The Patient-Related Burden of Pegylated-Interferon-α Therapy and Adverse Events among Patients with Viral Hepatitis C in Japan

Hiromitsu Kumada; Marco daCosta DiBonaventura; Yong Yuan; Anupama Kalsekar; Lewis Kopenhafer; Ann Tang; Timothy W Victor; Gilbert L'Italien; Kazuaki Chayama; Joji Toyota

doi:10.1016/j.vhri.2014.01.002

The Patient-Related Burden of Pegylated-Interferon-α Therapy and Adverse Events among Patients with Viral Hepatitis C in Japan

Value Health Reg Issues. 2014 May:3:50-58. doi: 10.1016/j.vhri.2014.01.002. Epub 2014 Apr 21.

Authors

Affiliations

¹ Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
² Health Outcomes Practice, Kantar Health, New York, NY, USA. Electronic address: marco.dibonaventura@kantarhealth.com.
³ Global Health Economics and Outcomes Research, Bristol-Myers Squibb, Lawrenceville, NJ, USA.
⁴ Health Outcomes Practice, Kantar Health, New York, NY, USA.
⁵ Health Economics and Outcomes Research, Bristol-Myers K.K., Tokyo, Japan.
⁶ Global Health Economics and Outcomes Research, Bristol-Myers Squibb, Lawrenceville, NJ, USA; Yale University School of Medicine, New Haven, CT, USA.
⁷ Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan.
⁸ Department of Hepatology, Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital, Sapporo, Japan.

PMID: 29702938
DOI: 10.1016/j.vhri.2014.01.002

Abstract

Objectives: Pegylated-interferon-α (IFN-α)-based therapies for viral hepatitis C (HCV) are effective, but they are associated with several adverse events (AEs). The primary objectives of this study were to quantify the burden of IFN-α-based treatment and to measure the prevalence and burden of IFN-α-related AEs in Japan.

Methods: A cross-sectional survey was administered online to patients with HCV in 2013. Patients who were currently taking IFN-α-based therapy (n = 188) were compared with patients who were taking a liver protectant but not IFN-α-based therapy (n = 180) and with patients who were untreated (n = 365) on measures of health-related quality of life (using the Hepatitis Quality of Life Questionnaire, version 2), work productivity, and health care resource use, controlling for sociodemographic characteristics and health history. Among patients taking IFN-α-based therapy, the prevalence and burden of AEs was examined on the same set of health outcomes as noted above along with treatment satisfaction and adherence.

Results: Compared with untreated patients, patients using IFN-α reported poorer health-related quality of life (physical component summary score, 50.13 vs. 52.04; mental component summary score, 44.12 vs. 47.97), more overall work impairment (32.73 vs. 25.64), more physician visits in the past 6 months (14.51 vs. 8.36), and an increased likelihood of an emergency room visit (odds ratio = 7.25) and hospitalization (odds ratio = 4.05) (all P < 0.05). The mean number of AEs was 6.05 for patients using IFN-α. All AEs were associated with poorer health outcomes (particularly the mental component summary score), and most were also associated with lower treatment satisfaction and medication adherence.

Conclusions: A significant patient burden for IFN-α treatment itself and various AEs was observed. The results suggest that effective, non-IFN-α-based treatments may reduce the societal burden.

Keywords: adherence; adverse events; hepatitis C; interferon; quality of life; resource use; satisfaction; work impairment.