Sofosbuvir+RBV for 16 or 24 Weeks and Sofosbuvir+PEG+RBV for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01962441
First received: October 10, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

This study is to assess the safety and efficacy of 16 or 24 weeks of sofosbuvir+ribavirin (RBV), and 12 weeks of sofosbuvir+pegylated interferon alfa-2a (PEG)+RBV in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.


Condition Intervention Phase
Hepatitis C
Drug: Sofosbuvir
Drug: RBV
Drug: PEG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection.

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of subjects achieving sustained viral response 12 weeks after discontinuation of treatment (SVR12) [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
    Sustained virologic response (SVR) is defined as HCV RNA < the lower limit of quantitation (LLOQ) (< 15 IU/mL).

  • Adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Baseline to Week 12, 16, or 24 ] [ Designated as safety issue: No ]
    Adverse events leading to permanent discontinuation of study drug(s) during the sofosbuvir treatment period (through Week 12, 16, or 24 depending on the treatment arm to which a participant is randomized).


Secondary Outcome Measures:
  • Proportion of participants with HCV RNA < LLOQ during treatment [ Time Frame: Baseline to Week 12, 16, or 24 ] [ Designated as safety issue: No ]
    Levels of HCV RNA will be assessed during the sofosbuvir treatment period (through Week 12, 16, or 24 depending on the treatment arm to which a participant is randomized).

  • Change from baseline in HCV RNA (log10 IU/mL) [ Time Frame: Baseline to Post-treatment Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving sustained viral response 4 weeks after discontinuation of treatment (SVR4) and 24 weeks after discontinuation of treatment (SVR24) [ Time Frame: Post-treatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR is defined as HCV RNA < LLOQ (< 15 IU/mL).

  • Proportion of participants experiencing viral breakthrough [ Time Frame: Baseline to Week 12, 16, or 24 ] [ Designated as safety issue: No ]

    Viral breakthrough is defined as either:

    • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment)
    • HCV RNA ≥ LLOQ at the last available on-treatment measurement with no subsequent follow-up values Viral breakthrough will be assessed during the sofosbuvir treatment period, either 12, 16, or 24 weeks depending on the treatment arm to which a participant is randomized.

    Viral breakthrough will be assessed during the sofosbuvir treatment period (through Week 12, 16, or 24 depending on the treatment arm to which a participant is randomized).


  • Proportion of participants experiencing viral relapse [ Time Frame: Week 12, 16, or 24 to Post-treatment Week 24 ] [ Designated as safety issue: No ]
    Viral relapse is defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. Viral relapse will be assessed from the end of study treatment (Week 12, 16, or 24, depending on the treatment arm to which a participant is randomized) through post-treatment Week 24.


Estimated Enrollment: 600
Study Start Date: September 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sofosbuvir+RBV 16 weeks
Participants received sofosbuvir+RBV for 16 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Experimental: Sofosbuvir+RBV 24 weeks
Participants received sofosbuvir+RBV for 24 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Experimental: Sofosbuvir+PEG+RBV 12 weeks
Participants received sofosbuvir+PEG+RBV for 12 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age greater than or equal to 18 years.
  • Confirmed chronic HCV infection.
  • Subjects will have cirrhosis status assessment; liver biopsy may be required.
  • Genotype 2 subjects must have cirrhosis of the liver to be eligible.
  • Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event
  • Infection with HCV genotype 2 or 3 as determined at Screening
  • Body mass index (BMI) greater than or equal to 18 kg/m2
  • Screening laboratory values within predefined thresholds.
  • Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.
  • Subject must be of generally good health as determined by the Investigator.

Exclusion Criteria:

  • Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase
  • Pregnant or nursing female or male with pregnant female partner
  • History of any other clinically significant chronic liver disease.
  • HIV or chronic hepatitis B virus (HBV) infection.
  • Malignancy with the exception of certain resolved skin cancers.
  • Chronic use of systemically administered immunosuppressive agents.
  • Clinically-relevant drug or alcohol abuse.
  • History of solid organ transplantation.
  • Current or prior history of clinical hepatic decompensation.
  • History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
  • Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962441

  Show 78 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Jeffrey Bornstein, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01962441     History of Changes
Other Study ID Numbers: GS-US-334-0153
Study First Received: October 10, 2013
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
New Zealand: Medsafe
Canada: Health Canada

Keywords provided by Gilead Sciences:
7977
GS-7977
PSI-7977
Sofosbuvir (SOF)
Pegylated Interferon (PEG)
Ribavirin (RBV)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014