Telaprevir in treatment of chronic hepatitis C: safety issues

The aim of review. To analyze results of controlled clinical studies of efficacy and safety of telaprevir within triple antiviral therapy of chronic hepatitis C (CHC) with evaluation of frequency and spectrum of adverse effects (AE), and also approaches of their management.Original positions. Invest...

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Main Author: T. M. Ignatova
Format: Article
Language:Russian
Published: Gastro LLC 2012-07-01
Series:Российский журнал гастроэнтерологии, гепатологии, колопроктологии
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Online Access:https://www.gastro-j.ru/jour/article/view/1310
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author T. M. Ignatova
author_facet T. M. Ignatova
author_sort T. M. Ignatova
collection DOAJ
description The aim of review. To analyze results of controlled clinical studies of efficacy and safety of telaprevir within triple antiviral therapy of chronic hepatitis C (CHC) with evaluation of frequency and spectrum of adverse effects (AE), and also approaches of their management.Original positions. Investigations carried out to the present time demonstrated, that addition of telaprevir to standard therapy by pegilated interferon-alpha and ribavirin increases frequency of achievement sustained virologic response in CHC patients with the 1 genotype of virus almost 2-fold. Tolerability of treatment with addition of telaprevir was satisfactory as a whole; however frequency of skin rashes and pruritus (over 50%), anemia (about 40%) and anorectal symptoms (26%) was higher, than at standard double therapy (placebo group). A little higher frequency of serious AE (7%), cancellation of all drugs due to AE (8%) was observed. Increase of frequency and severity of skin reactions, that was a principal cause of treatment cancellation, is of special importance. AE spectrum at telaprevir application differs from AE spectrum at triple therapy with addition of another new protease inhibitor – boceprevir (predominance of anemia, dysgeusia). Original approach of monitoring and effective management of AE allowed to decrease frequency of cancellation of treatment due to dermal reactions in III phase investigations in comparison to results of II phase studies. Special attention is given to prophylaxis of interactions with other pharmaceuticals, as telaprevir is P450 (СYP) 3A4 substrate and inhibitor and P-glycoprotein transporter.Conclusion. Application of telaprevir within triple therapy of CHC results in change of AE spectrum. The major importance has elevation of frequency and severity of skin reactions. Tactics of early diagnostics, monitoring and active treatment of AE, and drug interactions prophylaxes increase safety and efficacy of treatment.
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spelling doaj-art-d4ced9d02b0a46e89c4e74c2df26b21c2025-02-10T16:14:32ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732012-07-012244757882Telaprevir in treatment of chronic hepatitis C: safety issuesT. M. Ignatova0ФГБУ «Научно-исследовательский институт ревматологии» Российской академии медицинских наукThe aim of review. To analyze results of controlled clinical studies of efficacy and safety of telaprevir within triple antiviral therapy of chronic hepatitis C (CHC) with evaluation of frequency and spectrum of adverse effects (AE), and also approaches of their management.Original positions. Investigations carried out to the present time demonstrated, that addition of telaprevir to standard therapy by pegilated interferon-alpha and ribavirin increases frequency of achievement sustained virologic response in CHC patients with the 1 genotype of virus almost 2-fold. Tolerability of treatment with addition of telaprevir was satisfactory as a whole; however frequency of skin rashes and pruritus (over 50%), anemia (about 40%) and anorectal symptoms (26%) was higher, than at standard double therapy (placebo group). A little higher frequency of serious AE (7%), cancellation of all drugs due to AE (8%) was observed. Increase of frequency and severity of skin reactions, that was a principal cause of treatment cancellation, is of special importance. AE spectrum at telaprevir application differs from AE spectrum at triple therapy with addition of another new protease inhibitor – boceprevir (predominance of anemia, dysgeusia). Original approach of monitoring and effective management of AE allowed to decrease frequency of cancellation of treatment due to dermal reactions in III phase investigations in comparison to results of II phase studies. Special attention is given to prophylaxis of interactions with other pharmaceuticals, as telaprevir is P450 (СYP) 3A4 substrate and inhibitor and P-glycoprotein transporter.Conclusion. Application of telaprevir within triple therapy of CHC results in change of AE spectrum. The major importance has elevation of frequency and severity of skin reactions. Tactics of early diagnostics, monitoring and active treatment of AE, and drug interactions prophylaxes increase safety and efficacy of treatment.https://www.gastro-j.ru/jour/article/view/1310telaprevirantiviral therapyhepatitis csafetyadverse effectsdermal reactionsanemia
spellingShingle T. M. Ignatova
Telaprevir in treatment of chronic hepatitis C: safety issues
Российский журнал гастроэнтерологии, гепатологии, колопроктологии
telaprevir
antiviral therapy
hepatitis c
safety
adverse effects
dermal reactions
anemia
title Telaprevir in treatment of chronic hepatitis C: safety issues
title_full Telaprevir in treatment of chronic hepatitis C: safety issues
title_fullStr Telaprevir in treatment of chronic hepatitis C: safety issues
title_full_unstemmed Telaprevir in treatment of chronic hepatitis C: safety issues
title_short Telaprevir in treatment of chronic hepatitis C: safety issues
title_sort telaprevir in treatment of chronic hepatitis c safety issues
topic telaprevir
antiviral therapy
hepatitis c
safety
adverse effects
dermal reactions
anemia
url https://www.gastro-j.ru/jour/article/view/1310
work_keys_str_mv AT tmignatova telaprevirintreatmentofchronichepatitiscsafetyissues