Telaprevir can be successfully and safely used to treat older patients with genotype 1b chronic hepatitis C

Furusyo, Norihiro; Ogawa, Eiichi; Nakamuta, Makoto; Kajiwara, Eiji; Nomura, Hideyuki; Dohmen, Kazufumi; Takahashi, Kazuhiro; Satoh, Takeaki; Azuma, Koichi; Kawano, Akira; Tanabe, Yuji; Kotoh, Kazuhiro; Shimoda, Shinji; Hayashi, Jun

doi:10.1016/j.jhep.2013.03.020

Cited by 66 publications

(73 citation statements)

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“…16) Similarly, the rate of treatment discontinuation in our study for patients over the age of 65 years was consistent with previously reported rates in the general population. Considering the above information, it is likely that careful management and monitoring of adverse events among patients on T/PR therapy was effective in avoiding discontinuation.…”

Section: Discussionsupporting

confidence: 92%

“…This issue is of relevance in Japan, where the proportion of elderly in the general population is significantly higher than in Europe and the United States. 16) Therefore, our aim was to compare the rate of treatment discontinuation due to adverse events for T/PR and PR for the treatment of HCV infection among elderly patients, over the age of 65 years, in Japan. This study is of clinical relevance to establish real-world evidence of the effectiveness of HCV therapy in elderly individuals.…”

Section: )mentioning

confidence: 99%

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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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Section: Discussionsupporting

confidence: 92%

Section: )mentioning

confidence: 99%

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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“…107,108 The SVR rates increased to 70%-82% with an additional 12 weeks of PEG-IFN α plus RBV, except for one small trial 112 enrolling the most difficult-to-treat partial responders and nonresponders, which showed an SVR rate of 27%. 107,[109][110][111][112][113][114][115] In line with Western reports, IL-28B genotypes and RVR strongly affected the SVR rates in Asian HCV-1 patients receiving BOC-or TVR-based triple therapy. 107,109,115 Because the numbers of Asian HCV-1 patients who received BOC were low, and no studies were designed for TVR-based RGT in Asian HCV-1 patients, the optimized strategies for shortening treatment duration on the basis of early viral kinetics and IL-28B genotypes have not yet been determined.…”

Section: Boc or Tvr-based Triple Therapy In Asian Patients With Chronsupporting

confidence: 79%

Nanomedicines in the treatment of hepatitis C virus infection in Asian patients: optimizing use of peginterferon alfa

Liu¹,

Kao

2014

IJN

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Asia is endemic for hepatitis C virus (HCV) infection, which is the leading cause of cirrhosis, hepatic decompensation, hepatocellular carcinoma, and liver transplantation worldwide. HCV has six major genotypes and each HCV genotype has its specific geographic distribution. HCV genotypes 1, 2, 3, and 6 are common in Asia. The aim of HCV treatment is to eradicate the virus by effective therapeutic agents; viral clearance is durable after long-term post-treatment follow-up. In most Asian countries, peginterferon alfa (PEG-IFN α) in combination with ribavirin remains the standard of care, and the overall sustained viral response (SVR) rate in Asian HCV patients is higher than that in Western patients. The differences are most significant in patients with HCV genotype 1 (HCV-1) infection, which is attributed to the higher frequency of IFN-responsive or favorable interleukin-28B (IL-28B) genotype in Asian populations than in other ethnic populations. In addition, the introduction of response-guided therapy, where the optimized treatment duration is based on the early viral kinetics during the first 12 weeks of treatment, increases the SVR rate. Recently, telaprevir or boceprevir-based triple therapy was found to further improve the SVR rate in treated and untreated HCV-1 patients and has become the new standard of care in Western and some Asian countries. Many novel direct-acting antiviral agents, either in combination with PEG-IFN α plus ribavirin or used as IFN-free regimens are under active investigation. At the time of this writing, simeprevir and sofosbuvir have been approved in the US. Because the SVR rates in Asian HCV patients receiving PEG-IFN α plus ribavirin therapy are high, health care providers should judiciously determine the clinical usefulness of these novel agents on the basis of treatment duration, anticipated viral responses, patient tolerance, financial burdens, and drug accessibility.

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“…However, many adverse effects have been reported during TVR-based triple therapy, including severe anemia and drug-induced skin disorders (13,17,18). Malaise, anorexia, increased serum creatinine and depression have also been reported (19). Nevertheless, there remain little data regarding the occurrence of bacterial infections during TVR-based triple therapy in clinical practice.…”

Section: Introductionmentioning

confidence: 99%

Bacterial Infection as an Adverse Effect of Telaprevir-based Triple Therapy for Chronic Hepatitis C Infection

et al. 2015

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Objective There is little information regarding the incidence of bacterial infections as an adverse effect of telaprevir (TVR)-based triple therapy. This study was performed in order to evaluate the baseline and ontreatment predictors of bacterial infections in patients treated with TVR-based triple therapy. Methods This multicenter study evaluated 430 patients with chronic hepatitis C who received 12 weeks of TVR in combination with 24 weeks of pegylated interferon α2b plus ribavirin. The occurrence of a bacterial infection during anti-viral treatment was defined as the onset of local or systemic inflammation as a result of pathogenic bacteria. Results Bacterial infections occurred in 21 of the 430 (4.9%) patients during TVR-based triple therapy. Among these subjects, 71.4% (15 of 21) experienced bacterial infections during the initial eight weeks of treatment. Urinary tract infections were the most frequent infection, observed in 2.8% of cases (12 of 430). The rate of urinary tract infection among women (11 of 215, 5.1%) was significantly higher than that observed among men (1 of 215, 0.5%) (p<0.0001). According to a multivariable logistic regression analysis, the only significant independent predictor was the pretreatment serum albumin level (p=0.0008). Of the 21 patients who experienced bacterial infections, only one (4.8%) had to discontinue the treatment; however, the others were able to continue anti-viral treatment in combination with antibiotic treatment. Conclusion Clinicians should be concerned regarding the incidence of bacterial infections among patients treated with TVR-based triple therapy, especially those with a low serum albumin level.

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Telaprevir can be successfully and safely used to treat older patients with genotype 1b chronic hepatitis C

Cited by 66 publications

References 24 publications

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

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

Nanomedicines in the treatment of hepatitis C virus infection in Asian patients: optimizing use of peginterferon alfa

Bacterial Infection as an Adverse Effect of Telaprevir-based Triple Therapy for Chronic Hepatitis C Infection

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