A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection (ENDURANCE-5 6)

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus (HCV)
• Intervention / Treatment: Drug: Glecaprevir/Pibrentasvir

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital Kingswood /ID# 157027
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital /ID# 157025
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital /ID# 157024
• Belgium
  • Kortrijk, Belgium, 8500
    • AZ Groeninge /ID# 157029
  • Leuven, Belgium, 3000
    • UZ Leuven /ID# 157030
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary /ID# 157031
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital /ID# 157032
• France
  • Clermont Ferrand, France, 63100
    • CHU Estaing /ID# 157034
  • Paris, France, 75012
    • Hopital Saint Antoine /ID# 157036
  • Gironde
    • Pessac CEDEX, Gironde, France, 33604
      • Hopital Haut-Lévêque /ID# 157035
  • Ile-de-France
    • Clichy, Ile-de-France, France, 92110
      • Hopital Beaujon /ID# 157028
• New Zealand
  • Auckland, New Zealand, 1010
    • Auckland Clinical Studies Ltd /ID# 157033
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital /ID# 156855
  • Singapore, Singapore, 169608
    • Singapore General Hospital /ID# 157037
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research Site /ID# 157038
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • University of Cape Town /ID# 157039
• United States
  • California
    • San Diego, California, United States, 92105
      • Research & Education, Inc. /ID# 157042
    • San Diego, California, United States, 92154
      • Kaiser Permanente /ID# 157044
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco Gener /ID# 157040
    • West Hollywood, California, United States, 90048
      • Cedars-Sinai Medical Center - West Hollywood /ID# 157045
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center /ID# 157436
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington /ID# 157041
• Vietnam
  • Hanoi, Vietnam, 100000
    • National Hospital of Tropical Diseases /ID# 162282
  • Ho Chi Minh, Vietnam, 700000
    • Hoa Hao Medic Co. Ltd. /ID# 162283
  • Ho Chi Minh, Vietnam
    • Tropical Diseases Hospital /ID# 162281

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.
• Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at Screening Visit.
• Participant must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-HCV medication) or treatment-experienced (i.e., has failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed greater than or equal to 2 months prior to screening.
• Participant must be documented as having no cirrhosis or compensated cirrhosis.

Exclusion Criteria:

• Female participant who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
• Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
• Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
• HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
• History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glecaprevir/Pibrentasvir for 8 Weeks; Non-cirrhotic participants with hepatitis C virus genotype 5 or 6 received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 8 weeks, according to label.	Drug: Glecaprevir/Pibrentasvir; Fixed-dose combination tablets taken orally once a day.; Other Names: ABT-493/ABT-530; MAVYRET™
Experimental: Glecaprevir/Pibrentasvir for 12 Weeks; Participants with hepatitis C virus genotype 5 or 6 and compensated cirrhosis received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 12 weeks, according to label.	Drug: Glecaprevir/Pibrentasvir; Fixed-dose combination tablets taken orally once a day.; Other Names: ABT-493/ABT-530; MAVYRET™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug.	12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With On-treatment HCV Virologic Failure	HCV virologic failure was defined as one of the following conditions: confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during the Treatment Period; or confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the Treatment Period; or; HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.	8 or 12 weeks (depending on the treatment regimen)
Percentage of Participants With Relapse	Relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.	End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Brown RS Jr, Collins MA, Strasser SI, Emmett A, Topp AS, Burroughs M, Ferreira R, Feld JJ. Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension. Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 2022 Feb 17.
• Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A, Lim SG, Abergel A, Sasadeusz J, Gane E, Zadeikis N, Schnell G, Zhang Z, Porcalla A, Mensa FJ, Nguyen K. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):45-51. doi: 10.1016/S2468-1253(18)30341-8. Epub 2018 Nov 2.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Actual): June 6, 2018
• Study Completion (Actual): August 29, 2018

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: glecaprevir; pibrentasvir; Chronic; non-cirrhotic; compensated cirrhosis; interferon (IFN); Sustained Virologic Response 12 weeks post dosing (SVR12); pegylated interferon (pegIFN); ribavirin (RBV); sofosbuvir (SOF); Genotype 5 or 6 Infection
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Infections; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: M16-126; 2016-003192-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• 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.: No