Результаты исследования “Deti-2”: эффективность комбинации глекапревир/пибрентасвир в реальной клинической практике у подростков 12–17 лет с хроническим гепатитом С в России

Abstract

The introduction of interferon-free combinations made it possible to effectively conduct antiviral therapy of chronic infection caused by hepatitis C virus (HCV) first in adults and later in adolescents. Glecaprevir/pibrentasvir (GLE/PIB) allowed to achieve sustained virological response (SVR12) in 100% (47/47) of adolescents in the DORA clinical trial. In the meantime there is insufficient data describing the effectiveness of GLE/PIB in adolescents in real clinical practice in Russia. Objective. Evaluation of the effectiveness of GLE/PIB in the treatment of chronic hepatitis C in adolescents 12–17 years of age in real clinical practice in the Russian Federation. Patients and methods. This prospective multicenter observational study enrolled adolescents (12–17 years old) chronically infected with HCV who were prescribed GLE/PIB for 8–16 weeks according to the label approved in the Russian Federation. Efficacy was evaluated based on the sustained virological response rate (SVR12), defined as the HCV RNA level < 50 IU/ml (or undetectable) 12 weeks after the last dose of GLE/PIB. Results. Of the 99 patients enrolled in the study, 92 received GLE/PIB for 8 weeks and 7 for 16 weeks. The overall SVR12 rate was 96.77% (90/93). In subgroups receiving 8- and 16-week courses of therapy, the efficacy was 96.51% (83/86) and 100% (7/7), respectively. SVR was achieved in 96.43% (81/84) of treatment-naive patients, and in 100.00% (9/9) of treatmentexperienced patients. Adverse events (AEs) were reported in 7.07% of patients (7/99), while no AEs of the 3rd degree of severity were observed, as well as no serious adverse events. All patients who did not achieve SVR12 had been diagnosed with stage 4 HIV infection. Conclusion. GLE/PIB was highly effective and well tolerated by adolescents infected with HCV in real clinical practice in Russia, which corresponds to the results previously obtained in the DORA clinical trial. Key words: hronic hepatitis C, hepatitis C virus, glecaprevir, pibrentasvir, SVR12, adolescents