A breakthrough in HIV treatment, which gives women 100% protection through a twice-yearly injection, is unlikely to be available in Africa soon because of high prices and short supply. South African scientists say low- and middle-income countries face a wait of three years or more.
The “miracle” pre-exposure prophylaxis (PrEP) drug, lenacapavir, which recently underwent a successful trial in South Africa and Uganda, was approved by the Food & Drug Administration in December 2022 for use in the US. It has also been approved in Canada, the UK and the EU.
“It’s another fantastic breakthrough that we can admire from a distance — while lots of rich people get to use it,” says Prof Francois Venter, executive director of Ezintsha at Wits University. Ezintsha uses technology to tackle health problems and to extend access to effective drugs.
Prof Linda-Gail Bekker, director of the Desmond Tutu HIV Centre at the University of Cape Town (UCT), who helped to conduct the trial in Africa, says: “We must continue to advocate for it and, if necessary, be quite activist about making this available and affordable.”
Lenacapavir costs R760,500 per person a year. Another PrEP drug available in South Africa, cabotegravir, which needs to be injected every two months, costs about R3,240 per person a year.
But even for cabotegravir, “accessibility remains a pipe dream”, says Venter. “The availability of injectable cabotegravir is almost homeopathic on a population level here. It’s bitterly disappointing. We need to give it to tens of millions of women to make a difference. We’re scared that it will be the same story with lenacapavir.”
Bekker says a decent flow of cabotegravir can be expected only by 2027, with access to lenacapavir “anyone’s guess”.
She says the makers of lenacapavir, Gilead Sciences, “are saying all the right things. I’d like to give them the benefit of the doubt. We’ve only known for a week that we have this efficacy.” The results of the Africa trials were released on June 20.
The availability of injectable cabotegravir is almost homeopathic on a population level here. It’s bitterly disappointing
— Prof Francois Venter
Bekker says ViiV, the manufacturer of cabotegravir, was “caught with its pants down” in 2000 because when phase 3 trials ended, it was low on manufacturing capability.
The South African government budgets R720 per person a year for oral antiretroviral (ARV) pills. The injectable PrEP drugs are out of its financial reach. Prices could drop once generic licences are granted; both are game-changers in the battle against HIV.
Lenacapavir is the first HIV prevention drug for which trial results for women have become available before those for men.
Bekker says both manufacturers have promised to grant generic licences to other companies, but these first have to develop the manufacturing capability. “There’s a lead-in time and probably an investment cost as well, and that’s again where we’re seeing the delay.”
She says Gilead has promised to ensure sufficient manufacturing capacity, undertaking to ship “sufficient volumes” of lenacapavir to low- and middle-income countries as soon as these have regulatory approval — while signing voluntary licences with makers of generic drugs in several regions,
ViiV granted a licence to the Medicines Patent Pool, a UN-backed agency that tries to make medical technologies more accessible, and which contracted with three generic makers.
Bekker’s team at UCT has initiated oral PrEP in more than 1-million South Africans.
However, she cautions, “initiation does not equal persistence and effective use. Often by three months the young women change their minds and don’t return to the clinic,” illustrating the importance of the new injectables.
Clinicians talk about “effective use” with PrEP, while “adherence” is the preferred term for ARVs. That’s because PrEP can be likened to antimalarial pills that you take only in a mosquito-ridden area.
For women, the World Health Organisation guideline is to take the oral PrEP for a week before possible exposure and for a week after, while for men it’s one pill within 24 hours of exposure and one a day later.
Bekker says demand has been very low. “There’s stigma because the oral pill looks like an ARV,” she says.
Backed by the Bill & Melinda Gates Foundation, Bekker’s team is using mobile trailers, hairdressing salons and clinics to reach women between 15 and 29 in the Klipfontein and Mitchells Plain areas of Cape Town.
Called “FastPrEP” the project has reached 20,000 people so far with 12,000 on oral PrEP. HIV prevalence in the area is 25% with incidence among young girls attending clinics at 4%.
Bekker says the aim once injectables are widely available is to get people to visit clinics for jabs. Self-injecting is the ultimate, but somewhat idealistic, goal.
“The thing about lenacapavir is that you can inject it subcutaneously into the tummy, whereas with cabotegravir it goes into the muscle of the backside,” she says.
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