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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

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ClinicalTrials.gov Identifier: NCT01962441
Recruitment Status : Completed
First Posted : October 14, 2013
Results First Posted : February 5, 2016
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE October 10, 2013
First Posted Date  ICMJE October 14, 2013
Results First Submitted Date  ICMJE January 7, 2016
Results First Posted Date  ICMJE February 5, 2016
Last Update Posted Date June 20, 2017
Actual Study Start Date  ICMJE September 24, 2013
Actual Primary Completion Date January 7, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
  • Proportion of subjects achieving sustained viral response 12 weeks after discontinuation of treatment (SVR12) [ Time Frame: Post-treatment Week 12 ]
    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 ]
    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).
Change History Complete list of historical versions of study NCT01962441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    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 ]
  • HCV RNA at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
  • Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12 ]
  • Percentage of Participants Experiencing On-Treatment Virologic Failure [ Time Frame: Up to 24 weeks ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
  • Proportion of participants with HCV RNA < LLOQ during treatment [ Time Frame: Baseline to Week 12, 16, or 24 ]
    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 ]
  • 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 ]
    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 ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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.
Brief Summary 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+ pegylated interferon (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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: SOF
    400 mg tablet administered orally once daily
    Other Names:
    • Sovaldi®
    • GS-7977
    • PSI-7977
  • Drug: 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)
  • Drug: Peg-IFN
    180 µg administered via subcutaneous injection once weekly
Study Arms  ICMJE
  • Experimental: SOF+RBV 16 weeks
    SOF+RBV for 16 weeks
    Interventions:
    • Drug: SOF
    • Drug: RBV
  • Experimental: SOF+RBV 24 weeks
    SOF+RBV for 24 weeks
    Interventions:
    • Drug: SOF
    • Drug: RBV
  • Experimental: SOF+RBV+Peg-IFN 12 weeks
    SOF+RBV+Peg-IFN for 12 weeks
    Interventions:
    • Drug: SOF
    • Drug: RBV
    • Drug: Peg-IFN
  • 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.
    Interventions:
    • Drug: SOF
    • Drug: RBV
    • Drug: Peg-IFN
Publications * Foster GR, Pianko S, Brown A, Forton D, Nahass RG, George J, Barnes E, Brainard DM, Massetto B, Lin M, Han B, McHutchison JG, Subramanian GM, Cooper C, Agarwal K; BOSON Study Group. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with hepatitis C virus genotype 3 infection and treatment-experienced patients with cirrhosis and hepatitis C virus genotype 2 infection. Gastroenterology. 2015 Nov;149(6):1462-70. doi: 10.1053/j.gastro.2015.07.043. Epub 2015 Aug 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)
601
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2013)
600
Actual Study Completion Date  ICMJE July 7, 2016
Actual Primary Completion Date January 7, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key 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.

Key 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   New Zealand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01962441
Other Study ID Numbers  ICMJE GS-US-334-0153
2013-002641-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP