UK MHRA approves ViiV's cabotegravir for HIV-1

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently approved two new formulations of ViiV Healthcare's cabotegravir, expanding prevention options against sexually transmitted HIV-1 infection. The newly approved products include Apretude 30mg film-coated tablets and Apretude 600mg prolonged-release suspension for injection, both intended for pre-exposure prophylaxis (PrEP).

Cabotegravir is geared towards adults and adolescents weighing at least 35kg who are at a higher risk of HIV-1 infection. The approval marks a significant milestone, especially with the 600mg long-acting injection, which is the first injectable treatment for HIV prevention to receive UK approval. This injectable regimen starts with two initial monthly injections, followed by one injection every two months.

It's mandatory for individuals to test negative for HIV before starting cabotegravir. For those opting for the injectable form, an oral lead-in with 30mg tablets taken daily for one month can be used to evaluate suitability for the injection.

The MHRA's decision follows compelling evidence from two major studies that highlighted the effectiveness of cabotegravir in reducing HIV-1 incidence compared to the standard PrEP regimen, which includes tenofovir disoproxil fumarate/emtricitabine. One study, conducted with around 4,500 HIV-negative cisgender men and transgender women, reported a 66% reduction in HIV-1 incidence. Another study involving over 3,200 HIV-negative cisgender women demonstrated an 88% reduction in HIV-1 incidence.

Common side effects associated with cabotegravir include headache, diarrhoea, fever, and changes in liver function. Julian Beach, the interim executive director of MHRA Healthcare Quality and Access, emphasized the agency's commitment to patient safety and access to high-quality, safe, and effective medical products. He assured that the regulatory standards for this medicine's approval have been met and that its safety will continue to be closely monitored.

The availability of cabotegravir in both tablet and long-acting injection forms offers a flexible prevention strategy for those at significant risk of HIV-1, thereby potentially reducing new HIV infections in the UK.