HTB

US FDA approves long-acting cabotegravir injections for PrEP

Simon Collins, HIV i-Base

On 20 December 2021, the US FDA approved long-acting cabotegravir injections for pre-exposure prophylaxis (PrEP) against HIV infection. [1]

The indication is for HIV negative adults and adolescents weighing at least 35 kg who are at risk of HIV. Dosing involves a single 600 mg (3 mL) intramuscular gluteal injection given monthly for the first two doses, and then given every two months. The use of a monthly oral lead-in period to test for sensitivity is optional.

Dosing can be brought forward by up to seven days but missed injections include the recommendation to use various schedules of daily oral cabotegravir, depending on timing of missed doses.

Approval is based on results from two large international randomised phase 3 studies (HPTN 083 and 084) that used daily oral TDF/FTC as an active control.

For full details see the full product information, including for side effects, risk of developing drug resistance and that residual concentrations of cabotegravir can persist for more than a year after a single injection.

Cabotegravir injections for PrEP are manufactured by ViiV Healthcare and marketed by under the trade name Apretude.

Long-acting injections of both cabotegravir plus rilpivirine were approved by the FDA as HIV treatment in January 2021. [2]

comment

The scientific achievement of this new option for PrEP is clearly recognised and welcomed.

But for all the potential advantages, access for most people will be linked to pricing, and the wholesale price announced in the US is $22,000 a year.

In a press release on 23 December 2021, the US activist organisation the Fair Price Coalition has denounced the price as both exorbitant and unsustainable. It notes this price is 25% higher than when cabotegravir is used as HIV treatment. And also the the US now has access to generic oral PrEP with TDF/FTC marketed at approximately $30 for 30 tablets. [3]

Throughout the development stages ViiV Healthcare stated many times that pricing would be easily affordable, including for people in low and middle-income countries that contributed clinical sites for the large phase 3 studies. Guaranteeing access in countries where research is run is actually an ethical requirement of the Helsinki declaration for running international studies.

This would involve setting a price in these countries that is comparable to generic oral PrEP – but this seems difficult given the signal from the US price.

References

  1. FDA news release. FDA approves first injectable treatment for HIV pre-exposure prevention (20 December 2021).
    https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention
  2. US FDA approves long-acting injectable HIV treatment: monthly dosing. HTB, (22 January 2021).
    https://i-base.info/htb/39697
  3. Fair Pricing Coalition press release. Fair Pricing Coalition welcomes approval of two-month HIV prevention shot, denounces ViiV Healthcare’s exorbitant, unsustainable pricing. (23 December 2021).
    https://www.fairpricingcoalition.org

This report was updated on 23 December 2021 to include comments on drug pricing.

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