Generic medications for hepatitis C.

The recent development and approval of expensive but highly effective oral agents against hepatitis C has led to restrictions and access limitations in many countries with limited healthcare budgets. Generic formulations of many of these agents are available at a fraction of the retail price in several countries because of generic licensure agreements. The discounted alternatives are only accessible in developing countries and require manufacturing and distribution regulations to ensure the quality and bioequivalence of the new drug formulations. The continued medication access limitations have driven great interest in the practice of personal drug importation of the generic formulations. This review and debate will address the medical and legal issues involved in the purchase and importation of these medicines.

Genotype 1 hepatitis C virus and the pharmacist's role in treatment.

PURPOSE: The treatment of hepatitis C virus (HCV) genotype 1 has changed rapidly with recently approved direct-acting antiviral (DAA) regimens. The role of the pharmacist in the management of HCV therapy has increased. SUMMARY: Chronic HCV infection is the main cause of end-stage liver disease and the primary reason for liver transplantation, liver-related death, and hepatocellular carcinoma in the United States. The recent approval of several DAAs has led to improved tolerability, sustained virological response (SVR) rates, and shorter treatment durations compared with treatment with pegylated interferon and ribavirin. Most HCV cases can be treated with the currently available regimens, and expected SVR rates exceed 90%. Several fixed-dose and pangenotypic antiviral regimens are currently in various phases of clinical trials. Pharmacists are well equipped to assist the medical team and patients with comprehensive management of HCV treatment. Pharmacists in various settings can play an instrumental role in access to HCV medications, selection of HCV treatment, detection of drug-drug interactions, and education of patients about potential adverse effects and the importance of adherence and laboratory test monitoring during HCV treatment. However, the high cost of HCV treatment poses challenges for ubiquitous treatment. CONCLUSION: Available DAA regimens have improved HCV treatment outcomes and are selected based on efficacy, potential drug interactions, and the patient's ability to obtain medication coverage. Each of these factors provides an opportunity for pharmacist involvement in HCV management.