ABSTRACT Background: This study aimed to evaluate the effectiveness and safety of direct-acting antivirals (DAAs) for hepatitis C treatment by measuring sustained virologic response (SVR) and serious adverse events to help design effective interventions for reducing disease prevalence. Methods: This was a retrospective, observational, real-life study of patients with chronic hepatitis C receiving DAA treatment in the state of Ceará, Brazil. Data were collected in REDCap and analyzed using R® software by the Student's t, chi-square, and Fisher’s exact tests, with a significance level of 5%. Results: In this study, 1075 patients who were diagnosed with hepatitis C infection between October 2015 and October 2023 were included. The mean age of the participants was 56.6 ± 11 years and 60.2% were men. The sample included 51 HIV-infected patients (6.6%), 166 (15,4%) liver transplant recipients, 34 (3,1%) kidney transplant recipients, and 446 patients with cirrhosis (41.4%). The overall SVR rate was 96.4%. The sofosbuvir/daclatasvir/ribavirin regimen used in 354 (32.9%) patients achieved an SVR of 96%. The cure rate was 96.5%, with a lower SVR in patients with cirrhosis (93.4%) than in those with less severe fibrosis (97.9%) (p=0.0015). Serious adverse events associated with ribavirin use occurred in 3.5% of patients. Conclusions: DAA treatment for hepatitis C achieved SVR in real life in all patient profiles, including transplant recipients, HIV carriers, and patients with cirrhosis. Although these drugs are safe, a few decompensated patients with cirrhosis died during treatment. Background directacting direct acting DAAs (DAAs (SVR prevalence Methods retrospective observational reallife Ceará Brazil R Students Student s t chisquare, chisquare chi square, square chi-square Fishers Fisher tests 5 5% Results 107 201 202 566 56 6 56. 1 602 60 2 60.2 men HIVinfected infected 6.6%, 66 6.6% , (6.6%) 16 15,4% 154 15 4 (15,4% recipients 3 3,1% 31 (3,1% 44 41.4%. 414 41.4% . 41 (41.4%) 964 96 96.4% sofosbuvirdaclatasvirribavirin sofosbuvir daclatasvir 35 32.9% 329 32 9 (32.9% 96% 965 96.5% 93.4% 934 93 (93.4% 97.9% 979 97 (97.9% p=0.0015. p00015 p p=0.0015 0 0015 (p=0.0015) 3.5 Conclusions profiles carriers safe 10 20 60. 6.6 (6.6% 15,4 (15,4 3,1 (3,1 41.4 (41.4% 96.4 32.9 (32.9 96.5 93.4 (93.4 97.9 (97.9 p0001 p=0.001 001 (p=0.0015 3. 6. (6.6 15, (15, 3, (3, 41. (41.4 96. 32. (32. 93. (93. 97. (97. p000 p=0.00 00 (p=0.001 (6. (15 (3 (41. (32 (93 (97 p00 p=0.0 (p=0.00 (6 (1 ( (41 (9 p0 p=0. (p=0.0 (4 p=0 (p=0. p= (p=0 (p= (p

Abstract INTRODUCTION: In 2013, combination therapy using peginterferon, ribavirin, and boceprevir or telaprevir was introduced to treat hepatitis C virus genotype 1 infection in Brazil. The effectiveness of this therapy in four Brazilian regions was evaluated. METHODS: Clinical and virological data were obtained from patients of public health institutions in five cities, including sustained virological response (SVR) and side effects. Patients with advanced fibrosis (F3/4), moderate fibrosis (F2) for > 3 years, or extra-hepatic manifestations were treated according to Ministry of Health protocol. Treatment effectiveness was verified by using bivariate and multivariate analysis; p-values of < 0.05 were considered significant. RESULTS: Of 275 patients (64.7% men; average age, 57 years old), most (61.8%) were treatment-experienced; 53.9% had subgenotype 1a infection, 85.1% had advanced fibrosis, and 85.5% were treated with telaprevir. SVR was observed in 54.2%. Rapid virological response (RVR) was observed in 54.6% of patients (data available for 251 patients). Overall, 87.5% reported side effects and 42.5% did not complete treatment. Skin rash, severe infection, and death occurred in 17.8%, 2.5%, and death in 1.4% of cases, respectively. SVR was associated with treatment completion, RVR, and anemia. CONCLUSIONS: The effectiveness of hepatitis C virus triple therapy was lower than that reported in phase III clinical trials, possibly owing to the prioritized treatment of patients with advanced liver fibrosis. The high frequency of side effects and treatment interruptions observed supported the decision of the Brazilian authorities to suspend its use when safer and more effective drugs became available in 2015.