Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian Adults with Advanced Fibrosis
Introduction and aim. Approximately 650,000 people in Brazil have chronic hepatitis C virus (HCV) infection. We evaluated the safety and efficacy of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) plus dasabuvir (DSV) with/without ribavirin (RBV) in an open-label multicenter phase 3b trial in trea...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2018-11-01
|
| Series: | Annals of Hepatology |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1665268119310580 |
| _version_ | 1819101205263024128 |
|---|---|
| author | Mario G. Pessoa José V. Ramalho-Madruga Katia Alves Estevão P. Nunes Hugo Cheinquer Carlos E. Brandão-Mello Maria C. Mendes-Correa Maria L. Ferraz Paulo R.A. Ferreira Mário R. Álvares-da-Silva Henrique S. Coelho Evaldo S. Affonso-de-Araújo Juvencio Furtado Raymundo Parana Giovanni Silva Sara A. Lari Li Liu Rakesh Tripathi Tami Pilot-Matias Daniel E. Cohen Nancy S. Shulman Ana Martinelli |
| author_facet | Mario G. Pessoa José V. Ramalho-Madruga Katia Alves Estevão P. Nunes Hugo Cheinquer Carlos E. Brandão-Mello Maria C. Mendes-Correa Maria L. Ferraz Paulo R.A. Ferreira Mário R. Álvares-da-Silva Henrique S. Coelho Evaldo S. Affonso-de-Araújo Juvencio Furtado Raymundo Parana Giovanni Silva Sara A. Lari Li Liu Rakesh Tripathi Tami Pilot-Matias Daniel E. Cohen Nancy S. Shulman Ana Martinelli |
| author_sort | Mario G. Pessoa |
| collection | DOAJ |
| description | Introduction and aim. Approximately 650,000 people in Brazil have chronic hepatitis C virus (HCV) infection. We evaluated the safety and efficacy of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) plus dasabuvir (DSV) with/without ribavirin (RBV) in an open-label multicenter phase 3b trial in treatment-naive or interferon (IFN) treatment-experienced Brazilian patients with advanced hepatic fibrosis (METAVIR F3/4) and HCV genotype (GT) 1 infection.Material and methods. All patients received coformulated OBV/ PTV/r daily + DSV twice daily (3-DAA). GTIa-infected patients received 3-DAA plus RBV for 12 weeks, except for prior pegIFN/ RBV nonresponders with cirrhosis who were treated for 24 weeks. GTIb-infected patients received 3-DAA alone (F3) or in combination with RBV (F4) for 12 weeks. The primary endpoint was sustained virologic response (HCV RNA < 15 IU/mL) at post-treatment Week 12 (SVR12).Results. The study enrolled 222 patients, 214 achieved an SVR12 (96.4%; 95% CI, 93.1-98.2%), one GT1a-infected patient experienced virologic breakthrough, six (5 GT1a) relapsed, and one was lost to follow-up. SVR12 was achieved in 111/ 112 (99.1%) GT1b-infected patients, including 42/43 (97.7%) noncirrhotic, and 69/69 (100%) cirrhotic patients; and in 103/110 (93.6%) GT1a-infected patients, including 44/46 (95.7%) noncirrhotic and 59/64 (92.2%) cirrhotic patients. Overall there was a low rate of serious adverse events (n = 6, 2.7%). One patient experienced a treatment-related serious adverse event and one patient discontinued treatment because of an adverse event.Discussion. The results confirm that the 3-DAA regimen with/without RBV is well tolerated and had a favorable safety profile and is efficacious in GT1-infected patients with advanced fibrosis (METAVIR F3/4). |
| first_indexed | 2024-12-22T01:14:58Z |
| format | Article |
| id | doaj.art-b9fd528e38274baba3f07c3e21f76fb0 |
| institution | Directory Open Access Journal |
| issn | 1665-2681 |
| language | English |
| last_indexed | 2024-12-22T01:14:58Z |
| publishDate | 2018-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Annals of Hepatology |
| spelling | doaj.art-b9fd528e38274baba3f07c3e21f76fb02022-12-21T18:43:54ZengElsevierAnnals of Hepatology1665-26812018-11-01176959968Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian Adults with Advanced FibrosisMario G. Pessoa0José V. Ramalho-Madruga1Katia Alves2Estevão P. Nunes3Hugo Cheinquer4Carlos E. Brandão-Mello5Maria C. Mendes-Correa6Maria L. Ferraz7Paulo R.A. Ferreira8Mário R. Álvares-da-Silva9Henrique S. Coelho10Evaldo S. Affonso-de-Araújo11Juvencio Furtado12Raymundo Parana13Giovanni Silva14Sara A. Lari15Li Liu16Rakesh Tripathi17Tami Pilot-Matias18Daniel E. Cohen19Nancy S. Shulman20Ana Martinelli21Division of Gastroenterology and Hepatology, University of São Paulo School of Medicine, São Paulo, Brazil; Correspondence and reprint request:Centro de Referência e Treinamento DST/AIDS, São Paulo, BrazilAbbVie Inc., North Chicago, Illinois, United StatesNational Institute of Infectious Diseases/FIOCRUZ, BrazilUniversidade Federal de Rio Grande de Sul, Gastroenterology and Hepatology Unit, Hospital de Clinicas de Porto Alegre, BrazilInternal Medicine Department, College of Medicine & Surgery, Universidade Federal do Estado do Rio de Janeiro – UNIRIO, Rio de Janeiro, BrazilDepartment of Infectious Diseases, São Paulo University Medical School, University of São Paulo, BrazilDepartment of Gastroenterology, Escola Paulista de Medicina, UNIFESP, São Paulo, BrazilDepartment of Infectious Diseases, Federal University of São Paulo, São Paulo, BrazilUniversidade Federal do Rio Grande do Sul, Porto Alegre, Brazil Graduate Program in Gastroenterology and Hepatology Sciences, BrazilServicio de Hepatologia, Departamento de Clinica Medica, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, BrazilUniversity of São Paulo Hospital das Clínicas, Infectious Diseases Department-Hepatitis Unit, São Paulo, BrazilUGA I - Hospital Heliópolis; São Paulo, BrazilUniversidade Federal da Bahia, Ambulatório Magalhães Neto, HUPES-UFBA, Salvador-BA, BrazilBotucatu School of Medicine - UNESP; Botucatu, BrazilAbbVie Inc., North Chicago, Illinois, United StatesAbbVie Inc., North Chicago, Illinois, United StatesAbbVie Inc., North Chicago, Illinois, United StatesAbbVie Inc., North Chicago, Illinois, United StatesAbbVie Inc., North Chicago, Illinois, United StatesAbbVie Inc., North Chicago, Illinois, United StatesDepartment of Medicine, Gastroenterology Division, Ribeirao Preto School of Medicine, University of São Paulo, BrazilIntroduction and aim. Approximately 650,000 people in Brazil have chronic hepatitis C virus (HCV) infection. We evaluated the safety and efficacy of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) plus dasabuvir (DSV) with/without ribavirin (RBV) in an open-label multicenter phase 3b trial in treatment-naive or interferon (IFN) treatment-experienced Brazilian patients with advanced hepatic fibrosis (METAVIR F3/4) and HCV genotype (GT) 1 infection.Material and methods. All patients received coformulated OBV/ PTV/r daily + DSV twice daily (3-DAA). GTIa-infected patients received 3-DAA plus RBV for 12 weeks, except for prior pegIFN/ RBV nonresponders with cirrhosis who were treated for 24 weeks. GTIb-infected patients received 3-DAA alone (F3) or in combination with RBV (F4) for 12 weeks. The primary endpoint was sustained virologic response (HCV RNA < 15 IU/mL) at post-treatment Week 12 (SVR12).Results. The study enrolled 222 patients, 214 achieved an SVR12 (96.4%; 95% CI, 93.1-98.2%), one GT1a-infected patient experienced virologic breakthrough, six (5 GT1a) relapsed, and one was lost to follow-up. SVR12 was achieved in 111/ 112 (99.1%) GT1b-infected patients, including 42/43 (97.7%) noncirrhotic, and 69/69 (100%) cirrhotic patients; and in 103/110 (93.6%) GT1a-infected patients, including 44/46 (95.7%) noncirrhotic and 59/64 (92.2%) cirrhotic patients. Overall there was a low rate of serious adverse events (n = 6, 2.7%). One patient experienced a treatment-related serious adverse event and one patient discontinued treatment because of an adverse event.Discussion. The results confirm that the 3-DAA regimen with/without RBV is well tolerated and had a favorable safety profile and is efficacious in GT1-infected patients with advanced fibrosis (METAVIR F3/4).http://www.sciencedirect.com/science/article/pii/S1665268119310580Chronic hepatits CDirect-acting antiviralsGenotype 1Advanced fibrosis |
| spellingShingle | Mario G. Pessoa José V. Ramalho-Madruga Katia Alves Estevão P. Nunes Hugo Cheinquer Carlos E. Brandão-Mello Maria C. Mendes-Correa Maria L. Ferraz Paulo R.A. Ferreira Mário R. Álvares-da-Silva Henrique S. Coelho Evaldo S. Affonso-de-Araújo Juvencio Furtado Raymundo Parana Giovanni Silva Sara A. Lari Li Liu Rakesh Tripathi Tami Pilot-Matias Daniel E. Cohen Nancy S. Shulman Ana Martinelli Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian Adults with Advanced Fibrosis Annals of Hepatology Chronic hepatits C Direct-acting antivirals Genotype 1 Advanced fibrosis |
| title | Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian Adults with Advanced Fibrosis |
| title_full | Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian Adults with Advanced Fibrosis |
| title_fullStr | Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian Adults with Advanced Fibrosis |
| title_full_unstemmed | Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian Adults with Advanced Fibrosis |
| title_short | Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian Adults with Advanced Fibrosis |
| title_sort | efficacy and safety of ombitasvir paritaprevir ritonavir and dasabuvir ribavirin for hcv in brazilian adults with advanced fibrosis |
| topic | Chronic hepatits C Direct-acting antivirals Genotype 1 Advanced fibrosis |
| url | http://www.sciencedirect.com/science/article/pii/S1665268119310580 |
| work_keys_str_mv | AT mariogpessoa efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT josevramalhomadruga efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT katiaalves efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT estevaopnunes efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT hugocheinquer efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT carlosebrandaomello efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT mariacmendescorrea efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT marialferraz efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT pauloraferreira efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT marioralvaresdasilva efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT henriquescoelho efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT evaldosaffonsodearaujo efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT juvenciofurtado efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT raymundoparana efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT giovannisilva efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT saraalari efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT liliu efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT rakeshtripathi efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT tamipilotmatias efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT danielecohen efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT nancysshulman efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis AT anamartinelli efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirribavirinforhcvinbrazilianadultswithadvancedfibrosis |