HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection
Autor(a) principal: | |
---|---|
Data de Publicação: | 2016 |
Outros Autores: | , , , , , , , , , , , , , , , , |
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. |
id |
RCAP_62ebe96e37c7b425669d46ecc48ec807 |
---|---|
oai_identifier_str |
oai:repositorio.chlc.min-saude.pt:10400.17/2589 |
network_acronym_str |
RCAP |
network_name_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository_id_str |
7160 |
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 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
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 instacron:RCAAP |
instname_str |
Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
collection |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository.name.fl_str_mv |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
repository.mail.fl_str_mv |
|
_version_ |
1799131296120700928 |