Эффективность 8-недельного курса глекапревир/пибрентасвир у пациентов с хроническим гепатитом С и компенсированным циррозом печени (исследование “EASY”)

Abstract

Objective. To determine how the efficacy and safety of an 8-week course of glecaprevir/pibrentasvir (GLE/PIB) in patients with chronic hepatitis C (CHC) and compensated cirrhosis, as demonstrated in the respective clinical trial, translate to real-world clinical practice. Patients and methods. A prospective multicenter observational study was conducted in treatment-naive patients aged ≥12 years with CHC (viral genotypes 1–6) and compensated liver cirrhosis taking GLE/PIB for 8 weeks in routine clinical practice in Russia. GLE/PIB was prescribed in accordance with the Russian label prior to patient inclusion in the study. Patients were followed for 8 weeks of GLE/PIB therapy and at least 12 weeks after its termination to assess the rate of sustained virologic response (SVR). Diagnostic methods, procedures, and visits were consistent with routine clinical practice. Each patient's data were documented in the electronic database. Results. Ninety-nine patients at 6 centers were enrolled; in 93 of these patients, follow-up data were sufficient to assess SVR 12 weeks (ie, ≥70 days) after completion of GLE/PIB therapy (SVR12). The overall SVR12 rate was 98.9% (92/93); only 1 patient did not achieve SVR12 due to virologic failure (non-response). The following SVR12 rates were found in the subgroups to which this patient belonged: 98.3% (59/60) among non-drug users, 97.1% (33/34) among those infected with GT1b virus, 98.7% (78/79) among young and middle-aged patients (<65 years), and 98.5% (65/66) among patients without HIV. In contrast, SVR12 was achieved in all patients (100%) in the remaining subgroups: patients with genotype 2 (n = 8), 3 (n = 44), and other (n = 7); drug users (n = 31) and patients with unknown drug use status (n = 2); HIV co-infected (n = 27); and elderly (≥65 years, n = 14) patients. No adverse events, including cases of hepatic failure, were observed in patients during this study. Conclusion. An 8-week course of GLE/PIB demonstrated high efficacy and favorable safety profile in treatment-naive patients with compensated cirrhosis infected with different genotypes of hepatitis C virus, including genotype 3 in routine clinical practice in Russia. These results are consistent with data obtained in GLE/PIB clinical trials and real-world studies conducted in other countries. Key words: chronic hepatitis C, compensated cirrhosis, glecaprevir/pibrentasvir combination, 8 weeks