Efficacy and safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian adults with advanced fibrosis
dc.contributor.author | Pessôa, Mário Guimarães | pt_BR |
dc.contributor.author | Cheinquer, Hugo | pt_BR |
dc.contributor.author | Álvares-da-Silva, Mário Reis | pt_BR |
dc.contributor.author | Martinelli, Ana de Lourdes Candolo | pt_BR |
dc.date.accessioned | 2019-08-29T02:35:21Z | pt_BR |
dc.date.issued | 2018 | pt_BR |
dc.identifier.issn | 1665-2681 | pt_BR |
dc.identifier.uri | http://hdl.handle.net/10183/198615 | pt_BR |
dc.description.abstract | 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 openlabel 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). GT1a-infected patients received 3-DAA plus RBV for 12 weeks, except for prior pegIFN/ RBV nonresponders with cirrhosis who were treated for 24 weeks. GT1b-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). | en |
dc.format.mimetype | application/pdf | pt_BR |
dc.language.iso | eng | pt_BR |
dc.relation.ispartof | Annals of Hepatology. Cidade do México. Vol. 17, no. 6 (2018:), p. 959-968 | pt_BR |
dc.rights | Open Access | en |
dc.subject | Chronic hepatits C | en |
dc.subject | Hepatite C | pt_BR |
dc.subject | Direct-acting antivirals | en |
dc.subject | Cirrose hepática | pt_BR |
dc.subject | Ritonavir | pt_BR |
dc.subject | Genotype 1 | en |
dc.subject | Ribavirina | pt_BR |
dc.subject | Advanced fibrosis | en |
dc.subject | Antivirais | pt_BR |
dc.title | Efficacy and safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian adults with advanced fibrosis | pt_BR |
dc.type | Artigo de periódico | pt_BR |
dc.identifier.nrb | 001098511 | pt_BR |
dc.type.origin | Estrangeiro | pt_BR |
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