Efficacy and safety of bulevirtide in patients with chronic hepatitis D and compensated cirrhosis
- Authors: Bogomolov P.O.1,2, Ivashkin V.T.3, Bueverov A.O.1,3, Maev I.V.2, Sagalova O.I.4, Sleptsova S.S.5, Yushuk N.D.2, Gusev D.A.6, Zhdanov K.V.7, Chulanov V.P.3,8
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Affiliations:
- Vladimirsky Moscow Regional Research Clinical Institute
- Yevdokimov Moscow State University of Medicine and Dentistry
- Sechenov First Moscow State Medical University (Sechenov University)
- South Ural State Medical University
- Ammosov North-Eastern Federal University
- Botkin Clinical Infectious Diseases Hospital
- Kirov Military Medical Academy
- National Medical Research Center of Phthisiopulmonology and Infectious Diseases
- Issue: Vol 93, No 11 (2021)
- Pages: 1290-1299
- Section: Original articles
- URL: https://journals.rcsi.science/0040-3660/article/view/99543
- DOI: https://doi.org/10.26442/00403660.2021.11.201163
- ID: 99543
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Abstract
Aim. To study the efficacy and safety of bulevirtide, the HBV and HDV entry inhibitor.
Materials and methods. Analysis of the results of using bulevirtide in randomized controlled open-label comparative studies MYR202 and MYR203 in 56 patients with chronic hepatitis D and compensated cirrhosis, in monotherapy and combination with pegylated interferon alpha-2a (PEG-IFN).
Results. Monotherapy with bulevirtide for 24 weeks in the MYR202 study in 46 patients with compensated liver cirrhosis demonstrated: 1) a high rate of virological (100%) and biochemical response (alanine aminotransferase normalization rate – 45.7%), 2) superiority of bulevirtide in efficacy over the control group (tenofovir), 3) comparability of treatment efficacy in patients with and without cirrhosis, 4) no progression of liver fibrosis with elastometry in most patients.
Treatment with bulevirtide in monotherapy and combination with PEG-IFN for 48 weeks in 10 patients with compensated liver cirrhosis in the MYR203 study was accompanied by a high rate of virological response (80%) and normalization of alanine aminotransferase (70%).
Bulevirtide was well tolerated, there was no deterioration in tolerability compared with patients without cirrhosis, there were no serious adverse events and cases of treatment cancellation due to adverse events.
Conclusion. Bulevirtide is recommended as the first line of treatment for chronic hepatitis D in patients with compensated cirrhosis in monotherapy and combination with PEG-IFN.
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##article.viewOnOriginalSite##About the authors
Pavel O. Bogomolov
Vladimirsky Moscow Regional Research Clinical Institute; Yevdokimov Moscow State University of Medicine and Dentistry
Author for correspondence.
Email: hepatology@monikiweb.ru
ORCID iD: 0000-0003-2346-1216
канд. мед. наук, рук. отд-ния гепатологии ГБУЗ МО «МОНИКИ им. М.Ф. Владимирского», доц. каф. фармакологии ФГБОУ ВО «МГМСУ им. А.И. Евдокимова»
Russian Federation, MoscowVladimir T. Ivashkin
Sechenov First Moscow State Medical University (Sechenov University)
Email: hepatology@monikiweb.ru
ORCID iD: 0000-0002-6815-6015
акад. РАН, д-р мед. наук, проф., зав. каф. пропедевтики внутренних болезней ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова (Сеченовский Университет)»
Russian Federation, MoscowAlexey O. Bueverov
Vladimirsky Moscow Regional Research Clinical Institute; Sechenov First Moscow State Medical University (Sechenov University)
Email: hepatology@monikiweb.ru
ORCID iD: 0000-0002-5041-3466
д-р мед. наук, проф. каф. медико-социальной экспертизы, неотложной и поликлинической терапии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова (Сеченовский Университет)», вед. науч. сотр. отд. гепатологии ГБУЗ МО «МОНИКИ им. М.Ф. Владимирского»
Russian Federation, MoscowIgor V. Maev
Yevdokimov Moscow State University of Medicine and Dentistry
Email: hepatology@monikiweb.ru
ORCID iD: 0000-0001-6114-564X
акад. РАН, д-р мед. наук, проф., зав. каф. пропедевтики внутренних болезней и гастроэнтерологии ФГБОУ ВО «МГМСУ им. А.И. Евдокимова»
Russian Federation, MoscowOlga I. Sagalova
South Ural State Medical University
Email: hepatology@monikiweb.ru
ORCID iD: 0000-0003-3814-7342
д-р мед. наук, зав. инфекционным отд-нием Клиники ФГБОУ ВО ЮУГМУ
Russian Federation, ChelyabinskSnezhana S. Sleptsova
Ammosov North-Eastern Federal University
Email: hepatology@monikiweb.ru
ORCID iD: 0000-0002-0103-4750
д-р мед. наук, доц., зав. каф. инфекционных болезней, фтизиатрии и дерматовенерологии медицинского института ФГАОУ ВО «СВФУ им. М.К. Аммосова»
Russian Federation, YakutskNikolay D. Yushuk
Yevdokimov Moscow State University of Medicine and Dentistry
Email: hepatology@monikiweb.ru
ORCID iD: 0000-0003-1928-4747
акад. РАН, д-р мед. наук, проф., зав. каф. инфекционных болезней и эпидемиологии, президент ФГБОУ ВО «МГМСУ им. А.И. Евдокимова»
Russian Federation, MoscowDenis A. Gusev
Botkin Clinical Infectious Diseases Hospital
Email: hepatology@monikiweb.ru
ORCID iD: 0000-0001-9202-3231
д-р мед. наук, проф., гл. врач ГБУЗ «Клиническая инфекционная больница им. С.П. Боткина»
Russian Federation, Saint PetersburgKonstantin V. Zhdanov
Kirov Military Medical Academy
Email: hepatology@monikiweb.ru
ORCID iD: 0000-0002-3679-1874
чл.-кор. РАН, д-р мед. наук, проф., нач. каф. инфекционных болезней (с курсом медицинской паразитологии и тропических заболеваний) ФГБВОУ ВО «ВМА им. С.М. Кирова»
Russian Federation, Saint PetersburgVladimir P. Chulanov
Sechenov First Moscow State Medical University (Sechenov University); National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Email: hepatology@monikiweb.ru
ORCID iD: 0000-0001-6303-9293
д-р мед. наук, зам. дир. по научной работе и инновационному развитию ФГБУ НМИЦ ФПИ, проф. каф. ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова (Сеченовский Университет)»
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