Clinical trial NCT01826981: Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
Official title: A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-04-09
Enrollment: 359
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 purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.


Eligibility criteria: Inclusion Criteria:

* Chronic genotype 1, 2, 3, or 6 HCV infection
* Cirrhosis determination; a liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

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 With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
timeFrame: Up to 24 weeks plus 30 days
Secondary outcomes:
measure: Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
timeFrame: Weeks 1 and 2
measure: Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
timeFrame: Weeks 4, 6, and 8
measure: Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
timeFrame: Week 10
measure: Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
timeFrame: Week 12
measure: Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
timeFrame: Weeks 16, 20, and 24
measure: Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
timeFrame: Posttreatment Weeks 2, 4, 8, and 24
measure: For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)
timeFrame: Posttreatment Weeks 16 and 20
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: Up to Posttreatment Week 24
measure: Percentage of Participants Experiencing Viral Relapse
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies Ltd.
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust
Study officials:
affiliation: Gilead Sciences
name: Robert H Hyland, DPhil
role: STUDY_DIRECTOR
References:
citation: Gane EJ, Hyland RH, An D, Svarovskaia E, Pang PS, Brainard D, Stedman CA. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015 Nov;149(6):1454-1461.e1. doi: 10.1053/j.gastro.2015.07.063. Epub 2015 Aug 7.
citation: Gane EJ, Hyland RH, An D, Svarovskaia ES, Brainard D, McHutchison JG. Ledipasvir and sofosbuvir for HCV infection in patients coinfected with HBV. Antivir Ther. 2016;21(7):605-609. doi: 10.3851/IMP3066. Epub 2016 Jul 1.