Safety Profile of Telaprevir-Based Triple Therapy in Elderly Patients: A Real-World Retrospective Cohort Study.

Abstract

To compare the rate of treatment discontinuation due to adverse events for telaprevir-based triple (T/PR) and pegylated interferon-alfa-2b and ribavirin (PR) therapy for the treatment of hepatitis C virus (HCV) infection in patients over the age of 65 years, in Japan. Retrospective analysis of the health data of patients over the age of 65 years treated for a HCV infection genotype 1 using T/PR or PR therapy, from 38 prefectures in Japan. The primary outcome was the rate of treatment discontinuation due to adverse events for T/PR and PR. The secondary outcome was to evaluate the prevalence and type of adverse events during the treatment period that resulted in treatment discontinuation for both therapies. For comparison, the T/PR and PR populations were matched using the propensity score method, and adjusted odds ratios (ORs) for treatment discontinuation calculated by multivariate logistic regression analysis. The study group included 1330 patients, 328 in the T/PR group and 1002 in the PR group. The rate of treatment discontinuation due to adverse events in the matched population was lower for T/PR (19.82%) than PR (35.98%) therapy, (adjusted OR, 0.418; 95% confidence interval, 0.292-0.599; p<0.01). Malaise was the principal cause of treatment discontinuation in both groups (T/PR, 30.77%, and PR, 42.37%). Using real-world health data of elderly individuals in Japan, we identified a lower rate of treatment discontinuation for T/PR than PR. Our outcomes provide information for a segment of the population that is generally excluded for clinical trials.

• Authors: Maiko Akutagawa, Kazuki Ide, Yohei Kawasaki, Mie Yamanaka, Ryo Iketani, Hiroshi Yamada, Naohiko Masaki
• Journal: Biological & pharmaceutical bulletin (Biol Pharm Bull) Vol. 40 Issue 9 Pg. 1525-1529 (Sep 01 2017) ISSN: 1347-5215 [Electronic] Japan
• PMID: 28603159 (Publication Type: Comparative Study, Journal Article)

Chemical References

• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• Oligopeptides
• Recombinant Proteins
• Polyethylene Glycols
• Ribavirin
• telaprevir
• peginterferon alfa-2b

Topics

• Aged
• Antiviral Agents (adverse effects, therapeutic use)
• Drug Therapy, Combination
• Female
• Hepacivirus
• Hepatitis C (drug therapy, virology)
• Humans
• Interferon alpha-2
• Interferon-alpha (adverse effects, therapeutic use)
• Japan
• Logistic Models
• Male
• Odds Ratio
• Oligopeptides (adverse effects, therapeutic use)
• Patient Dropouts
• Polyethylene Glycols (adverse effects, therapeutic use)
• Recombinant Proteins (adverse effects, therapeutic use)
• Retrospective Studies
• Ribavirin (adverse effects, therapeutic use)