Category: Federal Forum Posters
Purpose: Hepatitis C virus (HCV) infection is a common blood-borne infection in the United States. Response-guided therapy, using on-treatment viral kinetics to determine treatment duration, was standard with interferon-based regimens but is no longer used for new potent direct-acting antivirals (DAAs). Some evidence suggests that week 4 viral kinetics predicts sustained virologic response (SVR) with DAAs, but there is minimal evidence to suggest whether using viral kinetics to guide therapy duration impacts clinical outcomes. This study seeks to examine the impact of DAA therapy extension in patients with slow virologic response (detected HCV RNA at week 4 of therapy).
Methods: This retrospective study has been submitted to the Institutional Review Board for approval. Subjects will be identified using a DAA treatment database from a VA health care system. Patients with chronic HCV infection initiated on DAA therapy between 1/1/2014-7/31/2018 with a measured and detectable HCV RNA at week 4 of therapy will be included in the study. Patients will be stratified by therapy duration (traditional versus extended duration). The following data will be collected: age, race, gender, weight, HIV or HBV coinfection, severity of liver fibrosis, history of liver transplant or hepatocellular carcinoma, HCV genotype and resistance testing, HCV RNA levels, prior HCV treatment, current DAA regimen and duration, and rationale for extension of therapy, where applicable. The primary objective is to compare rates of sustained virologic response at least 12 weeks after treatment (SVR12) between traditional duration and extended duration groups. Secondary objectives are to compare SVR12 rates among subgroups (genotype, fibrosis severity, race, treatment regimen, prior treatment experience), to assess rationale for extension of therapy, and to determine premature discontinuation rates.
Results: not applicable
Conclusion: not applicable
Ashley McKnight– PGY1 Pharmacy Practice Resident, Durham VA Healthcare System, Durham, NC