PATIENT CHARACTERISTICS AND EFFICACY OF PANGENOTYPIC DIRECT-ACTING ANTIVIRAL REGIMENS AMONG A COHORT OF CHRONIC HEPATITIS C PATIENTS RECEIVING ROUTINE CLINICAL CARE IN THE US
Gordon SC, Li J, Moorman AC, Spradling PR, Teshale EH, Boscarino JA, Daida Y, Schmidt MA, Zhou YR, Rupp LB, Trudeau S, and Lu M. PATIENT CHARACTERISTICS AND EFFICACY OF PANGENOTYPIC DIRECT-ACTING ANTIVIRAL REGIMENS AMONG A COHORT OF CHRONIC HEPATITIS C PATIENTS RECEIVING ROUTINE CLINICAL CARE IN THE US. Hepatology 2020; 72:540A-541A.
Background: Using recent data from the Chronic Hepatitis Cohort study (CHeCS), we report patient characteristics and “real world” efficacy of three pangenotypic direct-acting antiviral (DAA) regimens used to treat chronic hepatitis C (CHC) patients with a range of HCV genotypes (GT 1-4 and 6) under routine care.
Methods: CHeCS CHC patients were followed through mid-2019. Baseline patient characteristics and rates of sustained virological response 12 weeks after end of treatment (SVR12) were compared among the three pangenotypic regimens (SOF/VEL, SOF/VEL/VOX, and GLE/PIB).
Results: A total of 1842 patients were included, of which 1019 were treated with SOF/VEL, 753 with GLE/ PIB, and 70 with SOF/VEL/VOX. There were statistically significant differences in patient characteristics among the three groups (p-values <0.05): (1) 46% and 54% of patients treated with SOF/VEL and GLE/PIB were aged 60 years and older, respectively, versus only 25% of those treated with SOF/VEL/VOX; (2) 7% of patients treated with SOF/VEL had decompensated cirrhosis (DCC) while almost none treated with the other regimens had DCC (≤1%); (3) 93% of the SOF/ VEL/VOX-treated group were DAA experienced, compared with only 2-4% in the other treated groups; (4) GT distribution varied among the three regimens (Table). Observed rates of SVR12 were 97%, 98% and 97% with SOF/VEL, GLE/PIB, and SOF/VEL/VOX, respectively, with no significant difference observed (p-values in the range of 0.50 to 0.62 from pairwise comparisons). Among the 48 patients that did not achieve SVR12: (1) 19% were DAA experienced (vs. 6% of those that achieved SVR12); (2) 10% had DCC (vs. 4% of those that achieved SVR12); (3) 21% experienced a toxicity (vs. 11% of those that achieved SVR12); (4) 31% had diabetes and 4% were on proton pump inhibitor therapy at time of DAA initiation (vs. 21% and 1%, respectively, of those that achieved SVR12).
Conclusion: Observed rates of SVR12 were very high for all three pangenotypic regimens, with no significant difference between them. A sizeable majority of CHC patients treated with SOF/VEL/VOX and GLE/PIB had GT 1, while the largest proportion of patients treated with SOF/VEL had GT 2. Patients with DCC were mostly treated with SOF/VEL, as would be expected based on treatment guidelines. Patients who did not achieve SVR12 had higher rates of prior DAA experience, DCC, diabetes, and on-treatment toxicities.