Interim data from a Phase-2a study to evaluate the safety, tolerability, and pharmacokinetics show that it is safe and was generally well tolerated through 24 weeks. Monthly doses of Islatravir, 60 mg and 120 mg, also achieved the pre-specified efficacious pharmacokinetic threshold for PrEP.
Two Phase-3 clinical studies (IMPOWER 024 and IMPOWER 022) to evaluate its efficacy and safety in cisgender women, men, and transgender women who have sex with men, have already begun. But it could be another 2-3 years from now till we have it. Phase-2 studies for the once-a-year removable Islatravir implant are also underway.
Lenacapavir Long Acting: twice-yearly injectable for HIV prevention
Lenacapavir (the first HIV capsid inhibitor) as a once every 6 months injectable for HIV prevention is in the early stages of development. Two studies to evaluate its efficacy and safety are to take place - one in South Africa and Uganda (in adolescent girls and young women) and the other in USA, Brazil, Peru, and South Africa (in cisgender men, transgender women, transgender men and gender non-binary individuals). It is also being developed as long acting treatment and implant.
Broadly neutralising antibodies
Broadly neutralising antibodies provide a new approach to HIV-1 prevention and treatment. But they are still in very early stages of development.
HIV Vaccine
There is currently no vaccine available to prevent or treat HIV infection. However, scientists are working to develop one. Research efforts undertaken by USA's National Institutes of Health include two late-stage, multinational vaccine clinical studies called Imbokodo and Mosaico.
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