Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C.

Abstract

In late 2014, Portugal implemented a national program for the treatment of patients with chronic hepatitis C with directactingantiviral agents. This program has made Portugal one of the first European countries to implement a structured measure oftreatment to eliminate this serious public health problem. The aim of this study was to assess the effectiveness of direct-acting antiviraltherapy in the treatment of patients with chronic hepatitis C virus infection. A retrospective observational study was conducted at Centro Hospitalar de Lisboa Ocidental on the nationalonline platform from December 2014 until February 2017 and included patients with hepatitis C virus infection who underwent treatment.The primary endpoint was sustained virologic response at least 12 weeks post treatment. Data was analyzed with the SPSS 17.0program. During the study period, 820 patients completed therapy and achieved sufficient follow-up time to assess sustained virologicresponse with an overall response rate of 97.2% (n = 797) and a response rate of 98.0%, 99.5%, 90.9%, 95.1% and 94.2% forgenotypes 1a, 1b, 2, 3 and 4, respectively. Data suggested that advanced fibrosis (F3/F4), human immunodeficiency virus co-infectionand treatment failure with interferon and ribavirin were not negatively related with sustained virologic response in our population.Most patients (80.1%) completed treatment with ledipasvir/sofosbuvir ± ribavirin. The most common adverse events were fatigue andinsomnia followed by headache and weight loss. Patients predominantly had genotype 1 infection which correlates with HCV distribution in Europe, but we found a majorproportion in genotype 4 which can be explained by immigration from African countries. Our patients' ages ranging from 22 to 90 years,reflected a new approach with no upper age limit. Direct-acting antivirals regimens resulted in remarkably high SVR rates compared tointerferon-based regimens, which were consistent with clinical trials data. Our data showed that direct-acting antiviral-based regimens are safe and have a high success rate in the treatment ofpatients with hepatitis C virus infection in a real-world setting.