HTB

Cabotegravir-LA submitted to EMA for use as PrEP in Europe

Simon Collins, HIV i-Base

On 28 October 2022, ViiV Healthcare announced that the European Medicine’s Agency had ‘validated’ its application for cabotegravir-LA (CAB-LA) to be used as PrEP. 

CAB-LA is a long-acting formulation that is given by intramuscular injection every two months to prevent HIV transmission, irrespective of condom use.

The application is largely based on results from two large international phase 3 studies called HPTN 083 and 084. Both studies randomised participants to either CAB-LA or to daily oral PrEP using TDF/FTC and reported that significantly fewer people receiving CAB-LA became HIV positive. These results have previously been reported in HTB. [2, 3]

CAB-LA is already approved for PrEP in the US, Australia and, most recently, Zimbabwe. [4]

It is marketed under the brand name Apretude.

comment

This is welcome news, although it doesn’t say whether the validation is technical or related to the regulatory and administrative content. It is more usual for a company to press release submission which happens first, rather than validation.

However, submitting CAB-LA recognised that access in the EU is essential – and showing a different strategy by ViiV compared to Gilead.

Although ViiV has previously stated a commitment to submitting for approval in the EU, regulatory documents have already been submitted in South Africa, Malawi, Botswana, Brazil, Kenya, Uganda, Vietnam, Malaysia, Myanmar, Philippines and China. [5]

Access however is also dependent on having an affordable price, which in Europe will be compared to generic oral PrEP.

It is unclear how this will be reconciled with the significantly higher price for CAB-LA when used as treatment, not just in the EU but in all regions.  In the US, CAB-LA for PrEP is currently listed at $22,000 pa,

The lack of an effective market for high-priced PrEP is the reason that Gilead cancelled their PrEP application for F/TAF (Descovy) in the EU. [6]

References

  1. ViiV press release. European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV Prevention. (28 October 2022).
    https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/october/european-medicines-agency-validates-viiv-healthcare
  2. Cabotegravir long-acting injections prevent HIV as PrEP. HTB (June 2020).
    https://i-base.info/htb/37961
  3. Two-monthly cabotegravir injections prevent HIV infection in African women: HPTN 084 study recommends early unblinding. HTB (November 2020).
    https://i-base.info/htb/39327
  4. ViiV press release. Progress in our commitment to enabling access to cabotegravir long-acting for hiv prevention, as first sub-Saharan African country approves Apretude. (Undated, but likely 20 October 2022).
    https://viivhealthcare.com/hiv-news-and-media/news/company-statements/progress-in-our-commitment-to-enabling-access
  5. ViiV Healthcare. Worldwide registration: cabotegravir PrEP. [Accessed 28 October 2022].
    https://viivhealthcare.com/content/dam/cf-viiv/viivhealthcare/en_GB/files/cab-prep-wwrs-10oct2022-for-external-use.pdf (PDF)
  6. Gilead withdraws application for F/TAF as PrEP in the EU. HTB (October 2021).
    https://i-base.info/htb/41427

 

Links to other websites are current at date of posting but not maintained.