RESUMO
Treatment of chronic hepatitis C virus (HCV) infection remains a priority in the veterans affairs (VA) health care system nationwide, as there is a high burden of liver disease due to HCV infection among US veterans. The combination of sofosbuvir and simeprevir was the first all-oral antiviral regimen used in clinical practice to treat veterans with HCV infection. In this study, we report a single-center experience showing both the feasibility and effectiveness of this all-oral combination to treat HCV genotype 1 infection. One hundred patients with HCV genotype 1 infection were treated between December 2013 and June 2014. Eighty-six patients were treated with sofosbuvir and simeprevir, with or without ribavirin, for 12 weeks; 12 patients were treated with sofosbuvir, pegylated interferon, and ribavirin for 12 weeks; and 2 patients were treated with sofosbuvir and ribavirin for 24 weeks. Overall, treatment was well tolerated and feasible, with compliance rates over 95% in patients treated with all-oral therapy. The sustained virologic response (SVR) rate for sofosbuvir and simeprevir (88.4%) was superior to the rate for sofosbuvir, pegylated interferon, and ribavirin (50.0%). Subgroup analysis showed diminished SVR rates in cirrhotic patients vs noncirrhotic patients. There were no significant differences in SVR when comparing treatment with or without ribavirin or among genotype subtypes. In conclusion, this study demonstrated excellent completion rates for all-oral treatment of veterans with chronic HCV infection. Additionally, treatment was highly effective, nearing a 90% cure rate. Thus, we recommend that the VA health care system continue to incorporate new HCV medications into its formulary so as to expand HCV treatment for US veterans.
RESUMO
OBJECTIVES: To describe an innovative hepatitis C virus (HCV) care program and treatment outcomes resulting from pharmacist services. SETTING: Adult ambulatory care HCV clinic within the Miami Veteran Affairs Healthcare System. PRACTICE DESCRIPTION: Pharmacists with limited prescriptive authority are integrated into a medical hepatology care team. PRACTICE INNOVATION: Pharmacists screen patients with HCV infection for treatment eligibility, counsel patients upon treatment initiation, assess ongoing treatment success and toxicity through patient appointments, telephone calls, and the ordering of pertinent laboratory data, and provide oversight of all patients on HCV therapies. Treatment outcomes are reported to the institutional Antimicrobial Stewardship Program. EVALUATION: Data produced from a continuous quality assurance initiative were utilized. Descriptive statistics were used to present data. RESULTS: From January 2014 through September 2015 there were 1619 pharmacist encounters for 532 unique patients and 597 screenings (including 578 approvals) were completed by a pharmacist. During this time 555 patients were initiated on at least 1 HCV treatment course, with 565 total treatment courses initiated. As new agents became available for use, fluctuation in regimen selection was seen. The most commonly prescribed medications were sofosbuvir (46%), ledipasvir/sofosbuvir (37%), and simeprevir (33%). Of the 565 HCV treatment courses initiated, 360 were completed, 29 were stopped early during treatment, and 176 were ongoing. Of the 360 completed courses, 249 had sustained virologic response at week 12 results available, of which 225 (90%) achieved treatment success and 24 (10%) relapsed. Of the 29 courses stopped early, 11 were due to poor medication adherence and 8 were due to adverse drug reaction. CONCLUSION: Through a structured process employing a scope of practice, pharmacists can extend the capacity of medical hepatology providers and provide pharmacotherapy services to enhance care. Information provided here may serve beneficial to others looking to initiate or expand existing HCV pharmacist services.
