US FDA approves long-acting injectable HIV treatment: monthly dosing

Simon Collins, HIV i-Base

On 22 January 2021, ViiV Healthcare announced that the combination of long-acting injections of cabotegravir and rilpivirine had been approved by the US FDA. In the US, both injections are being distributed under a single trade name of Cabenuva. [1, 2]

The indication is as an HIV treatment for people who are stable on current ART with an undetectable viral load on current treatment. It also includes having no history of treatment failure, and no known or suspected drug resistance to either drugs.

The US indication is every month (12 treatments a year).

The company plans to submit an extension for two-monthly injections in the US within the first six months of 2021.

The US approval also included details on pricing:

• Oral drugs for the first four weeks are provided free.
• The initial loading dose will cost $5,940 (600 mg CAB-LA and 900 mg RPV-LA).
• Subsequent monthly continuation doses will cost $3,960 (400 mg CAB-LA plus 600 mg PRV-LA).

These prices are based on the wholesale list price and work out at $ 47,520 a year on stable ART. [3]

On 21 December 2020, the same drugs were approved by the EMA in the EU but with separate trade names: cabotegravir (Vocabria) and rilpivirine (Rekambys). EU approval included the option of two-monthly dosing, but using the higher 600/900 dose throughout. [4]

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Approval is welcomed for this first combination that doesn’t depend on oral pills. Alternative formulations have always been awaited for many years. This will also offer a completely different option for people who struggle with daily medication.

The EU option for injections every two months involves 6 treatments a year, using the higher 600/900 dose throughout.

References

1. FDA press notice. FDA approves first extended-release, injectable drug regimen for adults living with HIV. (21 January 2021).
   https://www.fda.gov/news-events/press-announcements/fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv
2. ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment. (21 January 2021).
   https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-fda-approval-of-cabenuva-cabotegravir-rilpivirine-the-first-and-only-complete-long-acting-regimen-for-hiv-treatment
3. ViiV Healthcare. Personal communication. (22 January 2021).
4. Long-acting injectable HIV treatment approved in the EU: includes two-monthly dosing. (HTB) (21 December 2020).
   https://i-base.info/htb/39602
5. Cabenuva. Full prescribing information.
   https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212888s000lbl.pdf (PDF)