Methods: Northwestern University Viral Hepatitis Registry is a prospective, observational, cohort study of HIV/HCV co-infected outpatients ≥18 yrs of age. From Feb 2014-Apr 2015, 54 pts were evaluated by an ID physician and referred to an ID PharmD for HCV Rx counseling and medication initiation. Information collected included pt clinical characteristics, ART use, DDIs with HCV Rx, insurance and DAA prior authorization (PA) requirements, time to Rx approval, and time in PharmD counseling.
Results: Among 54 pts referred for PharmD consultation for HCV DAA Rx (median 3 consults/pt), 39 (72%) were treated with sofosbuvir (SOF)/simeprevir (SMV), 6 (11%) SOF/ribavirin, and 9 (17%) ledipasvir/SOF. Pts were predominantly male (n=44, 81%), Caucasian (n=28, 52%), with median age 54 yrs (IQR 46-60), median CD4 count 448 cells/mm3(IQR 284-621), and 32 (59%) had cirrhosis. All pts had undetectable HIV viral loads. Median pre-DAA HCV RNA was 1,681,496 copies/mL (IQR 683,298-3,720,617). Fifty (93%) pts were infected with genotype 1. There were 34 (63%) required ART changes due to DDIs. Among DAA Rx, 47 (87%) required a PA (median 2 forms/pt) and 16 (30%) were initially denied and required appeal. Median PharmD time required for counseling, PAs, appeals, and follow-up was 2.1 hours/pt (IQR 1.5-2.8). Median time to Rx approval from PA submission was 5 days (IQR 2-19; n=53 pts approved for Rx). To date, 49 pts have completed Rx and 52 pts had at least one undetectable HCV viral load.
Conclusion: In this successful model of ID clinic-centered care of HIV/HCV co-infected pts initiating HCV DAA Rx, time-intensive pharmacy-based resources were essential and included pt counseling, DDI management, and DAA payment approval. Resources for PharmD personnel must be considered in the financial cost assessments of modern HCV Rx.
Served on Advisory Board
J. Grant, None
C. Hawkins, None
J. Cottreau, None
F. Palella, Gilead Sciences: Consultant and Speaker's Bureau , Consulting fee
Janssen Pharmaceuticals: Consultant and Speaker's Bureau , Consulting fee
Merck: Consultant and Speaker's Bureau , Consulting fee
Bristol Myers Squibb: Consultant and Speaker's Bureau , Consulting fee
V. Stosor, None
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