Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection
1 other identifier
interventional
335
4 countries
41
Brief Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1. Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2014
41 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
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 25, 2014
CompletedFirst Posted
Study publicly available on registry
February 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
October 21, 2016
CompletedNovember 16, 2018
August 1, 2016
9 months
February 25, 2014
August 30, 2016
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 12 weeks
Secondary Outcomes (10)
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Weeks 1, 2, 4, 6, 8, 10, and 12
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
Baseline; Weeks 1, 2, 4, 6, and 8
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 24
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment
Weeks 4, 8, and 12
- +5 more secondary outcomes
Study Arms (2)
LDV/SOF 12 Weeks
EXPERIMENTALLDV/SOF for 12 weeks
Retreatment Substudy
EXPERIMENTALLDV/SOF plus RBV for 24 weeks
Interventions
90/400 mg FDC tablet administered orally once daily
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)
Eligibility Criteria
You may qualify if:
- HCV RNA ≥ 10,000 IU/mL at screening
- HCV genotype 1 or 4
- HIV-1 infection
- Cirrhosis determination, a fibroscan or liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male
You may not qualify if:
- Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol
- Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC), or other malignancy (with the exception of certain resolved skin cancers)
- Hepatitis B virus (HBV) infection
- Pregnant or nursing female
- Chronic use of systemically administered immunosuppressive agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (41)
Unknown Facility
Birmingham, Alabama, 35294-2170, United States
Unknown Facility
Los Angeles, California, 90027, United States
Unknown Facility
Newport Beach, California, 92663, United States
Unknown Facility
Palo Alto, California, 94304-5350, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Francisco, California, 94110, United States
Unknown Facility
Torrance, California, 90502, United States
Unknown Facility
Denver, Colorado, 80209, United States
Unknown Facility
Washington D.C., District of Columbia, 20815, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
Atlanta, Georgia, 30312, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Lutherville, Maryland, 21093, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Kansas City, Missouri, 64111, United States
Unknown Facility
Santa Fe, New Mexico, 87505, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
The Bronx, New York, 10468, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cincinnati, Ohio, 45267-0595, United States
Unknown Facility
Allentown, Pennsylvania, 18102, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Providence, Rhode Island, 02906, United States
Unknown Facility
Dallas, Texas, 75235, United States
Unknown Facility
Houston, Texas, 77004, United States
Unknown Facility
Annandale, Virginia, 22003, United States
Unknown Facility
Richmond, Virginia, 23298-0341, United States
Unknown Facility
Seattle, Washington, 98104, United States
Unknown Facility
Vancouver, British Columbia, V6Z 1Y6, Canada
Unknown Facility
Ottawa, Ontario, K1H 8L6, Canada
Unknown Facility
Toronto, Ontario, M5G 2N2, Canada
Unknown Facility
Montreal, Quebec, H2L 5B1, Canada
Unknown Facility
Auckland, 1142, New Zealand
Unknown Facility
Christchurch, 8011, New Zealand
Unknown Facility
San Juan, 00936-5607, Puerto Rico
Related Publications (5)
Cooper C, Naggie S, Saag M, Yang JC, Stamm LM, Dvory-Sobol H, et al. Retreatment of Patients Who Failed 12 Weeks of Ledipasvir/Sofosbuvir-Based Regimens with Ledipasvir/Sofosbuvir with Ribavirin for 24 Weeks [Poster Presentation]. 23nd Conference on Retroviruses and Opportunistic Infections (CROI); 2016 February 22-25; Boston, MA.
RESULTNaggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ, Marks K, Luetkemeyer A, Baden RP, Sax PE, Gane E, Santana-Bagur J, Stamm LM, Yang JC, German P, Dvory-Sobol H, Ni L, Pang PS, McHutchison JG, Stedman CA, Morales-Ramirez JO, Brau N, Jayaweera D, Colson AE, Tebas P, Wong DK, Dieterich D, Sulkowski M; ION-4 Investigators. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):705-13. doi: 10.1056/NEJMoa1501315. Epub 2015 Jul 21.
PMID: 26196665RESULTNaggie S, Cooper C, Saag M, Stamm LM, Yang JC, Pang PS, et al. Ledipasvir/Sofosbuvir for 12 Weeks in Patients Coinfected With HCV and HIV-1 [Oral Presentation]. 22nd Conference on Retroviruses and Opportunistic Infections (CROI); 2015 February 23-26; Seattle, WA.
RESULTCooper C, Naggie S, Saag M, Yang JC, Stamm LM, Dvory-Sobol H, Han L, Pang PS, McHutchison JG, Dieterich D, Sulkowski M. Successful Re-treatment of Hepatitis C Virus in Patients Coinfected With HIV Who Relapsed After 12 Weeks of Ledipasvir/Sofosbuvir. Clin Infect Dis. 2016 Aug 15;63(4):528-31. doi: 10.1093/cid/ciw349. Epub 2016 May 25.
PMID: 27225242RESULTSaeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferriere V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study; Cohen J, Conway B, Cooper C, Cote P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6.
PMID: 26743093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Jenny Yang, PharmD
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2014
First Posted
February 27, 2014
Study Start
February 1, 2014
Primary Completion
November 1, 2014
Study Completion
December 1, 2015
Last Updated
November 16, 2018
Results First Posted
October 21, 2016
Record last verified: 2016-08
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.