Acesso aos antivirais de ação direta Sofosbuvir, Simeprevir e Daclatasvir para o tratamento de Hepatite C Crônica no Sistema Único de Saúde

Abstract

Introduction: Chronic hepatitis C (CHC) represents a significant public health issue, and expanding access to direct-acting antiviral (DAA) therapy is a critical goal set by the World Health Organization to reverse the disease's burden by 2030. Globally, only 20% of CHC patients are diagnosed, and merely 7.4% initiate appropriate treatment. In Brazil, the estimated prevalence of CHC in 2014 was 1,450,000. Patient care is provided by the Unified Health System (SUS), which includes necessary medications for treatment. In 2015, DAAs (sofosbuvir, simeprevir, and daclatasvir) became available free of charge to all eligible patients, revolutionizing CHC treatment in the country as interferon-free therapy. The initial expectation was to provide 30,000 treatments in the first year. Objectives: This study aimed to investigate the access of CHC patients to new DAA therapy from its incorporation into SUS in June 2015 until December 2017. Methods: This was a cross-sectional observational study using real-world data. The number of CHC patients treated with DAAs (sofosbuvir and/or simeprevir and/or daclatasvir) was obtained from the SUS Ambulatory Information System database. The eligible population for DAAs was calculated based on epidemiological data, following treatment indications outlined in the 2015 Clinical Protocol and Therapeutic Guidelines for Hepatitis C Management from the Ministry of Health, which included Metavir fibrosis stages F3 and F4 and patients co-infected with human immunodeficiency virus (HIV), regardless of hepatic fibrosis stage. Access was defined as the proportion of patients treated with DAAs among the eligible population. Data manipulation and analysis were performed using IBM SPSS version 22. Results: Between 2015 and 2017, 34,291 (52.2%) of CHC patients undergoing treatment received DAAs. In 2015, only 2.3% of eligible patients in Brazil received DAA treatment. Access varied across Brazilian geographic regions: 1.3% in the South, 1.9% in the Southeast, 4.6% in the Northeast, 8.3% in the Midwest, and 9.4% in the North. By 2016, DAA access increased to 21.9% nationwide, with regional breakdowns of 18.1%, 20.8%, 30%, 36.9%, and 54% in the South, Southeast, Northeast, Midwest, and North, respectively. In 2017, there was a reduction in DAA access nationwide, particularly in the Midwest and North (decreases of 21% and 14%, respectively). During this year, approximately 13.6%, 15.5%, 15.9%, 21.9%, and 39.6% of eligible patients received appropriate DAA treatment in the South, Southeast, Midwest, Northeast, and North, respectively. Conclusion: Access to DAA therapy within SUS was heterogeneous among regions, with higher rates observed in 2016 and 2017. The South and Southeast regions exhibited lower access levels during the study period, while the North demonstrated higher access. The total number of treatments provided was lower than initially estimated, highlighting ongoing challenges in achieving equitable access across Brazil.