SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults 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: January 7, 2016
Last verified: January 2016
  Purpose
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+peginterferon alfa-2a (Peg-IFN) 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: SOF
Drug: RBV
Drug: Peg-IFN
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.

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

  • Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

  • Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 [ Time Frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
  • HCV RNA at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants Experiencing On-Treatment Virologic Failure [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

    On-treatment virologic failure was defined as:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

  • Percentage of Participants Experiencing Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]
    Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.


Enrollment: 601
Study Start Date: September 2013
Estimated Study Completion Date: June 2016
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOF+RBV 16 weeks
SOF+RBV for 16 weeks
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
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: SOF+RBV 24 weeks
SOF+RBV for 24 weeks
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
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: SOF+RBV+Peg-IFN 12 weeks
SOF+RBV+Peg-IFN for 12 weeks
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
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-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Experimental: Retreatment Substudy
Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
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-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly

  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/m^2
  • 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: Benedetta Massetto, MD Gilead Sciences
  More Information

Publications:
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
Results First Received: January 7, 2016
Last Updated: January 7, 2016
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)

ClinicalTrials.gov processed this record on April 27, 2016