ViiV Healthcare Cabotegravir long-acting injectable for HIV prevention gets EMA validation

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: "With approximately 100,000 people in Europe newly diagnosed with HIV each year, this submission is an important step forward in offering expanded options for HIV prevention. Long-acting prevention options, if used appropriately and at scale, could have the potential to transform the shape of the HIV epidemic, and we look forward to continuing to work with community groups, governments, and regulatory authorities to make this option available for those who need it."

Submission to the EMA was supported by data from two international phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in HIV-negative men who have sex with men, transgender women, and cisgender women who were at increased risk of HIV. The studies demonstrated that cabotegravir long-acting for PrEP was superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), with clinical trial participants experiencing a 69% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 083, and a 90% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084.

Cabotegravir long-acting for PrEP is currently approved in the US, Australia, and Zimbabwe as Apretude.

Cabotegravir long-acting for PrEP is an integrase strand transfer inhibitor (INSTI). INSTIs, like cabotegravir extended-release injectable suspension, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells).