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

February 18, 2020 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
      • Beijing, China, 100050
      • Beijing, China, 100034
      • Beijing, China, 100069
      • Beijing, China, 100015
      • 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
      • Busan, Korea, Republic of, 602-739
      • Busan, Korea, Republic of, 614-735
      • Busan, Korea, Republic of, 602-715
      • Daegu, Korea, Republic of, 700-721
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 135-720
      • Seoul, Korea, Republic of, 152-703
      • Seoul, Korea, Republic of, 735-710
    • Gyeonggi-do
      • 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
  • Taiwan
      • Changhua City, Taiwan, 50006
      • Kaohsiung City, Taiwan, 82445
      • Kaohsiung City, Taiwan, 80708
      • Kaohsiung City, Taiwan, 83301
      • Keelung, Taiwan, 20401
      • Taichung City, Taiwan, 40447
      • Tainan City, Taiwan, 70457
      • Tainan city, Taiwan, 73657
      • Taipei City, Taiwan, 11217
      • Taipei City, Taiwan, 10048
      • Taipei City, Taiwan, 10449
      • Taoyuan, Taiwan, 33305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Posttreatment Weeks 4 and 24
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).
Up to 12 weeks
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.
Week 12 to Posttreatment Week 24
HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only
Time Frame: Baseline; Week 12
Baseline; Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2013

Primary Completion (Actual)

July 8, 2017

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-337-0131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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