MHRA approves new medicine formulations for HIV prevention

Two new formulations cabotegravir (cabotegravir extended-release injectable suspension and tablets) have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The treatment consists of Apretude 30mg film-coated tablets and Apretude 600mg prolonged-release suspension for injection. These treatments are indicated for the prevention of sexually transmitted HIV-1 infection — pre-exposure prophylaxis (PrEP) in adults and adolescents weighing at least 35kg with a higher infection risk, MHRA confirmed.

About cabotegravir

This medicine has been authorised as tablets and as a long-acting injection administered every two months. The MHRA stated that both the formulations tablet and long-acting injection of cabotegravir are approved by the agency in Great Britain under a national application procedure.

Cabotegravir long-acting (LA) for PrEP is the first and only long-acting HIV prevention option approved in the UK that is dosed via intra-muscular injection via just six doses a year, according to ViiV Healthcare UK Limited, the company given authorisation by the MHRA.

The anti-retroviral therapy can help to prevent HIV infection by blocking the integrase enzyme which the HIV-1 virus uses replicate in the body. The integrase inhibitor lowers a person’s risk of the virus multiplying and spreading away from the original infection site, MHRA explained.

Evidence supporting the approval

Regulatory approval by the MHRA is supported by evidence from two Phase IIb/III studies which compared cabotegravir to standard PrEP (tenofovir disoproxil fumarate/emtricitabine) for preventing HIV over approximately three years.

One study demonstrated a 66 percent reduction in HIV-1 incidence among the HIV-negative participants who received cabotegravir compared to the standard treatment. A second clinical study found an 88 percent reduction in HIV-1 incidence among the HIV-negative individuals given cabotegravir compared to standard PrEP, MHRA shared.