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
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.
2 other identifiers
interventional
601
5 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2013
Typical duration for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 24, 2013
CompletedFirst Submitted
Initial submission to the registry
October 10, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2015
CompletedResults Posted
Study results publicly available
February 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2016
CompletedJune 20, 2017
May 1, 2017
1.3 years
October 10, 2013
January 7, 2016
May 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 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 24 weeks
Secondary Outcomes (6)
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Weeks 1, 2, 4, 8, 12, 16, 20, and 24
HCV RNA at Weeks 1, 2, 4, 8, and 12
Weeks 1, 2, 4, 8, and 12
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Baseline; Weeks 1, 2, 4, 8, and 12
Percentage of Participants Experiencing On-Treatment Virologic Failure
Up to 24 weeks
- +1 more secondary outcomes
Study Arms (4)
SOF+RBV 16 weeks
EXPERIMENTALSOF+RBV for 16 weeks
SOF+RBV 24 weeks
EXPERIMENTALSOF+RBV for 24 weeks
SOF+RBV+Peg-IFN 12 weeks
EXPERIMENTALSOF+RBV+Peg-IFN for 12 weeks
Retreatment Substudy
EXPERIMENTALParticipants 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
400 mg tablet administered orally once daily
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)
180 µg administered via subcutaneous injection once weekly
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (78)
Unknown Facility
Riverside, California, 92501, United States
Unknown Facility
San Diego, California, 92123, United States
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San Francisco, California, 94115, United States
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Aurora, Colorado, 80045, United States
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Englewood, Colorado, 80113, United States
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Miami, Florida, 33136, United States
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Wellington, Florida, 33414, United States
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Marietta, Georgia, 30060, United States
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New Orleans, Louisiana, 70121, United States
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Boston, Massachusetts, 02215, United States
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Novi, Michigan, 48377, United States
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Saint Paul, Minnesota, 55114, United States
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Hillsborough, New Jersey, 08844, United States
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Newark, New Jersey, 07102, United States
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Binghamton, New York, 13903, United States
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New York, New York, 10021, United States
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Germantown, Tennessee, 38138, United States
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Nashville, Tennessee, 37211, United States
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Nashville, Tennessee, 37212-1610, United States
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Arlington, Texas, 76012, United States
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Austin, Texas, 78705, United States
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Norfolk, Virginia, 23502, United States
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Seattle, Washington, 98101, United States
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Camperdown, New South Wales, 2050, Australia
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Kogarah, New South Wales, 2217, Australia
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Westmead, New South Wales, 2145, Australia
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Brisbane, Queensland, 4029, Australia
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Greenslopes, Queensland, 4120, Australia
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Woolloongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5000, Australia
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Clayton, Victoria, 3168, Australia
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Fitzroy, Victoria, 3065, Australia
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Heidelberg, Victoria, 3084, Australia
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Melbourne, Victoria, 3004, Australia
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Nedlands Perth, Western Australia, 6009, Australia
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Calgary, Alberta, T2N 4Z6, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Vancouver, British Columbia, V6Z 2C7, Canada
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Vancouver, British Columbia, V6Z 2K5, Canada
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Winnipeg, Manitoba, R3E 3P4, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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London, Ontario, N6A 5A5, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5T 2S8, Canada
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Toronto, Ontario, M6H 3M1, Canada
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Montreal, Quebec, H2X 3J4, Canada
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Québec, Quebec, G1V 4G2, Canada
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Grafton, Auckland, 1010, New Zealand
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Grafton, Auckland, 1023, New Zealand
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Christchurch, Chatham Islands, 8011, New Zealand
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Hamilton, Waikato Region, 3204, New Zealand
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Wellington, 6021, New Zealand
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Edgbaston, Birmingham, B15 2TH, United Kingdom
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Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
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London, LN, E1 1BB, United Kingdom
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London, LN, SE5 9RS, United Kingdom
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London, LN, SW17 ORE, United Kingdom
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London, LN, W2 1NY, United Kingdom
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Birmingham, B9 5SS, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Edinburgh, EH16 4SA, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Frimley, GU46 6HU, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Glasgow, G4 0SF, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SW10 9NH, United Kingdom
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Manchester, M85RB, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
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Oxford, OX3 9DU, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
Unknown Facility
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
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.
PMID: 26248087RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2013
First Posted
October 14, 2013
Study Start
September 24, 2013
Primary Completion
January 7, 2015
Study Completion
July 7, 2016
Last Updated
June 20, 2017
Results First Posted
February 5, 2016
Record last verified: 2017-05