Ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin is safe and effective in HCV‐infected patients in a real‐life cohort from Latin America. Issue 9 (6th June 2017)

• Record Type: Journal Article
• 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.
• Is Part Of: Journal of medical virology. Volume 89:Issue 9(2017)
• Page Start: 1590
• Page End: 1596
• Publication Date: 2017-06-06
• Subjects: antiviral agents -- disease control -- hepatitis C virus -- public policy; Virology -- Periodicals; 616
• DOI: 10.1002/jmv.24816
• Languages: English
• ISSNs: 0146-6615

Abstract

Abstract : 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.