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

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; ArgentinaFil: Haddad, Leila. Hospital Italiano; ArgentinaFil: Gallardo, Patricia E.. Fundación Sayani; ArgentinaFil: Ferrada, Alejandro. Hospital Clinico San Borja Arriaran; ChileFil: Soza, Alejandro A.. Universidad Católica de Chile; Chile. Pontificia Universidad Católica de Chile; ChileFil: Adrover, Raul. Centro de Hepatología; ArgentinaFil: Aravena, Edmundo. Hospital Clinico San Borja Arriaran; ChileFil: Roblero, Juan P.. Hospital Clinico San Borja Arriaran; ChileFil: Prieto, Jhon. Clínica Universitaria Colombia y Centro de Enfermedades Hepáticas y Digestivas; ColombiaFil: Vujacich, Claudia. Fundacion Centro de Estudios Infectologicos; ArgentinaFil: Romero, Gustavo. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología ; ArgentinaFil: Muñoz, Alberto. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología ; ArgentinaFil: Anders, Margarita. Hospital Alemán; ArgentinaFil: Hernández, Nelia. Hospital de Clinicas Dr. Manuel Quintela; UruguayFil: Coccozella, Daniel. Centro de Hepatología; ArgentinaFil: Gruz, Fernando. Fundación Favaloro; ArgentinaFil: Reggiardo, Maria V.. Provincia de Santa Fe. Ministerio de Salud y Medio Ambiente - Rosario. Hospital Provincial del Centenario; ArgentinaFil: Ruf, Andres E.. FUNDIEH; ArgentinaFil: Varón, Adriana. Instituto de Cardiologia; ColombiaFil: Cartier, Mariano. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología ; ArgentinaFil: Pérez Ravier, Roberto. Instituto Universidad Escuela de Medicina del Hospital Italiano; ArgentinaFil: Ridruejo, Ezequiel. Hospital Universitario Austral; Argentina. Centro de Educación Medica E Invest.clinicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Peralta, Mirta. Gobierno de la Ciudad de Buenos Aires. Hospital de Infecciosas ; ArgentinaFil: Poncino, Daniel. Sanatorio Municipal Dr. Julio Méndez; ArgentinaFil: Vorobioff, Julio. Universidad Nacional de Rosario; ArgentinaFil: Aballay Soteras, Gabriel. Sanatorio Mitre; ArgentinaFil: Silva, Marcelo O.. Hospital Universitario Austral; Argentin