Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Gilead Sciences Identifier:
First received: February 25, 2014
Last updated: December 8, 2015
Last verified: December 2015

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.

Condition Intervention Phase
Hepatitis C Virus
Drug: RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

  • Incidence of adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with sustained virologic response at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 is defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

  • Proportion of participants with HCV RNA < LLOQ on treatment [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • For retreatment group only: Proportion of participants with HCV RNA < LLOQ on treatment [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Change in HCV RNA from baseline [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with virologic failure [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]
    Virologic failure is defined as virologic breakthrough (participant achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment), nonresponse (HCV RNA ≥ LLOQ through 12 weeks of treatment), or relapse (participant achieved undetectable HCV RNA levels during treatment maintained undetectable HCV RNA for the duration of treatment or achieved undetectable HCV RNA within 4 weeks of the end of treatment but did not achieve SVR at 4, 12, or 24 weeks posttreatment).

  • For retreatment group only: Proportion of participants with sustained virologic response at 4, 12 and 24 weeks after discontinuation of therapy (SVR4, SVR12, and SVR24) [ Time Frame: Posttreatment Weeks 4, 12, and 24 ] [ Designated as safety issue: No ]
  • Proportion of participants that maintain HIV-1 RNA < 50 copies/mL while on treatment [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline of serum creatinine at end of treatment, posttreatment weeks 12 and 24 [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]

Enrollment: 335
Study Start Date: February 2014
Study Completion Date: December 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDV/SOF 12 weeks
Participants will receive LDV/SOF for 12 weeks.
Ledipasvir 90 mg /sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: Retreatment substudy
Participants in the retreatment substudy will receive LDV/SOF plus RBV for 24 weeks.
Ledipasvir 90 mg /sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Drug: RBV
Ribavirin (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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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 identifier: NCT02073656

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35294-2170
United States, California
Los Angeles, California, United States, 90027
Newport Beach, California, United States, 92663
Palo Alto, California, United States, 94304-5350
Sacramento, California, United States, 95817
San Diego, California, United States, 92103
San Francisco, California, United States, 94110
Torrance, California, United States, 90502
United States, Colorado
Denver, Colorado, United States, 80209
United States, District of Columbia
Washington, District of Columbia, United States, 20815
United States, Florida
Bradenton, Florida, United States, 34209
Miami, Florida, United States, 33136
Orlando, Florida, United States, 32803
Tampa, Florida, United States, 33614
United States, Georgia
Atlanta, Georgia, United States, 30312
Decatur, Georgia, United States, 30033
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Maryland
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Missouri
Kansas City, Missouri, United States, 64111
United States, New Mexico
Santa Fe, New Mexico, United States, 87505
United States, New York
Bronx, New York, United States, 10468
New York, New York, United States, 10065
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati, Ohio, United States, 45267-0595
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18102
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, Texas
Dallas, Texas, United States, 75235
Houston, Texas, United States, 77004
United States, Virginia
Annandale, Virginia, United States, 22003
Richmond, Virginia, United States, 23298-0341
United States, Washington
Seattle, Washington, United States, 98104
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Montreal, Quebec, Canada, H2L 5B1
New Zealand
Auckland, New Zealand, 1142
Christchurch, New Zealand, 8011
Puerto Rico
San Juan, Puerto Rico, 00936-5607
Sponsors and Collaborators
Gilead Sciences
Study Director: Jenny Yang, PharmD Gilead Sciences
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gilead Sciences Identifier: NCT02073656     History of Changes
Other Study ID Numbers: GS-US-337-0115 
Study First Received: February 25, 2014
Last Updated: December 8, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
New Zealand: Medsafe

Keywords provided by Gilead Sciences:
genotype 1
genotype 4

Additional relevant MeSH terms:
Hepatitis C
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Parasitic Diseases
Antiviral Agents
Anti-Infective Agents processed this record on September 26, 2016