US approves F/TAF for PrEP (Descovy): indication excludes risk from receptive vaginal sex
18 October 2019. Related: HIV prevention and transmission.
On 3 October 2019, the US FDA approved the dual formulation F/TAF with a new indication for HIV pre-exposure prophylaxis (PrEP). [1]
This is the second oral drug to be approved as PrEP.
Approval was based on results from the phase 3 DISCOVER study reported earlier this year at CROI that used F/TDF as an active control. [2]
However, approval was controversial for only allowing a limited indication based on the study population in DISCOVER: gay or bisexual men and transgender women.
The application had been for adult use (including woman) and the split panel decided that efficacy data was required in all populations for a broad indication.
The decision not to include women in the initial phase 3 studies was questioned at the time and the manufacturers now have a post marketing commitment to run additional studies in cisgender women and adolescent girls. [1]
More recent data from the DISCOVER study have shown that the pharmacokinetic benefits of F/TAF might have significant advantages for women. [3]
F/TAF is manufactured by Gilead Sciences with the trade name Descovy.
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The FDA Antimicrobial Drugs Advisory Committee voted 16 to 2 for approval of F/TAF in men who have sex with men and transgender women but 8 to 10 against approval in cisgender women. [4]
This was based on the potential for different pharmacokinetics in rectal vs vaginal tissue to affect clinical efficacy and lack of efficacy data in cisgender women.
References
- Gilead press release. US Food and Drug Administration approves Descovy for HIV pre-exposure prophylaxis (PrEP). (03 October 2019).
https://www.gilead.com/news-and-press/press-room/press-releases/2019/10/us-food-and-drug-administration-approves-descovy-for-hiv-preexposure-prophylaxis-prep - Collins S. New option for PrEP – TAF/FTC is non-inferior to TDF/FTC: results of phase 3 DISCOVER study. HTB 12 March 2019.
https://i-base.info/htb/35809 - Collins S. PK advantages of TAF/FTC over TDF/FTC for HIV PrEP might compensate for low adherence: sub-analysis of DISCOVER study. HTB (23 August 2019).
https://i-base.info/htb/36592 - NATAP. FDA hearing ongoing Wed Aug 7 2019 on Descovy for PrEP vote. (7 August 2019).
http://www.natap.org/2019/HIV/080819_01.htm