Abstract
Objective. To analyze the results of usage of pangenotype combination glecaprevir/pibrentasvir (GLE/PIB) in real clinical practice in Stavropol Krai within the framework of the regional program on chronic hepatitis C (CHC) treatment. Materials and methods. In the framework of this study, a retrospective analysis of the use of GLE/PIB combination in the period from 2018 to 2022 within the framework of the regional program for the treatment of CHC in the Stavropol region was carried out. The drug was prescribed in accordance with the current label approved in Russia. Patients were observed during the entire period of GLE/PIB therapy and for 12 weeks after treatment completion. Data for analysis were collected from outpatient records and protocols of the “Regional Medical Commission on Diagnosis, Treatment and Drug Supply of Patients with Chronic Viral Hepatitis B and C in Stavropol Krai”. Results. The analysis included 405 patients treated within the framework of the regional program on drug supply of patients with chronic viral hepatitis B and C in the territory of the Stavropol region. The scope of the examination allowed to assess the sustained virologic response 12 weeks after the end of GLE/PIB therapy (SVR12). 92.6% (375/405) of patients had not previously received antiviral therapy. Absence or minimal manifestations of hepatic fibrosis (F0-1) were noted in 50.9% of patients, advanced stage of fibrosis (F3-4 by METAVIR scale) in 34.6%. The distribution by fibrosis stage was as follows: F0 – 21.98% (89/405), F1 – 28.9% (117/405), F2 – 14.6% (59/405), F3 – 13.1% (53/405), F4 (CP-A) – 21.5% (87/405). All patients with liver cirrhosis had compensated stage of the disease – class A according to Child-Pugh. In the study population, genotype (Gt) 3 prevailed, detected in 55.1% (223/405) of patients. Hepatitis C virus (HCV) Gt1 was diagnosed in 29.4% (119/405) of patients. Among them, 16.5% (67/405) of patients had Gt1b, 0.5% (2/405) had Gt1a, and 12.3% (50/405) of patients with Gt1 had no subtype identified. Gt2 was detected in 11.4% of patients (46/405), 3 (0.7%) patients had a genotype other than 1–3, and 14 (3.5%) patients had no HCV genotype determined. 14 (3.6%, 14/405) patients were co-infected with HCV and HIV. 23.5% (95/405) of patients belonged to the age group older than 60 years. The distribution of patients according to the duration of antiviral therapy was as follows: 8 weeks – 89.4% (362/405), 12 weeks – 6.4% (26/405) and 16 weeks – 4,2% (17/405). 405 (100,0%) out of 405 patients achieved SVR12. There were no cases of serious adverse events and treatment withdrawal during antiviral therapy. Conclusion. GLE/PIB has demonstrated high efficacy in patients with different HCV genotypes (including Gt3) and different stages of liver fibrosis (including compensated cirrhosis) in the real-world setting. The SVR12 rate obtained in this analysis is fully consistent with the data of clinical trials and real clinical practice published earlier. Key words: chronic hepatitis C, glecaprevir/pibrentasvir, pangenotypic, real clinical practice
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