Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

NCT03212521 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M16-1332016-004876-23
• Study Type: interventional
• Target: 230
• Locations: 10 countries
• Sites: 42

Brief Summary

A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

Conditions

Hepatitis C Virus (HCV)

Keywords

chronic hepatitis C virus (HCV); Hepatitis; HCV genotype; aspartate aminotransferase; platelet; Aspartate aminotransferase to Platelet Ratio Index (APRI); glecaprevir; pibrentasvir; Sustained Virologic Response 12 weeks post dosing (SVR12)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

  SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug. The 95% confidence interval (95%CI) was calculated using the Wilson's score method. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%.

  12 weeks after the last actual dose of study drug, Week 20

Secondary Outcomes (3)

• Percentage of Participants in the Intention-to-Treat Population With SVR12

  12 weeks after the last actual dose of study drug, Week 20

• Percentage of Participants With On-treatment Virologic Failure

  Up to 8 weeks

• Percentage of Participants With Post-treatment Relapse

  From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20)

Study Arms (1)

Glecaprevir/Pibrentasvir

EXPERIMENTAL

Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.

Drug: Glecaprevir/Pibrentasvir

Interventions

Glecaprevir/Pibrentasvir DRUG

Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.

Also known as: ABT-493/ABT-530, MAVYRET™

Glecaprevir/Pibrentasvir

Eligibility Criteria

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

You may qualify if:

• Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
• Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.
• Does not have current active hepatitis B virus infection defined as:
• positive hepatitis B surface antigen (HBsAg), OR
• hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \> lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface\[HBs\])
• Platelets ≥ 150,000 cells/mm³
• Albumin ≥ lower limit of normal (LLN)
• Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
• No past history/evidence of cirrhosis.
• No history of hepatocellular carcinoma.
• Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
• If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (42)

Parkway Medical Center /ID# 161261

Birmingham, Alabama, 35215, United States

Location

Arkansas Gastroenterology /ID# 161266

North Little Rock, Arkansas, 72117, United States

Location

UC Davis Medical Center /ID# 161138

Sacramento, California, 95817, United States

Location

Yale University /ID# 161258

New Haven, Connecticut, 06510, United States

Location

Univ Maryland School Medicine /ID# 161157

Baltimore, Maryland, 21201, United States

Location

Digestive Disease Associates - Baltimore /ID# 161260

Baltimore, Maryland, 21229, United States

Location

University of Michigan Hospitals /ID# 161265

Ann Arbor, Michigan, 48109-5008, United States

Location

Northwest Gastroenterology Cli /ID# 161257

Portland, Oregon, 97210, United States

Location

Liver Associates of Texas, P.A /ID# 161262

Houston, Texas, 77030-2783, United States

Location

University of Vermont Medical Center /ID# 161263

Burlington, Vermont, 05401-1473, United States

Location

Digestive and Liver Disease Sp /ID# 161259

Norfolk, Virginia, 23502, United States

Location

DCC Aleksandrovska /ID# 161340

София, Sofia, 1431, Bulgaria

Location

DCC Mladost M /ID# 161339

Varna, 9000, Bulgaria

Location

South Health Campus /ID# 161385

Calgary, Alberta, T3M 1M4, Canada

Location

The Moncton Hospital /ID# 161384

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Brampton Civic Hospital /ID# 161380

Brampton, Ontario, L6R 3J7, Canada

Location

Toronto Liver Centre /ID# 161381

Toronto, Ontario, M6H 3M1, Canada

Location

Hopital Saint Joseph /ID# 161571

Marseille, Bouches-du-Rhone, 13285, France

Location

CHU de Rennes - PONTCHAILLOU /ID# 161492

Rennes, Brittany Region, 35000, France

Location

CHU de Besancon - Jean Minjoz /ID# 161485

Besançon, Doubs, 25000, France

Location

Hopitaux de Brabois Adultes /ID# 161482

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

Universitätsklinikum Frankfurt /ID# 161397

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Charité Universitätsmedizin Campus Mitte /ID# 161395

Berlin, 10117, Germany

Location

ICH Study Center GmbH & Co KG /ID# 161394

Hamburg, 20146, Germany

Location

Centrum Badan Klinicznych /Id# 162218

Wroclaw, Lower Silesian Voivodeship, 50-349, Poland

Location

HepID - Diagnostyka I Terapia /ID# 162219

Lublin, Lublin Voivodeship, 20-884, Poland

Location

Uniwersytecki Szpital Kliniczn /ID# 162216

Bialystok, 15-276, Poland

Location

ID Clinic /ID# 162217

Mysłowice, 41-406, Poland

Location

Innovative Care P.S.C. /ID# 162787

San Juan, 00959, Puerto Rico

Location

A. F. Agafonov Republican Clin /ID# 163164

Kazan', Tatarstan, Respublika, 420140, Russia

Location

South Ural State Medical univ /ID# 163163

Chelyabinsk, 454052, Russia

Location

A.I. Evdokimov Moscow State Un /ID# 163162

Moscow, 127473, Russia

Location

Hospital Fundacion Alcorcon /ID# 161436

Alcorcón, 28922, Spain

Location

Hospital Clinic de Barcelona /ID# 161437

Barcelona, 08036, Spain

Location

Hospital Vall d'Hebron /ID# 162022

Barcelona, 8035, Spain

Location

Hosp Uni Virgen de la Victoria /ID# 164383

Málaga, 29010, Spain

Location

Complexo Hospitalario universi /ID# 165603

Pontevedra, 36071, Spain

Location

Bradford Teaching Hospitals /ID# 161424

Bradford, BD9 6RJ, United Kingdom

Location

Glasgow Royal Infirmary /ID# 161458

Glasgow, G4 0SF, United Kingdom

Location

Gloucester Royal Hospital /ID# 161423

Gloucester, GL1 3NN, United Kingdom

Location

Freeman Hospital /ID# 161459

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

• Fontana RJ, Lens S, McPherson S, Elkhashab M, Ankoma-Sey V, Bondin M, Dos Santos AGP, Xue Z, Trinh R, Porcalla A, Zeuzem S. Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naive, HCV-Infected Patients with APRI </= 1 in a Single-Arm, Open-Label, Multicenter Study. Adv Ther. 2019 Dec;36(12):3458-3470. doi: 10.1007/s12325-019-01123-0. Epub 2019 Oct 23.

  PMID: 31646465 DERIVED

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic; Hepatitis

Interventions

glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  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
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: August 7, 2017
• Primary Completion: August 13, 2018
• Study Completion: August 13, 2018
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• 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.

Locations

RU (3); DE (4); PR (1); GB (4); FR (4); PL (4); US (11); CA (4); ES (5); BU (2)