Abstract

BackgroundDirect-acting antivirals (DAAs) are known to improve tolerability and have higher efficacy and shorter treatment durations compared with conventional interferon (IFN)-based treatments for hepatitis C virus (HCV) infection. Management of drug interactions and maintenance of patient adherence are important to achieve adequate therapeutic effects, sustained virological response (SVR). In order to maximize the benefits of oral DAA therapy, we established an ambulatory care pharmacy practice, a model of integrated collaboration between physicians and pharmacists, for patients receiving IFN-free DAA therapy. In this study, we evaluated pharmaceutical intervention for patients visiting the ambulatory care pharmacy practice.MethodsHCV-infected outpatients who visited our ambulatory care pharmacy practice between September 2014 and May 2017 were eligible for inclusion in the study. When IFN-free DAAs were first prescribed, the physicians recommended all patients to visit the ambulatory care pharmacy practice after their clinical examination. Subsequently, at the second visit or later, the patients visited the pharmacy service before the physician’s examination. The primary endpoint was SVR, defined as HCV RNA below the lower limit of quantification after the completion of treatment. We also evaluated the adherence rate to DAAs, suggestions to the physicians by the pharmacists, and questions from the patients. All data were obtained retrospectively using an electronic medical record system.ResultsAmong the 401 study subjects, 386 patients completed the IFN-free DAA therapy. A total of 365 patients have reached 12 or 24 weeks after completing the treatment. The overall SVR rate was 98.1% (358/365). The proportion of patients with adherence ≥90% was 99.3% (398/401). Two-hundred and sixty-seven (84%) among 318 suggestions of prescription made by the pharmacists mainly to manage the adverse events were accepted by the physicians. The pharmacists received and answered 1072 questions on DAA therapy from the patients.ConclusionsThis study indicates that the pharmaceutical intervention may contribute to enhanced adherence to DAAs and higher SVR rates in comparison with previous reports. This study also demonstrates that collaboration between physicians and pharmacists in an ambulatory setting provides favorable outcomes for patients receiving IFN-free DAAs.

Highlights

  • Direct-acting antivirals (DAAs) are known to improve tolerability and have higher efficacy and shorter treatment durations compared with conventional interferon (IFN)-based treatments for hepatitis C virus (HCV) infection

  • We have established an ambulatory care pharmacy practice for HCV-infected outpatients receiving IFN-free DAA therapy to maximize the benefits of the therapy

  • The SVR12 rate was 99.6% (Table 2), which is relatively higher than in the previous studies [9, 12, 16,17,18]. These results indicate that the pharmaceutical support provided by the ambulatory care pharmacy practice, including explanation of the importance of adherence and the management of adverse drug events, helped the achievement of favorable sustained virological response (SVR) rates, probably due to the enhancement of adherence

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Summary

Introduction

Direct-acting antivirals (DAAs) are known to improve tolerability and have higher efficacy and shorter treatment durations compared with conventional interferon (IFN)-based treatments for hepatitis C virus (HCV) infection. Since 2014, several IFN-free regimens, based on combinations of direct-acting antivirals (DAAs), have been launched for the treatment of HCV infection in Japan. These have some attractive characteristics, including oral medication, fewer adverse drug events, higher efficacy, and shorter treatment durations, compared with conventional IFN-based therapy [3,4,5,6,7,8]. Management of drug interactions and facilitating patient adherence to DAAs are important to achieve adequate therapeutic effects

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