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

Hepatitis C Virus Infection Clinical Trial

— VALOR-HCV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128542
• Other study ID #: GS-US-334-1379
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2014
• Last updated: July 1, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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; a1-antitrypsin deficiency), except 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
• RBV
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)	SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.	Posttreatment Week 12	No
Primary	Incidence of adverse events leading to permanent discontinuation of study drug(s)		Baseline to Week 12	No
Secondary	Proportion of participants with sustained virologic response (SVR) at 4 weeks after discontinuation of therapy (SVR4)	SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.	Posttreatment Week 4	No
Secondary	Proportion of participants experiencing viral breakthrough	Viral breakthrough is defined as either: HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while receiving treatment; HCV RNA = LLOQ at the last available on-treatment measurement with no subsequent follow-up values	Baseline to Week 12	No
Secondary	Proportion of participants experiencing viral relapse	Viral relapse is defined as HCV RNA = LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment.	Week 12 to Posttreatment Week 12	No