A Phase 4, Multicenter, Open Label Study to Investigate the Efficacy and Safety of an All Oral Combination of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis VALOR-HCV: Veterans Affairs alL Oral Regimen of SOF+RBV in GT2 HCV

Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis

Sponsors

Lead sponsor: Gilead Sciences

Source Gilead Sciences
Brief Summary

This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans with compensated cirrhosis and genotype 2 HCV infection.

Overall Status Completed
Start Date June 2014
Completion Date June 2015
Primary Completion Date June 2015
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event Up to 12 weeks
Secondary Outcome
Measure Time Frame
Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4) Posttreatment Week 4
Percentage of Participants Experiencing Viral Breakthrough Up to Posttreatment Weak 12
Percentage of Participants Experiencing Viral Relapse Up to Posttreatment Week 12
Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment Pretreatment and Posttreatment Week 12
Enrollment 66
Condition
Intervention

Intervention type: Drug

Intervention name: Sofosbuvir

Description: Sofosbuvir 400 mg tablet administered orally once daily

Arm group label: Sofosbuvir+RBV 12 weeks

Intervention type: Drug

Intervention name: RBV

Description: Ribavirin (RBV) 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)

Arm group label: Sofosbuvir+RBV 12 weeks

Eligibility

Criteria:

Inclusion Criteria:

- Willing and able to provide written informed consent.

- Treatment-naive or treatment-experienced adult, U.S. Veteran

- Chronic genotype 2 (GT2) HCV infection Classified as:

- Eligible for treatment with interferon (IFN)-based therapy

- Ineligible for IFN treatment

- Intolerant to IFN.

- Cirrhosis determination

- Laboratory parameters within prespecified ranges at screening:

- A negative serum pregnancy test is required for females of childbearing potential

- Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

- Lactating females must agree to discontinue nursing before study drug is administered.

- Males must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV, or 90 days after their last dose of study drug if not taking RBV.

- Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

- Must be of generally good health as determined by the Investigator.

Exclusion Criteria:

- Current participation in an interventional clinical trial.

- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

- History of any other clinically significant chronic liver disease (e.g., hemochromatosis; Wilson's disease; α1-antitrypsin deficiency), except nonalcoholic steatohepatitis (NASH).

- Decompensated liver

- History of hemoglobinopathies

- Contraindication or hypersensitivity to RBV

- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participation for the full duration of the study, such that it is not in the best interest of the individual to participate.

- Clinically significant ECG abnormality at screening.

- History of solid organ transplantation.

- Presence of hepatocellular carcinoma (HCC) Malignancy within 5 years prior to screening, with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer and prostate cancer in remission). Individuals under evaluation for possible malignancy are not eligible.

- Prior treatment with an NS5B polymerase inhibitor.

- Chronic use of systemic immunosuppressive agents or immunomodulatory agents (e.g., prednisone equivalent > 10 mg/day).

- Concomitant disallowed as per the Sovaldi Packet Insert.

- Known hypersensitivity to the study drug, the metabolites, or formulation excipient.

- History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.

- Use of any prohibited concomitant medications as described in the study protocol

- Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.

- Male with pregnant female partner.

- In the judgment of the investigator any clinically-relevant drug or alcohol abuse within 12 months of screening that may interfere with treatment, assessment or compliance with the protocol.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Lorenzo Rossaro, MD Study Director Gilead Sciences
Location
facility
| Long Beach, California, 90822, United States
| Los Angeles, California, 90073, United States
| Palo Alto, California, 94394, United States
| San Diego, California, 92102, United States
| San Francisco, California, 94121, United States
| New Haven, Connecticut, 06520, United States
| Miami, Florida, 33125, United States
| Decatur, Georgia, 30033, United States
| Baltimore, Maryland, 21201, United States
| Kansas City, Missouri, 64128, United States
| Durham, North Carolina, 27705, United States
| Portland, Oregon, 97239, United States
| Philadelphia, Pennsylvania, 19104, United States
| Pittsburgh, Pennsylvania, 15240, United States
| Dallas, Texas, 75216, United States
| Houston, Texas, 77030, United States
| Richmond, Virginia, 23249, United States
Location Countries

United States

Verification Date

June 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Sofosbuvir+RBV 12 weeks

Arm group type: Experimental

Description: Participants will receive sofosbuvir+RBV for 12 weeks.

Acronym VALOR-HCV
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov