Effects on anemia of drug adjustment in patients with chronic hepatitis C during telaprevir-combined therapy

Tamori, Akihiro; Kioka, Kiyohide; Sakaguchi, Hiroki; Enomoto, Masaru; Hoang, Hai; Kawamura, Etsushi; Hagihara, Atsushi; Fujii, Hideki; Iwai, Shuji; Morikawa, Hiroyasu; Murakami, Yoshiki; Kawasaki, Yasuko; Tsuruta, Daisuke; Kawada, Norifumi

doi:10.1016/s1665-2681(19)30798-7

Cited by 4 publications

(2 citation statements)

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“…Previous studies have reported significantly higher SVR rates in both treatment‐naïve and treatment‐experienced CHC subjects with HCV genotype 1 who were treated with TVR‐combined triple therapy as compared to those treated with PEG‐IFN and RBV combination therapy . However, severe anemia and other serious AEs occur more frequently in patients with CHC undergoing TVR‐combined triple therapy …”

Section: Introductionmentioning

confidence: 99%

“…[4][5][6][7] However, severe anemia and other serious AEs occur more frequently in patients with CHC undergoing TVR-combined triple therapy. 8,9 Simeprevir is a potent, macrocyclic NS3/4 A protease inhibitor that shows pronounced antiviral activity in vitro and in vivo and has been approved as a combination therapy with PEG-IFN and RBV for patients with HCV genotype 1. 10,11 In phase III trials, SMV combined triple therapy achieved an 85% SVR rate in treatmentnaïve patients, and 90% and 50% SVR rates in previously relapsed patients and non-responders, respectively.…”

Section: Introductionmentioning

confidence: 99%

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Randomized trial of combined triple therapy comprising two types of peginterferon with simeprevir in patients with hepatitis C virus genotype 1b

Tamori

Yoshida

Katoh³

et al. 2016

Hepatology Research

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Randomized trial of combined triple therapy comprising two types of peginterferon with simeprevir in patients with hepatitis C virus genotype 1b

Tamori

Yoshida

Katoh³

et al. 2016

Hepatology Research

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The Safety Profile of Telaprevir-Based Triple Therapy in Clinical Practice: A Retrospective Cohort Study

Iketani

Ide

Yamada

et al. 2017

Biological & Pharmaceutical Bulletin

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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. Key words telaprevir; real world database; hepatitis C; retrospective cohort study; interferon; ribavirin About 130-150 million people are infected with the hepatitis C virus (HCV) worldwide, and approximately 700000 people die annually of liver diseases related to HCV infection.

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

Akutagawa

Ide

Kawasaki

et al. 2017

Biological & Pharmaceutical Bulletin

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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.Key words elder patient; hepatitis C; safety profile; telaprevir; real-world data Hepatitis C virus (HCV) infection is one of the most serious diseases worldwide, with 70% of individuals infected with HCV developing a chronic infection status 1) and 22% developing liver cirrhosis within 20 years of HCV infection, 2) with progression to liver cancer in some cases. Considering that liver cancer is the second highest cause of mortality in the world, 3) providing anti-viral treatment to individuals infected with HCV would be important to prevent the development of these secondary HCV-related comorbidities. 4)The effectiveness of anti-viral treatment for HCV infection has improved recently with the approval of direct-acting anti-viral agents (DAAs), used as an alternative to or in combination with pegylated interferon-alfa-2b and ribavirin (PR) therapy. Telaprevir is one such DAA that has been used in combination with PR therapy for the treatment of HCV genotype 1 infection. Telaprevir-based triple therapy (T/PR) has been shown to be effective in achieving a sustained virologic response (SVR) in 60-70% of HCV cases, compared to a 40-50% SVR with PR therapy.5,6) Moreover, a 90% SVR has been reported in clinical trials using DAA interferon-free therapy. [7][8][9] In practice, HCV treatment is selected based on a patient's individual clinical background. 10)T/PR therapy, however, is associated with a high risk of adverse events, with a discontinuation rate of >10% for T/PR ...

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Effects on anemia of drug adjustment in patients with chronic hepatitis C during telaprevir-combined therapy

Cited by 4 publications

References 35 publications

Randomized trial of combined triple therapy comprising two types of peginterferon with simeprevir in patients with hepatitis C virus genotype 1b

Randomized trial of combined triple therapy comprising two types of peginterferon with simeprevir in patients with hepatitis C virus genotype 1b

The Safety Profile of Telaprevir-Based Triple Therapy in Clinical Practice: A Retrospective Cohort Study

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

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