Clinical trial NCT02346721: Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
Official title: An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Keywords: Sofosbuvir
SOF/GS-5816
GS-5816
Hepatitis C
HCV
Cirrhosis
Velpatasvir
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.


Eligibility criteria: Key Inclusion Criteria:

* Willing and able to provide written informed consent
* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
* Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138
* HCV RNA ≥ 10\^4 IU/mL at screening
* Classification as treatment naive or treatment experienced
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

* Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
* Screening electrocardiogram (ECG) with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at screening
* Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 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 12 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 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 While on Treatment
timeFrame: Baseline to Week 12
measure: HCV RNA Change From Baseline
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Richmond
country: United States
state: Virginia
city: Antwerp
country: Belgium
city: Brussels
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Montreal
country: Canada
state: Quebec
city: Toronto
country: Canada
city: Clermont-Ferrand
country: France
city: Clichy
country: France
city: Creteil
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Paris
country: France
city: Pessac
country: France
city: Toulouse
country: France
city: Villejuif
country: France
city: Duesseldorf
country: Germany
state: North Rhine-Westphalia
city: Koln
country: Germany
state: NRW
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: München
country: Germany
city: Hong Kong
country: Hong Kong
city: San Giovanni Rotondo
country: Italy
state: Foggia
city: Firenze
country: Italy
city: San Juan
country: Puerto Rico
city: Plymouth
country: United Kingdom
state: Devon
city: Portsmouth
country: United Kingdom
state: Hampshire
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Oxford
country: United Kingdom
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Asselah T, Shafran S, Bourgeois S, Lai CL, Cramp M, Mathurin P, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in HCV Infected Patients Previously Treated With Placebo: Results of the Deferred Treatment Study (GS-US-342-1446 Study) [Abstract SAT-279]. J Hepatology 2016;64:S827-8.
citation: Asselah T, Shafran SD, Bourgeois S, Lai CL, Mathurin P, Willems B, Nguyen MH, Davis MN, Huang KC, Svarovskaia E, Osinusi A, McNally J, Brainard DM, Shaikh OS, Tran TT. Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. J Viral Hepat. 2019 Oct;26(10):1229-1232. doi: 10.1111/jvh.13159. Epub 2019 Aug 4.