South Florida Center of Gastroenterology, P.A	Wellington	Florida
United States	Digestive Health Specialists, PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (4)

Doehle B, Gontcharova V, Chodavarapu1 RK, McNally J, Chung RT, Everson GT, McHutchison JG, Miller MD, Mo H. Resistance Analysis of Treatment-Naive HCV Genotype 1-6 Infected Patients Treated with Sofosbuvir in Combination with GS-5816 for 12 Weeks. Hepatol

Everson GT, Towner WJ, Davis MN, Wyles DL, Nahass RG, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, Rabinovitz M, McNally J, Brainard DM, Han L, Doehle B, McHutchison JG, Morgan T, Chung RT, Tran TT. Sofosbuvir With Velpatasvir in Treatment-Naive Noncirr — View Citation

Everson GT, Tran TT, Towner WJ , Davis MN, Wyles D, Nahass R, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, Symonds WT, McHutchison JG, Morgan T, Chung RT. Safety and Efficacy of Treatment with the Interferon-Free, Ribavirin-Free Combination of Sof

Tran TT, Morgan TR, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Chung RT, Everson GT. Safety and Efficacy of Treatment with Sofosbuvir+ GS-5816±Ribavirin for 8 or 12 Weeks in Treatmen

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