A Real-life Study of the Positive Response to DAA-based Therapies for Hepatitis C in Brazil

Abstract

Treating hepatitis C virus (HCV) infections reduces overall mortality and the risk of multiple extrahepatic complications. Direct-acting antivirals (DAAs) are molecules that target specific non-structural proteins of the virus, resulting in the disruption of viral replication and infection. This report describes the activities undertaken to assess the cure of HCV in patients of different age groups, supported by the Viral Hepatitis National Program of the Unified Health System in Brazil. Around 11,000 patients wereevaluated in an electronic retrospective cohort, which used therapeutic schemes with Sofosbuvir (SOF), Daclatasvir (DCV), Simeprevir (SMV), and an association of Ombitasvir, Veruprevir/Ritonavir and Dasabuvir (3D) with or without Ribavirin (RBV), with sustained virologic response (SVR) or viral cure after a 12-week treatment. We conducted logistic regressions to identify factors independently associated with positive response to DAA-based therapies. Among evaluated patients, 57.1% were male; 48.3% identified as white; 78.3% were over 50 years old; 44.1% were from the Southeast region; 47.7% had genotype 1b; and 84.5% were treated for 12 weeks. The SVR rates with DAAs ranged from 87% to 100%. Genotypes 1 and 4 had a better response (96.3 to 100% of SVR) to therapy with DAAs, and genotypes 2 and 3 had SVR of 90.6% to 92.2%. Different treatment periods showed SVR with an average of 95.0% and 95.9% for 12 and 24 weeks, respectively. In the odds ratio assessment, we verified that females were half as likely (OR 0.5; CI 95% 0.4-0.6) to have a negative response to therapy, when compared to males, and that genotypes 2 and 3 were around twice more likely (OR 1.5-2.2; CI 95% 0.7-2.9; 1.2-3.6 and OR 2.7-2.8; CI 95% 2.0-3.8, respectively) to not have SVR after therapy when compared to genotype 1. Patients aged between 50 and 69 years old were 1.2 times (OR 1,2; CI95% 0,7-1,9) more likely to not have SVR when treated with DAAs, when compared to other age groups. This study is the first of this magnitude to be held in a Latin-American country with high SVR results, supported by a free-of- charge universal and public health system. We confirm the high performance of DAA-based therapies which support the Brazilian public health policy decision of adopting them as an important part of the countrys strategy to eliminate HCV by 2030.