One size does not fit all: Expanding the buffet of choices for preventing HIV
Shobha Shukla – CNS
Contd from previous issue
Women of reproductive age do need multipurpose prevention technology products to address two or more overlapping health risks, such as, unintended pregnancy and HIV. The dual prevention pill is an answer to their prayers.
Dual Prevention Pill : A daily oral pill for women for protection against HIV and pregnancy
Dual prevention pill, a co-formulated tablet containing oral PrEP (TDF/FTC) and a combined oral contraceptive, is currently being developed for daily use to prevent both HIV and pregnancy and is likely to be a new multipurpose prevention technology to go to market. Since both the ingredients of dual prevention pill are already approved for individual use, their combination pill just needs to undergo bio-equivalence study to determine if they are as safe and effective in combination. Regulatory timelines suggest that dual prevention pill could receive US FDA approval by 2024.
Several other multipurpose prevention technologies for HIV and pregnancy prevention are in various stages of development, but still many years away from market launch.
Islatravir: Once a month oral PrEP
Islatravir is the first nucleoside reverse transcriptase translocation inhibitor currently being evaluated across a variety of dosing regimens, for both - treatment as well as prevention of HIV infection. It has a novel mechanism of action, as it can persist in the body for a long period of time and is being developed as a monthly pill and also as a sub-dermal implant for prevention that could provide protection for one year.
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.
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.
Basket of choices to prevent HIV
We need a basket of HIV prevention options. It is about choices and preferences depending on where people are in their life cycle, local realities, and contexts. Moreover, prevention options should be accessible, affordable, simple to use, and easy to adhere, for everyone! It is only then that we may expect better coverage of all people and of all exposures, rightly said Bekker.
(Shobha Shukla is the award-winning founding Managing Editor and Executive Director of CNS (Citizen News Service) and is a feminist, health and development justice advocate. She is a former senior Physics faculty of prestigious Loreto Convent College and current Coordinator of Asia Pacific Regional Media Alliance for Health and Development (APCAT Media). Follow her on Twitter @shobha1shukla or read her writings here www.bit.ly/ShobhaShukla)