Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study

NCT02939989 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M15-9422016-002491-26
• Study Type: interventional
• Target: 33
• Locations: 12 countries
• Sites: 26

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.

Conditions

Hepatitis C Virus Infection

Keywords

Chronic Hepatitis C (HCV); HCV Genotype 1 (HCV GT1); HCV Genotype 2 (HCV GT2); HCV Genotype 3 (HCV GT3); HCV Genotype 4 (HCV GT4); HCV Genotype 5 (HCV GT5); HCV Genotype 6 (HCV GT6); Compensated Cirrhosis; Non-cirrhotics; Virologic failure

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants 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.

  12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.

Secondary Outcomes (2)

• Percentage of Participants With On-treatment Virologic Failure

  12 or 16 weeks depending on the treatment regimen

• Percentage of Participants With Post-treatment Relapse

  From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).

Study Arms (2)

Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks

EXPERIMENTAL

Participants without cirrhosis who had non-genotype 3 infection and were naïve to protease inhibitor (PI) and/or nonstructural viral protein 5A inhibitor (NS5Ai) prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.

Drug: Sofosbuvir; Drug: Glecaprevir/Pibrentasvir; Drug: Ribavirin

Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks

EXPERIMENTAL

Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.

Drug: Sofosbuvir; Drug: Glecaprevir/Pibrentasvir; Drug: Ribavirin

Interventions

Sofosbuvir DRUG

Tablet for oral administration

Also known as: SOVALDI

Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks; Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks

Glecaprevir/Pibrentasvir DRUG

Coformulated tablet for oral administration

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

Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks; Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks

Ribavirin DRUG

Tablet for oral administration

Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks; Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects must be adults (18 years of age or older) or adolescents (12 to less than 18 years of age weighing at least 35 kg).
• Subject must have experienced virologic failure during or after treatment with ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at AbbVie's discretion. Treatment in the parent study must have been completed or discontinued at least 1 month prior to the Screening Visit.
• Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
• Cirrhotic subjects must have compensated cirrhosis, (Child-Pugh score of ≤ 6) at Screening and no current or past evidence of Child-Pugh B or C Classification or no clinical history of liver decompensation, including ascites noted on physical exam, hepatic encephalopathy or esophageal variceal bleeding.
• Cirrhotic subjects must have absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative US at Screening.

You may not qualify if:

• History of severe, life-threatening or other clinically significant sensitivity to any study drug or drug component.
• Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for 4 months after the last dose of study drug, or as directed per the local RBV label, whichever is more restrictive.
• 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).
• Screening laboratory analyses showing calculated creatinine clearance \< 30 mL/min.
• Discontinuation from the AbbVie HCV parent study for reasons other than virologic failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse event).
• Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV parent study.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (26)

Digestive Health Specialists of the Southeast /ID# 155719

Dothan, Alabama, 36305, United States

Location

Ruane Clinical Research Group /ID# 155714

Los Angeles, California, 90036, United States

Location

Digestive Disease Associates - Baltimore /ID# 155713

Baltimore, Maryland, 21229, United States

Location

Henry Ford Health System /ID# 155720

Detroit, Michigan, 48202, United States

Location

University of Buffalo /ID# 155721

Buffalo, New York, 14203, United States

Location

Carolinas Center For Liver Dis /ID# 155731

Statesville, North Carolina, 28677, United States

Location

Gastro One /ID# 155729

Germantown, Tennessee, 38138, United States

Location

TX Liver Inst, Americ Res Corp /ID# 157881

San Antonio, Texas, 78215, United States

Location

Royal Brisbane and Women's Hospital /ID# 200944

Herston, Queensland, 4029, Australia

Location

The Royal Melbourne Hospital /ID# 155727

Parkville, Victoria, 3050, Australia

Location

University of Calgary /ID# 155726

Calgary, Alberta, T2N 4Z6, Canada

Location

Beijing Di Tan Hospital, Capital Medical University /ID# 218496

Beijing, 100015, China

Location

West China Hospital, Sichuan University /ID# 217613

Chengdu, 610041, China

Location

The First Hospital Affiliated to AMU (Southwest Hospital) /ID# 218494

Chongqing, 400038, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 218495

Fuzhou, 350025, China

Location

Zentru fur HIV und Heaptogastroenterologie /ID# 155592

Düsseldorf, North Rhine-Westphalia, 40237, Germany

Location

Asklepios Klinik St. Georg /ID# 155733

Hamburg, 20099, Germany

Location

Auckland City Hospital /ID# 200945

Grafton, Auckland, 1023, New Zealand

Location

Dunedin Hospital /ID# 155591

Otago, Otago, 9016, New Zealand

Location

Waikato Hospital /ID# 155728

Hamilton, Waikato Region, 3240, New Zealand

Location

Medical Company Hepatolog /ID# 214314

Samara, Samara Oblast, 443063, Russia

Location

Samsung Medical Center /ID# 214844

Seoul, 06351, South Korea

Location

Hospital Universitario Puerta de Hierro, Majadahonda /ID# 155734

Majadahonda, Madrid, 28222, Spain

Location

Duplicate_Karolinska Univ Sjukhuset /ID# 155735

Solna, 171 64, Sweden

Location

Inselspital, Universitätsspital Bern /ID# 155716

Bern, 3010, Switzerland

Location

Duplicate_Imperial College Healthcare NHS Trust /ID# 155718

London, W2 1NY, United Kingdom

Location

Related Publications (1)

• Wyles D, Weiland O, Yao B, Weilert F, Dufour JF, Gordon SC, Stoehr A, Brown A, Mauss S, Zhang Z, Pilot-Matias T, Rodrigues L Jr, Mensa FJ, Poordad F. Retreatment of patients who failed glecaprevir/pibrentasvir treatment for hepatitis C virus infection. J Hepatol. 2019 May;70(5):1019-1023. doi: 10.1016/j.jhep.2019.01.031. Epub 2019 Mar 8. No abstract available.

  PMID: 30857780 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

Sofosbuvir; glecaprevir and pibrentasvir; Ribavirin

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; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 20, 2016
• Study Start: November 21, 2016
• Primary Completion: May 7, 2021
• Study Completion: July 30, 2021
• Last Updated: May 4, 2022
• Results First Posted: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• 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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

Locations

US (8); RU (1); KR (1); CN (4); ES (1); SE (1); NZ (3); CA (1); DE (2); CH (1); AU (2); GB (1)