Gilead withdraws application for F/TAF as PrEP in the EU

Simon Collins, HIV i-Base

On 20 October 2021, Gilead Sciences announced that the company will no longer look to market F/TAF (Descovy) as PrEP in the EU.

This is a significant policy change given the years of investment and positive results from phase 3 studies showing that F/TAF had potential advantages compared to F/TDF. However, these were generally slight: statistically significant reductions in bone and kidney toxicity were unlikely to be clinically significant for most people and numerically fewer HIV infections were not statistically significant.

The reason for the withdrawal is likely be linked to the large price difference charged for F/TAF compared to F/TDF would not be acceptable to European health systems.

EU countries have wider access to generic versions of F/TDF which is at least 90% cheaper than the hoped for marketing price for F/TAF. 

The press release states that Gilead will continue to provide F/TAF to study participants in the EU who were enrolled in the phase 3 DISCOVER study.

This may be to cover the ethical and regulatory requirements (including in the Helsinki declaration) that pharmaceutical companies need to provide post-trial access to treatment for patients participating in clinical trials. [2]

comment

This decision is a shame. If both options were the same price, F/TAF might be more widely used.

It is a smaller tablet and it has better pharmacokinetics that likely make is more protective if doses are missed.

UK residents are able to buy and important generic versions of F/TAF online for personal use, although this is only allowed in a few other EU countries.

References

1. Gilead press statement. Gilead announces decision not to pursue marketing authorization for Descovy for pre-exposure prophylaxis in the European Union. (20 October 2021).
   https://www.gilead.com/news-and-press/company-statements/gilead-announces-decision-not-to-pursue-marketing-authorization-for-descovy-for-pre-exposure-prophylaxis-in-the-european-union
2. World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects.
   https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects

This report was first published on 20 October 2021.