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
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection
1 other identifier
interventional
359
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
September 16, 2016
CompletedNovember 16, 2018
September 1, 2016
1.9 years
April 1, 2013
July 28, 2016
October 19, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Up to 24 weeks plus 30 days
Secondary Outcomes (9)
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Weeks 1 and 2
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Weeks 4, 6, and 8
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 10
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 12
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Weeks 16, 20, and 24
- +4 more secondary outcomes
Study Arms (15)
Cohort 1,Group 1: LDV/SOF + RBV 12 wk (GT1 SOF retreatment)
EXPERIMENTALLDV/SOF + RBV for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir study
Cohort 1,Group 2:SOF+Peg-IFN+RBV 12 wk (GT2,3 SOF retreatment)
EXPERIMENTALSOF + PEG + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, liver disease)
EXPERIMENTALLDV/SOF+RBV for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Cohort 2,Group 2: LDV/SOF+GS-9669 12wk (GT1 TE, liver disease)
EXPERIMENTALLDV/SOF + GS-9669 for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
EXPERIMENTALLDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
EXPERIMENTALLDV/SOF + RBV for 12 weeks in treatment-naive participants with genotype 3 HCV infection
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
EXPERIMENTALLDV/SOF for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
EXPERIMENTALLDV/SOF + RBV for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 cirrhotic CPT B)
EXPERIMENTALLDV/SOF for 12 weeks in participants with genotype 1 HCV infection and Child-Pugh Turcotte (CPT) B cirrhosis
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN noncirrhotic)
EXPERIMENTALSOF+VEL (25 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Cohort 4,Group 2:SOF+VEL 25mg+RBV 8 wk (GT3 TN noncirrhotic)
EXPERIMENTALSOF+VEL(25 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN noncirrhotic)
EXPERIMENTALSOF+VEL (100 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN noncirrhotic)
EXPERIMENTALSOF+VEL (100 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Cohort 5,Group 1: LDV/SOF + RBV 24 wk (SOF retreatment)
EXPERIMENTALLDV/SOF+RBV for 24 weeks in participants with genotype 1, 2, 3, or 6 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HBV coinfection)
EXPERIMENTALLDV/SOF for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Interventions
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
SOF 400 mg tablet administered orally once daily
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly
GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily
Velpatasvir (VEL) tablet(s) administered orally once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (2)
Auckland Clinical Studies Ltd.
Auckland, New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Related Publications (2)
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.
PMID: 26261007RESULTGane 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.
PMID: 27367295RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were no limitations affecting the analysis or results.
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Robert H Hyland, DPhil
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2013
First Posted
April 9, 2013
Study Start
April 1, 2013
Primary Completion
March 1, 2015
Study Completion
May 1, 2015
Last Updated
November 16, 2018
Results First Posted
September 16, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.