‘Miracle’ new anti-HIV jab could revolutionise virus prevention

Lenacapavir performed so well in clinical trials that researchers stopped the controlled test early

A “miracle” new anti-HIV jab giving protection from the deadly virus for six months is being hailed as a chance to revolutionise prevention of an infection which still kills one person every minute.
Excitement about the potential of Lenacapavir and discussions on how to cut the price of the costly injection have dominated this week’s 25th annual international Aids conference.
The drug brings hope of helping to solve a stubborn problem which has been holding back efforts to curb HIV and Aids, particularly in Africa.
Protective pills, called pre-exposure prophylaxis (or PrEP), to stop people getting HIV are already effective, but need to be taken every day.
But failing or being unable to adhere to a routine of daily pills means people are still getting infected. Some do not want to be seen with the tablets because of stigma around HIV, Aids and homosexuality. Others in rural remote areas have to travel long distances for refills.
Lenacapavir injections provided total protection to young women in a clinical trial spanning South Africa and Uganda, with around two per cent of a group taking daily prevention pills catching HIV from partners.
A large clinical trial has now shown Lenacapavir injections provided total protection in young African women for six months at a time, potentially revolutionising prevention.
High risk groups, such as young women, young gay men and injecting drug users could be given this new long-lasting PrEP jab and then allowed to carry on with their lives, only needing to have another shot twice a year.
Protection given by the antiviral drug is so strong and so long lasting that some have described it as “vaccine-like” in its potential.
Preliminary results from the trial attracted excitement in June. The full results of the trial have now been published in the New England Journal of Medicine.
The trial found Lenacapavir was so effective that not one of the 2,134 women given the drug became infected. The results were so clear cut that researchers stopped the trial early.
Sharon Lewin, president of the International Aids Society, said: “These data confirm that twice-yearly Lenacapavir for HIV prevention is a breakthrough advance with huge public health potential.”
Winnie Byanyima, head of the United Nations Aids body, UNAIDS, described Lenacapavir as a “miracle product”.
Excitement at a potential breakthrough has been in contrast to what has often been a long difficult public health slog against HIV and Aids.
More than four decades after the virus was first recognised, there were still 1.3m new infections last year and 630,000 deaths. Some 40m people currently have HIV and infections are still rising in some countries.
Public health experts told the Telegraph the drug was very exciting, but they stressed it was not a silver bullet to ending the HIV pandemic. Treating those who already have HIV would remain the focus of stopping its spread.
The drug’s manufacturer, California-based Gilead Sciences, has come under immediate pressure to make the costly drug cheaper for poor countries that need it.
Ms Byanyima called on Gilead to open it up to the UN-backed Medicines Patent Pool so that cheaper generic versions could be sold under licence in poorer nations.
She said: “Gilead has an opportunity to take us closer to ending Aids as a public health threat.”
“Gilead has an opportunity to save the world. To save the world, literally,” from the pandemic.
Lenacapavir currently costs patients over $40,000 (£31,000) a year in countries including the United States, France, Norway and Australia. Research unveiled at this week’s conference estimated it could be made for $100.
Ravi Gupta, Professor of Clinical Microbiology at Cambridge, said: “There will be pressure right from the outset for this to be available at the lowest possible price.
“One of the barriers to implementation may unfortunately be cost, but we have been there before with antiretroviral therapy and I think that if enough of a case is made and funders and donors are behind it, then hopefully we can overcome it.”
Lenacapavir works by targeting a viral protein called capsid. Capsid is central to many steps of viral replication, so the new drug stops the virus at several points in its replication cycle.
The drug has already been used as a treatment of last resort in a small number of patients infected with HIV. But the latest trial followed a different strategy, using the drug as PrEP in young women who have not been infected.
Prof Salim Abdool Karim, director of the Centre for the Aids Program of Research in South Africa, which contributed to the trial, said: “We thought the drug was amazing before the trial and it proved itself in the trial.
“I have been undertaking research on HIV prevention in women for just over 35 years. In all of that time, I have never seen a result as compelling as this. This was a stunning result.”
Young women aged 18-25 are particularly at risk of infection in Africa, where they bear the brunt of the continent’s epidemic.
“If you want to make an impact on the global pandemic, you’ve got to make an impact on preventing HIV infection in young women,” he said.
Another trial looking at young gay men is still ongoing, but is now expected to deliver similar results.
Dr Kate Bishop, principal group leader at the Retroviral Replication Laboratory at the Francis Crick Institute said: “Having an injection twice a year means that people don’t have to remember to take a tablet every day, or plan when they might need protection.
“This makes it much easier for people to take the medication correctly which in turn means it is better at stopping the spread of HIV.”
The jab is so long lasting that some have said it is comparable to a vaccine, though others worry the comparison could lull people into complacency.
Dr Bishop said: “It is not a vaccine because it doesn’t teach the body to defend itself against the virus, but if you only need to take the drug a couple of times a year it is almost as easy as vaccination and boosters.
“However, protection will wear off faster than a vaccine and people will need to continue to take the drug to get protection. For this reason, it’s probably better not to call it a vaccine as people may get the false impression it can protect them in the same way.”
Researchers are likely to be keen to investigate how the new long-lasting jab will work alongside other preventative measures like condom use.
Prof Karim said despite the promising results, treating those who already have HIV and suppressing the infection so it cannot be passed on, will remain the cornerstone of attempts to defeat the pandemic.
Ambitious UN 2025 targets aim for countries to have diagnosed 95 per cent of people with HIV, and of those, 95 per cent need to be on antiretroviral treatment. From that group, 95 per cent need to have had their HIV levels reduced so much that they are unable to transmit the virus to others through sex. This stops them spreading it to others.
He said Lenacapavir was so useful because in some parts of the world, such as Africa, the treatment approach on its own was not enough. Large numbers of people were undiagnosed, meaning the virus continued to spread. By giving vulnerable groups such as young women, young gay men and injecting drug users long-acting protection, the virus could be halted.
He said: “Right now treatment remains our main strategy. That will always be the case.”
“In most of Africa treatment works, but it doesn’t get you to epidemic control. So in those countries, you want to carry on doing treatments, because that stops people with the virus from spreading it to others, but in addition you want to take those who don’t have the infection, you want to provide them with some protection. That’s what Lenacapavir can do.”
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