Early virologic response to сеpeginterferon alfa-2b in combination with ribavirin in treatment of patients with chronic hepatitis C
Algeron (cepeginterferon alfa-2b) is a new pegylated form of interferon alfa containing linear polyethylene glycol (molecular weight 20 kDa). Pharmacokinetic profile of Algeron allows once weekly administration. In phase II–III study 150 treatment-naive patients with compensated liver function were...
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| Format: | Article |
| Language: | Russian |
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Journal Infectology
2014-09-01
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| Series: | Журнал инфектологии |
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| Online Access: | https://journal.niidi.ru/jofin/article/view/158 |
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| author | O. O. Znoyko M. V. Maevskaya E. A. Klimova S. L. Maksimov S. N. Kizhlo N. A. Petrochenkova F. I. Nagimova R. A. Ivanov Yu. N. Linkova T. V. Chernovskaya |
| author_facet | O. O. Znoyko M. V. Maevskaya E. A. Klimova S. L. Maksimov S. N. Kizhlo N. A. Petrochenkova F. I. Nagimova R. A. Ivanov Yu. N. Linkova T. V. Chernovskaya |
| author_sort | O. O. Znoyko |
| collection | DOAJ |
| description | Algeron (cepeginterferon alfa-2b) is a new pegylated form of interferon alfa containing linear polyethylene glycol (molecular weight 20 kDa). Pharmacokinetic profile of Algeron allows once weekly administration. In phase II–III study 150 treatment-naive patients with compensated liver function were randomized into 3 groups: Algeron 1,5 μg/kg/week, Algeron 2,0 μg/kg/week, and a reference group of PegIntron 1.5 μg/kg/week in combination with ribavirin 800– 1400 mg/day. Comparative ITT -analysis of early virologic response (EVR) showed absence of differences between groups in frequency of EVR. In Algeron groups (regardless of a dose – 1,5 or 2,0 μg/kg) EVR was observed in 94%, in PegIntron group – – in 88% of patients. Complete EVR (HCV RNA≤15 I I U/mL) was recorded in 88% and 84% of patients receiving Algeron 1,5 and 2,0 μg/kg, respectively, in the reference group – – in 84% of patients. There were no statistically significant differences between groups where patients received Algeron in different doses and the reference group, with or without genotype stratification. Adverse events occurring during the treatment with Algeron are dose-dependent; however, their frequency is no more than in patients receiving standard doses of PegIntron. Based on the absence of differences in efficacy and more favorable safety profile of a lower dose of the study drug, the therapeutic dose of Algeron was selected to be 1,5 μg/kg/week. |
| format | Article |
| id | doaj-art-8309c85f05cb4ce69fe7e97dad55ad44 |
| institution | Kabale University |
| issn | 2072-6732 |
| language | Russian |
| publishDate | 2014-09-01 |
| publisher | Journal Infectology |
| record_format | Article |
| series | Журнал инфектологии |
| spelling | doaj-art-8309c85f05cb4ce69fe7e97dad55ad442025-08-20T04:00:07ZrusJournal InfectologyЖурнал инфектологии2072-67322014-09-0151839010.22625/2072-6732-2013-5-1-83-90172Early virologic response to сеpeginterferon alfa-2b in combination with ribavirin in treatment of patients with chronic hepatitis CO. O. Znoyko0M. V. Maevskaya1E. A. Klimova2S. L. Maksimov3S. N. Kizhlo4N. A. Petrochenkova5F. I. Nagimova6R. A. Ivanov7Yu. N. Linkova8T. V. Chernovskaya9Moscow State University of Medicine and Dentistry, MoscowThe First Moscow State Medical University named after I.M. Sechenov, MoscowMoscow State University of Medicine and Dentistry, MoscowMoscow State University of Medicine and Dentistry, MoscowSaint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, Saint-PetersburgSmolensk State Medical Academy, SmolenskRepublic Center for Prevention and Control of AIDS and Infectious Diseases, KazanCJSC «BIOCAD», Saint-PetersburgCJSC «BIOCAD», Saint-PetersburgCJSC «BIOCAD», Saint-PetersburgAlgeron (cepeginterferon alfa-2b) is a new pegylated form of interferon alfa containing linear polyethylene glycol (molecular weight 20 kDa). Pharmacokinetic profile of Algeron allows once weekly administration. In phase II–III study 150 treatment-naive patients with compensated liver function were randomized into 3 groups: Algeron 1,5 μg/kg/week, Algeron 2,0 μg/kg/week, and a reference group of PegIntron 1.5 μg/kg/week in combination with ribavirin 800– 1400 mg/day. Comparative ITT -analysis of early virologic response (EVR) showed absence of differences between groups in frequency of EVR. In Algeron groups (regardless of a dose – 1,5 or 2,0 μg/kg) EVR was observed in 94%, in PegIntron group – – in 88% of patients. Complete EVR (HCV RNA≤15 I I U/mL) was recorded in 88% and 84% of patients receiving Algeron 1,5 and 2,0 μg/kg, respectively, in the reference group – – in 84% of patients. There were no statistically significant differences between groups where patients received Algeron in different doses and the reference group, with or without genotype stratification. Adverse events occurring during the treatment with Algeron are dose-dependent; however, their frequency is no more than in patients receiving standard doses of PegIntron. Based on the absence of differences in efficacy and more favorable safety profile of a lower dose of the study drug, the therapeutic dose of Algeron was selected to be 1,5 μg/kg/week.https://journal.niidi.ru/jofin/article/view/158chronic hepatitis ctreatmentearly virologic responsepegylated interferon alfacepeginterferon alfa-2balgeron |
| spellingShingle | O. O. Znoyko M. V. Maevskaya E. A. Klimova S. L. Maksimov S. N. Kizhlo N. A. Petrochenkova F. I. Nagimova R. A. Ivanov Yu. N. Linkova T. V. Chernovskaya Early virologic response to сеpeginterferon alfa-2b in combination with ribavirin in treatment of patients with chronic hepatitis C Журнал инфектологии chronic hepatitis c treatment early virologic response pegylated interferon alfa cepeginterferon alfa-2b algeron |
| title | Early virologic response to сеpeginterferon alfa-2b in combination with ribavirin in treatment of patients with chronic hepatitis C |
| title_full | Early virologic response to сеpeginterferon alfa-2b in combination with ribavirin in treatment of patients with chronic hepatitis C |
| title_fullStr | Early virologic response to сеpeginterferon alfa-2b in combination with ribavirin in treatment of patients with chronic hepatitis C |
| title_full_unstemmed | Early virologic response to сеpeginterferon alfa-2b in combination with ribavirin in treatment of patients with chronic hepatitis C |
| title_short | Early virologic response to сеpeginterferon alfa-2b in combination with ribavirin in treatment of patients with chronic hepatitis C |
| title_sort | early virologic response to сеpeginterferon alfa 2b in combination with ribavirin in treatment of patients with chronic hepatitis c |
| topic | chronic hepatitis c treatment early virologic response pegylated interferon alfa cepeginterferon alfa-2b algeron |
| url | https://journal.niidi.ru/jofin/article/view/158 |
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