Clinical trial NCT02607735: Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
Official title: A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 416
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: The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.

Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.


Eligibility criteria: Key Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic HCV infection (≥ 6 months)
* Treatment experienced with a direct acting antiviral medication for HCV
* Use of protocol specified methods of contraception

Key Exclusion Criteria:

* Current or prior history of clinically significant illness that may interfere with participation in the study
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at screening
* Pregnant or nursing female
* Chronic liver disease not caused by HCV
* 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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
timeFrame: Weeks 1, 2, 4, 8 and 12
measure: Change From Baseline in HCV RNA (Primary Study)
timeFrame: Baseline; Weeks 1, 2, 4, 8 and 12
measure: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)
timeFrame: Posttreatment Week 24
measure: Percentage of Participants With Virologic Failure (Primary Study)
timeFrame: Up to Posttreatment Week 24
measure: Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
timeFrame: Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)
measure: Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
timeFrame: Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)
measure: Change From Baseline in HCV RNA (Deferred Treatment Substudy)
timeFrame: Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)
measure: Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)
timeFrame: Up to Posttreatment Week 24 (Deferred Treatment Substudy)
Other outcomes:
Locations:
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Rialto
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: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
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: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Catonsville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Hillsborough
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Philadelphia
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: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Falls Church
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Camperdown
country: Australia
state: New South Wales
city: Darlinghurst
country: Australia
state: New South Wales
city: Herston
country: Australia
state: Queensland
city: Clayton
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Brampton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Clermont-Ferrand
country: France
city: Clichy
country: France
city: Creteil
country: France
city: Grenoble
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Paris
country: France
city: Pessac
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Vandoeuvre-les-Nancy
country: France
city: Villejuif
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Frankfurt am Main
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Köln
country: Germany
city: Christchurch
country: New Zealand
city: Grafton
country: New Zealand
city: San Juan
country: Puerto Rico
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Portsmouth
country: United Kingdom
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Bourlière M, Gordon SC, Ramji A, Ravendhran N, Tran TT, Hyland RH, et al. Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients with Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study [Abstract 194]. J Hepatology 2016;63 (1S):102A.
citation: Younossi ZM, Stepanova M, Gordon S, Zeuzem S, Mann MP, Jacobson I, Bourliere M, Cooper C, Flamm S, Reddy KR, Kowdley K, Younossi I, Hunt S. Patient-Reported Outcomes Following Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir. Clin Gastroenterol Hepatol. 2018 Apr;16(4):567-574.e6. doi: 10.1016/j.cgh.2017.11.023. Epub 2017 Nov 16.
citation: Bourliere M, Gordon SC, Schiff ER, Tran TT, Ravendhran N, Landis CS, Hyland RH, Stamm LM, Zhang J, Dvory-Sobol H, Subramanian GM, Brainard DM, McHutchison JG, Serfaty L, Thompson AJ, Sepe TE, Curry MP, Reddy KR, Manns MP. Deferred treatment with sofosbuvir-velpatasvir-voxilaprevir for patients with chronic hepatitis C virus who were previously treated with an NS5A inhibitor: an open-label substudy of POLARIS-1. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):559-565. doi: 10.1016/S2468-1253(18)30118-3. Epub 2018 May 31.
citation: Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.