Ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin is safe and effective in HCV-infected patients in a real-life cohort from Latin America

Authors
Mendizabal, Manuel; Haddad, Leila; Gallardo, Patricia E.; Ferrada, Alejandro; Soza, Alejandro A.; Adrover, Raul; Aravena, Edmundo; Roblero, Juan P.; Prieto, Jhon; Vujacich, Claudia; Romero, Gustavo; Muñoz, Alberto; Anders, Margarita; Hernández, Nelia; Coccozella, Daniel; Gruz, Fernando; Reggiardo, Maria V.; Ruf, Andres E.; Varón, Adriana; Cartier, Mariano; Pérez Ravier, Roberto; Ridruejo, Ezequiel; Peralta, Mirta; Poncino, Daniel; Vorobioff, Julio; Aballay Soteras, Gabriel; Silva, Marcelo O.
Publication Year
2017
Language
English
Format
article
Status
Published version
Description
Information about the use of ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin (OBV/PTV/r/DSV ± RBV) in real-clinical practice in Latin America is scarce. We aimed to confirm safety and effectiveness of OBV/PTV/r/DSV ± RBV therapy in real-world setting. We analyzed a cohort of patients with genotype 1 infection treated with OBV/PTV/r/DSV ± RBV. Data on demographics, clinical features, safety, and virological response were retrospectively collected from 21 centers in Latin America. A total of 96 patients received OBV/PTV/r/DSV, associated with RBV in 68% of the cases. Most were genotype 1b (80%), 56 (58%) had cirrhosis, and 45 (47%) failed prior HCV treatment. Adverse events occurred in 62% of patients. The most common adverse events were pruritus (21%), hyperbilirubinemia (17%), and asthenia (17%). Five patients discontinued therapy prematurely due to hepatic decompensation, three of them were Child-Pugh B at baseline and one patient died due to multi-organ failure. Follow up HCV-RNA 12 weeks after completion of therapy was evaluated in all the patients and sustained virologic response rate was 97%. No virologic breakthrough was detected. Our study confirms that OBV/PTV/r/DSV treatment is highly effective in patients with chronic HCV without cirrhosis or with Child-Pugh A cirrhosis in non-European populations. Adverse events were often mild and rarely led to treatment discontinuation except for patients with Child-Pugh B cirrhosis or with previous history of hepatic decompensation. These results can support the development of public strategies to expand the access of OBV/PTV/r + DSV and other DAAs combinations in order to reduce the burden of HCV infection in our region.
Fil: Mendizabal, Manuel. Hospital Universitario Austral; Argentina
Fil: Haddad, Leila. Hospital Italiano; Argentina
Fil: Gallardo, Patricia E.. Fundación Sayani; Argentina
Fil: Ferrada, Alejandro. Hospital Clinico San Borja Arriaran; Chile
Fil: Soza, Alejandro A.. Universidad Católica de Chile; Chile. Pontificia Universidad Católica de Chile; Chile
Fil: Adrover, Raul. Centro de Hepatología; Argentina
Fil: Aravena, Edmundo. Hospital Clinico San Borja Arriaran; Chile
Fil: Roblero, Juan P.. Hospital Clinico San Borja Arriaran; Chile
Fil: Prieto, Jhon. Clínica Universitaria Colombia y Centro de Enfermedades Hepáticas y Digestivas; Colombia
Fil: Vujacich, Claudia. Fundacion Centro de Estudios Infectologicos; Argentina
Fil: Romero, Gustavo. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología ; Argentina
Fil: Muñoz, Alberto. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología ; Argentina
Fil: Anders, Margarita. Hospital Alemán; Argentina
Fil: Hernández, Nelia. Hospital de Clinicas Dr. Manuel Quintela; Uruguay
Fil: Coccozella, Daniel. Centro de Hepatología; Argentina
Fil: Gruz, Fernando. Fundación Favaloro; Argentina
Fil: Reggiardo, Maria V.. Provincia de Santa Fe. Ministerio de Salud y Medio Ambiente - Rosario. Hospital Provincial del Centenario; Argentina
Fil: Ruf, Andres E.. FUNDIEH; Argentina
Fil: Varón, Adriana. Instituto de Cardiologia; Colombia
Fil: Cartier, Mariano. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología ; Argentina
Fil: Pérez Ravier, Roberto. Instituto Universidad Escuela de Medicina del Hospital Italiano; Argentina
Fil: Ridruejo, Ezequiel. Hospital Universitario Austral; Argentina. Centro de Educación Medica E Invest.clinicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Peralta, Mirta. Gobierno de la Ciudad de Buenos Aires. Hospital de Infecciosas ; Argentina
Fil: Poncino, Daniel. Sanatorio Municipal Dr. Julio Méndez; Argentina
Fil: Vorobioff, Julio. Universidad Nacional de Rosario; Argentina
Fil: Aballay Soteras, Gabriel. Sanatorio Mitre; Argentina
Fil: Silva, Marcelo O.. Hospital Universitario Austral; Argentina
Subject
ANTIVIRAL AGENTS
DISEASE CONTROL
HEPATITIS C VIRUS
PUBLIC POLICY
Medicina Critica y de Emergencia
Medicina Clínica
CIENCIAS MÉDICAS Y DE LA SALUD
Access level
Open access
License
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repository
CONICET Digital (CONICET)
Institution
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identifier
oai:ri.conicet.gov.ar:11336/58834