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It was previously known as the female condom—until the FDA made these three big regulatory changes.
Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) includes Pifeltro (doravirine) in a three-drug single-tablet regimen.
Gilead Sciences has released multiple combo tablets that contain the updated tenofovir, which is linked to improved bone and kidney makers.
In clinical trials, the single-tablet regimen of Tivicay (dolutegravir) and Epivir (lamivudine) was as effective as a three-drug treatment.
Compared with a regimen based on Prezista, doravirine was better for blood lipids, including cholesterol and triglycerides.
The single-tablet antiretroviral regimen includes Janssen’s darunavir plus Gilead’s cobicistat, emtricitabine and tenofovir alafenamide.
Charles Lyons, president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), analyzes data from a 2018 UNAIDS report.
PrEP is officially approved for adults and adolescents at risk for HIV who weigh at least 77 pounds.
A recent online survey found a high level of awareness of PrEP.
The combo of dolutegravir and lamivudine controlled HIV as well as a triple-drug combo of dolutegravir plus Truvada.
Congress passes legislation to increase access to unapproved therapies for life-threatening diseases.
Neither does the focus on Pharmacy Benefits Managers.
The integrase inhibitor is included in the single-tablet HIV regimens Triumeq and Juluca.
The approval is based on a small study of 15- to 17-year-olds.
The newly approved single-tablet regimen contains the integrase inhibitor bictegravir plus emtricitabine and tenofovir alafenamide.
The Food and Drug Administration approves antibody treatment Trogarzo for multidrug-resistant HIV.
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