Specialist HIV company ViiV Healthcare has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its long-acting and injectable cabotegravir to treat HIV pre-exposure prophylaxis (PrEP).
The status was based on efficacy and safety results from HPTN 083 phase IIb/III randomised, multicentre, double-blind and clinical trial.
The study compared long-acting and injectable cabotegravir to daily oral emtricitabine/tenofovir disoproxil fumarate 200mg and 300mg (FTC/TDF) for HIV prevention among men who have sex with men and transgender women who have sex with men.
According to the company, the final analysis of HPTN 083 demonstrated the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets.
ViiV’s HPTN 083 phase IIb/III double-blind study was framed to assess the safety and efficacy of long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets.
The study commenced recruitment in November 2016, and each participant was to secure a maximum of three years of blinded study medication.
ViiV Healthcare carried out the study in around 4,566 men who have sex with men and transgender women who have sex with men at research centres in Argentina, Brazil, Peru, the US, South Africa, Thailand and Vietnam.
The blinded phase of HPTN 084, a partner HIV prevention study in sub-Saharan African women, was stopped at the starting of this month based on the recommendation of the independent data safety monitoring board (DSMB) following the demonstration that long-acting cabotegravir was superior to oral FTC/TDF tablets.
ViiV Healthcare research and development head Dr Kimberly Smith said: “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.
“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.”
In August this year, ViiV Healthcare secured FDA approval for its Dovato (dolutegravir/lamivudine) as a complete regimen to treat HIV-1 infection.