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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

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: SOF Drug: RBV Drug: Peg-IFN Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 601 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : September 24, 2013
Actual Primary Completion Date : January 7, 2015
Actual Study Completion Date : July 7, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: SOF+RBV 16 weeks
SOF+RBV for 16 weeks
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)

Experimental: SOF+RBV 24 weeks
SOF+RBV for 24 weeks
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)

Experimental: SOF+RBV+Peg-IFN 12 weeks
SOF+RBV+Peg-IFN for 12 weeks
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

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
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




Primary Outcome Measures :
  1. 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.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. 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 ]
  3. HCV RNA at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
  4. Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12 ]
  5. 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)

  6. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962441


  Hide Study Locations
Locations
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United States, California
Riverside, California, United States, 92501
San Diego, California, United States, 92123
San Francisco, California, United States, 94115
United States, Colorado
Aurora, Colorado, United States, 80045
Englewood, Colorado, United States, 80113
United States, Florida
Miami, Florida, United States, 33136
Wellington, Florida, United States, 33414
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Novi, Michigan, United States, 48377
United States, Minnesota
Saint Paul, Minnesota, United States, 55114
United States, New Jersey
Hillsborough, New Jersey, United States, 08844
Newark, New Jersey, United States, 07102
United States, New York
Binghamton, New York, United States, 13903
New York, New York, United States, 10021
United States, Tennessee
Germantown, Tennessee, United States, 38138
Nashville, Tennessee, United States, 37211
Nashville, Tennessee, United States, 37212-1610
United States, Texas
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
United States, Virginia
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle, Washington, United States, 98101
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Kogarah, New South Wales, Australia, 2217
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Brisbane, Queensland, Australia, 4029
Greenslopes, Queensland, Australia, 4120
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Clayton, Victoria, Australia, 3168
Fitzroy, Victoria, Australia, 3065
Heidelberg, Victoria, Australia, 3084
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Nedlands Perth, Western Australia, Australia, 6009
Canada, Alberta
Calgary, Alberta, Canada, T2N 4Z6
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver, British Columbia, Canada, V6Z 2C7
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Hamilton, Ontario, Canada, L8N 4A6
London, Ontario, Canada, N6A 5A5
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5T 2S8
Toronto, Ontario, Canada, M6H 3M1
Canada, Quebec
Montreal, Quebec, Canada, H2X 3J4
Québec, Quebec, Canada, G1V 4G2
New Zealand
Grafton, Auckland, New Zealand, 1010
Grafton, Auckland, New Zealand, 1023
Christchurch, Chatham Islands, New Zealand, 8011
Hamilton, Waikato, New Zealand, 3204
Wellington, New Zealand, 6021
United Kingdom
Edgbaston, Birmingham, United Kingdom, B15 2TH
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
London, LN, United Kingdom, E1 1BB
London, LN, United Kingdom, SE5 9RS
London, LN, United Kingdom, SW17 ORE
London, LN, United Kingdom, W2 1NY
Birmingham, United Kingdom, B9 5SS
Bradford, United Kingdom, BD9 6RJ
Dundee, United Kingdom, DD1 9SY
Edinburgh, United Kingdom, EH16 4SA
Edinburgh, United Kingdom, EH4 2XU
Frimley, United Kingdom, GU46 6HU
Glasgow, United Kingdom, G12 0YN
Glasgow, United Kingdom, G4 0SF
Leeds, United Kingdom, LS9 7TF
Liverpool, United Kingdom, L7 8XP
London, United Kingdom, NW3 2QG
London, United Kingdom, SW10 9NH
Manchester, United Kingdom, M85RB
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Nottingham, United Kingdom, NG7 2UH
Oxford, United Kingdom, OX3 9DU
Plymouth, United Kingdom, PL6 8DH
Portsmouth, United Kingdom, PO6 3LY
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications of Results:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01962441     History of Changes
Other Study ID Numbers: GS-US-334-0153
2013-002641-11 ( EudraCT Number )
First Posted: October 14, 2013    Key Record Dates
Results First Posted: February 5, 2016
Last Update Posted: June 20, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
7977
GS-7977
PSI-7977
Sofosbuvir (SOF)
Pegylated Interferon (Peg-IFN)
Ribavirin (RBV)
Additional relevant MeSH terms:
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Sofosbuvir
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Interferons
Ribavirin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action