HTB

US approves F/TAF for PrEP (Descovy): indication excludes risk from receptive vaginal sex

Simon Collins, HIV i-Base

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

  1. 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
  2. Collins S. New option for PrEP – TAF/FTC is non-inferior to TDF/FTC: results of phase 3 DISCOVER study. HTB 12 March 2019.
    http://i-base.info/htb/35809
  3. 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).
    http://i-base.info/htb/36592
  4. 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

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