INTRODUCTION:
Glecaprevir-Pibrentasvir (G/P) is pan-genotypic direct-acting antiviral agent (DAA) which has achieved 99% success rate in the treatment of chronic Hepatitis C (HCV) genotypes (GTs) 2, 4, 5, or 6 infection, and 95% in genotype (GT) 1 and 3 infections in clinical trials. Real world data in the compensated cirrhotic population is lacking.
METHODS:
A retrospective study of patients treated for chronic HCV of any GT using G/P between January 2018 through January 2019. A successful G/P treatment is defined as an undetectable Hepatitis C Viral Load at 12 weeks post-treatment (SVR12). The percentage of successful G/P treatments will be calculated for two groups of patients: patients with chronic HCV without cirrhosis and patients with chronic HCV with compensated cirrhosis. The proportion of successfully treated patients from the two groups will be compared to evaluate whether the performance of the G/P treatment is similar between compensated cirrhotic and non-cirrhotic groups of patients. Wilcoxon Rank Sum test and Chi-square/ Fisher’ Exact tests were used to calculate continuous and categorical variables, respectively. P-value of 0.05 was considered statistically significant.
RESULTS:
A total of 187 subjects were eligible for inclusion in the study: 76 (40.64%) were Hispanic, 111 (59.36%) were non-Hispanic. 126 (67.38%) were male, 61 (32.62%) were female. 17.5% of subjects were diabetic, and 33% had hypertension. 28.3% (53) of subjects had compensated cirrhosis, 68.5% (128) were non-cirrhotic. 129 subjects had GT1 infection, 19 had GT2 infection, 25 had GT3 infection, 3 had mixed GT1 and GT2 infection, 2 had GT4 infection, and one subject was of unknown GT. Cirrhotic subjects had a mean age of 55.1 years, mean age of non-cirrhotics was 48.7 years. Of the 53 cirrhotic subjects, 26 achieved documented SVR, 27 were lost to follow-up (50.9%). Of the 128 non-cirrhotic subjects, 58 achieved documented SVR, 70 were lost to follow-up (54.6%). 20 were excluded from the study: 6 for unwillingness to proceed with initial workup, and 14 started their therapy after the cut-off date.
CONCLUSION:
Our study suggests achieving a documented SVR in the setting of treatment based in a safety-net hospital system is difficult due to challenges with patient follow-up. Data suggest an overall improvement in hepatic measurements: APRI, FIB-4, Metavir, and Elastography. However, due to poor patient follow-up, there was insufficient data to complete an accurate evaluation of overall hepatic health post G/P treatment.
