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Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021656
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : December 28, 2018
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.

Condition or disease Intervention/treatment Phase
Chronic HCV Infection Drug: LDV/SOF Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 384 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
Actual Study Start Date : December 10, 2013
Actual Primary Completion Date : July 8, 2017
Actual Study Completion Date : September 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C
Drug Information available for: Sofosbuvir

Arms and Interventions
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Arm Intervention/treatment
Experimental: LDV/SOF
Treatment-experienced and treatment-naive participants will receive LDV/SOF for 12 weeks.
 Drug: LDV/SOF
90/400 mg FDC tablet administered orally once daily without regard to food
Other Names:
  • Harvoni®
  • GS-5885/GS-7977


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 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 in Korea and Taiwan and < 15 IU/mL in China) 12 weeks following the last dose of study drug.

  2. Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage 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 ]
    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

  2. Percentage of Participants Experiencing Viral Breakthrough [ Time Frame: Up to 12 weeks ]
    Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR).

  3. Percentage of Participants Experiencing Viral Relapse [ Time Frame: Week 12 to Posttreatment Week 24 ]
    Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.

  4. HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only [ Time Frame: Baseline; Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL at screening
  • HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
  • Genotype 1 HCV at screening
  • HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

Key Exclusion Criteria:

  • Pregnant or nursing female
  • Chronic liver disease of a non-HCV etiology
  • Current or prior history of any clinically-significant illness (other than HCV)
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021656


Locations
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China
Beijing, China, 100015
Beijing, China, 100034
Beijing, China, 100044
Beijing, China, 100050
Beijing, China, 100069
Chongqing, China, 400010
Guangdong, China, 510515
Guangxi, China, 530021
Hubei, China, 430030
Hunan, China, 410011
Jiangxi, China, 210029
Jiangxi, China, 330006
Jilin, China, 130021
Shandong, China, 250021
Shanghai, China, 200025
Shanghai, China, 200083
Shijiazhuang, China, 050051
Sichuan, China, 610041
Korea, Republic of
Ansan-si, Gyeonggi-do, Korea, Republic of, 425-707
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Incheon, Gyeonggi-do, Korea, Republic of, 405-760
Seongnam-si, Gyeonggi-do, Korea, Republic of, 467-707
Busan, Korea, Republic of, 602-715
Busan, Korea, Republic of, 602-739
Busan, Korea, Republic of, 614-735
Daegu, Korea, Republic of, 700-721
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 135-720
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 152-703
Seoul, Korea, Republic of, 735-710
Taiwan
Changhua City, Taiwan, 50006
Kaohsiung City, Taiwan, 80708
Kaohsiung City, Taiwan, 82445
Kaohsiung City, Taiwan, 83301
Keelung, Taiwan, 20401
Taichung City, Taiwan, 40447
Tainan City, Taiwan, 70457
Tainan city, Taiwan, 73657
Taipei City, Taiwan, 10048
Taipei City, Taiwan, 10449
Taipei City, Taiwan, 11217
Taoyuan, Taiwan, 33305
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] May 28, 2013
Study Protocol: Amendment 2  [PDF] August 1, 2014
Study Protocol: Amendment 3  [PDF] February 12, 2016
Statistical Analysis Plan  [PDF] July 28, 2017

More Information
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Publications of Results:
Wei L, Xie Q, Hou JL, et al. Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3 Clinical Trial. Poster No. 1191, AASLD 2017.
Wei L, Xie Q, Hou JL, et al. Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3 Clinical Trial., [Abstract 1191]. The Liver Meeting® 2017 - The 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2017 20-24 October; Washington, D. C.

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02021656    
Other Study ID Numbers: GS-US-337-0131
First Posted: December 27, 2013    Key Record Dates
Results First Posted: December 28, 2018
Last Update Posted: March 5, 2020
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
 Liver Diseases
Digestive System Diseases
Sofosbuvir
Ledipasvir, sofosbuvir drug combination
Ledipasvir
Antiviral Agents
Anti-Infective Agents