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

NCT02613871 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GS-US-337-1655
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 8

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.

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  Posttreatment Week 12

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

  First dose date up to 12 weeks

Secondary Outcomes (14)

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

  Posttreatment Week 4

• Percentage of Participants With HCV RNA < LLOQ While on Treatment

  Weeks 1, 2, 4, 8, and 12

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

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

• HCV RNA Change From Baseline While on Treatment

  Weeks 1, 2, 4, 8, and 12

• Percentage of Participants With Virologic Failure

  First dose date up to Posttreatment Week 12

Study Arms (1)

LDV/SOF

EXPERIMENTAL

LDV/SOF FDC for 12 weeks

Drug: LDV/SOF

Interventions

LDV/SOF DRUG

90/400 mg FDC tablet administered orally once daily

Also known as: Harvoni®, GS-5885/GS-7977

LDV/SOF

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (8)

Unknown Facility

Changhua, Taiwan

Location

Unknown Facility

Chiayi City, Taiwan

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Keelung, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Taoyuan District, Taiwan

Location

Related Publications (5)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 29174546 RESULT

• 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.

  RESULT

• 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.

  PMID: 34864948 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: December 22, 2015
• Primary Completion: January 4, 2017
• Study Completion: November 7, 2018
• Last Updated: March 6, 2020
• Results First Posted: February 13, 2018

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

TW (8)