Efficacy and safety of the Russian protease inhibitor narlaprevir at treatment-naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis C (PIONEER study)
Aim of investigation. To estimate efficacy and safety of narlaprevir (NVR) with ritonavir (RTV), pegilated interferon (peg-IFN) and ribavirin (RBV) at treatmentnaïve and earlier treated noncirrhotic patients with chronic hepatitis C caused by the 1st virus genotype in double blind placebo-controlled...
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Gastro LLC
2018-08-01
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| Series: | Российский журнал гастроэнтерологии, гепатологии, колопроктологии |
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| Online Access: | https://www.gastro-j.ru/jour/article/view/191 |
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| author | M. V. Mayevskaya V. T. Ivashkin O. O. Znoyko Ye. A. Klimova D. T. Abdurakhmanov I. G. Bakulin P. O. Bogomolov E. Z. Burnevich M. Yu. Galushko N. I. Geyvandova K. V. Zhdanov Ye. V. Esaulenko S. N. Kizhlo D. Yu. Konstantinov N. I. Mironova V. G. Morozov Ye. A. Strebkova I. G. Nikitin M. F. Osipenko V. D. Pasechnikov O. I. Sagalova I. M. Khayertynova V. P. Chulanov A. A. Yakovlev I. A. Vasyutin Ye. P. Tarkhova E. N. Krasavina M. Yu. Samsonov |
| author_facet | M. V. Mayevskaya V. T. Ivashkin O. O. Znoyko Ye. A. Klimova D. T. Abdurakhmanov I. G. Bakulin P. O. Bogomolov E. Z. Burnevich M. Yu. Galushko N. I. Geyvandova K. V. Zhdanov Ye. V. Esaulenko S. N. Kizhlo D. Yu. Konstantinov N. I. Mironova V. G. Morozov Ye. A. Strebkova I. G. Nikitin M. F. Osipenko V. D. Pasechnikov O. I. Sagalova I. M. Khayertynova V. P. Chulanov A. A. Yakovlev I. A. Vasyutin Ye. P. Tarkhova E. N. Krasavina M. Yu. Samsonov |
| author_sort | M. V. Mayevskaya |
| collection | DOAJ |
| description | Aim of investigation. To estimate efficacy and safety of narlaprevir (NVR) with ritonavir (RTV), pegilated interferon (peg-IFN) and ribavirin (RBV) at treatmentnaïve and earlier treated noncirrhotic patients with chronic hepatitis C caused by the 1st virus genotype in double blind placebo-controlled 3rd phase study (PIONEER). Material and methods. The main group received NVR (200 mg od orally) in combination to RTV (100 mg) and pegIFN/RBV for 12 weeks that was followed by peg-IFN/ RBV for 12 weeks. Comparison group received pegIFN/ RBV for 48 weeks, for the first 12 weeks in combination to placebo. Results. The sustained virologic response in 24 weeks after treatment termination (SVR24) in the main group (NVR/RTV, PEG IFN/RBV)) was achieved in 89.1% (163/183) of treatment-naïve and 69.7% (69/99) of earlier treated patients. SVR24 was achieved in 86.5% (32/37) of patients with relapse after previous peg-IFN/ RBV treatment course. The viral load decreased for the mean of 5.3 log10 in 2 weeks and 5.9 log10 in 4 weeks of treatment in the main group vs 1.5 log10 in 2 weeks and 2.5 log10 in 4 weeks in comparison group. In treatment-naïve patients from the main group SVR24 was achieved in 90.8% at initial METAVIR F0-F2 liver fibrosis stage and in 75% at F3 liver fibrosis stage. In those who were previously treated by peg-IFN/RBV, in the main group SVR-24 was attained in 72.6% at liver fibrosis stage F0-F2 and in 53.3% with F3 liver fibrosis stage. NVR/RTV addition to peg-IFN/RBV treatment did not alter safety profile as compared to peg-IFN/RBV therapy. Conclusions. In PIONEER study the narlaprevir combination therapy was characterized by high efficacy, convenience of administration and favorable safety profile. |
| format | Article |
| id | doaj-art-0686acb179664d0d893a6a2414c4957c |
| institution | Kabale University |
| issn | 1382-4376 2658-6673 |
| language | Russian |
| publishDate | 2018-08-01 |
| publisher | Gastro LLC |
| record_format | Article |
| series | Российский журнал гастроэнтерологии, гепатологии, колопроктологии |
| spelling | doaj-art-0686acb179664d0d893a6a2414c4957c2025-02-10T16:14:29ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732018-08-01276415110.22416/1382-4376-2017-27-6-41-51191Efficacy and safety of the Russian protease inhibitor narlaprevir at treatment-naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis C (PIONEER study)M. V. Mayevskaya0V. T. Ivashkin1O. O. Znoyko2Ye. A. Klimova3D. T. Abdurakhmanov4I. G. Bakulin5P. O. Bogomolov6E. Z. Burnevich7M. Yu. Galushko8N. I. Geyvandova9K. V. Zhdanov10Ye. V. Esaulenko11S. N. Kizhlo12D. Yu. Konstantinov13N. I. Mironova14V. G. Morozov15Ye. A. Strebkova16I. G. Nikitin17M. F. Osipenko18V. D. Pasechnikov19O. I. Sagalova20I. M. Khayertynova21V. P. Chulanov22A. A. Yakovlev23I. A. Vasyutin24Ye. P. Tarkhova25E. N. Krasavina26M. Yu. Samsonov27Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical UniversityFederal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical UniversityFederal state government-financed educational institution of higher education «Yevdokimov Moscow State University of Medicine and Dentistry»Federal state government-financed educational institution of higher education «Yevdokimov Moscow State University of Medicine and Dentistry»Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical UniversityState educational government-financed institution of higher professional education «Mechnikov North-Western State Medical university»«Tsentrosoyuz» clinical hospitalCity clinical hospital #24LLC «Medelitkonsalting»State government-financed healthcare institution «Stavropol Regional Hospital»State military educational government-financed institution of higher professional education «Kirov military medical academy»St. Petersburg state government-financed healthcare institution «Botkin clinical infectious diseases hospital»St. Petersburg center for prevention and control of AIDS and infectious diseasesState educational government-financed institution of higher professional education «Samara State Medical University»Razumovsky City clinical hospital #2LLC medical company «Gepatolog»State educational government-financed institution of higher professional education «Samara State Medical University»Federal state autonomous institution «Treatment and rehabilitation Center»State educational government-financed institution of higher professional education «Novosibirsk state medical university»State educational government-financed institution of higher professional education «Stavropol state medical university»Clinical hospital, Federal state educational institution of higher education «South Ural State Medical University»State autonomous healthcare institution «Agafonov Republican clinical infectious diseases hospital»Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University; Federal government-financed institution of science «Central research institute of epidemiology»Federal state government-financed educational institution of higher education «St. Petersburg University»«R-Pharm» joint-stock company«R-Pharm» joint-stock company«R-Pharm» joint-stock company«R-Pharm» joint-stock companyAim of investigation. To estimate efficacy and safety of narlaprevir (NVR) with ritonavir (RTV), pegilated interferon (peg-IFN) and ribavirin (RBV) at treatmentnaïve and earlier treated noncirrhotic patients with chronic hepatitis C caused by the 1st virus genotype in double blind placebo-controlled 3rd phase study (PIONEER). Material and methods. The main group received NVR (200 mg od orally) in combination to RTV (100 mg) and pegIFN/RBV for 12 weeks that was followed by peg-IFN/ RBV for 12 weeks. Comparison group received pegIFN/ RBV for 48 weeks, for the first 12 weeks in combination to placebo. Results. The sustained virologic response in 24 weeks after treatment termination (SVR24) in the main group (NVR/RTV, PEG IFN/RBV)) was achieved in 89.1% (163/183) of treatment-naïve and 69.7% (69/99) of earlier treated patients. SVR24 was achieved in 86.5% (32/37) of patients with relapse after previous peg-IFN/ RBV treatment course. The viral load decreased for the mean of 5.3 log10 in 2 weeks and 5.9 log10 in 4 weeks of treatment in the main group vs 1.5 log10 in 2 weeks and 2.5 log10 in 4 weeks in comparison group. In treatment-naïve patients from the main group SVR24 was achieved in 90.8% at initial METAVIR F0-F2 liver fibrosis stage and in 75% at F3 liver fibrosis stage. In those who were previously treated by peg-IFN/RBV, in the main group SVR-24 was attained in 72.6% at liver fibrosis stage F0-F2 and in 53.3% with F3 liver fibrosis stage. NVR/RTV addition to peg-IFN/RBV treatment did not alter safety profile as compared to peg-IFN/RBV therapy. Conclusions. In PIONEER study the narlaprevir combination therapy was characterized by high efficacy, convenience of administration and favorable safety profile.https://www.gastro-j.ru/jour/article/view/191хронический гепатит слечениенарлапревир |
| spellingShingle | M. V. Mayevskaya V. T. Ivashkin O. O. Znoyko Ye. A. Klimova D. T. Abdurakhmanov I. G. Bakulin P. O. Bogomolov E. Z. Burnevich M. Yu. Galushko N. I. Geyvandova K. V. Zhdanov Ye. V. Esaulenko S. N. Kizhlo D. Yu. Konstantinov N. I. Mironova V. G. Morozov Ye. A. Strebkova I. G. Nikitin M. F. Osipenko V. D. Pasechnikov O. I. Sagalova I. M. Khayertynova V. P. Chulanov A. A. Yakovlev I. A. Vasyutin Ye. P. Tarkhova E. N. Krasavina M. Yu. Samsonov Efficacy and safety of the Russian protease inhibitor narlaprevir at treatment-naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis C (PIONEER study) Российский журнал гастроэнтерологии, гепатологии, колопроктологии хронический гепатит с лечение нарлапревир |
| title | Efficacy and safety of the Russian protease inhibitor narlaprevir at treatment-naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis C (PIONEER study) |
| title_full | Efficacy and safety of the Russian protease inhibitor narlaprevir at treatment-naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis C (PIONEER study) |
| title_fullStr | Efficacy and safety of the Russian protease inhibitor narlaprevir at treatment-naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis C (PIONEER study) |
| title_full_unstemmed | Efficacy and safety of the Russian protease inhibitor narlaprevir at treatment-naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis C (PIONEER study) |
| title_short | Efficacy and safety of the Russian protease inhibitor narlaprevir at treatment-naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis C (PIONEER study) |
| title_sort | efficacy and safety of the russian protease inhibitor narlaprevir at treatment naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis c pioneer study |
| topic | хронический гепатит с лечение нарлапревир |
| url | https://www.gastro-j.ru/jour/article/view/191 |
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