Identification of Patient Factors Associated With Hepatitis C Treatment Failure in a Pharmacist Managed Hepatitis C Program

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Background. Data regarding the incidence of and risk factors for hepatitis C (HCV) treatment failure (TF) with direct acting antiviral agents (DAAs) has not been well described in real world clinical practice. Due to the high levels of efficacy with DAAs, variables associated with TF may be related to patient (pt) specific parameters (e.g. comorbidities) and pt adherence to therapy. Pharmacists are poised to appropriately manage interventions at DAA initiation. The objective of this study was to identify pt factors that are associated with an increased risk of TF with DAAs during HCV therapy in a pharmacist managed HCV program. Methods. Pts were considered for inclusion if they were >18 years old, HCV mono-infected, managed for HCV treatment through the Northwestern Medicine Specialty Pharmacy, and completed HCV therapy. Treatment failures (TFs) were matched 1:4 with treatment successes (TSs) based on HCV regimen and pre-/posttransplant status. Pt demographic, HCV, and pharmacist intervention variables were assessed. Stepwise multivariate regression was performed to assess predictors of HCV TF. Results. 19 TFs were matched with 76 TSs. All pts received baseline pharmacist counseling and follow-up phone calls to identify treatment issues. Sofosbuvir/simeprevir (n = 64) and sofosbuvir/ribavirin (n = 31) were used for treatment. There were more male pts (n = 16, 84% versus n = 44, 58%, p = 0.04) and pts with diabetes (n = 13, 69% versus n = 24, 32%, p < 0.01) in the TFs than TSs group. Pts with a lower education level (grade school versus college or above) were more likely to fail (p < 0.01) as were pts that were unemployed (n = 18, 95% versus n = 56, 74%, p = 0.03). Experiencing an adverse effect (p = 0.02) and pt reported missed doses >1 (p < 0.01) were also associated with TF. More pts in the TSs group had >1 outpatient clinic visit with a pharmacist than the TFs group (n = 58, 76% versus n = 9, 47%, p = 0.01). In a multivariate analysis, the comorbidity diabetes remained a significant predictor of TF (OR 7.2, 95% CI 1.7-30.8). Conclusion. Pharmacists may be able to target resources to pts with these TF risk factors for intensive intervention. Increased pharmacist contact was associated with treatment success. Further study is needed to elucidate the impact of education level and diabetes on successful HCV treatment. Disclosures. H. Brooks, Abbvie: Employee, Salary; M. Mclaughlin, BioCryst Pharmaceuticals: Served on Advisory Board, Consulting fee