Long-acting injectable HIV treatment approved in the EU: includes two-monthly dosing
22 January 2021. Related: Antiretrovirals.
Simon Collins, HIV i-Base
On 21 December 2021, ViiV Healthcare announced that the combination of long-acting injections of cabotegravir (Vocabria) and rilpivirine (Rekambys) had been approved for HIV treatment. [1]
Both drugs are also available as oral tablets to be used for four weeks before switching to long-acting injections.
Cabotegravir is an integrase inhibitor and rilipivirine is an NNRTI, and long acting intramuscular injections are given concurrently, rather than in the same formulation. Rilpivirine LA requires cold-chain storage.
Although approval was largely based on results from three phase 3 studies using monthly injections, the EMA decision includes the option to use either monthly or two-monthly dosing schedules, although the two-monthly injections use a higher dose. A lead-in phase using oral versions of both drugs is also required. [2]
Contraindicated medications due to potential drug interactions include carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort.
This full approval comes two-months after the EMA issued a positive opinion on this new combination, although the original application was submitted in July 2019. [3]
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This breakthrough treatment will be an especially important option for people who have difficulty with oral tablets or with adherence. This is especially important as these people do not have the loudest voices.
Access in England will depend on the outcomes of an ongoing review by NICE – the first time that it will be reviewing HIV medicines. The NICE decision is expected by 20 October 2021. [4]
Although information about price has not yet been provided, this will be a key factor for access in the UK. There might be reasons for optimism linked to the potential for cabotegravir to be used as PrEP.
Results from two large phase 3 studies (HPTN 083 and 084) recently reported that cabotegravir injections are highly effective as HIV PrEP. In this context ViiV Healthcare included a commitment to wide access to cabotegravir PrEP in the sub-Saharan African countries where the study was run. [5] The results as PrEP also led to innovation status. [6]
This perhaps implies a flexibility for pricing in high-income countries that could be comparable to price of other commonly prescribed ART combinations.
There is always a narrow window for new drugs to recover development cost for new drugs – whether as treatment or PrEP. The most successful business model is for pricing to be affordable in all countries.
It is always better for these exciting advances become widely used with a more marginal profit rather than remain out of use with a higher (unused) price.
References
- ViiV press statement. ViiV Healthcare announces the Marketing Authorisation of the first complete long-acting injectable HIV treatment in Europe. (21 December 2020).
https://viivhealthcare.com/en-gb/media/press-releases/2020/december/viiv-healthcare-announces-the-marketing-authorisation - EMA. Vocabria.
https://www.ema.europa.eu/en/medicines/human/EPAR/vocabria - EMA issues positive opinion to approve cabotegravir LA/rilpivirine LA injections (Vocabria/Rekambys) as new HIV treatment. HTB (November 2020).
https://i-base.info/htb/39235 - NICE. Cabotegravir and rilpivirine for treating HIV-1 [ID3766].
https://www.nice.org.uk/guidance/proposed/gid-ta10658 - Two-monthly cabotegravir injections prevent HIV infection in African women: HPTN 084 study recommends early unblinding. HTB (11 November 2020).
https://i-base.info/htb/39327 - Innovation benefits of cabotegravir LA injections for HIV PrEP will enable a closer FDA review. HTB (11 November 2020).
https://i-base.info/htb/39528
This article was first posted on 21 December 2020.