More encouraging news has been announced about the new, twice-yearly PrEP injection currently undergoing trials.
Lenacapavir is already in use as a treatment for HIV. However, pharma giant Gilead has been testing it as an injectable form of PrEP. Currently, only one form of long-acting PrEP, taken every two months, has FDA approval.
Back in June, Gilead said its first lenacapavir study showed it to be 100% effective. That’s a rare result for any clinical trial. In that instance, researchers studied over 2,000 young women in South Africa and Uganda. Both countries have high infection rates.
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At present, current forms of PrEP don’t work as well in women as they do in men. This is because the medication’s efficiency is tied to maintaining a sufficient concentration in crucial body tissues. For example, higher concentrations of Truvada accumulate in rectal tissue compared to the vagina.
Yesterday, Gilead released further data at the 5th HIV Research for Prevention Conference (HIVR4P) in Lima, Peru.
Its latest trial included 2,180 gay and queer men, and trans individuals, who have sex with men. It found that lenacapavir reduced HIV infections by 96%. Of the 2,180 participants, 99.9% did not acquire HIV. Two individuals did so.
This is a better result than those who take a daily PrEP pill. However, that’s primarily because some people are not very good at remembering to take their daily pill. Daily PrEP remain highly effective when taken correctly by gay and bisexual men.
“Potential … to end the epidemic”
The benefits of any new medication have to be considered alongside any side effects. In its latest trial, Gilead says less than 1% of participants discontinued having injections due to unwanted problems (bruising, soreness, etc), at the site of injection.
The pharma giant sees its latest data as another good result and will be filing for approval in early 2025.
“With such remarkable outcomes across two Phase 3 studies, lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead in a statement.
“Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, for all those who want or need PrEP.”
Generic versions will be allowed… in some countries
HIV experts and health campaigners also regard lenacapavir as a game-changer that could vastly reduce HIV infection globally. However, some are concerned as to whether the medication will be available at an affordable rate everywhere it is needed.
In May, 300 advocates and healthcare experts wrote an open letter to Gilead urging it to make lenacapavir—if approved—available to low-income and middle-income countries at an affordable cost.
Signatories of the letter included celebrities such as Karamo Brown, Stephen Fry, Gillian Anderson, and Alan Cummings.
Last week, Gilead announced it had struck a royalty-free deal with six smaller pharma companies to produce generic versions of lenacapavir for sale in 120 “high-incidence, resource-limited” countries. These include Botswana, South Africa and Thailand.
Although cautiously welcomed, advocates say the announcement still avoided clarifying the price of generic lenacapavir. Some researchers claim it could be produced for as cheaply as $40 per patient per year.
They also note that many middle-income countries, including most of Latin America, were not on the list of 120 countries.
Winnie Byanyima, UNAids executive director, said: “Lenacapavir, which requires only two injections per year, could be gamechanging – if all who would benefit can access it.
“We applaud Gilead for licensing the medicine without waiting for registration, which should be the norm. We are battling a pandemic and the speed at which generic versions come to market will dictate whether this medicine can really be transformative.”
She went on to warn that excluding upper middle-income countries from generics “is deeply worrying and undermines the potential of this scientific breakthrough.”
Latin America
Peru’s hosting of the HIV Research for Prevention Conference is the first time the event has taken place in Latin America.
“We hope that by holding the conference in Lima, we can help draw attention to the urgent need to scale up HIV prevention efforts across Latin America,” said Beatriz Grinsztejn, the President of the International AIDS Society. “Ours is one of the only regions in the world where HIV is on the rise. It’s alarming that new HIV acquisitions in Latin America increased by 9% between 2010 and 2023 despite broadly expanded access to antiretroviral therapy. Unfortunately, the scale of powerful new prevention tools like PrEP remains significantly limited.”
“The IAS commends Gilead for signing voluntary licensing agreements with generic manufacturers to increase access to lenacapavir in high-incidence, resource-limited countries,” Grinsztejn added. “However, we’re highly concerned that these agreements do not cover large parts of the world, including the majority of countries in Latin America.”
Related*
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Promising news for PrEP users & the fight against HIV
In a new clinical trial, none of more than 2,000 participants contracted HIV after having a new, twice-yearly injection.
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