Retrospective Analysis of the Medication Utilization and Clinical Outcomes of Patients Treated with Various Regimens for Hepatitis C Infection.

BACKGROUND: The hepatitis C virus (HCV) is the most common chronic blood-borne infection and the leading cause of liver transplantation in the United States. There are approximately 3.2 million people currently infected with HCV in the United States. In late 2013, the introduction of sofosbuvir and simeprevir represented a critical advancement in the treatment of HCV by improving sustained virologic response (SVR) rates. PURPOSE: The purpose of this study was to evaluate medication utilization and clinical outcomes of patients with HCV who were treated with any Food and Drug Administration-approved combination of ribavirin, peginterferon products, simeprevir, and sofosbuvir. METHODS: Prescription records and clinical assessment forms of patients who started HCV therapy and were eligible for SVR between January 1, 2014, and December 31, 2014, were retrospectively reviewed. Data collection included patient demographics, genotype, SVR, patient-reported adverse events, discontinuations, and adherence markers. RESULTS: A total of 367 eligible patients were identified who had initiated treatment during the study period. Genotype 1 was the most common genotype, and an overall SVR rate of 86.9% was observed. Results were similar to those seen in phase III clinical trials. In addition, adverse events of these medications were more tolerable, and discontinuation rates were lower than with previous therapies.

Utilization patterns for oral oncology medications in a specialty pharmacy cycle management program.

BACKGROUND: The cycle management program (CMP) was implemented in 2008 at a national specialty pharmacy with a focus on providing specialized counseling and monitoring for patients on select oral oncology medications. The program now includes nine medications: bexarotene, dasatinib, erlotinib, everolimus, nilotinib, pazopanib, sorafenib, sunitinib, and vorinostat. Patients receive frequent assessments to encourage adherence, identify adverse events, and track discontinuations through a pharmacist outreach at the initiation of therapy, day 10 and 20 of the first month, then monthly thereafter. The use of oral agents is increasing in cancer patients, shifting away from regimens exclusively involving intravenous chemotherapy. This offers advantages for patients in terms of convenience, but introduces risk as patients become more responsible for the administration and monitoring of the medications. PURPOSE: To evaluate utilization patterns of the oral oncology medications in the CMP including adverse event occurrence, medication discontinuations, and adherence markers. METHODS: This study is a retrospective review of patient-reported data from the CMP assessments completed in 2013. Data collected include adverse events and grades, adherence markers, and discontinuation rates. A total of 1163 assessments were reviewed from 557 patients. The assessments included in the analysis were the initial assessment, 10-day assessment, 20-day assessment, and the first monthly follow-up assessment, which encompasses the first two months of therapy. RESULTS: A total of 1453 adverse events were reported. Adverse events were cited as the reason for 39% of discontinuations and 28% of missed/held doses. A total of 101 discontinuations were reported across the nine CMP medications based on the first two months of data. Missed or held doses were reported in 130 assessments. CONCLUSIONS: Patient engagement and pharmacist interventions, through programs such as the CMP, are important to help patients manage these complex, high-risk medications.