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Completed

NCT Number: NCT02613871

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

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.

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Key information

Conditions

Hepatitis C Virus Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Changhua, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LDV/SOF

Drug

90/400 mg FDC tablet administered orally once daily

Other names: Harvoni®, GS-5885/GS-7977

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 25, 2015
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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