Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

Hepatitis C Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722837
• Other study ID #: GS-US-342-1522
• Secondary ID: 2015-003001-42
• Status: Completed
• Phase: Phase 3
• Start date: April 4, 2016
• Est. completion date: September 13, 2017

Study information

• Verified date: June 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 13, 2017
• Est. primary completion date: June 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Virus Diseases

Intervention

Drug:
• SOF/VEL
400/100 mg FDC tablet administered orally once daily

Locations

Country	Name	City	State
Russian Federation	Krasnoyarsk Regional Center of AIDS Prevention	Krasnoyarsk
Russian Federation	Central Research Institute of Epidemiology	Moscow
Russian Federation	Central Scientific-Research Institute of Epidemiology	Moscow
Russian Federation	City Clinical Hospital # 24	Moscow
Russian Federation	First Moscow Medical University I.M.Sechenov.	Moscow
Russian Federation	First Moscow State Medical University I.M. Sechenov	Moscow
Russian Federation	Limited Liability Company "Clinic Tour"	Moscow
Russian Federation	Scientific Research Institute of Nutrition	Moscow
Russian Federation	Sklifosovsky Scientific Research Institution of Emergency Care	Moscow
Russian Federation	Center for Prevention and Control of AIDS and Infectious Diseases	Saint Petersburg
Russian Federation	Kirov Medical Military Academy	Saint Petersburg
Russian Federation	North-Western State Medical University named after I.I. Mechnikov	Saint Petersburg
Russian Federation	LLC Medical Company "Hepatolog"	Samara
Sweden	Sahlgrenska Universitetsjukhuset	Göteborg
Sweden	Karolinska University Hospital Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

Russian Federation,  Sweden, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event		Up to 12 weeks
Secondary	Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.	Posttreatment Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)	SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.	Posttreatment Week 24
Secondary	Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1		Week 1
Secondary	Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2		Week 2
Secondary	Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4		Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8		Week 8
Secondary	Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12		Week 12
Secondary	Change From Baseline in HCV RNA at Week 1		Baseline (Day 1); Week 1
Secondary	Change From Baseline in HCV RNA at Week 2		Baseline (Day 1); Week 2
Secondary	Change From Baseline in HCV RNA at Week 4		Baseline (Day 1); Week 4
Secondary	Change From Baseline in HCV RNA at Week 8		Baseline (Day 1); Week 8
Secondary	Change From Baseline in HCV RNA at Week 12		Baseline (Day 1); Week 12
Secondary	Percentage of Participants With Virologic Failure	Virologic failure was defined as: Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while on treatment), or; Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment), or; Relapse (HCV RNA = LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)	Up to Posttreatment Week 24