Clinical trial NCT02441283: A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530
Official title: A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatitis C
Keywords: Chronic hepatitis C
Hepatitis C virus
Sustained virologic response
Hepatitis C
Direct Acting Antiviral
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.

Detailed description: This was a Phase 2/3, multicenter study offered to participants who received at least one dose of an ABT-493- and/or ABT-530-containing regimen at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV and elected to enroll in this study. The participant must have completed the follow-up period of the prior eligible AbbVie study. Participants were followed for a total of approximately 3 years after their last dose of DAA in the previous HCV clinical study. The 3 years were inclusive of any post-treatment period in the prior study, as well as any gaps between the end of the prior study and enrollment in this study.

Eligibility criteria: Inclusion Criteria:

1. Participant is male or female 18 years of age or older
2. Participant has received at least one dose of an ABT-493- and/or ABT- 530 containing regimen in a prior AbbVie hepatitis C virus (HCV) Phase 2 or 3 study
3. The interval between the last dose of the AbbVie direct-acting antiviral agent (DAA) therapy from the previous clinical study and enrollment in Study M13-576 must be no longer than 2 years for subjects who have not been retreated. Participants who have been treated with a commercially available anti-HCV treatment may be enrolled greater than 2 years after the last dose of the AbbVie DAA therapy from the previous clinical study.
4. Participant must voluntarily sign and date the informed consent form approved by an Independent Review Board or Ethics Committee prior to the initiation of any study-specific procedures.
5. Participant completed the post-treatment period of an eligible prior study.

Exclusion Criteria:

1. The investigator considers the participant unsuitable for the study for any reasons (e.g., failure to comply with study procedures in the prior AbbVie clinical study).
2. Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or ABT-530 in the prior study.
3. Participants who experienced non-virologic treatment failure due to premature discontinuation of study drug in prior study of ABT-493/ABT-530.
4. Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic failure in the prior Phase 2 or 3 study.

Primary outcomes:
measure: Percentage of Participants Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen
timeFrame: From the end of treatment in the previous study up to 3 years post-treatment
measure: Percentage of Participants Who Relapsed or Had a New Hepatitis C Virus (HCV) Infection at Any Time up to the Last Follow-up in This Study Among Participants Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen
timeFrame: From the end of treatment in the previous study up to 3 years post-treatment
measure: Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure
timeFrame: From Day 1 to Month 12
Secondary outcomes:
measure: Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection
timeFrame: After Day 1 up to 3 years post-treatment
measure: Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time
timeFrame: From Day 1 up to 3 years post-treatment
measure: Mean FibroTest Score Over Time
timeFrame: From Day 1 up to 3 years post-treatment
measure: Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time
timeFrame: From Day 1 up to 3 years post-treatment
measure: Mean FibroScan Scores Over Time
timeFrame: Up to 3 years post-treatment
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast /ID# 136725
state: Alabama
city: Bakersfield
country: United States
facility: Felizarta /ID# 141033
state: California
city: Coronado
country: United States
facility: Southern California Res. Ctr. /ID# 141799
state: California
city: San Diego
country: United States
facility: Research & Education, Inc. /ID# 169591
state: California
city: San Diego
country: United States
facility: eStudySite San Diego /ID# 141040
state: California
city: San Diego
country: United States
facility: eStudySite San Diego /ID# 141047
state: California
city: San Diego
country: United States
facility: eStudySite San Diego /ID# 141048
state: California
city: Fort Pierce
country: United States
facility: Midway Immunology and Research /ID# 169477
state: Florida
city: Bastrop
country: United States
facility: Delta Research Partners /ID# 141028
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Ctr. LLC /ID# 141024
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System /ID# 141039
state: Michigan
city: Binghamton
country: United States
facility: Binghamton Gastroenterology /ID# 141026
state: New York
city: Statesville
country: United States
facility: Carolinas Center for Liver Dis /ID# 155390
state: North Carolina
city: Portland
country: United States
facility: Northwest Gastroenterology Cli /ID# 141036
state: Oregon
city: Germantown
country: United States
facility: Gastro One /ID# 169478
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research, PLLC /ID# 141042
state: Tennessee
city: Arlington
country: United States
facility: TX Clinical Research Institute /ID# 141037
state: Texas
city: Baytown
country: United States
facility: Inquest Clinical Research /ID# 141045
state: Texas
city: San Antonio
country: United States
facility: TX Liver Inst, Americ Res Corp /ID# 136727
state: Texas
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospita /ID# 165106
state: Virginia
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital, Darlinghurst /ID# 155395
state: New South Wales
city: East Lismore
country: Australia
facility: St. Vincents Hospital /ID# 155394
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 155392
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital /ID# 155396
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 155391
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital /ID# 155393
state: Victoria
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint Luc /ID# 155397
state: Bruxelles-Capitale
city: Brussels
country: Belgium
facility: CHU St. Pierre /ID# 155399
city: Leuven
country: Belgium
facility: UZ Leuven /ID# 155398
city: Calgary
country: Canada
facility: University of Calgary /ID# 155400
state: Alberta
city: Toronto
country: Canada
facility: Toronto Liver Centre /ID# 155401
state: Ontario
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt /ID# 169817
state: Hessen
city: Dusseldorf
country: Germany
facility: Mauss, Schmutz, Hegener, Athma /ID# 155402
city: Kiel
country: Germany
facility: Gastroenterologisch-Hepatologi /ID# 169820
city: Auckland
country: New Zealand
facility: Auckland City Hospital /ID# 155403
city: Ponce
country: Puerto Rico
facility: Gastro-Hepato & Geriatric Ctr /ID# 141060
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group /ID# 141059
city: San Juan
country: Puerto Rico
facility: Innovative Care P.S.C. /ID# 141061
city: London
country: United Kingdom
facility: The Royal London Hospital /ID# 155405
state: London, City Of
city: London
country: United Kingdom
facility: King's College Hospital NHS /ID# 155406
city: London
country: United Kingdom
facility: St. Mary's Hospital /ID# 155404
city: Plymouth
country: United Kingdom
facility: Derriford Hospital /ID# 155407
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Poordad F, Felizarta F, Yao BB, Overcash JS, Hassanein T, Agarwal K, Gane E, Shaw D, Waters M, Krishnan P, Topp A, Burroughs M, Nevens F. Durability of sustained virological response to glecaprevir/pibrentasvir and resistance development: A long-term follow-up study. Liver Int. 2022 Jun;42(6):1278-1286. doi: 10.1111/liv.15211. Epub 2022 Mar 14.