GlaxoSmithKline subsidiary ViiV Healthcare has announced that its long-acting injectable cabotegravir has scored a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for HIV prevention.

The BTD is based on results from the phase IIb/III HPTN 083 trial which compared injectable cabotegravir to daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) for HIV prevention among men who have sex with men and transgender women who have sex with men.

In the final analysis of this study, cabotegravir was 66% more effective at preventing HIV compared to daily oral FTC/TDF tablets, which translated to an HIV incidence rate of 0.41% in the cabotegravir group and 1.22% in the FTC/TDF group.

In addition, another prevention study – HPTN 084 – was stopped earlier this month based on an independent data safety monitoring board (DSMB) recommendation after long-acting cabotegravir was found to be superior to oral FTC/TDF tablets.

“New medicines that decrease the risk of HIV acquisition in at-risk populations are an essential tool to help us end the global HIV epidemic,” said Kimberly Smith, head of research & development at ViiV Healthcare.

“Our data from the HPTN 083 and 084 studies show that long-acting cabotegravir is superior to daily oral FTC/TDF tablets for HIV prevention. We are looking forward to working closely with the FDA to make this prevention option available to people at risk of acquiring HIV,” she added.

Approximately 38 million people are living with HIV currently, with 1.7 million new cases of HIV reported at the end of 2019, according to ViiV.