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Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
This study has been completed.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01726517
First received: November 10, 2012
Last updated: November 7, 2014
Last verified: November 2014
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Purpose
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Hepatitis C Virus | Drug: LDV/SOF Drug: RBV | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection |
Resource links provided by NLM:
MedlinePlus related topics:
Hepatitis C
Drug Information available for:
Ribavirin
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.
- Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Baseline to Week 12 ]The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.
Secondary Outcome Measures:
- Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24) [ Time Frame: Posttreatment Weeks 2, 4, 8, and 24 ]SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.
- Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse [ Time Frame: Baseline to Posttreatment Week 24 ]
- Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
- Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
| Enrollment: | 100 |
| Study Start Date: | October 2012 |
| Study Completion Date: | January 2014 |
| Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: LDV/SOF 8 Weeks (TN)
Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks.
|
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Name: Harvoni®
|
|
Experimental: LDV/SOF+RBV 8 Weeks (TN)
Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks.
|
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Name: Harvoni®
Drug: RBV
RBV 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)
|
|
Experimental: LDV/SOF 12 Weeks (TN)
Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks.
|
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Name: Harvoni®
|
|
Experimental: LDV/SOF 12 Weeks (TE)
Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks.
|
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Name: Harvoni®
|
|
Experimental: LDV/SOF+RBV 12 Weeks (TE)
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.
|
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Name: Harvoni®
Drug: RBV
RBV 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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years, with chronic genotype 1 HCV infection
- HCV RNA equal to or greater than 10,000 IU/mL at screening
- 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
- Current or prior history of clinical hepatic decompensation
- 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 subject treatment, assessment or compliance with the protocol
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726517
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726517
Locations
| United States, Texas | |
| San Antonio, Texas, United States, 78215 | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Rob Hyland | Gilead Sciences |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01726517 History of Changes |
| Other Study ID Numbers: |
GS-US-337-0118 |
| Study First Received: | November 10, 2012 |
| Results First Received: | November 7, 2014 |
| Last Updated: | November 7, 2014 |
Keywords provided by Gilead Sciences:
|
HCV genotype 1 (GT-1) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 GS-5885 |
Ribavirin Open Label Sofosbuvir Treatment-Naïve Protease Inhibitors PI |
Additional relevant MeSH terms:
|
Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases |
Digestive System Diseases Ribavirin Sofosbuvir Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 27, 2017