TY - JOUR
T1 - Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study
AU - Cornberg, Markus
AU - Ahumada, Adriana
AU - Aghemo, Alessio
AU - Andreoni, Massimo
AU - Bhagat, Abhi
AU - Butrymowicz, Isabel
AU - Carmiel, Michal
AU - Chodick, Gabriel
AU - Conway, Brian
AU - Song, Yanna
AU - Gasbarrini, Antonio
AU - Hüppe, Dietrich
AU - Plaza, Francisco Jorquera
AU - Lampertico, Pietro
AU - Alonso, Maria Luisa Manzano
AU - Myles, Lindsay
AU - Persico, Marcello
AU - Ramji, Alnoor
AU - Sarrazin, Christoph
AU - Villa, Erica
AU - Weil, Clara
AU - Otano, Juan Isidro Uriz
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - Compensated cirrhosis
KW - Direct-acting antivirals
KW - Treatment-naïve
KW - Real world
KW - Hepatitis C virus
KW - Compensated cirrhosis
KW - Direct-acting antivirals
KW - Treatment-naïve
KW - Real world
KW - Hepatitis C virus
UR - http://hdl.handle.net/10807/230814
U2 - 10.1007/s12325-022-02158-6
DO - 10.1007/s12325-022-02158-6
M3 - Article
SN - 1865-8652
VL - 39
SP - 3146
EP - 3158
JO - Advances in Therapy
JF - Advances in Therapy
ER -