DISCOVER trial of Descovy shows efficacy in HIV pre-exposure prophylaxis.- Gilead Sciences

Gilead Sciences presented longer-term results from the DISCOVER trial of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets, F/TAF) for pre-exposure prophylaxis (PrEP), demonstrating continued non-inferior efficacy and continued favorable changes in key markers of renal and bone safety at Week 96 compared with Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, F/TDF) for PrEP. This 96-week analysis of the DISCOVER trial (Oral 2940) demonstrated significant differences in key markers of bone and renal safety in study participants across different age groups. These differences were also observed in the overall population, in addition to differences in lipid parameters and change in baseline weight. The long-term clinical significance of these differences in renal, bone and lipid parameters are not known; however, these measures are important to consider as people at risk increasingly use PrEP for longer periods of time. At Week 96, statistically significant differences in measurements of renal safety favoring Descovy were observed in the overall trial population, as well as in older participants and in those with moderate renal impairment. The analysis also found changes in bone mineral density (BMD) favoring Descovy in the overall trial population and among participants younger than 25 years of age. These results were achieved in the overall study population of men and transgender women at risk for HIV infection, as well as in study sub-populations of participants age 50 and older, those younger than 25 years, and those with moderate renal impairment. A separate analysis of the DISCOVER trial demonstrated that Descovy and Truvada were effective and well-tolerated in Black and Hispanic/Latino participants. In addition to new data from the DISCOVER trial, the company also presented the results of a preclinical study with an investigational combination of bictegravir, emtricitabine and tenofovir alafenamide (BIC+F/TAF; 100+200/25 mg) for event-driven post-exposure prophylaxis (PEP). These data were presented at the 2020 Conference on Retroviruses and Opportunistic Infections.