Efficacy and safety of 3D-therapy at HCV-related subcompensated liver cirrhosis (genotype 1b)

Aim of the study. To estimate efficacy and safety of 3D mode of interferon­free therapy in patients with subcompensated liver cirrhosis (LC) of HCV etiology (genotype 1b). Material and methods. Original study included the data of 66 patients (26 men and 40 women) with subcompensated LC of HCV etiology (genotype 1b) who underwent interferon­free therapy by ombitasvir/paritaprevir/ritonavir, dasabuvir and ribavirin for 12 weeks (the latter was cancelled at receiving the new data on treatment efficacy after 4 weeks of therapy) in September, 2015, before the drug instruction was updated. Mean age of patients was 56.4±10.0 years. At onset of etiological therapy 21 patients (31.8%) had Child­Pugh score of 9, eleven patients (16.7%) had Child­Pugh 8, 34 patients (51.5%) had Child­Pugh 7. The causes of inefficacy of previous modes of combined antiviral therapy (CAT) included absence of virologic response in 43.9% of the cases, recurrence of HCV replication - in 30.3%, virological breakthrough - in 16.7%, development of serious adverse effects - in 9.1%. Taking into account the change of the group quantity during the course of therapy because of treatment cancellation for safety reasons and the subsequent assessment of its efficacy in patients with early treatment cancellation, the modified «intent­to­treat» (ITT) analysis was the basic method of results evaluation. Along with that «per protocol» (PP) analysis was carried out as well. Results. During the treatment course aviremia in 14 days was achieved in 53.8% of patients (in 35 patients of 65), prompt virologic response - at 79.7% (in 51 of 64 patients). All patients underwent complete 12 week course of CAT (n=60) and those for whom treatment was canceled for safety reasons (n=3) - in terms from 14 to 30 days - sustained virologic response (SVR) in 12 weeks and SVR in 24 weeks was registered. The assessment of liver function compensation degree in 6 months after CAT termination demonstrated 3 to 4 points reduction of the Child-Pugh Score in 21 patients (33.9 %), 1 to 2 points in 35 patients (56.5 %). According to the MELD score the clinical improvement was achieved in 66.1% of patients. The early treatment termination was caused by progression of hepatic encephalopathy symptoms and/or jaundice development (4 cases). Most cases of the progression­related treatment termination due to liver failure were reversible after CAT interruption. Three lethal outcomes after the early treatment termination and 1 patients dea