Introduction In clinical trials with hepatitis C virus-infected treatment-naive (TN) patients with compensated cirrhosis (CC), glecaprevir/pibrentasvir (G/P), a fixed-dose, once-daily, pangenotypic regimen, has demonstrated sustained virologic response at posttreatment Week 12 (SVR12) > 95%. We evaluated the real-world safety and effectiveness of 8-week G/P therapy in TN patients with CC, including certain subgroups of interest. Methods The CREST study is a real-world, noninterventional, multicenter study retrospectively assessing data from Canada, Germany, Israel, Italy, and Spain. The full analysis set (FAS) designated all patients in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 data. The primary endpoint was SVR12; safety endpoints were also assessed. Results A total of 386 patients were included in the FAS, 375 patients completed the study, and 325 patients were included in the MAS; 51 patients had missing SVR12 data. Overall, in the MAS and FAS, SVR12 was achieved in 99.1% and 84.2% of patients, respectively. In subgroups of interest, the percentage of patients achieving SVR12 in the MAS (and FAS) was: genotype (GT)3: 97.5% (80.6%); FibroScan(R) >= 12.5 kPa: 98.9% (89.3%); platelet count < 100 x 10(9)/l: 100% (88.2%); both platelets < 150 x 10(9)/l and FibroScan(R) > 20 kPa: 100% (88.9%); aspartate aminotransferase-to-platelet ratio index > 1.09: 98.7% (83.1%); fibrosis-4 index > 3.25: 98.6% (84.0%); albumin < 3 g/dl: 100% (91.7%); people who use drugs: 97.7% (84.3%); psychiatric disorders: 96.6% (84.8%); and human immunodeficiency virus coinfection: 100% (95.0%). Overall, 26.9% (104/386) of patients experienced an adverse event, none of which were classed as serious. Conclusion In this real-world cohort, 8 weeks of G/P therapy was well tolerated in TN patients with CC. SVR12 rates were similar to clinical trials, supporting 8-week treatment in TN patients with CC, including those with signs of advanced liver disease and GT3 infection.

Cornberg, M., Ahumada, A., Aghemo, A., Andreoni, M., Bhagat, A., Butrymowicz, I., Carmiel, M., Chodick, G., Conway, B., Song, Y., Gasbarrini, A., Hüppe, D., Plaza, F. J., Lampertico, P., Alonso, M. L. M., Myles, L., Persico, M., Ramji, A., Sarrazin, C., Villa, E., Weil, C., Otano, J. I. U., Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study, <<ADVANCES IN THERAPY>>, N/A; 39 (7): 3146-3158. [doi:10.1007/s12325-022-02158-6] [https://hdl.handle.net/10807/230814]

Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

Gasbarrini, Antonio;
2022

Abstract

Introduction In clinical trials with hepatitis C virus-infected treatment-naive (TN) patients with compensated cirrhosis (CC), glecaprevir/pibrentasvir (G/P), a fixed-dose, once-daily, pangenotypic regimen, has demonstrated sustained virologic response at posttreatment Week 12 (SVR12) > 95%. We evaluated the real-world safety and effectiveness of 8-week G/P therapy in TN patients with CC, including certain subgroups of interest. Methods The CREST study is a real-world, noninterventional, multicenter study retrospectively assessing data from Canada, Germany, Israel, Italy, and Spain. The full analysis set (FAS) designated all patients in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 data. The primary endpoint was SVR12; safety endpoints were also assessed. Results A total of 386 patients were included in the FAS, 375 patients completed the study, and 325 patients were included in the MAS; 51 patients had missing SVR12 data. Overall, in the MAS and FAS, SVR12 was achieved in 99.1% and 84.2% of patients, respectively. In subgroups of interest, the percentage of patients achieving SVR12 in the MAS (and FAS) was: genotype (GT)3: 97.5% (80.6%); FibroScan(R) >= 12.5 kPa: 98.9% (89.3%); platelet count < 100 x 10(9)/l: 100% (88.2%); both platelets < 150 x 10(9)/l and FibroScan(R) > 20 kPa: 100% (88.9%); aspartate aminotransferase-to-platelet ratio index > 1.09: 98.7% (83.1%); fibrosis-4 index > 3.25: 98.6% (84.0%); albumin < 3 g/dl: 100% (91.7%); people who use drugs: 97.7% (84.3%); psychiatric disorders: 96.6% (84.8%); and human immunodeficiency virus coinfection: 100% (95.0%). Overall, 26.9% (104/386) of patients experienced an adverse event, none of which were classed as serious. Conclusion In this real-world cohort, 8 weeks of G/P therapy was well tolerated in TN patients with CC. SVR12 rates were similar to clinical trials, supporting 8-week treatment in TN patients with CC, including those with signs of advanced liver disease and GT3 infection.
2022
Inglese
Cornberg, M., Ahumada, A., Aghemo, A., Andreoni, M., Bhagat, A., Butrymowicz, I., Carmiel, M., Chodick, G., Conway, B., Song, Y., Gasbarrini, A., Hüppe, D., Plaza, F. J., Lampertico, P., Alonso, M. L. M., Myles, L., Persico, M., Ramji, A., Sarrazin, C., Villa, E., Weil, C., Otano, J. I. U., Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study, <<ADVANCES IN THERAPY>>, N/A; 39 (7): 3146-3158. [doi:10.1007/s12325-022-02158-6] [https://hdl.handle.net/10807/230814]
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