Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: Results of the Italian cohort of a post-marketing observational study
| Autor: | Aghemo, A, Alberti, A, Andreone, P, Angelico, M, Brunetto, Mr, Chessa, L, Ciancio, A, Craxì, A, Gaeta, Gb, Galli, M, Gasbarrini, A, Giorgini, A, Grilli, E, Lampertico, P, Lichtner, M, Milella, M, Morisco, F, Persico, M, Pirisi, M, Puoti, M, Raimondo, G, Romano, A, Russello, M, Sangiovanni, V, Schiavini, M, Serviddio, G, Villa, E, Vinci, M, De Michina, A, Gallinaro, V, Gualberti, G, Roscini, As, Zignego, Al, MARS Study Group |
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| Přispěvatelé: | Aghemo A., Alberti A., Andreone P., Angelico M., Brunetto M.R., Chessa L., Ciancio A., Craxi A., Gaeta G.B., Galli M., Gasbarrini A., Giorgini A., Grilli E., Lampertico P., Lichtner M., Milella M., Morisco F., Persico M., Pirisi M., Puoti M., Raimondo G., Romano A., Russello M., Sangiovanni V., Schiavini M., Serviddio G., Villa E., Vinci M., De Michina A., Gallinaro V., Gualberti G., Roscini A.S., Zignego A.L., Aghemo, A, Alberti, A, Andreone, P, Angelico, M, Brunetto, M, Chessa, L, Ciancio, A, Craxi, A, Gaeta, G, Galli, M, Gasbarrini, A, Giorgini, A, Grilli, E, Lampertico, P, Lichtner, M, Milella, M, Morisco, F, Persico, M, Pirisi, M, Puoti, M, Raimondo, G, Romano, A, Russello, M, Sangiovanni, V, Schiavini, M, Serviddio, G, Villa, E, Vinci, M, De Michina, A, Gallinaro, V, Gualberti, G, Roscini, A, Zignego, A, Aghemo, A., Alberti, A., Andreone, P., Angelico, M., Brunetto, M. R., Chessa, L., Ciancio, A., Craxi, A., Gaeta, G. B., Galli, M., Gasbarrini, A., Giorgini, A., Grilli, E., Lampertico, P., Lichtner, M., Milella, M., Morisco, F., Persico, M., Pirisi, M., Puoti, M., Raimondo, G., Romano, A., Russello, M., Sangiovanni, V., Schiavini, M., Serviddio, G., Villa, E., Vinci, M., De Michina, A., Gallinaro, V., Gualberti, G., Roscini, A. S., Zignego, A. L. |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
Adult medicine.medical_specialty Pyrrolidines Quinoxaline Sustained Virologic Response Settore MED/12 - GASTROENTEROLOGIA Population Antiviral Agents elderly Benzimidazole GLE/PIB Quinoxalines Internal medicine Drug Combination Clinical endpoint medicine Product Surveillance Postmarketing Humans Prospective Studies education Adverse effect Aged Antiviral Agent Sulfonamides education.field_of_study Hepatology business.industry Settore MED/09 - MEDICINA INTERNA Gastroenterology PWUD Glecaprevir Middle Aged HCV Hepatitis C Chronic Pibrentasvir Discontinuation Drug Combinations Italy Cohort Quality of Life Benzimidazoles Female Observational study business |
| Popis: | Background and Aims The MARS post-marketing, observational study evaluates glecaprevir/pibrentasvir in a large population of Italian patients who are infected with HCV. Patients and Methods Achievement of SVR12 was the primary endpoint in the overall population and by subpopulations of interest (treatment-naive and treatment-experienced patients, subjects infected with different HCV genotype/sub-genotype, cirrhotic and non-cirrhotic patients, patients with different severity of fibrosis, patients with an APRI score ≥1, subjects with comorbidities, HIV-coinfected patients, elderly patients and people who use drugs). Safety and quality of life (assessed by SF-36 and Work Productivity and Activity Impairment) were also evaluated. Results The SVR12 rate was 99.4% (319/321; 95% CI: 97.8–99.8%) in the core population with sufficient follow-up (n = 321), 99.7% (289/290) in 8-week treated patients, and high (>96%) across subgroups. Only three patients (0.9%) had treatment-related adverse events that led to treatment discontinuation. In total, 30.1% of patients showed an improvement of ≥2.5 points in the Physical Component Summary of the SF-36 from baseline to the end of treatment, and this figure raised to 37.5% with the achievement of SVR12. Corresponding values for MCS were 42.2% and 42.8%, respectively. Conclusion Glecaprevir/pibrentasvir is safe and effective across subpopulations who are underserved in clinical trials. |
| Databáze: | OpenAIRE |
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