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MedTech Outlook | Thursday, January 02, 2020
Gilead Sciences presents the new preventive medication for HIV, Descovy, showing significant improvements in critical measures of bone and renal safety in patients.
FREMONT, CA: The food and drug administration has recently approved a preventive medicine for HIV. Foster City, California-based Gilead Sciences said in a press release that FDA had approved Descovy containing emtricitabine 200mg, tenofovir alafenamide 25mg for pre-exposure prophylaxis (PrEP) among adolescents and adults. The medication is designed for those who are HIV-negative and are at risk for sexually acquired HIV but not for those at risk for contracting it through vaginal sex. Earlier, Truvada containing emtricitabine 200mg, tenofovir disoproxil fumarate 300mg, was approved for PrEP.
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Initially, Descovy was used for treating HIV infection, but now, when applied for PrEP, it provides a new preventive option matching Truvada’s high efficacy observed in renal and bone safety. Descovy and Truvada share the same list price. Based on Phase III head-to-head DISCOVER trial comparing Descovy against Truvada among 5,300 cisgender men and transgender women who have sex with men, scientists approved Descovy for PrEP. The results showed that Descovy was non-inferior to Truvada on efficacy. However, patients who switched from Truvada to Descovy observed the lower incidence of reduced bone mineral density and kidney function.
There are concerns for bone and renal toxicity for Truvada and is well-tolerated. The toxicity is minimal in otherwise healthy individuals using Truvada for PrEP and will be continuously applied, especially as it soon goes generic. Although Truvada remains a safe and highly effective PrEP alternative for men and women, Descovy is another best option for people having kidney or bone disease. By addressing stigma, cost and access issues, and other structural barriers to getting and staying on PrEP can create the most significant impact. To further expand participation, the studies for underrepresented communities, including cisgender women, Gilead is conducting research evaluating Descovy in cisgender women and adolescent girls.
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