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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection

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: NCT02613871
Recruitment Status : Completed
First Posted : November 25, 2015
Results First Posted : February 13, 2018
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: LDV/SOF Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection
Actual Study Start Date : December 22, 2015
Actual Primary Completion Date : January 4, 2017
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: LDV/SOF
LDV/SOF FDC for 12 weeks
Drug: LDV/SOF
90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.

  2. Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug [ Time Frame: First dose date up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.

  2. Percentage of Participants With HCV RNA < LLOQ While on Treatment [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
    LLOQ = 15 IU/mL

  3. Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 [ Time Frame: Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 ]
    LLOQ = 15 IU/mL

  4. HCV RNA Change From Baseline While on Treatment [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
  5. Percentage of Participants With Virologic Failure [ Time Frame: First dose date up to Posttreatment Week 12 ]

    Virologic failure was defined as :

    • Breakthrough (confirmed HCV RNA ≥ LLOQ [15 IU/mL] after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or
    • Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)

  6. Plasma HBV DNA Change From Baseline While on Treatment [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
  7. Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 [ Time Frame: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 ]
  8. HBsAg Level Change From Baseline While on Treatment [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
  9. HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 [ Time Frame: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 ]
  10. Serum LOXL-2 Level Change From Baseline While on Treatment [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
  11. Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36 [ Time Frame: Posttreatment Weeks 4, 12, and 36 ]
  12. Percentage of Participants That Required HBV Therapy During the Study [ Time Frame: First dose date up to Posttreatment Week 108 ]
  13. Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108 [ Time Frame: Posttreatment Weeks 12, 60, and 108 ]

    FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:

    • Presence of cirrhosis = FibroScan result of > 12.5 kPa
    • Absence of cirrhosis = FibroScan result of ≤ 12.5 kPa

  14. Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study [ Time Frame: First dose date up to Posttreatment Week 108 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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:

  • Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection
  • Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
  • Cirrhosis determination by Fibroscan
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female or male is of childbearing potential

Key Exclusion Criteria:

  • Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
  • Pregnant or nursing female
  • Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)
  • Hepatocellular carcinoma (HCC) or other malignancy
  • Current or prior history of clinical hepatic decompensation

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


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): NCT02613871


Locations
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Taiwan
Changhua, Taiwan
Chiayi City, Taiwan
Kaohsiung City, Taiwan
Kaohsiung, Taiwan
Keelung, Taiwan
Taichung, Taiwan
Tainan City, Taiwan
Tainan, Taiwan
Taipei City, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications of Results:
Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients With Chronic Hepatitis C and Hepatitis B Coinfection: a Phase 3 Study in Taiwan [Poster SAT-243]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria.
Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Declines in HBsAg Levels Observed During Treatment With Ledispavir/Sofosbuvir in Patients With Chronic Hepatitis B Virus and Hepatitis C Virus Infection [Poster 1083]. 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.
Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients with Chronic Hepatitis C and Hepatitis B Coinfection: A Phase 3 Study in Taiwan [Presentation]. The International Liver Congress™ 2017: European Association for the Study of the Liver (EASL); 2017 19-23 April; Amsterdam, the Netherlands.

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02613871    
Other Study ID Numbers: GS-US-337-1655
First Posted: November 25, 2015    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Coinfection
Hepatitis A
Hepatitis C
Hepatitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Infection
Parasitic Diseases
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents