Safety and efficacy of telaprevir in treatment of a chronic hepatitis C in patients of the Russian population included in early access program study
Aim of investigation. HEP3002 is the international early access program of efficacy and safety estimation of telaprevir in combination to peginterferon alpha and ribavirin for patients with severe fibrosis or liver cirrhosis caused by hepatitis C virus (HCV) genotype 1. Efficacy and safety of this t...
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Gastro LLC
2014-07-01
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| Series: | Российский журнал гастроэнтерологии, гепатологии, колопроктологии |
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| Online Access: | https://www.gastro-j.ru/jour/article/view/1089 |
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| author | D. T. Abrurakhmanov V. G. Morozov I. G. Nikitin P. O. Bogomolov N. I. Geyvandova Ye. N. Bessonova I. G. Bakulin V. A. Isakov K. V. Zhdanov M. V. Mayevskaya Ye. A. Nurmukhametova E. Z. Burnevich Ye. V. Chesnokov V. D. Pasechnikov A. Hill I. Lonjon-Domanec S. N. Kizhlo |
| author_facet | D. T. Abrurakhmanov V. G. Morozov I. G. Nikitin P. O. Bogomolov N. I. Geyvandova Ye. N. Bessonova I. G. Bakulin V. A. Isakov K. V. Zhdanov M. V. Mayevskaya Ye. A. Nurmukhametova E. Z. Burnevich Ye. V. Chesnokov V. D. Pasechnikov A. Hill I. Lonjon-Domanec S. N. Kizhlo |
| author_sort | D. T. Abrurakhmanov |
| collection | DOAJ |
| description | Aim of investigation. HEP3002 is the international early access program of efficacy and safety estimation of telaprevir in combination to peginterferon alpha and ribavirin for patients with severe fibrosis or liver cirrhosis caused by hepatitis C virus (HCV) genotype 1. Efficacy and safety of this therapeutic mode were evaluated in intermediate analysis on 16-th week of treatment in 153 patients from Russia who have already reached the 16-th week of treatment or potentially can do so.Material and methods. The study has prospectively included 153 HCV infected patients (genotype 1), with bridging fibrosis or compensated liver cirrhosis who received treatment by telaprevir in combination to peginterferon-alpha and ribavirin for 12 wks with subsequent 12-or 36-week rate of antiviral therapy (AVT) by peginterferon alpha and ribavirin in relation to virologic response and fibrosis severity. Analysis has been carried out for intention to treat (ITT) populations with application of 16-th week AVT data.Results. Total of 153 patients have completed 12-week course of triple therapy and 4-week course of peginterferon-alpha and ribavirin treatment (48% cirrhotic patients, 97% – HCV-1b). The level of HCV RNA was undetectable both at the 4-th week, and at the 12-th week (extended rapid virologic response) in 42 (75%) of 56 previously untreated patients, in 34 (89%) of 38 with relapses after previous treatment, in 4 (57%) of 7 with previous incomplete response, in 22 (52%) of 42 with the previous zero response and in 7 (70%) of 10 with previous virologic breakthrough. Sustained virologic response was achieved in 73 (80%) of patients available for analysis (n=91). Most frequent adverse events of the 2-4 degrees, related to telaprevir, were anemia (63 patients, 41%), thrombocytopenia (15 patients, 10%) and skin rash (7 patients, 5%). For anemia treatment in 50 (33%) patients the doze of ribavirin has been reduced, erythropoietin was prescribed to 12 (8%) to patients and no blood transfusion was required; 10 (7%) patients have ahead of schedule stopped course of treatment by telaprevir in connection with development of anemia (6), thrombocytopenia (2) and occurrence of skin rash (2).Conclusion. In 153 patients with severe liver fibrosis caused by hepatitis C virus (genotype 1), on background of triple AVT with telaprevir high level of immediate virologic response and low level of the preterm treatment discontinuation was marked. |
| format | Article |
| id | doaj-art-f727f4d5f8664bfcb7a762333d267e4a |
| institution | Kabale University |
| issn | 1382-4376 2658-6673 |
| language | Russian |
| publishDate | 2014-07-01 |
| publisher | Gastro LLC |
| record_format | Article |
| series | Российский журнал гастроэнтерологии, гепатологии, колопроктологии |
| spelling | doaj-art-f727f4d5f8664bfcb7a762333d267e4a2025-02-10T16:14:33ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732014-07-012413946690Safety and efficacy of telaprevir in treatment of a chronic hepatitis C in patients of the Russian population included in early access program studyD. T. Abrurakhmanov0V. G. Morozov1I. G. Nikitin2P. O. Bogomolov3N. I. Geyvandova4Ye. N. Bessonova5I. G. Bakulin6V. A. Isakov7K. V. Zhdanov8M. V. Mayevskaya9Ye. A. Nurmukhametova10E. Z. Burnevich11Ye. V. Chesnokov12V. D. Pasechnikov13A. Hill14I. Lonjon-Domanec15S. N. Kizhlo16State educational government-financed institution of higher professional education «Sechenov First Moscow state medical university», Ministry of Healthcare of the Russian Federation«Gepatolog» medical clinicState educational government-financed institution of higher professional education «Pirogov Russian National Research Medical University»Vladimirsky Moscow regional research clinical institute«Stavropol state medical university»Sverdlovsk regional hepatological centerCentral scientific research institute of gastroenterologyInstitute of nutritionKirov military medical academyState educational government-financed institution of higher professional education «Sechenov First Moscow state medical university», Ministry of Healthcare of the Russian FederationInfectious diseases city hospita #1State educational government-financed institution of higher professional education «Sechenov First Moscow state medical university», Ministry of Healthcare of the Russian FederationTyumen regional diagnostic centerThe Stavropol state medical academyJanssen R&DJanssen PharmaceuticalsSaint Petersburg Federal budget healthcare institution «National Center for AIDS and infectious diseases prevention and control»Aim of investigation. HEP3002 is the international early access program of efficacy and safety estimation of telaprevir in combination to peginterferon alpha and ribavirin for patients with severe fibrosis or liver cirrhosis caused by hepatitis C virus (HCV) genotype 1. Efficacy and safety of this therapeutic mode were evaluated in intermediate analysis on 16-th week of treatment in 153 patients from Russia who have already reached the 16-th week of treatment or potentially can do so.Material and methods. The study has prospectively included 153 HCV infected patients (genotype 1), with bridging fibrosis or compensated liver cirrhosis who received treatment by telaprevir in combination to peginterferon-alpha and ribavirin for 12 wks with subsequent 12-or 36-week rate of antiviral therapy (AVT) by peginterferon alpha and ribavirin in relation to virologic response and fibrosis severity. Analysis has been carried out for intention to treat (ITT) populations with application of 16-th week AVT data.Results. Total of 153 patients have completed 12-week course of triple therapy and 4-week course of peginterferon-alpha and ribavirin treatment (48% cirrhotic patients, 97% – HCV-1b). The level of HCV RNA was undetectable both at the 4-th week, and at the 12-th week (extended rapid virologic response) in 42 (75%) of 56 previously untreated patients, in 34 (89%) of 38 with relapses after previous treatment, in 4 (57%) of 7 with previous incomplete response, in 22 (52%) of 42 with the previous zero response and in 7 (70%) of 10 with previous virologic breakthrough. Sustained virologic response was achieved in 73 (80%) of patients available for analysis (n=91). Most frequent adverse events of the 2-4 degrees, related to telaprevir, were anemia (63 patients, 41%), thrombocytopenia (15 patients, 10%) and skin rash (7 patients, 5%). For anemia treatment in 50 (33%) patients the doze of ribavirin has been reduced, erythropoietin was prescribed to 12 (8%) to patients and no blood transfusion was required; 10 (7%) patients have ahead of schedule stopped course of treatment by telaprevir in connection with development of anemia (6), thrombocytopenia (2) and occurrence of skin rash (2).Conclusion. In 153 patients with severe liver fibrosis caused by hepatitis C virus (genotype 1), on background of triple AVT with telaprevir high level of immediate virologic response and low level of the preterm treatment discontinuation was marked.https://www.gastro-j.ru/jour/article/view/1089hcv-infectiontelaprevirpegilated interferonribavirinanemiarashearly access program |
| spellingShingle | D. T. Abrurakhmanov V. G. Morozov I. G. Nikitin P. O. Bogomolov N. I. Geyvandova Ye. N. Bessonova I. G. Bakulin V. A. Isakov K. V. Zhdanov M. V. Mayevskaya Ye. A. Nurmukhametova E. Z. Burnevich Ye. V. Chesnokov V. D. Pasechnikov A. Hill I. Lonjon-Domanec S. N. Kizhlo Safety and efficacy of telaprevir in treatment of a chronic hepatitis C in patients of the Russian population included in early access program study Российский журнал гастроэнтерологии, гепатологии, колопроктологии hcv-infection telaprevir pegilated interferon ribavirin anemia rash early access program |
| title | Safety and efficacy of telaprevir in treatment of a chronic hepatitis C in patients of the Russian population included in early access program study |
| title_full | Safety and efficacy of telaprevir in treatment of a chronic hepatitis C in patients of the Russian population included in early access program study |
| title_fullStr | Safety and efficacy of telaprevir in treatment of a chronic hepatitis C in patients of the Russian population included in early access program study |
| title_full_unstemmed | Safety and efficacy of telaprevir in treatment of a chronic hepatitis C in patients of the Russian population included in early access program study |
| title_short | Safety and efficacy of telaprevir in treatment of a chronic hepatitis C in patients of the Russian population included in early access program study |
| title_sort | safety and efficacy of telaprevir in treatment of a chronic hepatitis c in patients of the russian population included in early access program study |
| topic | hcv-infection telaprevir pegilated interferon ribavirin anemia rash early access program |
| url | https://www.gastro-j.ru/jour/article/view/1089 |
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