Первая комбинация на основе TAF
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20.11.2015
В США одобрено применение комбинированного антиретровирусного препарата "Genvoya", разработанного компанией Gilead. Новое лекарственное средство, содержащее элвитегравир (150 мг), кобицистат (150 мг), эмтрицитабин (200 мг) и тенофовира алафенамид (10 мг), предназначено для лечения ВИЧ-инфекции у пациентов старше 12 лет. Эффективность и безопасность применения препарата была подтверждена результатами четырех клинических испытаний, прошедших при участии 3,71 тыс. пациентов. Согласно данным, опубликованным Gilead в прошлом месяце, "Genvoya" имеет схожую эффективность с предыдущим АРВ-препаратом компании "Stribild", но обладает лучшим профилем безопасности.
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GENVOYA First TAF-based Regimen Demonstrates High Efficacy with Improved Renal and Bone Parameters Compared to TDF-based Regimens | http://gileadhivmedia.com/ |
U.S. Food and Drug Administration (FDA) has approved Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based regimen to receive FDA approval.
GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA.
GENVOYA contains a new form of tenofovir that has not been previously approved. This new form of tenofovir provides lower levels of drug in the bloodstream, but higher levels within the cells where HIV-1 replicates. It was developed to help reduce some drug side effects. GENVOYA appears to be associated with less kidney toxicity and decreases in bone density than previously approved tenofovir containing regimens based on laboratory measures. Patients receiving GENVOYA experienced greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the studies.
The recommended dosage of GENVOYA is one tablet taken orally once daily with food.
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