Clinical trial NCT01962441: 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: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: 7977
GS-7977
PSI-7977
Sofosbuvir (SOF)
Pegylated Interferon (Peg-IFN)
Ribavirin (RBV)
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-10-14
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
timeFrame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24
measure: HCV RNA at Weeks 1, 2, 4, 8, and 12
timeFrame: Weeks 1, 2, 4, 8, and 12
measure: Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline; Weeks 1, 2, 4, 8, and 12
measure: Percentage of Participants Experiencing On-Treatment Virologic Failure
timeFrame: Up to 24 weeks
measure: Percentage of Participants Experiencing Viral Relapse
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Novi
country: United States
state: Michigan
city: Saint Paul
country: United States
state: Minnesota
city: Hillsborough
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Binghamton
country: United States
state: New York
city: New York
country: United States
state: New York
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Camperdown
country: Australia
state: New South Wales
city: Kogarah
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Greenslopes
country: Australia
state: Queensland
city: Woolloongabba
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Clayton
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Heidelberg
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Nedlands Perth
country: Australia
state: Western Australia
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Québec
country: Canada
state: Quebec
city: Grafton
country: New Zealand
state: Auckland
city: Grafton
country: New Zealand
state: Auckland
city: Christchurch
country: New Zealand
state: Chatham Islands
city: Hamilton
country: New Zealand
state: Waikato
city: Wellington
country: New Zealand
city: Edgbaston
country: United Kingdom
state: Birmingham
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: London
country: United Kingdom
state: LN
city: London
country: United Kingdom
state: LN
city: London
country: United Kingdom
state: LN
city: London
country: United Kingdom
state: LN
city: Birmingham
country: United Kingdom
city: Bradford
country: United Kingdom
city: Dundee
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Frimley
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Leeds
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Oxford
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Portsmouth
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.