Background: Current guidelines recommend newer therapies over previous interferon-based treatments. The creation of a specialty pharmacy program within our institution that provides managed care for this patient population was implemented to promote adherence and accessibility of treatment.

Objective: To evaluate the impact of a specialty pharmacy program regarding the safety and efficacy with the use of current HCV regimens. The primary outcome is to evaluate efficacy based on sustained virologic response (SVR). The secondary outcome includes reviewing adverse drug reactions for safety.

Methods: A retrospective review of HCV patients who had prescriptions filled through a specialty pharmacy program between 1/17/14 and 6/30/15 was conducted. A total of 204 patients received prescriptions during the timeframe. Five (2.4%) were excluded due to de-enrolling from treatment. Kaplan-Meier Method was used to examine time to SVR after medication regimen completion.

Results: A total of 199 patients completed treatment with a mean age of 58 ± 9 years and 117 (59%) were male. Seventy-five (38%) had previously received treatment. A majority 156 (78%) of the patients were of HCV genotype 1 (119 (60% were 1A), 17 (8%) were genotype 2, and 20 (10%) were genotype 3. Roughly half, 105 (53%) of the patients were given LED/SOF ± Ribavirin, 37 (19%) received SOF/Ribavirin, 30 (15%) received SOF/SMV ± Ribavirin, 24 (12%) received SOF/PEG/Ribavirin, and 3 (1%) received another combination. At 6 months post-medication completion, 92% of patients had achieved SVR. There was no difference in SVR rates between those with previous treatment and those without (92% vs. 92% at 6 months, p=0.56). Those with HCV Genotype 1A had slightly lower SVR rates (87% vs. 98% at 6 months) though not statistically significant, p=0.11. The side effects reported are as followed: no side effects (56%), 32 (16%) headaches, 10 (5%) nausea, 5 (3%) anemia, and 17 (8%) other side effects.

Conclusion: SVR rates are comparable to clinical trials in this real-life clinical setting using a specialty pharmacy program. Those with HCV Genotype 1A had lower SVR rates post-medication completion, though it did not reach statistical significance. There was no difference in SVR rates between previously treated and treatment-naïve patients.

CITATION INFORMATION: Aldag E, Pedone T, Pedersen R, Besur S, Safdar K, Sahajpal A. Evaluation of the Impact of the Implementation of a Specialty Pharmacy Program in the Treatment of Hepatitis C (HCV). Am J Transplant. 2016;16 (suppl 3).

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