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
- Registration Number
- NCT03212521
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
-
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.
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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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Glecaprevir/Pibrentasvir Glecaprevir/Pibrentasvir Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last actual dose of study drug, Week 20 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%.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With On-treatment Virologic Failure Up to 8 weeks On-treatment 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.Percentage of Participants in the Intention-to-Treat Population With SVR12 12 weeks after the last actual dose of study drug, Week 20 SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.
The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures.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) Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.
Trial Locations
- Locations (42)
Univ Maryland School Medicine /ID# 161157
🇺🇸Baltimore, Maryland, United States
Digestive Disease Associates - Baltimore /ID# 161260
🇺🇸Baltimore, Maryland, United States
University of Vermont Medical Center /ID# 161263
🇺🇸Burlington, Vermont, United States
The Moncton Hospital /ID# 161384
🇨🇦Moncton, New Brunswick, Canada
Brampton Civic Hospital /ID# 161380
🇨🇦Brampton, Ontario, Canada
Innovative Care P.S.C. /ID# 162787
🇵🇷San Juan, Puerto Rico
CHU de Rennes - PONTCHAILLOU /ID# 161492
🇫🇷Rennes, Bretagne, France
CHU de Besancon - Jean Minjoz /ID# 161485
🇫🇷Besancon, Doubs, France
Centrum Badan Klinicznych /Id# 162218
🇵🇱Wrocław, Dolnoslaskie, Poland
Arkansas Gastroenterology /ID# 161266
🇺🇸North Little Rock, Arkansas, United States
Toronto Liver Centre /ID# 161381
🇨🇦Toronto, Ontario, Canada
Gloucester Royal Hospital /ID# 161423
🇬🇧Gloucester, United Kingdom
DCC Aleksandrovska /ID# 161340
🇧🇬София, Sofia, Bulgaria
South Ural State Medical univ /ID# 163163
🇷🇺Chelyabinsk, Russian Federation
Freeman Hospital /ID# 161459
🇬🇧Newcastle Upon Tyne, United Kingdom
DCC Mladost M /ID# 161339
🇧🇬Varna, Bulgaria
A. F. Agafonov Republican Clin /ID# 163164
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
Charité Universitätsmedizin Campus Mitte /ID# 161395
🇩🇪Berlin, Germany
ID Clinic /ID# 162217
🇵🇱Myslowice, Poland
Hospital Fundacion Alcorcon /ID# 161436
🇪🇸Alcorcon, Spain
A.I. Evdokimov Moscow State Un /ID# 163162
🇷🇺Moscow, Russian Federation
Liver Associates of Texas, P.A /ID# 161262
🇺🇸Houston, Texas, United States
Digestive and Liver Disease Sp /ID# 161259
🇺🇸Norfolk, Virginia, United States
South Health Campus /ID# 161385
🇨🇦Calgary, Alberta, Canada
Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396
🇩🇪Mainz, Rheinland-Pfalz, Germany
Hopitaux de Brabois Adultes /ID# 161482
🇫🇷Vandoeuvre les Nancy, Lorraine, France
Universitätsklinikum Frankfurt /ID# 161397
🇩🇪Frankfurt am Main, Hessen, Germany
Hopital Saint Joseph /ID# 161571
🇫🇷Marseille CEDEX 08, Bouches-du-Rhone, France
ICH Study Center GmbH & Co KG /ID# 161394
🇩🇪Hamburg, Germany
HepID - Diagnostyka I Terapia /ID# 162219
🇵🇱Lublin, Lubelskie, Poland
Uniwersytecki Szpital Kliniczn /ID# 162216
🇵🇱Bialystok, Poland
Complexo Hospitalario universi /ID# 165603
🇪🇸Pontevedra, Spain
Hospital Vall d'Hebron /ID# 162022
🇪🇸Barcelona, Spain
Bradford Teaching Hospitals /ID# 161424
🇬🇧Bradford, United Kingdom
Hosp Uni Virgen de la Victoria /ID# 164383
🇪🇸Malaga, Spain
Hospital Clinic de Barcelona /ID# 161437
🇪🇸Barcelona, Spain
Glasgow Royal Infirmary /ID# 161458
🇬🇧Glasgow, United Kingdom
Yale University /ID# 161258
🇺🇸New Haven, Connecticut, United States
Parkway Medical Center /ID# 161261
🇺🇸Birmingham, Alabama, United States
UC Davis Medical Center /ID# 161138
🇺🇸Sacramento, California, United States
University of Michigan Hospitals /ID# 161265
🇺🇸Ann Arbor, Michigan, United States
Northwest Gastroenterology Cli /ID# 161257
🇺🇸Portland, Oregon, United States