Kenya is among seven African countries that have been picked to carry out large-scale trials for an injectable HIV pre-exposure prophylaxis (PrEP) among uninfected women.
The clinical trials of the new long-acting injectable drug known as cabotegravir (CAB) will be conducted among 3,200 HIV-uninfected, sexually active women in six other countries — Uganda, Botswana, Malawi, Swaziland, South Africa, and Zimbabwe.
The trial called HPTN 084 is meant to examine the safety and effectiveness of the injectable drug compared to the daily oral PrEP pills. It will be the first large-scale clinical trial of an injectable medication for HIV prevention in sexually active women aged 18 to 45 years.
The study will be conducted for four and a half years, and participants will be picked randomly.
“In sub-Saharan Africa, more than 60 per cent of all people living with HIV are women,” said Wafaa El-Sadr, the co-principal investigator and professor of epidemiology and medicine at Columbia University. “Young African women share a disproportionate burden and are especially vulnerable to this epidemic.”
A related study, HPTN 083, is testing the safety and efficacy of injectable CAB for HIV prevention in 4,500 men who have sex with men and transgender women who have sex with men. It is under way in seven countries in the Americas, Asia and Africa.
“The development of safe alternative options for PrEP could increase HIV prevention choices for women,” said Sinead Delany-Moretlwe, chair of the study at the Witwatersrand in Johannesburg, South Africa.
HPTN 084 trial is jointly funded through a partnership of the US National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health; the Bill & Melinda Gates Foundation and ViiV Healthcare.
If found to be safe and effective, the new drug may be an easier and more desirable option as opposed to the daily pill as it offers discreetness, the authors of the study said.
“Long-acting injectable agents like cabotegravir may be more acceptable to some women for HIV prevention by providing an alternative with different adherence requirements,” added Dr Delany-Moretlwe in a press statement.
According to the HIV Prevention Trials Network, the development of alternative agents for PrEP, and/or more adherence-friendly schedules for currently available agents could increase prevention choices and increase acceptability.
“Long-acting injectable agents have the potential to prevent HIV acquisition without relying on adherence to a daily oral regimen,” it notes.
Currently, the only licensed pre-exposure drug is a daily oral pill called tenofovir disoproxil fumarate 300 mg plus emtricitabine 200 mg (TDF/FTC), and sold under the brand name Truvada.
Several countries have approved Truvada for PrEP including Australia, Canada, France, Peru, South Africa, US and Kenya, which rolled out the drug for HIV-negative people at risk of contracting the virus.
Kenya became the second country after South Africa to introduce the drug as part of the war on HIV/Aids.