Direct-acting antivirals for chronic hepatitis C treatment: The experience of two tertiary university centers in Brazil

Abstract

BACKGROUND Hepatitis C virus (HCV) treatment has undergone major changes in recent years. Previous interferon-based therapies have been replaced by oral direct-actingantivirals (DAA) regimens, with high sustained virologic response (SVR) rates,and a lower incidence of adverse events (AEs).AIMTo evaluate the efficacy and safety of DAAs for HCV treatment in subjects fromtwo tertiary university centers in Brazil.METHODSThis is a multicenter retrospective cohort study of 532 patients with chronichepatitis C (CHC), undergoing treatment with interferon-free regimens fromNovember 2015 to November 2019. The therapeutic regimen was defined by thecurrent Brazilian guidelines for HCV management at the time of treatment.Demographic, anthropometric, clinical, and laboratory variables were evaluated.SVRs were assessed at 12 to 24 wk after therapy by intention-to-treat (ITT), andmodified ITT (m-ITT) analysis. AEs and serious adverse events (SAEs) wereregistered. In the statistical analysis, a P value of < 0.05 was consideredsignificant.RESULTSThe mean age was 56.88 years, with 415 (78.5%) being HCV genotype 1, followedby genotype 3 (20.1%). Moreover, 306 (57.5%) subjects had cirrhosis, and a third of them had decompensated cirrhosis. Sofosbuvir (SOF) plus daclatasvir ± ribavirinwas the most frequently used treatment (66.9%), followed by SOF plus simeprevir(21.2%). The overall ITT SVR was 92.6% (493/532), while the m-ITT SVR was96.8% (493/509). Variables associated with treatment failure via ITT evaluationwere hepatic encephalopathy (OR: 4.320; 95%CI: 1.920-9.721, P = 0.0004), presenceof esophageal varices (OR: 2.381; 95%CI: 1.137-4.988, P = 0.0215), previous portalhypertensive bleeding (OR: 2.756; 95%CI: 1.173-6.471, P = 0.02), higher model forend-stage liver disease scores (OR: 1.143, 95%CI: 1.060–1.233, P = 0.0005), lowerserum albumin levels (OR: 0.528, 95%CI: 0.322-0.867, P = 0.0115), higher serumcreatinine (OR: 1.117, 95%CI: 1.056-1.312, P = 0.0033), and internationalnormalized ratio (INR) levels (OR: 5.542, 95%CI: 2.023-15.182, P = 0.0009). AEswere reported in 41.1% (211/514) of patients, and SAEs in 3.7%. The femalegender, higher body mass index, esophageal varices, higher INR values, andlonger treatment duration were independently associated with AE occurrence.CONCLUSIONTreatment with oral DAAs attains a high SVR rate, with fewer SAEs in a real-lifecohort of subjects with CHC, from two tertiary university centers in Brazil