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

NCT02128542 | Completed Phase 4 Results

• 1 other identifier: GS-US-334-1379
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 17

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.

Conditions

Hepatitis C Virus Infection

Keywords

Veterans HCV

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy

  SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

  Posttreatment Week 12

• Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

  Up to 12 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

Sofosbuvir+RBV 12 weeks

EXPERIMENTAL

Participants will receive sofosbuvir+RBV for 12 weeks.

Drug: Sofosbuvir; Drug: RBV

Interventions

Sofosbuvir DRUG

Sofosbuvir 400 mg tablet administered orally once daily

Also known as: Sovaldi®, GS-7977, PSI-7977

Sofosbuvir+RBV 12 weeks

RBV DRUG

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)

Sofosbuvir+RBV 12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (17)

Unknown Facility

Long Beach, California, 90822, United States

Location

Unknown Facility

Los Angeles, California, 90073, United States

Location

Unknown Facility

Palo Alto, California, 94394, United States

Location

Unknown Facility

San Diego, California, 92102, United States

Location

Unknown Facility

San Francisco, California, 94121, United States

Location

Unknown Facility

New Haven, Connecticut, 06520, United States

Location

Unknown Facility

Miami, Florida, 33125, United States

Location

Unknown Facility

Decatur, Georgia, 30033, United States

Location

Unknown Facility

Baltimore, Maryland, 21201, United States

Location

Unknown Facility

Kansas City, Missouri, 64128, United States

Location

Unknown Facility

Durham, North Carolina, 27705, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15240, United States

Location

Unknown Facility

Dallas, Texas, 75216, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Richmond, Virginia, 23249, United States

Location

Related Publications (1)

• 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.

  PMID: 27237429 RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Limitations and Caveats

There were no limitations affecting the analysis or results.

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Lorenzo Rossaro, MD

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 3, 2016
• Results First Posted: August 3, 2016

Record last verified: 2016-06

Locations

US (17)