B.A.R.C.O.S. (Brazilian Argentine Hepatitis C Collaborative Observational Study): Effectiveness and clinical outcomes of HCV treatment with daclatasvir and sofosbuvir with or without ribavirin

RIDRUEJO, EZEQUIEL; CHEINQUER, HUGO; MARCIANO, SEBASTIÁN; MENDIZABAL, MANUEL; PIÑERO, FEDERICO; WOLFF, FERNANDO H.; ARAUJO, ALEXANDRE; COELHO BORGES, SILVIA; KLIEMANN, DIMAS; FLECK, ALFEU; DE MAMAN, ÍTALO; NADER, LYSANDRO A.; GARRASTAZUL, PATRICIA; BERMÚDEZ, CARLA; HADDAD, LEILA; GADANO, ADRIÁN; SILVA, MARCELO

JOURNAL OF VIRAL HEPATITIS.

WILEY-BLACKWELL PUBLISHING, INC

Año: 2019 vol. 26 p. 1200 - 1209

1352-0504

Real‐world data evaluating the effectiveness of direct‐acting antivirals (DAAs) inhepatitis C virus (HCV) treatment have been reported from different regions. Ouraim was to evaluate the effectiveness and clinical outcomes of daclatasvir (DCV) andsofosbuvir (SOF) ± ribavirin (RBV) in a prospective multicentre cohort study includingpatients from Argentina and Brazil who received DCV/SOF ± RBV for 12 or 24 weeksfrom 2015 to 2018. Multivariable logistic regression models were carried out toidentify factors associated with failure to achieve sustained virologic response (SVR)as a primary end point, and to death, decompensation, hepatocellular carcinoma(HCC) or liver transplantation (LT) as a composite secondary end point. From a totalof 1517 patients treated with DCV/SOF, 906 completed 12 weeks post‐treatmentevaluation and were included in the analysis. Overall SVR12 rate was 96.1% (95% CI:94.6%‐97.2%), and 95% (95% CI: 92.8%‐96.6%) in patients with cirrhosis. LT recipi‐ents and presence of cirrhosis were independently associated with failure to achieveSVR. During post‐SVR12 follow‐up, cumulative incidence of the secondary end pointwas 2.4% (95% CI: 1.5%‐3.6%); two patients died from nonliver‐related causes andtwo from HCC, five underwent LT, 12 developed HCC and 17 patients developedhepatic decompensation. Independent variables associated with these composite