БУЛЕВИРТИД. Клинические исследования

 

 

Булевиртид (прежнее название Мирклюдекс В) представляет собой липопептид из 47 аминокислот, созданный профессором Штефаном Урбаном из Хайдельбергского университета. Полученный из preS1-области белка оболочки вируса гепатита В, он продемонстрировал свойства блокатора печеночного транспортера желчных солей NTCP, используемый вирусами гепатита В и D для проникновения в клетки печени.

Результаты 5 клинических исследований Булевиртида позволили сделать вывод об эффективном предотвращении инфицирования гепатоцитов вирусом гепатита D, снижении вирусной нагрузки и уменьшении воспаления. Последнее проявилось нормализацией активности АЛТ у большинства больных – 67%; при этом биохимический ответ сохранялся более 48 нед. Следствием подавления вирус-индуцированного воспаления явилась интенсификация процессов лизиса соединительной ткани и регенерация паренхимы печени, что привело к уменьшению фиброза.

Булевиртид продемонстрировал почти идеальную безопасность. В клинических исследованиях не отмечено ни одного случая прерывания противовирусной терапии из-за побочных эффектов. По сути, все нежелательные явления ограничивались преходящими кожными реакциями в месте введения менее чем у 5% пациентов. Повышение сывороточного уровня желчных кислот на фоне терапии булевиртидом было транзиторным и не сопровождалось кожным зудом.

20 февраля 2020

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