Real-world data shows that glecaprevir/pibrentasvir (GLE/PIB) is safe and effective across various frail patient subpopulations with chronic hepatitis C virus (HCV), according to study results published in Digestive and Liver Disease. The findings are significant in that these populations have been generally less represented in clinical trials.
In this prospective, post-marketing observational study, patients achieved sustained virologic response at 12 weeks (SVR12) after treatment with GLE/PIB in the overall population and in several subpopulations including the following: treatment-naïve and treatment-experienced patients, patients infected by different HCV genotypes (GTs)/sub-GT, cirrhotic and non-cirrhotic patients, patients with different severity of fibrosis, patients with aspartate aminotransferase to platelet ratio index (APRI) score above and below 1, patients with comorbidities, patients coinfected with HIV/HCV, elderly (≥65 years) patients, and people who use drugs. Safety and quality of life (assessed by Short Form Health Survey [SF-36] and Work Productivity and Activity Impairment) were also evaluated.
The study was conducted in 29 Italian centers from December 2017 to January 2019. In total, 337 patients enrolled in the study; of these, 334 were part of the core population, and 321 comprised the core population with sufficient follow-up. Approximately half the patients were men (49.4%; n=165), median age was 56 years (range, 19-87), 82.3% (n=275) were naïve to HCV treatment, 44.6% (n=149) showed at least 1 comorbidity, 8.4% (n=28) patients had cirrhosis, all with a Child-Pugh score of 5 to 6. Most patients had normal or slightly reduced renal function (stage I, 40.4% [n=135]; stage II, 37.4% [n=125]). A total of 231 patients (69.2%) had an APRI score of 1 or less. Other observed GTs include GT1 (56.3%; n=188), GT2 (22.2%; n=74), and GT3 (10.5%; n=35). Other subpopulations worth noting are that HIV/HCV coinfection rate was 7.5% (n=25) and people who use drugs were 16.8% (n=56) of the core population.
The SVR12 rate was 99.4% (n=319/321; 95% CI, 97.8%-99.8%) in the core population with sufficient follow-up, 99.7% (n=318/319) in 8-week treated patients, and greater than 96% across all subpopulations of interest. Three patients (0.9%) had treatment-related adverse events that led to treatment discontinuation.
In total, 30.1% of patients showed an improvement of at least 2.5 points in the Physical Component Summary of the SF- 36 questionnaire from baseline to the end of treatment, and this figure increased to 37.5% with the achievement of SVR12. Corresponding values for the Mental Component Summary were 42.2% and 42.8%, respectively.
The findings from this study provide further evidence on the safety and effectiveness profile of GLE/PIB “in a real clinical practice setting and [hold] great potential to inform decisions both for the management and for the healthcare resources allocation to optimize access to treatment in a wide range of frail HCV subpopulations,” concluded the researchers.
Disclosure: AbbVie sponsored this study and participated in the study design, interpretation of data, writing, and approval of this publication. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Aghemo A, Alberti A, Andreone P, et al; MARS Study Group. Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: results of the Italian cohort of a post-marketing observational study. Published online September 8, 2020. Dig Liver Dis. doi:10.1016/j.dld.2020.08.007