Sumary of Trial results reveal that long-acting injectable cabotegravir as PrEP is highly effective in preventing HIV acquisition in women:
- The HIV Prevention Trials Network study (HPTN 084) on the safety and efficacy of the long-acting injectable antiretroviral drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected women, was stopped early by the trial Data and Safety Monitoring Board (DSMB) as results showed CAB LA to be highly effective in preventing HIV acquisition..
- Four were randomised to the long-acting cabotegravir arm and 34 were randomised to the daily, oral FTC/TDF arm..
- This translated to an HIV incidence rate of 0.21% (95% CI 0.06% – 0.54%) in the cabotegravir group and 1.79% (95% CI 1.24%-2.51%) in the FTC/TDF group..
- While both methods were highly effective at preventing HIV acquisition, long-acting cabotegravir was 89% (95% CI 68-96%) more effective than FTC/TDF..
- A long-acting injectable formulation has the potential to improve the prevention effect without relying on adherence to a daily oral PrEP regimen, and to increase prevention choices and acceptability among women..
- A long-acting PrEP product could offer a better choice for women at substantial HIV risk who either do not want to take or struggle with taking a daily tablet..
- Safety during pregnancy and breastfeedingWhen information was made available in May 2018 regarding Dolutegravir (DTG), which is an integrase inhibitor in the same class of drug as cabotegravir, that there was a possible association with foetal neural tube defects (NTDs) when taken periconceptually, a protocol amendment was made requiring all women enrolled in HPTN 084 to also take long-acting reversible contraceptives….