Clinical trial NCT02128542: Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C Virus Infection
Keywords: Veterans HCV
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-05-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants Experiencing Viral Breakthrough
timeFrame: Up to Posttreatment Weak 12
measure: Percentage of Participants Experiencing Viral Relapse
timeFrame: Up to Posttreatment Week 12
measure: Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment
timeFrame: Pretreatment and Posttreatment Week 12
Other outcomes:
Locations:
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Baltimore
country: United States
state: Maryland
city: Kansas City
country: United States
state: Missouri
city: Durham
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Gilead Sciences
name: Lorenzo Rossaro, MD
role: STUDY_DIRECTOR
References:
citation: Ho SB, Monto A, Peyton A, Kaplan DE, Byrne S, Moon S, Copans A, Rossaro L, Roy A, Le H, Dvory-Sobol H, Zhu Y, Brainard DM, Guyer W, Shaikh O, Fuchs M, Morgan TR; VALOR study team. Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities. Clin Gastroenterol Hepatol. 2017 Feb;15(2):282-288. doi: 10.1016/j.cgh.2016.05.024. Epub 2016 May 27.