Real-World Effectiveness of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve, Compensated Cirrhotic HCV Patients

Abstract

Introduction The EXPEDITION-8 clinical trial has demonstrated that treatment-naïve patients with compensated cirrhosis (TN/CC) of HCV genotypes 1–6 can achieve a 98% intent-to-treat sustained virologic response rate 12 weeks post-treatment with an 8-week glecaprevir/pibrentasvir (G/P) regimen. Further real-world evidence is needed to support the effectiveness of 8-week G/P in a clinical practice setting and to consolidate these treatment recommendations. The aim of this study is to contribute real-world evidence for the effectiveness of an 8-week G/P treatment in TN/CC patients with HCV genotypes 1–6. Methods Retrospective real-world data from 494 TN/CC patients with HCV genotypes 1–6 were collected between August 2017 to December 2020 from the Symphony Health Solutions administrative claims database. Demographic and clinical characteristics were collected at baseline. Patients were required to have a follow-up HCV ribonucleic acid level at least 8 weeks or more after the end of treatment. The percentage of patients achieving a sustained virologic response (SVR) is reported. Results The majority of patients were male (58%) and Caucasian (40%), with a mean age of 58 years; 74%, 12%, 12%, and 1% of patients were HCV genotype 1, 2, 3, and 4–6 infected, respectively. SVR was achieved in 95.5% of all patients. Across patient subgroups, SVR was achieved in 95.6% of patients with HCV genotype 3 and in 93% of HCV patients with a recent diagnosis of illicit drug use or abuse (within 6 months prior to G/P initiation). Conclusion Early real-world evidence indicates high effectiveness of the 8-week G/P regimen in TN/CC patients of HCV genotypes 1–6 from a large US claims database. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-023-00823-z.

Real-World Safety and Effectiveness of an 8-Week Regimen of Glecaprevir/Pibrentasvir in Patients with Hepatitis C and Cirrhosis

“…These results are consistent with those of the EXPEDITION-8 clinical trial of an 8-week GLE/PIB regimen in treatment-naïve patients without cirrhosis (99.7% in the per-protocol sample and 97.7% in the ITT sample) [ 4 ]. They are likewise consistent with a number of “real-world” studies of patients in Taiwan [ 6 ] and the US Veterans’ Administration [ 7 , 9 ], as well as a recent study drawn from a large US administrative database [ 8 ].…”

“…One USA-based study of an 8-week regimen in treatment-naïve patients with cirrhosis demonstrated a 96% SVR rate [ 7 ], but no safety data were collected and there was no comparison group. Likewise, a recent study using a large administrative database found that an 8-week regimen was effective in treatment-naïve patients with cirrhosis but did not include data regarding adverse events [ 8 ]. Another study in a Veterans Administration population [ 9 ] was overwhelmingly (97%) male and included a large proportion of patients without cirrhosis.…”

A Synopsis of Hepatitis C Virus Treatments and Future Perspectives

“…The combination of glecaprevir/pibrentasvir has been highly effective in drug users, with an SVR of 93%. In other patients, the SVR was around 95% [110].…”

Contemporary Insights into Hepatitis C Virus: A Comprehensive Review

“…The introduction of DAAs marked a revolutionary step in HCV management, with cure rates above 95% and defining SVR, specifically undetectable HCV RNA 12 weeks post-treatment (SVR12), as a new clinical benchmark instead of 24 weeks [ 306 , 307 ]. Additionally, 8-week regimens have shown effectiveness in real-world studies, with a positive impact on treatment adherence and reduction in costs [ 308 , 309 , 310 ]. DAAs offer the enhancement of patient tolerability to treatment and allow for the customization of treatment regimens based on individual patient factors such as HCV genotype, stage of liver fibrosis, co-existing medical conditions, prior treatment history, and potential RASs [ 311 , 312 ].…”