HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection

Detalhes bibliográficos
Autor(a) principal: Sarrazin, C
Data de Publicação: 2016
Outros Autores: Castelli, F, Andreone, P, Buti, M, Colombo, M, Pol, S, Calinas, F, Puoti, M, Olveira, A, Shiffman, M, Stern, J, Kukolj, G, Roehrle, M, Aslanyan, S, Deng, Q, Vinisko, R, Mensa, F, Nelson, D
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.17/2589
Resumo: The interferon-free combination of once-daily faldaprevir 120 mg, twice-daily deleobuvir 600 mg, and weight-based ribavirin was evaluated in two Phase III studies (HCVerso1, HCVerso2) in hepatitis C virus genotype-1b-infected, treatment-naïve patients, including those ineligible for peginterferon (HCVerso2). Patients without cirrhosis were randomized to 16 weeks (Arm 1; n=208 HCVerso1, n=213 HCVerso2) or 24 weeks (Arm 2; n=211 in both studies) of faldaprevir + deleobuvir + ribavirin. Patients with compensated cirrhosis received open-label faldaprevir + deleobuvir + ribavirin for 24 weeks (Arm 3; n=51, n=72). Primary endpoints were comparisons of adjusted sustained virologic response (SVR) rates with historical rates: 71% (HCVerso1) and 68% (HCVerso2). Adjusted SVR12 rates were significantly greater than historical controls for Arms 1 and 2 in HCVerso2 (76%, 95% confidence interval [CI] 71-81, P=0.002; 81%, 95% CI 76-86, P<0.0001) and Arm 2 in HCVerso1 (81%, 95% CI 77-86, P<0.0001), but not for Arm 1 of HCVerso1 (72%, 95% CI 66-77, P=0.3989). Unadjusted SVR12 rates in Arms 1, 2, and 3 were 71.6%, 82.5%, and 72.5%, respectively, in HCVerso1 and 75.6%, 82.0%, and 73.6%, respectively, in HCVerso2. Virologic breakthrough and relapse occurred in 24-week arms in 8%-9% and 1% of patients, respectively, and in 16-week arms in 7%-8% and 9%-11% of patients, respectively. The most common adverse events were nausea (46%-61%) and vomiting (29%-35%). Adverse events resulted in discontinuation of all medications in 6%-8% of patients. In treatment-naïve patients with hepatitis C virus genotype-1b infection, with or without cirrhosis, faldaprevir + deleobuvir + ribavirin treatment for 24 weeks resulted in adjusted SVR12 rates significantly higher than historical controls.
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spelling HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b InfectionCHLC GASChronic Hepatitis CNS3 Protease InhibitorNonnucleoside Polymerase InhibitorCirrhosisAntiviralThe interferon-free combination of once-daily faldaprevir 120 mg, twice-daily deleobuvir 600 mg, and weight-based ribavirin was evaluated in two Phase III studies (HCVerso1, HCVerso2) in hepatitis C virus genotype-1b-infected, treatment-naïve patients, including those ineligible for peginterferon (HCVerso2). Patients without cirrhosis were randomized to 16 weeks (Arm 1; n=208 HCVerso1, n=213 HCVerso2) or 24 weeks (Arm 2; n=211 in both studies) of faldaprevir + deleobuvir + ribavirin. Patients with compensated cirrhosis received open-label faldaprevir + deleobuvir + ribavirin for 24 weeks (Arm 3; n=51, n=72). Primary endpoints were comparisons of adjusted sustained virologic response (SVR) rates with historical rates: 71% (HCVerso1) and 68% (HCVerso2). Adjusted SVR12 rates were significantly greater than historical controls for Arms 1 and 2 in HCVerso2 (76%, 95% confidence interval [CI] 71-81, P=0.002; 81%, 95% CI 76-86, P<0.0001) and Arm 2 in HCVerso1 (81%, 95% CI 77-86, P<0.0001), but not for Arm 1 of HCVerso1 (72%, 95% CI 66-77, P=0.3989). Unadjusted SVR12 rates in Arms 1, 2, and 3 were 71.6%, 82.5%, and 72.5%, respectively, in HCVerso1 and 75.6%, 82.0%, and 73.6%, respectively, in HCVerso2. Virologic breakthrough and relapse occurred in 24-week arms in 8%-9% and 1% of patients, respectively, and in 16-week arms in 7%-8% and 9%-11% of patients, respectively. The most common adverse events were nausea (46%-61%) and vomiting (29%-35%). Adverse events resulted in discontinuation of all medications in 6%-8% of patients. In treatment-naïve patients with hepatitis C virus genotype-1b infection, with or without cirrhosis, faldaprevir + deleobuvir + ribavirin treatment for 24 weeks resulted in adjusted SVR12 rates significantly higher than historical controls.DovepressRepositório do Centro Hospitalar Universitário de Lisboa Central, EPESarrazin, CCastelli, FAndreone, PButi, MColombo, MPol, SCalinas, FPuoti, MOlveira, AShiffman, MStern, JKukolj, GRoehrle, MAslanyan, SDeng, QVinisko, RMensa, FNelson, D2016-12-09T11:27:17Z20162016-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.17/2589engClin Exp Gastroenterol. 2016 Nov 24;9:351-36310.2147/CEG.S111116info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-03-10T09:38:31Zoai:repositorio.chlc.min-saude.pt:10400.17/2589Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T17:19:56.195536Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection
title HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection
spellingShingle HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection
Sarrazin, C
CHLC GAS
Chronic Hepatitis C
NS3 Protease Inhibitor
Nonnucleoside Polymerase Inhibitor
Cirrhosis
Antiviral
title_short HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection
title_full HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection
title_fullStr HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection
title_full_unstemmed HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection
title_sort HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection
author Sarrazin, C
author_facet Sarrazin, C
Castelli, F
Andreone, P
Buti, M
Colombo, M
Pol, S
Calinas, F
Puoti, M
Olveira, A
Shiffman, M
Stern, J
Kukolj, G
Roehrle, M
Aslanyan, S
Deng, Q
Vinisko, R
Mensa, F
Nelson, D
author_role author
author2 Castelli, F
Andreone, P
Buti, M
Colombo, M
Pol, S
Calinas, F
Puoti, M
Olveira, A
Shiffman, M
Stern, J
Kukolj, G
Roehrle, M
Aslanyan, S
Deng, Q
Vinisko, R
Mensa, F
Nelson, D
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Repositório do Centro Hospitalar Universitário de Lisboa Central, EPE
dc.contributor.author.fl_str_mv Sarrazin, C
Castelli, F
Andreone, P
Buti, M
Colombo, M
Pol, S
Calinas, F
Puoti, M
Olveira, A
Shiffman, M
Stern, J
Kukolj, G
Roehrle, M
Aslanyan, S
Deng, Q
Vinisko, R
Mensa, F
Nelson, D
dc.subject.por.fl_str_mv CHLC GAS
Chronic Hepatitis C
NS3 Protease Inhibitor
Nonnucleoside Polymerase Inhibitor
Cirrhosis
Antiviral
topic CHLC GAS
Chronic Hepatitis C
NS3 Protease Inhibitor
Nonnucleoside Polymerase Inhibitor
Cirrhosis
Antiviral
description The interferon-free combination of once-daily faldaprevir 120 mg, twice-daily deleobuvir 600 mg, and weight-based ribavirin was evaluated in two Phase III studies (HCVerso1, HCVerso2) in hepatitis C virus genotype-1b-infected, treatment-naïve patients, including those ineligible for peginterferon (HCVerso2). Patients without cirrhosis were randomized to 16 weeks (Arm 1; n=208 HCVerso1, n=213 HCVerso2) or 24 weeks (Arm 2; n=211 in both studies) of faldaprevir + deleobuvir + ribavirin. Patients with compensated cirrhosis received open-label faldaprevir + deleobuvir + ribavirin for 24 weeks (Arm 3; n=51, n=72). Primary endpoints were comparisons of adjusted sustained virologic response (SVR) rates with historical rates: 71% (HCVerso1) and 68% (HCVerso2). Adjusted SVR12 rates were significantly greater than historical controls for Arms 1 and 2 in HCVerso2 (76%, 95% confidence interval [CI] 71-81, P=0.002; 81%, 95% CI 76-86, P<0.0001) and Arm 2 in HCVerso1 (81%, 95% CI 77-86, P<0.0001), but not for Arm 1 of HCVerso1 (72%, 95% CI 66-77, P=0.3989). Unadjusted SVR12 rates in Arms 1, 2, and 3 were 71.6%, 82.5%, and 72.5%, respectively, in HCVerso1 and 75.6%, 82.0%, and 73.6%, respectively, in HCVerso2. Virologic breakthrough and relapse occurred in 24-week arms in 8%-9% and 1% of patients, respectively, and in 16-week arms in 7%-8% and 9%-11% of patients, respectively. The most common adverse events were nausea (46%-61%) and vomiting (29%-35%). Adverse events resulted in discontinuation of all medications in 6%-8% of patients. In treatment-naïve patients with hepatitis C virus genotype-1b infection, with or without cirrhosis, faldaprevir + deleobuvir + ribavirin treatment for 24 weeks resulted in adjusted SVR12 rates significantly higher than historical controls.
publishDate 2016
dc.date.none.fl_str_mv 2016-12-09T11:27:17Z
2016
2016-01-01T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10400.17/2589
url http://hdl.handle.net/10400.17/2589
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Clin Exp Gastroenterol. 2016 Nov 24;9:351-363
10.2147/CEG.S111116
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eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Dovepress
publisher.none.fl_str_mv Dovepress
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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