Approved by the MHRA, Cabotegravir 600 mg long-acting injection is the first injectable treatment approved to help prevent HIV-1 infection in the UK
In a significant leap forward in the fight against HIV, the Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light to two groundbreaking formulations of cabotegravir.
Apretude 30 mg film-coated tablets and Apretude 600 mg prolonged-release suspension for injection are now authorized for preventing sexually transmitted HIV-1 infection in adults and adolescents weighing at least 35kg at increased risk.
This approval marks a pivotal moment in HIV (human immunodeficiency virus) prevention, offering an alternative to existing standard pre-exposure prophylaxis or PrEP treatments.
HIV, a virus notorious for compromising the immune system, has long been a global health concern.
Cabotegravir, a member of the integrase inhibitor group, works by blocking a key enzyme necessary for the replication of HIV-1, thereby reducing the virus's ability to spread.
The approval comes on the heels of groundbreaking research demonstrating cabotegravir's effectiveness in reducing HIV-1 incidence.
Two extensive studies, spanning three years, revealed remarkable results.
In one study involving over 4,500 HIV-negative cisgender men and transgender women, cabotegravir users experienced a 66 per cent reduction in HIV-1 incidence compared to standard PrEP.
In another study of over 3,200 HIV-negative cisgender women, the reduction was even more impressive, with an 88 per cent decrease in HIV-1 incidence among cabotegravir recipients.
Julian Beach, MHRA Interim Executive Director, emphasised the agency's commitment to patient safety and access to high-quality medical products as "safe and effective medical products are key priorities".
"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," he added.
Administration of cabotegravir requires an initial HIV-negative test.
The long-acting injection, administered six times annually by healthcare professionals, offers a revolutionary approach to HIV prevention.
Patients undergo an oral lead-in phase with daily cabotegravir tablets before transitioning to injections, allowing for careful assessment of suitability.
Despite its promise, cabotegravir is not without side effects.
Common reactions include headache, diarrhea, and temporary changes in liver function.
Injection site reactions, such as pain and induration, also require attention.
The approval of cabotegravir by the MHRA marks a significant milestone in HIV prevention efforts.
