The modern options of chronic hepatitis C antiviral therapy with daclatasvir: results of named patient program
Introduction. The options of antiviral therapy (AVT) in the stages of severe liver fibrosis and cirrhosis (LC) as well as in the patients with comorbidities for the long time were limited to the standard therapy by pegilated interferon (peg-IFN) in combination to ribavirin (RBV). Before official reg...
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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/192 |
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| author | V. T. Ivashkin M. V. Mayevskaya D. T. Abdurakhmanov I. G. Bakulin N. I. Geyvandova M. L. Zubkin S. N. Kizhlo A. V. Kuznetsova I. B. Latysheva N. A. Mamonova V. G. Morozov O. I. Sagalova Ye. V. Esaulenko Ye. O. Lyusina |
| author_facet | V. T. Ivashkin M. V. Mayevskaya D. T. Abdurakhmanov I. G. Bakulin N. I. Geyvandova M. L. Zubkin S. N. Kizhlo A. V. Kuznetsova I. B. Latysheva N. A. Mamonova V. G. Morozov O. I. Sagalova Ye. V. Esaulenko Ye. O. Lyusina |
| author_sort | V. T. Ivashkin |
| collection | DOAJ |
| description | Introduction. The options of antiviral therapy (AVT) in the stages of severe liver fibrosis and cirrhosis (LC) as well as in the patients with comorbidities for the long time were limited to the standard therapy by pegilated interferon (peg-IFN) in combination to ribavirin (RBV). Before official registration of interferon-free treatment modes in 2015 experience of the application was limited to clinical trials or treatment within early approach programs. Aim of investigation. To analyze the efficacy of PTV for chronic hepatitis C within the named patient program of expanded access to daclatasvir. Material and methods. Approval of Ministry of Healthcare of the Russian Federation to import of drugs was received for the treatment of 101 HCV-infected patients with compensated LC, who, been untreated had an urgent need for effective therapy, with estimated life expectancy less than 12 months, in 12 centers of the Russian Federation. The patients with 1b HCV genotype received treatment by combination of daclatasvir and asunaprevir 100 mg, patients with 2 and 3 HCV genotypes, and those with 1b HCV genotype after the liver transplantation received daclatasvir to sofosbuvir combination. Results. Sustained virologic response for 24 wks (SVR24) in early approach program was 89% (83 of 93) of patients with severe liver disease who urgently needed effective treatment with estimated life expectancy of less than 12 months if been untreated. In group of the patients receiving treatment mode of daclatasvir + asunaprevir the frequency of SVR24 achievement was 90%. Of 93 patients who underwent complete treatment course no severe adverse effects were registered. During treatment infrequent nonspecific adverse events, such as a headache and fatigue were observed. No significant elevation of alanine transaminase and aspartate aminotransferase activity, or bilirubin level were detected. Conclusions. Daclatasvir combination to asunaprevir or sofosbuvir demonstrated high efficacy, including that at treatment of patients with poor prognostic signs. |
| format | Article |
| id | doaj-art-648fb9a0265848459515bd7b7ee40f58 |
| institution | Kabale University |
| issn | 1382-4376 2658-6673 |
| language | Russian |
| publishDate | 2018-08-01 |
| publisher | Gastro LLC |
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| series | Российский журнал гастроэнтерологии, гепатологии, колопроктологии |
| spelling | doaj-art-648fb9a0265848459515bd7b7ee40f582025-02-10T16:14:29ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732018-08-01276526210.22416/1382-4376-2017-27-6-52-62192The modern options of chronic hepatitis C antiviral therapy with daclatasvir: results of named patient programV. T. Ivashkin0M. V. Mayevskaya1D. T. Abdurakhmanov2I. G. Bakulin3N. I. Geyvandova4M. L. Zubkin5S. N. Kizhlo6A. V. Kuznetsova7I. B. Latysheva8N. A. Mamonova9V. G. Morozov10O. I. Sagalova11Ye. V. Esaulenko12Ye. O. Lyusina13Federal 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 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»State educational government-financed institution of higher professional education «Stavropol state medical university»Federal government-financed scientific institution «Gabrichevsky Moscow scientific research institute of epidemiology and microbiology»Saint Petersburg Federal government-financed healthcare institution «National Center for AIDS and infectious diseases prevention and control»Regional state government-financed healthcare institution «Khabarovsk center for AIDS and infectious diseases prevention and control»Federal government-financed institution «Republican clinical infectious diseases hospital»Federal government-financed institution of science «Central research institute of epidemiology»LLC «Gepatolog»Federal state educational institution of higher education «South Ural State Medical University»State educational government-financed institution of higher professional education «Saint Petersburg state pediatric medical university»Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical UniversityIntroduction. The options of antiviral therapy (AVT) in the stages of severe liver fibrosis and cirrhosis (LC) as well as in the patients with comorbidities for the long time were limited to the standard therapy by pegilated interferon (peg-IFN) in combination to ribavirin (RBV). Before official registration of interferon-free treatment modes in 2015 experience of the application was limited to clinical trials or treatment within early approach programs. Aim of investigation. To analyze the efficacy of PTV for chronic hepatitis C within the named patient program of expanded access to daclatasvir. Material and methods. Approval of Ministry of Healthcare of the Russian Federation to import of drugs was received for the treatment of 101 HCV-infected patients with compensated LC, who, been untreated had an urgent need for effective therapy, with estimated life expectancy less than 12 months, in 12 centers of the Russian Federation. The patients with 1b HCV genotype received treatment by combination of daclatasvir and asunaprevir 100 mg, patients with 2 and 3 HCV genotypes, and those with 1b HCV genotype after the liver transplantation received daclatasvir to sofosbuvir combination. Results. Sustained virologic response for 24 wks (SVR24) in early approach program was 89% (83 of 93) of patients with severe liver disease who urgently needed effective treatment with estimated life expectancy of less than 12 months if been untreated. In group of the patients receiving treatment mode of daclatasvir + asunaprevir the frequency of SVR24 achievement was 90%. Of 93 patients who underwent complete treatment course no severe adverse effects were registered. During treatment infrequent nonspecific adverse events, such as a headache and fatigue were observed. No significant elevation of alanine transaminase and aspartate aminotransferase activity, or bilirubin level were detected. Conclusions. Daclatasvir combination to asunaprevir or sofosbuvir demonstrated high efficacy, including that at treatment of patients with poor prognostic signs.https://www.gastro-j.ru/jour/article/view/192hcvхронический гепатит спротивовирусная терапиядаклатасвириндивидуальный доступ |
| spellingShingle | V. T. Ivashkin M. V. Mayevskaya D. T. Abdurakhmanov I. G. Bakulin N. I. Geyvandova M. L. Zubkin S. N. Kizhlo A. V. Kuznetsova I. B. Latysheva N. A. Mamonova V. G. Morozov O. I. Sagalova Ye. V. Esaulenko Ye. O. Lyusina The modern options of chronic hepatitis C antiviral therapy with daclatasvir: results of named patient program Российский журнал гастроэнтерологии, гепатологии, колопроктологии hcv хронический гепатит с противовирусная терапия даклатасвир индивидуальный доступ |
| title | The modern options of chronic hepatitis C antiviral therapy with daclatasvir: results of named patient program |
| title_full | The modern options of chronic hepatitis C antiviral therapy with daclatasvir: results of named patient program |
| title_fullStr | The modern options of chronic hepatitis C antiviral therapy with daclatasvir: results of named patient program |
| title_full_unstemmed | The modern options of chronic hepatitis C antiviral therapy with daclatasvir: results of named patient program |
| title_short | The modern options of chronic hepatitis C antiviral therapy with daclatasvir: results of named patient program |
| title_sort | modern options of chronic hepatitis c antiviral therapy with daclatasvir results of named patient program |
| topic | hcv хронический гепатит с противовирусная терапия даклатасвир индивидуальный доступ |
| url | https://www.gastro-j.ru/jour/article/view/192 |
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