A drug initially used as treatment for HIV could be repurposed into a highly-effective prevention tool against the virus. However, affordability is going to be a major issue in its usage. — AFP
Twice-yearly shots used to treat AIDS (Acquired Immune Deficiency Syndrome) were 100% effective in preventing new infections in women, according to study results published July 24 (2024).
There were no infections in the young women and girls that got the shots in a study of about 5,000 patients in South Africa and Uganda, researchers reported.
In a group given daily prevention pills, roughly 2% ended up catching HIV (human immunodeficiency virus) from infected sex partners.
"To see this level of protection is stunning,” said Salim Abdool Karim of the injections.
He is a director of an AIDS research center in Durban, South Africa, who was not part of the research.
The antiretroviral drug called lenacapavir is approved for use in the United States, Canada, Europe and elsewhere, but only as a treatment for HIV.
Its manufacturer, the US biopharmaceutical company Gilead Sciences, said it is waiting for results of testing in men before seeking permission to use it to protect against infection.
The results in women were published in the New England Journal of Medicine and discussed at AIDS 2024, the 25th International AIDS Conference, held on July 22-26 in Munich, Germany.
Gilead paid for the study and some of the researchers are company employees.
Because of the surprisingly encouraging results, the study was stopped early and all participants were offered the shots.
Removing stigma
While there are other ways to prevent HIV infection, like condoms or daily pills, consistent use has been a problem in Africa.
In the new study, only about 30% of participants given one of two types of prevention pills actually took them – and that figure dropped over time.
The prospect of a twice-a-year shot is "quite revolutionary news” for our patients, said Thandeka Nkosi, who helped run the study at the Desmond Tutu Health Foundation in Masiphumelele, South Africa.
"It gives participants a choice and it just eliminates the whole stigma around taking pills” to prevent HIV.
Desmond Tutu Health Foundation health worker Olwethu Kemele predicted that the shots could boost the number of people coming in for HIV prevention and slow the virus’ spread.
She said young women often hide the pills to avoid questions from boyfriends and family members.
"It makes it hard for the girls to continue,” she said.
The Joint United Nations Programme on HIV/AIDS (UNAIDS) executive director Winnie Byanyima said that the people who need long-lasting protection the most include women and girls who are victims of domestic violence and gay men in countries where same-sex relationships are criminalised.
According to UNAIDS, 46% of new HIV infections globally in 2022 were in women and girls, who were three times more likely to get HIV than males in Africa.
In a report on the state of the global epidemic released on July 22 (2024), UNAIDS said that fewer people were infected with HIV in 2023 than at any point since the late 1980s.
Globally, HIV infects about 1.3 million people every year and kills more than 600,000, mainly in Africa.
While significant progress has been made in Africa, HIV infections are rising in Eastern Europe, Latin America and the Middle East.
Experts working to stop the spread of AIDS are excited about the lenacapavir shots, but are concerned that Gilead hasn’t yet agreed on an affordable price for those who need them the most.
The company said it would pursue a "voluntary licensing programme”, suggesting that only a select number of generic producers would be allowed to make them.
"Gilead has a tool that could change the trajectory of the HIV epidemic,” said Byanyima.
She compared the news about lenacapavir to the discovery decades ago of AIDS drugs that could turn HIV infection from a death sentence into a chronic illness.
Back then, South African President Nelson Mandela suspended patents to allow wider access to the drugs.
This resulted in the price dropping from about US$10,000 (about RM46,524) per patient per year to about US$50 (about RM233).
She said her organisation urged Gilead to share lenacapavir's patent with the United Nations-backed Medicines Patent Pool, which negotiates broad contracts allowing generic drugmakers to make cheap versions of drugs for poorer countries worldwide.
As an HIV treatment, the drug costs more than US$40,000 (about RM186,452) a year in the US, although what individuals pay varies.
Médécins Sans Frontières Access Campaign Non-Communicable Diseases advisor Dr Helen Bygrave said in a statement that the injections could "reverse the epidemic if it is made available in the countries with the highest rate of new infections”.
She urged Gilead to publish a price for lenacapavir that would be affordable for all countries.
In a statement in June (2024), Gilead said it was too early to say how much lenacapavir would cost for prevention in poorer countries.
The company's Clinical Development senior vice president Dr Jared Baeten said Gilead was already talking to generics manufacturers and understood how "deeply important it is that we move at speed”.
Another HIV prevention shot, cabotegravir, which is given every two months, is approved in some countries, including in Africa.
It sells for about US$180 (about RM839) per patient per year, which is still too pricey for most developing countries.
One thousand times cheaper
In other research presented at AIDS 2024, University of Liverpool Pharmacology Department senior visiting research fellow Dr Andrew Hill and colleagues estimated that once production of lenacapavir is expanded to treat 10 million people, the price should fall to about US$40 (about RM186) per treatment – 1,000 times less than the current price.
The treatment currently costs patients over US$40,000 (about RM186,448) a year in a range of countries, including the US, France, Norway and Australia.
The research, which has not been peer reviewed, looked into how much the cost of making the drug could come down if Gilead allowed for cheaper generic versions to be manufactured.
To estimate the cost, the researchers studied shipments of raw materials of the drug, and spoke to large generic manufacturers in China and India that already make its "building blocks", Dr Hill said.
The international team of researchers has been proven right about similar estimates in the past, he added.
A decade ago, the team said that the cost of making Gilead's hepatitis C drug – then priced at US$84,000 (about RM391,454) a patient – could plummet to US$100 (about RM466) if generics were allowed.
"Now it costs just under US$40 (about RM186) to cure Hepatitis C," Dr Hill said.
A Gilead spokesperson said that the company has a strategy to "supply high-quality, low-cost versions of lenacapavir" in countries "where the need is greatest".
It is also "moving with urgency" to negotiate contracts for a voluntary licencing programme to "expedite access to those versions of lenacapavir in high-incidence, resource-limited countries".
Dr Hill said it was critical that health authorities get access to lenacapavir as soon as possible.
"This is about as close as you can get to an HIV vaccine,” he said.
If the drug was given to people at high risk of contracting HIV – such as gay or bisexual men, sex workers, prisoners or notably young women in Africa – it could "basically shut down HIV transmission," he emphasised.
"We could actually control the epidemic." – AP and AFP
