Clinical trial NCT02722837: Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
Official title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-03-30
Enrollment: 119
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 objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.


Eligibility criteria: Key Inclusion Criteria:

* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

Key Exclusion Criteria:

* Any other chronic liver disease
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Clinical hepatic decompensation
* Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor

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 Study Drug Due to an Adverse Event
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
timeFrame: Posttreatment Week 24
measure: Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1
timeFrame: Week 1
measure: Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2
timeFrame: Week 2
measure: Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4
timeFrame: Week 4
measure: Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8
timeFrame: Week 8
measure: Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12
timeFrame: Week 12
measure: Change From Baseline in HCV RNA at Week 1
timeFrame: Baseline (Day 1); Week 1
measure: Change From Baseline in HCV RNA at Week 2
timeFrame: Baseline (Day 1); Week 2
measure: Change From Baseline in HCV RNA at Week 4
timeFrame: Baseline (Day 1); Week 4
measure: Change From Baseline in HCV RNA at Week 8
timeFrame: Baseline (Day 1); Week 8
measure: Change From Baseline in HCV RNA at Week 12
timeFrame: Baseline (Day 1); Week 12
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Center of AIDS Prevention
city: Moscow
country: Russian Federation
facility: Central Research Institute of Epidemiology
city: Moscow
country: Russian Federation
facility: Central Scientific-Research Institute of Epidemiology
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 24
city: Moscow
country: Russian Federation
facility: First Moscow Medical University I.M.Sechenov.
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University I.M. Sechenov
city: Moscow
country: Russian Federation
facility: Limited Liability Company "Clinic Tour"
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Nutrition
city: Moscow
country: Russian Federation
facility: Sklifosovsky Scientific Research Institution of Emergency Care
city: Saint Petersburg
country: Russian Federation
facility: Center for Prevention and Control of AIDS and Infectious Diseases
city: Saint Petersburg
country: Russian Federation
facility: Kirov Medical Military Academy
city: Saint Petersburg
country: Russian Federation
facility: North-Western State Medical University named after I.I. Mechnikov
city: Samara
country: Russian Federation
facility: LLC Medical Company "Hepatolog"
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetsjukhuset
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Weiland O, Zhdanov K, Chulanov VP, McNabb BL, Lu S, Svarovskaia EU, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-3 HCV Infected Russian and Swedish Population: Results from a Phase 3, Prospective Trial [Abstract 1186]. Hepatology 2017;66 (1):639A.
citation: Isakov V, Chulanov V, Abdurakhmanov D, Burnevich E, Nurmukhametova E, Kozhevnikova G, Gankina N, Zhuravel S, Romanova S, Hyland RH, Lu S, Svarovskaia ES, McNally J, Brainard DM, Ivashkin V, Morozov V, Bakulin I, Lagging M, Zhdanov K, Weiland O. Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden. Infect Dis (Lond). 2019 Feb;51(2):131-139. doi: 10.1080/23744235.2018.1535186. Epub 2018 Nov 30.