The Safety Profile of Telaprevir-Based Triple Therapy in Clinical Practice: A Retrospective Cohort Study.
This study was designed to evaluate the safety profile of adding telaprevir to therapy using pegylated interferon-alfa-2b and ribavirin (PR) using real world patient data obtained from a nationwide Japanese interferon database. This retrospective cohort study compared telaprevir-based triple therapy (T/PR) with PR therapy. The study population comprised patients with genotype 1 chronic hepatitis C represented in the database between December 2009 and August 2015. The primary endpoint was dropout from treatment due to adverse events during the relevant standard treatment duration based on guidelines from the Japan Society of Hepatology. The dropout odds ratio (OR) and 95% confidence interval (95% CI) were calculated using univariate logistic regression analysis. Covariates were detected using a stepwise logistic regression analysis, and the adjusted OR and 95% CI were calculated. A total of 25989 patients were registered, and 4619 patients (T/PR: 1334, PR: 3285) were appropriate for primary endpoint analysis. The dropout rate due to adverse events was lower in the T/PR group (13.4%) than in the PR group (22.6%) (OR: 0.530; 95% CI, 0.444-0.633). After adjustment for the covariates detected by stepwise selection, the OR was 0.529 (95% CI, 0.441-0.634). Our study showed that there was a difference in dropout rate between real world T/PR and PR therapy in Japan. Although the addition of telaprevir to PR therapy may improve treatment continuity under the care of hepatologists, this study could not fully determine which therapy was safer or the factors influencing this result. Therefore, additional research will be required to confirm this.
Department of Drug Evaluation & Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka.
Ryo
R
Iketani
Department of Drug Evaluation & Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka.|Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University.
Kazuki
K
Ide
Department of Drug Evaluation & Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka.
Hiroshi
H
Yamada
Department of Drug Evaluation & Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka.|Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University.
Yohei
Y
Kawasaki
Laboratory Testing Department, National Center for Global Health and Medicine.
Naohiko
N
Masaki
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000009:adverse effects*; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D009842:Oligopeptides; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C417083:peginterferon alfa-2b
hepatitis C; interferon; real world database; retrospective cohort study; ribavirin; telaprevir