A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment

NCT03069365 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M16-1272016-004182-60
• Study Type: interventional
• Target: 101
• Locations: 10 countries
• Sites: 38

Brief Summary

This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.

Conditions

Hepatitis C Virus (HCV)

Keywords

Chronic Hepatitis C Virus; Chronic Kidney Disease; Glecaprevir; Pibrentasvir; Hepatitis C Virus Genotype; Compensated cirrhosis; Non-cirrhotic; Interferon (IFN); Treatment naïve; Sofosbuvir (SOF); Pegylated interferon (pegIFN); Ribavirin (RBV)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Dosing (SVR12)

  SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.

  12 weeks after the last actual dose of study drug

Secondary Outcomes (2)

• Percentage of Participants With On-treatment Virologic Failure

  Up to 16 weeks

• Percentage of Participants With Post-treatment Relapse

  Up to 12 weeks after the last dose of study drug

Study Arms (3)

GLE/PIB for 8 weeks

EXPERIMENTAL

HCV genotype 1,2,4-6 non-cirrhotic, treatment-naive or treatment-experienced; genotype 3 non-cirrhotic, treatment-naïve participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 8 weeks

Drug: Glecaprevir/pibrentasvir

GLE/PIB for 12 weeks

EXPERIMENTAL

HCV genotype 1,2,4-6 compensated cirrhosis, treatment-naive or treatment-experienced; genotype 3 compensated cirrhosis, treatment- naïve participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 12 weeks

Drug: Glecaprevir/pibrentasvir

GLE/PIB for 16 weeks

EXPERIMENTAL

HCV genotype 3 non-cirrhotic or with compensated cirrhosis, treatment-experienced participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 16 weeks

Drug: Glecaprevir/pibrentasvir

Interventions

Glecaprevir/pibrentasvir DRUG

Film-coated tablet

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

GLE/PIB for 12 weeks; GLE/PIB for 16 weeks; GLE/PIB for 8 weeks

Eligibility Criteria

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

You may qualify if:

• Male or female (of non-childbearing potential or using allowed contraceptive methods) at least 18 years of age time of Screening
• Participant had a positive anti-hepatitis C virus (HCV) antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at the Screening Visit.
• Participant had an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m\^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method at Screening according to the following formula: eGFR (mL/min/1.73 m\^2 ) = 175 × (Serum Creatinine) \^-1.154 × Age\^-0.203 × (0.742 if female) × (1.212 if black), or were dialysis dependent. Subjects requiring dialysis had to have been receiving dialysis for at least 1 month prior to enrollment, and may have been on hemodialysis or peritoneal dialysis.
• Cirrhotic participants only: absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Participants who had an ultrasound with results suspicious of HCC followed by a subsequent negative CT or MRI of the liver were eligible for the study.

You may not qualify if:

• Female participants who were pregnant, breastfeeding, or were considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug
• Current hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection on screening tests, defined as:
• Positive test result at Screening for hepatitis B surface antigen (HBsAg), or;
• HBV deoxyribonucleic acid (DNA) greater than lower limit of quantification (LLOQ) in participants with isolated positive hepatitis B core antibody (HBcAb), (i.e., negative HBsAg and Anti-HBsAg), or;
• Positive anti-HIV antibody (Ab).
• Clinical history of acute renal failure in the 3 months prior to Screening
• History of severe, life-threatening, or other significant sensitivity to any excipients of the study drugs
• Clinically significant abnormalities or co-morbidities, or recent (within 6 months prior to study drug administration) alcohol or drug abuse that could preclude adherence to the protocol in the opinion of the investigator
• Receipt of any investigational or commercially available direct acting anti-HCV agents other than sofosbuvir

Sponsors & Collaborators

• AbbVie: lead

Study Sites (38)

Scripps Clinic /ID# 159116

La Jolla, California, 92037, United States

Location

Huntington Medical Foundation /ID# 160653

Pasadena, California, 91105, United States

Location

Tampa General Medical Group /ID# 159115

Tampa, Florida, 33606, United States

Location

Northwest Louisiana Nephrology /ID# 160652

Shreveport, Louisiana, 71101, United States

Location

Massachusetts General Hospital /ID# 159114

Boston, Massachusetts, 02114, United States

Location

North Shore University Hospital /ID# 159108

New Hyde Park, New York, 11040, United States

Location

Columbia Univ Medical Center /ID# 159112

New York, New York, 10032-3725, United States

Location

Carolinas Medical Center /ID# 159113

Charlotte, North Carolina, 28203, United States

Location

University of Pennsylvania /ID# 159117

Philadelphia, Pennsylvania, 19104-5502, United States

Location

Thomas Jefferson University /ID# 159754

Philadelphia, Pennsylvania, 19107-4414, United States

Location

TX Liver Inst, Americ Res Corp /ID# 159111

San Antonio, Texas, 78215, United States

Location

Zeidler Ledcor Centre /ID# 160600

Edmonton, Alberta, T6G 2X8, Canada

Location

Vancouver ID Research and Care /ID# 160598

Vancouver, British Columbia, V6Z 2C7, Canada

Location

GIRI Gastrointestinal Research Institute /ID# 160599

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Toronto General Hospital /ID# 160601

Toronto, Ontario, M5G 2C4, Canada

Location

Universitatsklinikum Mannheim /ID# 160829

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Universitätsklinikum Frankfurt /ID# 160826

Frankfurt am Main, Hesse, 60590, Germany

Location

Med Hochschule Hanover /ID# 160827

Hanover, 30625, Germany

Location

Univ Johannes Gutenberg /ID# 160828

Mainz, 55131, Germany

Location

General Hospital of Athens Laiko /ID# 160725

Athens, Attica, 115 27, Greece

Location

Gen Univ Hosp Alexandroupolis /ID# 160724

Alexandroupoli, 68100, Greece

Location

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 160726

Athens, 10676, Greece

Location

Bioclinic Thessaloniki /ID# 160723

Thessaloniki, 54622, Greece

Location

A.O.U. Policlinico S.Orsola-Malpighi /ID# 163349

Bologna, Emilia-Romagna, 40138, Italy

Location

Policlinico A. Gemelli /ID# 160719

Rome, Lazio, 00168, Italy

Location

Policlinico Paolo Giaccone /Id# 160718

Palermo, Sicily, 90127, Italy

Location

A.O. Uni Giovanni e Ruggi /ID# 160720

Salerno, 84100, Italy

Location

HepID - Diagnostyka I Terapia /ID# 161083

Lublin, Lublin Voivodeship, 20-884, Poland

Location

Uniwersytecki Szpital Kliniczn /ID# 161081

Bialystok, 15-276, Poland

Location

VA Caribbean Healthcare System /ID# 160754

San Juan, 00921-3201, Puerto Rico

Location

School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 160755

San Juan, 00935, Puerto Rico

Location

Hanyang University Seoul Hospi /ID# 160259

Seongdong, Seoul Teugbyeolsi, 04763, South Korea

Location

Severance Hospital /ID# 160261

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center /ID# 160260

Seoul, 05505, South Korea

Location

Hospital Regional de Malaga /ID# 159976

Málaga, Malaga, 29009, Spain

Location

Hospital Parc de Salut del Mar /ID# 159975

Barcelona, 08003, Spain

Location

Hospital Universitario Doce de /ID# 159974

Madrid, 28041, Spain

Location

Karolinska Uni /ID# 159523

Stockholm, SE-141 86, Sweden

Location

Related Publications (2)

• 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.

  PMID: 35174470 DERIVED

• Lawitz E, Flisiak R, Abunimeh M, Sise ME, Park JY, Kaskas M, Bruchfeld A, Worns MA, Aglitti A, Zamor PJ, Xue Z, Schnell G, Jalundhwala YJ, Porcalla A, Mensa FJ, Persico M. Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection. Liver Int. 2020 May;40(5):1032-1041. doi: 10.1111/liv.14320. Epub 2019 Dec 26.

  PMID: 31821716 DERIVED

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic; Renal Insufficiency, Chronic

Interventions

glecaprevir and pibrentasvir

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; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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: February 28, 2017
• First Posted: March 3, 2017
• Study Start: March 28, 2017
• Primary Completion: February 20, 2018
• Study Completion: June 5, 2018
• Last Updated: March 4, 2019
• Results First Posted: March 4, 2019

Record last verified: 2019-01

Locations

GR (4); CA (4); SE (1); PR (2); DE (4); ES (3); IT (4); KR (3); PL (2); US (11)