Bezopasnost' i effektivnost' skhem terapii gepatita S na osnove simeprevira i ispol'zovanie vo vremya lecheniya soputstvuyushchikh lekarstvennykh preparatov

Background. The use of pegylated interferon (P) containing regimens for chronic hepatitis C (HCV) virus infection has significantly diminished in recent years, although it still remains an important treatment option in some regions. Simeprevir (SMV) is a direct acting antiviral (DAA) approved for HCV treatment in multiple countries. This study aimed to compare both the efficacy of interferon-containing and interferon-free SMV-containing regimens and to analyse changes in the use of concomitant medication during therapy with SMV. Methods. This post-hoc analysis pooled data from 11 SMV Phase 2/3 prospective interventional studies and one US observational study. Patients evaluated were between 18 and 70 years old and had received 150 mg SMV once-daily for a planned duration of at least eight weeks. The primary outcome was a sustained virologic response at week 12 post-treatment (SVR12) comparing SMV+PR versus SMV+DAA±R. Results. Of 2439 patients, almost one third were female, the majority were white, HCV treatment naive and >20% had cirrhosis. In the Intent-To-Treat analysis, SVR12 was higher for patients receiving SMV+DAA±R (706/811 [87%]) vs. SMV+PR (1096/1544 [71%]). In the subgroup of former people who inject drugs (PWID) on opioid substitution therapy (OST), response rates were similar (SMV+DAA±R: 84%; SMV+PR: 70%). Low rates of discontinuation were observed, with only few patients discontinuing their therapy prematurely (0-15% across subgroups).Adverse events were reported in >90% of patients in the SMV+PR group and approximately 60% of the patients receiving SMV+DAA±R. Use of concomitant medication was generally high at baseline, with a rate of 87% in patients receiving SMV+DAA±R. Among patients receiving SMV+PR, the number of patients with concomitant medications increased from 71% to 87% during SMV treatment (OSTsubgroup: increased from 67% to 89%). Conclusion. Simeprevir-based therapy was well tolerated and effective in patients with chronic HCV infection, with or without PR, and feasible in patients with a high level of polypharmacy. Efficacy and tolerability in former PWID patients were similar to the general HCV population.

chronic hepatitis C (HCV), treatment regimens, simeprevir