Title: EARLY VIEW OF REAL-WORLD SUSTAINED VIROLOGIC RESPONSE RATES FOR NEW DIRECT ACTING ANTIVIRAL AGENTS IN HCV PATIENTS IN THE UNITED STATES VETERANS ADMINISTRATION HEALTH SYSTEM
Abstract: The real world effectiveness of the new direct acting antiviral agents in achieving sustained virologic response in patients with hepatitis C virus is limited. The aim of this study is to determine sustained virologic response rates at least 12 weeks post end-of-treatment in hepatitis C patients using the new direct acting antiviral agents in the Veterans Administration Health System. Retrospective cohort study of hepatitis C infected patients initiating new direct acting antiviral regimens through September 1, 2015 using data from the Veteran Administration’s electronic medical records data system. All hepatitis C diagnosed patients initiating either sofosbuvir/ledipasvir, ombitasvir/paritaprevir/ritonavir+dasabuvir, or sofosbuvir+simeprevir were selected. The primary outcome measure was sustained virologic response at least 12 weeks (SVR12) post end of treatment. Potential study patients (N=30,150) were screened for sufficient data with which to determine if a sustained virologic response had been achieved. A total of 9,854 (32.7%) patients met the data requirements, with the major reason for exclusion being initiating treatment too late in the data period to obtain a viral load assessment beyond 12 weeks of end-of-treatment. Overall, 93% of 5,642 sofosbuvir/ledipasvir patients, 93% of 1,026 ombitasvir/paritaprevir/ ritonavir+dasabuvir patients, and 85% of 3,186 sofosbuvir+simeprevir patients achieved a sustained viral response at 12 weeks. All three direct acting antiviral regimens studied here appear to be highly effective in achieving sustained viral response in patients treated in the V.A. system. Further research, including exploring the impact of genotype, co-morbidities, disease severity, and other patient characteristics on the real-world efficacy of these therapies is warranted.