The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for two new formulations of ViiV Healthcare’s cabotegravir, offering a new prevention option for sexually transmitted HIV-1 infection.
The approved products include Apretude 30mg film-coated tablets and Apretude 600mg prolonged-release suspension for injection, both intended for use as pre-exposure prophylaxis (PrEP).
Cabotegravir, now authorised as tablets and as a long-acting injection, is indicated for usage in adults and adolescents weighing a minimum of 35kg who are at greater HIV-1 infection risk.
The 600mg long-acting injection, administered every two months, is the first injectable treatment for HIV prevention approved in the UK. This regimen begins with two initial monthly injections, followed by one injection every two months.
Prior to starting cabotegravir, people must test negative for HIV.
An oral lead-in with cabotegravir 30mg tablets daily for one month may be used to assess suitability for the injection.
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The MHRA’s decision is based on evidence from two studies demonstrating significant reductions in HIV-1 incidence with cabotegravir versus standard PrEP comprising tenofovir disoproxil fumarate/emtricitabine.
One study, involving approximately 4,500 HIV-negative cisgender men and transgender women, showed a 66% decrease in HIV-1 incidence with cabotegravir.
Another study with over 3,200 HIV-negative cisgender women indicated an 88% reduction in the incidence.
Headache, diarrhoea, pyrexia, and changes in liver function were found to be the common side effects linked to cabotegravir usage.
MHRA Healthcare Quality and Access interim executive director Julian Beach said: “Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.
“We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review.”
