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

Primary Purpose

Hepatitis C Virus Infection

Status

Completed

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

LDV/SOF

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LDV/SOF

Arm Description

LDV/SOF FDC for 12 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.

Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug

Secondary Outcome Measures

Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.

Percentage of Participants With HCV RNA < LLOQ While on Treatment

LLOQ = 15 IU/mL

Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108

LLOQ = 15 IU/mL

HCV RNA Change From Baseline While on Treatment

Percentage of Participants With Virologic Failure

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)

Plasma HBV DNA Change From Baseline While on Treatment

Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

HBsAg Level Change From Baseline While on Treatment

HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

Serum LOXL-2 Level Change From Baseline While on Treatment

Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36

Percentage of Participants That Required HBV Therapy During the Study

Fibrosis Status as Assessed by Fibroscan Score at 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

Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study

Full Information

NCT ID

NCT02613871

First Posted

November 23, 2015

Last Updated

February 18, 2020

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02613871

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

December 22, 2015 (Actual)

Primary Completion Date

January 4, 2017 (Actual)

Study Completion Date

November 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Virus Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

111 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDV/SOF

Arm Type

Experimental

Arm Description

LDV/SOF FDC for 12 weeks

Intervention Type

Drug

Intervention Name(s)

LDV/SOF

Other Intervention Name(s)

Harvoni®, GS-5885/GS-7977

Intervention Description

90/400 mg FDC tablet administered orally once daily

Primary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Description

SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.

Time Frame

Posttreatment Week 12

Title

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 Measure Information:

Title

Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

Description

SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.

Time Frame

Posttreatment Week 4

Title

Percentage of Participants With HCV RNA < LLOQ While on Treatment

Description

LLOQ = 15 IU/mL

Time Frame

Weeks 1, 2, 4, 8, and 12

Title

Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108

Description

LLOQ = 15 IU/mL

Time Frame

Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108

Title

HCV RNA Change From Baseline While on Treatment

Time Frame

Weeks 1, 2, 4, 8, and 12

Title

Percentage of Participants With Virologic Failure

Description

Time Frame

First dose date up to Posttreatment Week 12

Title

Plasma HBV DNA Change From Baseline While on Treatment

Time Frame

Weeks 1, 2, 4, 8, and 12

Title

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

Title

HBsAg Level Change From Baseline While on Treatment

Time Frame

Weeks 1, 2, 4, 8, and 12

Title

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

Title

Serum LOXL-2 Level Change From Baseline While on Treatment

Time Frame

Weeks 1, 2, 4, 8, and 12

Title

Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36

Time Frame

Posttreatment Weeks 4, 12, and 36

Title

Percentage of Participants That Required HBV Therapy During the Study

Time Frame

First dose date up to Posttreatment Week 108

Title

Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108

Description

Time Frame

Posttreatment Weeks 12, 60, and 108

Title

Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study

Time Frame

First dose date up to Posttreatment Week 108

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

City

Changhua

Country

Taiwan

City

Chiayi City

Country

Taiwan

City

Kaohsiung City

Country

Taiwan

City

Kaohsiung

Country

Taiwan

City

Keelung

Country

Taiwan

City

Taichung

Country

Taiwan

City

Tainan City

Country

Taiwan

City

Tainan

Country

Taiwan

City

Taipei City

Country

Taiwan

City

Taipei

Country

Taiwan

City

Taoyuan

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

Citations:

Citation

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.

Results Reference

result

Citation

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.

Results Reference

result

PubMed Identifier

29174546

Citation

Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, Chang TT, Massetto B, Yang JC, Yun C, Knox SJ, Osinusi A, Camus G, Jiang D, Brainard DM, McHutchison JG, Hu TH, Hsu YC, Lo GH, Chu CJ, Chen JJ, Peng CY, Chien RN, Chen PJ. Efficacy of Ledipasvir and Sofosbuvir Treatment of HCV Infection in Patients Coinfected With HBV. Gastroenterology. 2018 Mar;154(4):989-997. doi: 10.1053/j.gastro.2017.11.011. Epub 2017 Nov 22.

Results Reference

result

Citation

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.

Results Reference

result

PubMed Identifier

34864948

Citation

Liu CJ, Sheen IS, Chen CY, Chuang WL, Wang HY, Tseng KC, Chang TT, Yang J, Massetto B, Suri V, Camus G, Jiang D, Zhang F, Gaggar A, Hu TH, Hsu YC, Lo GH, Chu CJ, Chen JJ, Peng CY, Chien RN, Chen PJ. Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment. Clin Infect Dis. 2022 Aug 31;75(3):453-459. doi: 10.1093/cid/ciab971.

Results Reference

derived

Learn more about this trial

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

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