DIRECT ACTING ANTIVIRAL (DAA) THERAPY IN REAL WORLD HCV COMPENSATED CIRRHOSIS

Abstract

Aim: Given the effectiveness of direct acting antiviral (DAA) therapy in patients with chronic hepatitis C virus (HCV) infection, we aimed to describe the demographic, clinical and biological characteristics of our patients who received treatment with direct acting antivirals during December 2015-October 2016 and September 2017-January 2018. Material and Methods: We performed a prospective study of 186 patients with chronic hepatitis C who have undergone treatment with paritaprevir/ombitasvir/ritonavir and dasabuvir with or without ribavirin during December 2015 - October 2016 (group 1) and September 2017 - January 2018 (group 2). The inclusion and exclusion criteria were established according to the national protocol.  Demographic, clinical and biological data were recorded before starting treatment. All patients underwent upper gastrointestinal endoscopy and abdominal ultrasound. The determination of HCV genotypes and subtypes was realized by the Abbott RealTime HCV assay. The presence of mild or advanced fibrosis, cirrhosis, the viral necro inflammatory activity and the presence of nonalcoholic steatohepatitis (NASH) were assessed by FibroMax non-invasive liver tests: ActiTest, FibroTest and NashTest. Results: The mean age was 58.7 years for the first group and 59.6 for the second group, with the predominance of female gender in both cases. Genotype 1b was present exclusively in the first group. Median HCV RNA at baseline was 1 264 123.180 IU/mL for the first group and 1 678 718.97 IU/mL for the second group. No patients were HBV or HIV co-infected. Most patients were naive to interferon therapy. The comorbidity rate was increased in both groups: 28.82% vs. 49.3% had cardiovascular diseases, 23.41% vs.  14.66% had diabetes mellitus (with or without insulin requirement), 2.7% vs.  10.6% had thyroid dysfunction, 1.8% vs.  0% had dermatological disease, 0.9% vs. 5.33% had psychiatric disorders, 1.8% vs. 1.33% had a history of cured neoplasm, 1.8% vs.  2.66% had pulmonary diseases and 0.9% vs. 1.33% had hematological diseases. No patient had a history of treated hepatocellular carcinoma. In both groups, the maximum number of drugs administered simultaneously with the antiviral therapy was 4. The necro inflammatory activity assessed by ActiTest highlights a high rate for severe activity for both groups - 66.6%. The prevalence of concomitant NASH assessed by NashTest (N2-severe inflammation) was 50% in group 1 and 53.3% in group 2. There were slight differences between the two groups in terms of biological constants, but without any statistical significance. Conclusions: The partial results of our study show a higher prevalence of HCV infection among people born between 1946 and 1964 (baby boom generation), especially women. In this geographical area, genotype 1b was found exclusively. Most patients, naïve to interferon therapy, associate numerous comorbidities and simultaneous treatments that may decrease adherence to therapy due to the possibility of significant drug-drug interactions, requiring optimal therapeutic management and close monitoring.