Gilead Sciences announced that the China National Medical Products Administration has approved Descovy, a fixed-dose combination for the treatment of HIV. In China, Descovy is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 in adults and adolescents. In the United States, Descovy has a boxed warning in its product label regarding the risk of post treatment acute exacerbation of hepatitis B. TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s TDF but at one-tenth of the dose. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to peripheral blood mononuclear cells compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. In clinical trials, TAF demonstrated improved renal and bone laboratory safety parameters compared to TDF. In 2017, there were 134,512 people newly diagnosed with HIV in China. The number of diagnoses has increased significantly in recent years, partially due to expanded screening. At the same time, the number of people living with HIV and receiving antiretroviral treatment has also increased steadily. The government of China has provided free antiretroviral treatment to all persons living with HIV since 2003. The approval of Descovy is supported by 144-week data from two pivotal Phase 3 studies in which the F/TAF-based regimen met its primary objective of non-inferiority compared to an F/TDF-based regimen among treatment naive adult patients. Tests of certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen. The approval also is supported by a Phase 3 study evaluating the F/TAF-based regimen among virologically suppressed adult patients who switched from F/TDF-based regimens. In the study, the F/TAF-based regimen was found to be statistically non-inferior to the F/TDF-based regimens and demonstrated improvements in certain bone and renal laboratory parameters compared to the F/TDF-based regimens. Additionally, the approval is supported by data from Phase 3 studies evaluating the F/TAF-based regimen among virologically suppressed adults with mild-to-moderate renal impairment and among treatment naive adolescents. Descovy received marketing approval from the U.S. Food and Drug Administration and the European Commission in 2016. In the U.S., only the emtricitabine 200 mg/tenofovir alafenamide 25 mg dosage form is approved. Descovy does not cure HIV infection or AIDS.
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