Clinical trial NCT03219216: A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection
Official title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naïve Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus (HCV)
Keywords: Chronic Hepatitis C Virus (HCV)
Genotype 1 - 6
Metavir System Fibrosis Score
Glecaprevir
Pibrentasvir
Treatment naïve
Cirrhosis
Compensated cirrhosis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve.

Detailed description: This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of GLE/PIB for an 8- or 12-week treatment duration in adults in Brazil with chronic HCV GT1 to GT6 infection, without cirrhosis or with compensated cirrhosis with a METAVIR System Fibrosis Score of F2 to F3 (without cirrhosis) or F4 (with compensated cirrhosis) or equivalent, who were HCV treatment-naïve.

Eligibility criteria: Inclusion Criteria:

* Participant had positive plasma hepatitis C virus (HCV) antibody and HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening Visit.
* Participant must have been documented as without cirrhosis with METAVIR equivalent fibrosis stage of F2 to F3 or with compensated cirrhosis (F4) based on results of a liver biopsy, or FibroScan, or FibroTest score.
* Participants who were known to be HCV/Human Immunodeficiency Virus (HIV) co-infected may have been enrolled if they had a positive test result for anti-HIV antibody at Screening and were: naïve to treatment with any antiretroviral therapy (ART), or on a stable, qualifying HIV ART regimen for at least 8 weeks prior to Baseline.
* Participants with compensated cirrhosis only: Absence of hepatocellular carcinoma (HCC) within 3 months prior to Screening or a negative ultrasound at Screening.

Exclusion Criteria:

* Current hepatitis B virus (HBV) infection on screening tests.
* Any current or past clinical evidence of Child-Pugh B or C classification (score of \> 6) or clinical history of liver decompensation including ascites on physical exam, including hepatic encephalopathy or variceal bleeding.
* Receipt of any investigational or commercially available anti-HCV agents.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen)
Secondary outcomes:
measure: Percentage of Participants With On-treatment HCV Virologic Failure
timeFrame: 8 or 12 weeks (depending on treatment regimen)
measure: Percentage of Participants With Post-treatment HCV Virologic Relapse
timeFrame: From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drug
Other outcomes:
Locations:
city: Vitoria
country: Brazil
facility: Hospital Universitário Cassiano Antônio Moraes - HCUFES /ID# 163512
state: Espirito Santo
city: São Luís
country: Brazil
facility: Hospital Universitario da Universidade Federal do Maranhao - CEPEC /ID# 163169
state: Maranhao
city: Maringá
country: Brazil
facility: Universidade Estadual de Maringá /ID# 166436
state: Parana
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 163166
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 163167
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles /ID# 163171
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 163066
state: Sao Paulo
city: Campinas
country: Brazil
facility: Instituto de Infectologia Campinas /ID# 163175
state: Sao Paulo
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163054
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto de Infectologia Emilio Ribas /ID# 163170
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 163168
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: UNIFESP/Unidade de Atendimento Pesquisa Clínica 1 /ID# 164188
city: Sao Paulo
country: Brazil
facility: Centro de Referência e Treinamento DST/AIDS /ID# 163174
city: Sao Paulo
country: Brazil
facility: Hospital Heliopolis /ID# 163063
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Peribanez-Gonzalez M, Cheinquer H, Rodrigues L, Lima MP, Alvares-da-Silva MR, Madruga J, Parise ER, Pessoa MG, Furtado J, Villanova M, Ferreira A, Mazzoleni F, Nascimento E, Silva GF, Fredrick L, Krishnan P, Burroughs M, Reuter T. Efficacy and safety of glecaprevir/pibrentasvir in treatment-naive adults with chronic hepatitis C virus genotypes 1-6 in Brazil. Ann Hepatol. 2021 Jan-Feb;20:100257. doi: 10.1016/j.aohep.2020.09.002. Epub 2020 Sep 17.