Imagine if every young woman had the option of getting a simple implant at school that could cut her risk of contracting HIV by 75%?
An under-the-skin implant that could protect you from contracting HIV may be just a few years away — and it could be as easy to use as birth control, according to new research released today at the International AIDS Conference on HIV science in Mexico City.
The implant slowly releases a new type of antiretroviral (ARV) drug, dubbed MK-8591, to prevent HIV infection. Scientists from the pharmaceutical company Merck presented the results of the first clinical trial to test whether the implant was safe to use in humans at the meeting.
The implant is just the latest in a new wave of experimental HIV prevention devices that rely on HIV treatment — ARVs — to prevent infection. This is also known as pre-exposure prophylaxis (PrEP).
PrEP depends on making sure that people have enough of these ARVs in their system when they are exposed to the virus to stop it in its tracks.
As part of the research presented at the conference, scientists tried out the tiny implant in 12 people over three months. Researchers found that not only was the device safe but that participants were able to retain even higher amounts of the drug in their system than scientists had hoped.
If larger studies show that the device effectively prevents HIV, it could be approved internationally for public use in the next five years, the president of the International AIDS Society Anton Pozniak said. Pozniak was speaking to journalists about the findings earlier this month.
About 3% of South African women between the ages of 15 and 49 already use similar contraceptive implants to prevent unwanted pregnancies, the country’s latest demographic health survey found.
Pozniak explained: “[Implants like these] show huge promise.”
Local is lekker: By the end of the year, SA will host its own trial into PrEP implants
By the end of 2019, South Africa will launch its own study into a similar, matchstick-size PrEP implant that could protect women from HIV for up to one year, says the director of Durban’s Centre for the Aids Programme of Research (Caprisa) Salim Abdool Karim. The South African upper arm implant will, however, use a different ARV — tenofovir alafenamide fumarate.
Caprisa researchers will first test the implants among 60 women to see whether they experience any problems with the devices, how well they like using them and if, for instance, it makes any difference into which arm the tiny rods are inserted.
If all goes well, the study will expand to 500 women — half of whom will get the real drug while the other 50% receive a placebo as part of a randomised controlled clinical trial.
This kind of randomisation means that any characteristics such as age or location that could have a bearing on the study’s outcome should be equally present in both groups. Studies designed in this way — also called randomised controlled clinical trials — are better at determining cause and effect than other types of studies and are often called the “gold standard” in research.
Listen: World-renowned HIV researcher Salim Abdool Karim explains the power and the promise of PrEP implants
A PreP could be a game-changer for South Africa’s young women between the ages of 20 and 24 who are three times more likely to be living with HIV than their male peers, according to the latest Human Sciences Research Council’s household survey.
“What we’ve come to realise is that only a small proportion of young women — mostly the ‘worried well’ take these [HIV] prevention tablets every day”, Abdool Karim explains. “The most at-risk young women, they won’t take it.”
The PrEP pill that is currently available for women has to be taken daily in order for it to be the most effective — the less regularly it is taken, the less it protects against HIV infection.
“We’ve done studies on this. It’s nothing against the pill; it’s just that they have difficulty taking any form of prevention”, Abdool Karim says.
“We have to find some ways in which to protect young girls so that they don’t have to…think about their risk of HIV every day and then act on it.”
It’s all about the Randelas
A year-long PrEP implant would mean people wouldn’t have to worry about taking a daily pill, HIV researcher Brenda Crabtree Ramirez explained at a conference press briefing. Crabtree is an assistant professor at Mexico’s National Autonomous University.
But only time will tell if implants will be affordable enough for the countries — like South Africa — that need it most.
The South African government provides the HIV prevention pill only to some high-risk groups such as young women. If taken daily, the tablet can reduce a person’s risk of contracting HIV by about 96%, studies have shown.
PrEP’s high price has been blamed for what some argue has been a slow rollout that still excludes some people at a high risk of HIV infection, including people in relationships in which one person is HIV-positive and the other is not.
As part of its new HIV treatment tender, government is hoping to pay about R55 per patient per month for the HIV prevention pill, according to health department director-general of communicable and non-communicable diseases Yogan Pillay.
About 24 000 young women in the country were on PrEP as of June, Pillay revealed.
“Some might say that’s low,” he admitted, speaking at a Bhekisisa policy dialogue in June. “The idea now is to scale up PrEP quite rapidly with adolescent girls and young women using a range of partners to strengthen our health services.”
“Just think about it : If we went to every school once a year, and every girl had an implant inserted — provided they agreed to it.”Salim Abdool Karim
The health department will be using national funding as well as money from the United States government to expand access to PrEP. Additional support is expected to come from the international health financing mechanism The Global Fund to Fight AIDS, TB and Malaria.
Meanwhile, Caprisa expects that if clinical trials are successful, it could be publicly available in South Africa in about six years.
If the home-grow invention cuts the risk of HIV infections by 75%, Karim argues, it could alter the course of South Africa’s HIV epidemic.
“Just think about it for a moment: If we could go to KwaZulu-Natal where young girls have the highest risk of HIV, and… went to every school once a year, and every girl had an implant inserted — provided they agreed to it.”