Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
2 other identifiers
interventional
153
2 countries
20
Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with 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 P25-P50 for phase_3
Started Jun 2015
Shorter than P25 for phase_3
20 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
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 16, 2015
CompletedStudy Start
First participant enrolled
June 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2016
CompletedResults Posted
Study results publicly available
May 10, 2017
CompletedNovember 16, 2018
March 1, 2017
10 months
June 12, 2015
March 30, 2017
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Posttreatment Week 12
Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)
Up to 12 weeks
Secondary Outcomes (6)
Percentage of Participants With Sustained Virologic Response (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 on Treatment
Up to 12 weeks
HCV RNA Change From Day 1
Up to 12 weeks
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 24
Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
Up to Posttreatment Week 4
- +1 more secondary outcomes
Study Arms (3)
LDV/SOF
EXPERIMENTALTreatment-naive participants with genotype 1 HCV infection without cirrhosis will receive LDV/SOF FDC for 8 weeks.
LDV/SOF Coinfected with HIV-1
EXPERIMENTALTreatment-naive participants with genotype 1 HCV infection without cirrhosis and who are coinfected with HIV-1 will receive LDV/SOF FDC for 8 weeks.
LDV/SOF+RBV Retreatment
EXPERIMENTALParticipants with genotype 1 or 3 HCV infection who failed to achieve SVR12 in Gilead Study GS-US-334-0119 will receive LDV/SOF FDC + RBV for 12 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 not qualify if:
- Chronic genotype 1 HCV infection
- HCV treatment-naive
- HCV RNA \> 10,000 IU/mL at screening
- Absence of cirrhosis
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
- Pregnant or nursing female or male with pregnant female partner
- Infection with hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- 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
- For HIV-1/HCV co-infected individuals:
- Opportunistic infection within 6 months prior to screening
- Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline
- Treatment with an antiretroviral (ARV) regimen other than one of those listed in the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (20)
Unknown Facility
Tallinn, 10167, Estonia
Unknown Facility
Tartu, 51014, Estonia
Unknown Facility
Krasnoyarsk, 660049, Russia
Unknown Facility
Moscow, 105275, Russia
Unknown Facility
Moscow, 107014, Russia
Unknown Facility
Moscow, 111123, Russia
Unknown Facility
Moscow, 115446, Russia
Unknown Facility
Moscow, 117593, Russia
Unknown Facility
Moscow, 119435, Russia
Unknown Facility
Moscow, 119991, Russia
Unknown Facility
Moscow, 125367, Russia
Unknown Facility
Moscow, 127015, Russia
Unknown Facility
Moscow, 129090, Russia
Unknown Facility
Moscow, 129110, Russia
Unknown Facility
Saint Petersburg, 190103, Russia
Unknown Facility
Saint Petersburg, 194044, Russia
Unknown Facility
Samara, 443063, Russia
Unknown Facility
Stavropol, 355017, Russia
Unknown Facility
Tyumen, 625026, Russia
Unknown Facility
Yekaterinburg, 620102, Russia
Related Publications (2)
Zhdanov K., Morozov V., Orlova-Morozova E.A., Salupere R., Kozhevnikova G., et al. Preliminary Results of an Evaluation of Ledipasvir/Sofosbuvir in Treatment-Naive Patients with Chronic HCV or HCV/HIV Co-Infection and Retreatment of Sofosbuvir-treated Patients. 8th International Conference of the White Nights of Hepatology. Saint Petersburg, Russia. June 2-3, 2016. Oral presentation.
RESULTIsakov V, Gankina N, Morozov V, Kersey K, Lu S, Osinusi A, Svarovskaia E, Brainard DM, Salupere R, Orlova-Morozova E, Zhdanov K. Ledipasvir-Sofosbuvir for 8 Weeks in Non-Cirrhotic Patients with Previously Untreated Genotype 1 HCV Infection +/- HIV-1 Co-Infection. Clin Drug Investig. 2018 Mar;38(3):239-247. doi: 10.1007/s40261-017-0606-0.
PMID: 29177645DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 16, 2015
Study Start
June 17, 2015
Primary Completion
March 30, 2016
Study Completion
June 30, 2016
Last Updated
November 16, 2018
Results First Posted
May 10, 2017
Record last verified: 2017-03
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.