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A Lenacapavir bottle, the new injectable HIV prevention drug which should only be administered twice a year but offers almost complete protection.

Nardus Engelbrecht / AP

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Nardus Engelbrecht / AP

The United States announced on Thursday that it would invest in the new HIV prevention medication called Lenacapavir which was greeted like “breakthrough“And one”game changer“By the medical community.

The State Department says that the objective is to reach up to 2 million people by 2028 with antiretroviral drugs which have the potential to save hundreds of thousands of lives. In the coming months, the United States will work with countries with the largest HIV / AIDS epidemics to develop deployment strategies by emphasizing the prevention of the transmission of mother-child.

This announcement was greeted by researchers and specialists who focus on HIV / AIDS. This news comes after the Trump administration’s foreign cuts seriously had an impact on clinics and programs in the lower resources countries that focus on prevention and treatment of virus.

The results of the clinical trials for the drug, Lenacapavir, have shown last year that injections twice a year can offer almost complete protection against contractual HIV for risky people in their intimate relationships and to prevent mother-child transmission. The drug is also used to treat HIV. The original discoveries that made this medication possible were funded by the National Institutes of Health (NIH).

Scientists believe that the drug could help end the HIV epidemic. “This is really the only way to master this epidemic,” said Dr. Linda-Gail Bekker, director of the Tutu Vih Center of the Institute of Infectious Diseases and Molecular Medicine at the University of Cap. “We have 31 million people on treatment in the world, but if we do not resolve to protect people likely to acquire HIV, we are not going to master the epidemic.”

American financial commitment is a partnership with the Global Fund, a Donor of Donor of the Fight against HIV, Tuberculosis and Malaria, and Gilead Science, Biopharma Society based in California which manufactures the drug. Jeremy Lewin, a senior foreign assistance, humanitarian affairs and religious freedom in the State Department, refuses to put a dollar figure on how the United States spends for this effort.

Financial support will help ensure that the drug is available in some low and intermediate income countries where the virus has a big impact. Lewin refused to specify which countries will receive the doses, but have said that more information would be available in the coming weeks.

“Many of us were largely of dismay and despair,” said Bekker, reflecting on the reductions in massive aid that have hindered many HIV programs. “This announcement brings hope. It’s huge.” She helped conduct LenacapAvir’s tests in South Africa.

“Pepfar and the US government are back”

For decades, the United States was the world leader in the fight against the HIV / AIDS epidemic. The PEPFAR – The President’s Emergency Plan for the relief of AIDS – received strong bipartisan support. With more than $ 120 billion in funding since its foundation in 2003, Pepfar represents the greatest commitment of any nation in history to fight a single disease.

In the past, the PEPFAR has led efforts to introduce drug prevention drugs – called prophylaxis prior to exposure or prep. A daily pill that prevents HIV infections is the most common form of pepfar preparation and accounts for more than 90% of preparation initiations worldwide.

However, President Trump’s work of work in January interrupted existing foreign assistance projects and had a serious impact on clinics and systems that supported preparation, forcing a lot to reduce services or close completely. A week later, Secretary of State Marco Rubio issued derogations to allow funds to continue to flow to Pepfar, but the conditions were limited: prevention work was only allowed to stop the transmission of the mother to the child.

“Prevention programs were absolutely emptied,” said Mitchell WarrenExecutive director of the FIDS Vaccine Advocacy Coalition (AVAC), an HIV prevention organization that works worldwide. “”[This announcement about lenacapavir] is a really important statement that Pepfar and the US government are back in the preparation sector. [It’s] A step forward compared to the place where we have been in a fairly paralytic state for seven months, and I hope it will break the logjam and can at least recover prevention on the agenda. “”

The Biden administration and the Trump administration focused on the transition of responsibility for AIDS responses to national governments and far from PEPFAR. Warren says that the deployment of Lenacapavir is the key to this broader objective and shows that the administration strategically reflects on transition plans.

“The best way to support this transition is to reduce the rate of new infections. Because if countries should start to take the treatment costs – which were often supported by Pepfar and the Global Fund – we have to stop the rate of new infections to increase,” he said.

Peter Sands, executive director of the Global Fund, has echoed this feeling, stressing that Lenacapavir could help reduce the 1.3 million HIV infections that occur each year.

“We can dramatically change the nature of the HIV / AIDS pandemic,” said Sands. “It will obviously save lives, but it will also reduce considerably future health system costs because if an 18 -year -old is infected with HIV, you talk about 50 [to] 60 years of [HIV] Treatment that someone in the system will have to bear. “”

Lewin said this announcement is an indication of the type of work that Pepfar will do in the future and, more broadly, what world health work will look like under the Trump administration.

“This is the type of thing we are going to do more,” he said during a press briefing on Thursday. “There has been a lot of media attention on some of the programs we cut because they are no longer aligned with our priorities. This is where our goal will be: on purchases, on a large scale, basic products that can really help have a dedicated impact in the fight against HIV and in our various fields of global health.”

Lewin also stressed that this work is in coordination with national health and health systems rather than non -governmental organizations [NGOs] And international health organizations, as was the case in the past.

“There is no NGOs involved in this. There is nothing of these types of Beltway bandits here,” he said. “It is not the work of the United States to pay ghost health workers – Americans in these countries saying to local health care systems that they do things badly and offering a competitor to the health system.

Warren of Avac said that it feared that this exclusion of NGOs “decreases the scope and impact” of the drug, which makes it more difficult to return it to people who need it, because non -governmental groups manage many programs and clinics that will be involved in deployment. But he agreed that countries should have and exploit their own AIDS responses.

When will the drug be available?

HIV / AIDS experts are thinking about the logistics and the chronology of deployment in the hope that drugs could go to hot spots in Africa by the end of this year or at the beginning of next year.

But the first African countries must shed light on the drug – as United States and Drug Administration,, World Health Organization And European Medicines Agency have already done. Warren says he expects these approvals to start in the coming months.

Bekker says that, in the field, clinics are able to mobilize quickly to support deployment. “We are ready. We have sites and installations arranged and capable. It is very feasible and very urgent,” she said.

Support in the United States will help to defray the cost – although the exact price that Gilead Charge is not public, Warren estimates that it is around $ 100 per person per year. It is more than double the cost of oral preparation.

The CEO of Gilead, Daniel O’Day, says that the company offers this drug in Pepfar and to the Global Fund at a cost and without profit. He said this is the result of 17 years of research and development work. “The support of the American government through Pepfar means that we can go to places with the greatest need,” said O’Day.

A cheaper generic version arrives. Gilead Sciences shared the Lenacapavir license as well as information on how to do so with six generic manufacturers. However, according to Bekker, generics will probably not be available before 2027 due to the time required to start production and carry out the required tests. Until then, she says, Lenacapavir “is probably outside most government’s budgets in low and intermediate income countries”.

Bekker says that this announcement made him think about the power of the Pepfar – in the past and today.

“I am eternally grateful to American taxpayers for what they have done for us [in Africa]. He changed lives, communities. It is completely transformed which could have been an eternal tragedy, and now we have hope. “”