• Scientists say the US FDA approval could have knock-on effect with more regulatory bodies around the world following suit.
• In a recent interview with Star, Kenya Medical Research Institute chief research officer Prof Elizabeth Bukusi said the cost of the injection has not been determined yet.
A drug tested in Kenya to prevent HIV through an injection once every two months has been approved for use.
HIV-negative people who wish to use the drug, called Apretude or Cabotegravir, will begin with two injections in the buttocks administered one month apart, and then an injection every two months.
The drug was approved on Tuesday in the US by the country’s Food and Drug Administration.
Scientists say the FDA approval could have knock-on effect with more regulatory bodies around the world following suit.
This is the first ever long-acting pre-exposure prophylaxis (PrEP) approved in the world.
In contrast, people who currently use Prep tablets must take them daily before and after sex.
“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, director of the division of antivirals at FDA, in a press statement.
In a recent interview with the Star, Kenya Medical Research Institute chief research officer Prof Elizabeth Bukusi said the cost of the injection has not been determined yet.
“Viiv healthcare (the manufacturer), has so far not specified or estimated the cost of the injection per dose, an omission that makes it difficult for advocates to mobilise demand for this new strategy,” she said.
However, the cost of Cabotegravir combined with rilpivirine drug, which was in January approved in US as a monthly ARV for HIV-positive people, could give an idea of the expected cost.
The Cabotegravir-rilpivirine injection initial loading dose costs Sh690,000 ($5,940), and subsequent monthly continuation doses cost Sh448,000 ( $3,960) per injection.
These prices are based on the wholesale list price and work out at Sh5.37 million ($47,520) a year.
Experts say the injection to prevent HIV should be much cheaper to become feasible.
“A recent cost-effectiveness analysis presented at the 2021 Conference on Retroviruses and Opportunistic Infections shows that the injection must be priced in the range of generic daily pills to be considered cost-effective in comparison to oral PrEP. Various advocacy groups are involved in advocating for affordability by lower and middle income countries,” Prof Bukusi told The Star.
The daily Prep pills cost about Sh20,000 a year and are free in Kenyan health facilities.
However, the uptake is poor because of stigma that sees people taking Prep as HIV positive or promiscuous.
The US approval comes after two key studies, one which took place in Kisumu.
Both studies showed that Cabotegravir (also called Apretude) works even better than daily PrEP pills.
In the HPTN 083 study, researchers compared the long-acting injections to the daily oral PrEP among gay and bisexual men.
The study was stopped ahead of schedule in May 2020 after an interim analysis showed that Apretude worked as well as daily pills.
The second study, HPTN 084, was partly conducted in Kenya. It compared the long acting Cabotegravir to daily oral PrEP among women.
It enrolled 3,224 women from seven African countries, including Kenya, Eswatini, Malawi, South Africa, Uganda and Zimbabwe.
It found that Cabotegravir was both safe and statistically superior to daily oral PrEP in this population, with an 89 per cent reduction in HIV incidence among study participants given the injection compared to daily oral PrEP.
Edited by A.N