• Soraia M Machado, Aline G Vigani, Andrea G Leite, Ana Claudia M Diaz, Paulo Roberto A Ferreira, Dimas Carnaúba-Júnior, Simone B Tenore, Carlos Eduardo Brandão-Mello, Mario P Gonzalez, Fabiana Siroma, Kleber D Prado, Delzi V Nunes, Gaspar Lisboa-Neto, João Renato R Pinho, Fernanda M Malta, Raymundo S Azevedo, Steven S Witkin, and Maria Cássia Mendes-Correa.
• University of São Paulo School of Medicine, São Paulo.
• Medicine (Baltimore). 2020 Jul 24; 99 (30): e21270e21270.

AbstractIn a hepatitis C virus (HCV)/HIV-positive Brazilian cohort, evaluate the safety and efficacy of HCV DAAs, the frequency of resistance substitutions in the HCV NS5A and NS5B genes and identify predictors of treatment failure.Retrospective multicenter study of HCV/HIV patients treated with sofosbuvir (SOF)-based regimens at 10 reference centers in Brazil.Clinical and virological data were collected. Genetic diversity in the NS5A and NS5B genes was assessed by direct nucleotide sequencing. The primary outcome was sustained virological response (SVR) 12 weeks after DAA completion.Of 643 HCV/HIV patients analyzed, 74.7% were male, median CD4+ T cell count was 617 cells/mm, 90% had an undetectable HIV viral load. HCV genotype 1 was detected in 80.2%, and 60% were taking at least 1 medication other than antiretroviral drugs during their DAA therapy. Cirrhosis was present in 42%. An SOF/daclatasvir (DCV) regimen was used in most patients (98%). The frequency of NS5A polymorphisms associated with clinically relevant resistance to DCV was 2%; no relevant NS5B variants were identified. The SVR12 rate was 92.8% in an intention to treat (ITT) analysis and 96% in a modified ITT (m-ITT) analysis. AE occurred in 1.6% of patients. By multivariate analysis, therapeutic failure was associated, in the m-ITT analysis, with concomitant use of anticonvulsant drugs (P = .001), age (P = .04), and female gender (P = .04).SOF/DCV regimens were associated with a high SVR rate in an HCV/HIV population. The use of concurrent anticonvulsant drugs and DAAs decreases the chances of achieving an SVR.

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