UNAIDS urges speed and compassion urging pharmaceutical companies to enable access to new, life-saving medicines

DAVOS/GENEVA, 21 January 2025—Today, at the World Economic Forum’s annual meeting in Davos, Switzerland the Joint United Nations Programme on HIV/AIDS (UNAIDS) has warned that new long-acting HIV prevention – and potentially treatment – medicines can help usher in the end of AIDS if corporate and political leaders move quickly and urgently to prioritise access for all low and middle-income countries.

Lenacapavir, produced by Gilead Sciences, has proved to be more than 95% effective in preventing HIV with just two doses a year and the company is now conducting trials of once-yearly shots. ViiV Healthcare has the injectable medicine Cabotegravir, administered once every two months to prevent HIV, which is already being used in some countries. Month-long vaginal rings are also in use and longer acting pills and vaginal rings are being trialled.

“These new technologies offer us a real shot at ending AIDS by 2030,” said Winnie Byanyima, Executive Director of UNAIDS and Under-Secretary-General of the United Nations. “But it comes with a caveat—only if pharmaceutical companies, governments, international partners and civil society unite around an HIV prevention and treatment revolution, can we use these medicines to their full potential and end AIDS much sooner than we previously thought.”

The breakthrough long-acting medicines could stem new HIV infections and are already being used to suppress the virus for some people living with HIV. But their potential can’t be unlocked unless everyone, everywhere who could benefit has access.

UNAIDS is urging pharmaceutical companies to move faster and ensure “affordable pricing and generic competition” in the market for the new HIV medicines. “We have no problem with profit, but we will not stand for profiteering,” said Ms Byanyima.

Gilead and ViiV have licensed generics manufacturing to a number of countries, which is to be applauded, but they are moving too slowly. Generics aren’t expected until next year- and many countries have been left out. Nearly all of Latin America, a region of rising HIV infections, has been excluded. In addition, to provide for the whole world, Gilead has licensed just six companies to make generic versions of the medicine – with no producer in sub-Saharan Africa. To make these medicines widely available and affordable, more generic production is needed.

Gilead has not announced a price for lenacapavir for prevention. However, used as treatment in the United States, the medicine can cost around US$ 40 000 per year per person. One study suggests that, if 10 million people are reached, generics could cost just $40 per person per year, a thousand times less.

At the end of 2023 only 3.5 million people are using pre-exposure prophylaxis. UNAIDS goal is to reach 10 million with preventative HIV medicine by the end of 2025. “This is possible, said Ms Byanyima, “But only if we have ambition. Look at injectable contraceptives—72 million women around the world accessed them in 2022. Look at COVID-19 vaccines in rich countries – 4.5 billion people were vaccinated in a year. Why can we not have the same ambition for HIV? We did it for HIV treatment and we can do it for prevention. We have done it before – and we can do it again.”

Today, 30 million of the 40 million people living with HIV are now on treatment—a huge, but long-awaited achievement which destroyed families and cost far too many lives.

While these new medicines are not a cure or a vaccine, they could halt the HIV pandemic.

The Global Fund to fight AIDS, TB and Malaria and the US President’s Emergency Plan for AIDS Relief (PEPFAR) recently announced a deal to get lenacapavir to 2 million people over the next three years. Which is a good start but not ambitious enough.

"Science has delivered a miraculous new tool: medicines that prevent HIV infection with injections just twice a year and which could work for treatment too,” said Ms Byanyima. “We must do better this time. Either companies step up, or governments step in. This is our shot to end AIDS – and we cannot afford to miss it."

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

NAIROBI, 10 December 2024—Today, at the 55th Programme Coordinating Board for the Joint United Nations Programme on HIV/AIDS (UNAIDS), HIV leaders from across the world called for access to long-acting medicines for everyone who would benefit from them, to build toward a new era in the AIDS response.

Over the last two years, scientific breakthroughs have brought to the fore a new class of anti-HIV medicines with long-acting effects, allowing people at risk of HIV infection and those living with the virus to take medicines every few months. One is injected just twice a year. Recent studies have shown these medicines to be among the most effective ever developed. One study showed zero new infections among young African women using long-acting prevention drugs, while a study among key populations showed them more effective than oral medicines. Another study highlighted at the session showed encouraging results using long-acting HIV treatment in low- and middle-income countries.

At the “Leadership in the AIDS Response” session at the UNAIDS board, government officials, researchers, manufacturers, and civil society called for accelerating global access to use these scientific breakthroughs to interrupt the continuing AIDS pandemic. Despite existing HIV prevention tools, in 2023 an estimated 1.3 million people newly contracted HIV – two every minute. Despite HIV treatment, there is still one AIDS-related deaths every minute.

Winnie Byanyima, Executive Director of UNAIDS, said: “We can usher in a new era by connecting technological innovation with access for all. Let us act boldly together, bring down the curve of new infections, and dramatically accelerate the HIV response.

“Let us learn from the painful lessons of the past so that we write a new story now. In the late 1990s and early 2000s, even after antiretroviral medicines were proven to be effective and rolled out in high-income countries, 12 million people on this continent still died waiting for those drugs. We can - and must – do better with long-actings. We urge the companies producing these medicines to expand their generics licenses. And we support governments making use of all their legal flexibilities to get access to affordable medicines.

“The usual trajectory is that the Global South waits years before the science reaches them. What if we do not wait for years, what if we ensure that science is treated as the public good it is? What if we disrupt the far too slow trajectory we are on and shift to a trajectory that accelerates progress, ends the pandemic, enables sustainability, and can be a model for the world?"

Secretary Ethel Maciel, Secretary of Health of Brazil, said: “Brazil has a long history of making use of technology in the HIV response. The possibility of having new long-acting medicines in the global response is a great opportunity. But we have the huge challenge of the high cost of these medicines, and the difficulty for a range of countries, including ours, to access them.

“Brazil is committed to work together in the fight to ensure that this new technology is made available to all people all over the world who are at risk of and living with HIV.”

Dr Cissy Kityo, Executive Director of the Joint Clinical Research Centre, Uganda, a leading scientist working on trials of long-acting medicines said:  “We have these fantastic new tools. The technology of long-acting ARV’s antiretrovirals is remarkable. The evidence is now clear that long acting medicines will be game-changers for both prevention and treatment. The science is in, the question is how well we will use it.”

Mr Javier Padilla Bernáldez, Secretary of State for Health, Spain, said: “This new long-acting technology puts us in an exceptional situation, not an ordinary one, an opportunity that we cannot afford to miss. Long-acting medicines can change the landscape of the HIV response. But if this game-changing innovation did not reach the people it would be a nothing-changer!

“We need to remember the 2000s’ fight for universal access. We cannot repeat the same mistakes and delays of before. We need to ensure that no countries should be pressured if they choose to use the safeguards in the TRIPS agreement. The inequality gap is a global problem. We need a universal perspective, so that all countries, including middle-income countries, are included.”

Dr Sylvia Vito, Africa Head of EVA Pharma, a company in Egypt licensed to produce a generic version of lenacapavir, said: “We are a company that will not sit comfortably, but rather be in a good hurry to support the unmet HIV medical needs for our people. We intend to move fast on product development, production, and eventual registration. It is our intention that high quality long-acting generic ARV medicine will not only be available, but made accessible and affordable as well. We intend to beat the current standard of care in HIV treatment and prevention by going further to improve on the current options for patients in low and middle-income countries.”

The importance of generic production was central to the interventions of speakers. Several speakers noted the obstacle that much of Latin America, a region of rising HIV infections, has been excluded from companies’ voluntary licenses for generic versions. This is despite Brazil, Peru, Mexico and Argentina participating in clinical trials. Speakers highlighted the importance of using TRIPS flexibilities for enabling access under World Trade Organization rules, which can enable governments to supply its citizens with generic versions of patented treatments either through domestic production or imports. In the 2021 Political Declaration on HIV/AIDS, countries committed to make use of TRIPS flexibilities, specifically geared to promoting access to medicines.

Although Gilead Sciences, the producer of lenacapavir, one of the new class of long-acting medicines, has not yet announced the price of its product for use as PrEP, it costs around $40,000 per person per year in the United States where it is used for treatment. However, experts have estimated that it could be produced and sold for $40 per person per year, in line with UNAIDS estimates for sustainable pricing in low- and middle-income countries. Speakers highlighted opportunities to bring down the price of these medicines through generics, expanded local and regional production, and the use of TRIPS flexibilities by member states.

One important opportunity for progress emphasized by speakers was to build on the progress on multilateral collaboration made by Brazil, which as chair of the G20 in 2024, successfully secured worldwide support for the Global Coalition for Local and Regional Production, Innovation and Equitable Access, laying the foundations for a greatly expanded and more equitable access to medicines.

Speakers noted also the importance of choice, and of widening access to a range of new technologies, of which lenacapavir is just one. Speakers highlighted important current innovations including 2-monthly injectable cabotegravir and a three-month dapivirine vaginal ring, as well as new technologies currently in the pipeline including a once-a-month pill may move into phase 3 trials next year.

Reinforcing the importance of accelerating access to long-acting medicines, The New England Journal of Medicine has today published an article by UNAIDS Executive Director Winnie Byanyima, Linda-Gail Becker of the Desmond Tutu HIV Centre, and Matthew Kavanagh of Georgetown University’s Center for Global Health Policy and Politics, entitled “Long-Acting HIV Medicines and the Pandemic Inequality Cycle — Rethinking Access”.

The article showed that the “pandemic inequality cycle” in HIV has usually meant a decade delay between access to breakthrough HIV technologies in the global North and the global South.

In their article the authors write: “The world may look back on 2024 as a pivotal time in the fight against AIDS — the start of a revolution in the global biomedical response to HIV using long-acting antiretroviral medicines. Whether they will do so depends on whether policymakers and pharmaceutical companies avoid repeating past mistakes.”

The authors call for “a nonlinear approach to global access to ARVs that combines far more rapid sharing of technology, decentralized global production, and research and development of products that meet the needs in Africa, Asia, Latin America, and the Caribbean.”

They highlight the need for progress on long-acting treatment as well as prevention and “to break the long-standing pattern of failing to get HIV technologies to the people who need them most, to stop playing catch-up, stop accepting that innovations must reach people in the Global South years late, and use long-acting medicines to help end the pandemic.” The article is available at https://www.nejm.org/doi/full/10.1056/NEJMms2412286

The importance of long-actings, and what is at stake in the discussions on access, was summed up by Jerop Limo, a 26 year old Kenyan activist born living with HIV who is Executive Director of the Ambassador for Youth and Adolescent Reproductive Health Program (AYARHEP):

“Taking a pill every day is not easy. It is a constant reminder of being different, and the stigmatising and shaming we experience because of it can discourage us from taking our medicines.

“This is not just about convenience. Young people living with HIV, and young people at risk of HIV, are clear: with all the pressures we face, long-acting medicines would help us stay on the medicines and help transform, and save, our lives.

“We deserve to live, and to live fully. We can’t have access on paper only. We need access for all people in all countries.

“I am inspired to see leaders coming together to centre communities and to call for access to long-acting HIV medicines. With partnership we can do this. We don’t have time to wait.”

The UNAIDS Programme Coordinating Board brings together governments, civil society and the United Nations to help guide the HIV response. UNAIDS sees the development of long-actings as a vital disruptive innovation.

“The arrival of long-acting injections is a game-changer which can help prevent millions of new HIV infections, if we ensure access to all who would benefit from them,” said Ms Byanyima. “Today, in Nairobi, leaders in the global HIV response took a bold and vital step forward on the path to access for all.”

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

The only HIV prevention that Elena Felix knew of was condoms. But condoms were not something that she was able to make use of, and she contracted HIV. Thirty years after her diagnosis, she’s helped conduct research to determine whether women in the Philippines would use a more confidential tool, and one that does not need a man to agree, to lower women’s risk of HIV infection.

“We hear from women that some partners insist on not using condoms. We hear cases too of rape. Women need protection that does not depend on men” the Association of Positive Women Advocates founder explained.

The Dapivirine Vaginal Ring or DVR was given the green light by the World Health Organization for women at high risk of contracting HIV in 2021. Unlike other types of pre-exposure prophylaxis (PrEP), this one is exclusively for women. It is a silicone vaginal ring that is inserted and worn for 28 days before being replaced. It releases an antiretroviral drug locally, reducing the risk of HIV infection through vaginal sex by half.

Since its introduction, the technology was made available in several (11) African countries. And with good reason. Around two-thirds of new HIV infections in Eastern and southern Africa and Western and central Africa are among adolescent girls and women. The combination prevention strategies implemented in these two regions have super-charged progress, driving the global 39% decline in new infections since 2010.

But the Asia Pacific picture is quite different.

“This region has an HIV prevention crisis,” Eamonn Murphy, UNAIDS Regional Director for Asia Pacific and Eastern Europe Central Asia said. “And I am not speaking only of the countries where new infections have doubled, tripled or increased six times since 2010. The average regional decline in new infections is far too slow. At 13% it has virtually flatlined.”

He was speaking to a group of community, government, research and development partners from Cambodia, Indonesia, Papua New Guinea and the Philippines who met from November 11 – 12 in Bangkok. Findings were disseminated from a DVR acceptability and feasibility study conducted by ThinkPlace, and a discussion held on next steps. UNAIDS and the World Health Organization (WHO) are providing technical support for this initiative. The Australia Department of Foreign Affairs and Trade (DFAT) funded the research as part of its ongoing support for prevention work in the region.

Seven percent of new infections in Asia Pacific are among sex workers while 12 percent occur among the intimate partners of key populations. Angeli Achrekar, UNAIDS Deputy Executive Director, called for women in Asia and the Pacific to be provided more HIV prevention options.

“Choice is the way to go!” Ms Achrekar stressed. “Providing options in prevention tools and service delivery increases overall use and results. We must ensure that people have access and that they are supported with the appropriate policies and enabling environment. The ring has great potential to be empowering as an additional choice for women, including in Asia Pacific.”

A person newly acquires HIV in the Asia Pacific region every two minutes. Despite this, the overall momentum on rolling out pre-exposure prophylaxis (PrEP) options has been sluggish. At the end of 2023 there were just 204,000 PrEP users in this region, 98% short of the 8,200,000 target by 2025. The vast majority of those on PrEP were men.

ThinkPlace Regional Director, Elliot Duffy, revealed that overall, the studies found women have high interest in this discreet, woman-controlled prevention method. Sex workers in the four countries sought the DVR given their high vulnerability to sexual violence. And in all countries the sex workers indicated that they would want to access the DVR through community-based health services or their local healthcare facilities. The research also found that healthcare providers in the four countries were enthusiastic about offering this new prevention option.

“The number one barrier is the extent to which women understand how the ring would fit. Many had questions like, “would it be lost in my body? Will I feel pain? Will I be able to have sex?’ Some women worried about a partner thinking they distrusted them,” Mr Duffy explained. “The DVR is not immune to the challenges of other HIV programs and continued effort is needed to increase awareness, generate demand and create services that are accessible.”

Already the research findings have resulted in the introduction and phased implementation of the DVR into 2024 – 2026 Global Fund grant implementation for Cambodia and Indonesia. Cambodia has begun pilot testing. At the meeting the four country teams developed plans to guide their next steps, including on further research, legal and policy reviews, regulatory approvals and community system strengthening.

DFAT Health Adviser, Joshua Metcalf-Wallach, emphasized that as stakeholders switched gears from research to rollout, they should keep communities in the driver’s seat.

“Our Indo-Pacific prevention work has shown that HIV services work best when they are key population- and community-led. As we expand prevention options for women, let us be guided by their needs and demands,” he ended.

New long-acting technologies are changing the HIV prevention landscape. In recent years, innovation in pre-exposure prophylaxis (PrEP) has accelerated. Long acting injectable cabotegravir and the dapivirine vaginal ring as innovative formulations of PrEP have already joined oral PrEP containing tenofovir as WHO-recommended effective and acceptable options for HIV prevention, and there are additional antiretroviral-based options on the immediate horizon. These options complement other effective, non-antiretroviral-based HIV prevention products including condoms and lubricants, and harm reduction strategies.

This year clinical trial results for PURPOSE 1 and 2 showed the high prevention effectiveness of the 6-monthly long-acting injectable drug, lenacapavir for cisgender adolescent girls and women, cisgender men and transgender women.  Among the cisgender adolescent girls and women participating in the trial, no HIV acquisitions were recorded during 12 months of follow-up among the women who received injectable lenacapavir. The Global HIV Prevention Coalition (GPC), UNAIDS and other partners called on Gilead Sciences to accelerate their efforts in ensuring that it is made available, accessible and cost effective especially to low- and middle-income countries. This twice-yearly injection is a promising option and offers increased choice, discretion and convenience for people who may benefit from HIV prevention.

In October 2024, at the Research for Prevention (R4P) conference in Peru, the Population Council announced phase 1 trial results from IPM 054, showing that the three-month dapivirine ring is as safe as the currently available one-month ring with similar levels of drug release. The 3-month ring like the 1-month ring is a woman-controlled option but would be more cost effective (an estimated 60% reduction in cost per user) and potentially an even more convenient HIV prevention option for women and adolescent girls.

“We need to follow the science, and the science has shown us that by making a range of effective HIV prevention options available and accessible, we can stop HIV transmission and drop new infections by addressing biomedical, behavioral and structural drivers simultaneously. Ending AIDS remains a political and financial choice”, says Angeli Achrekar, UNAIDS Deputy Executive Director Programmes.

This complements a partnership announcement by the Global Fund and the Children’s Investment Fund Foundation (CIFF) of an USD 2 million initiative for 2024-2025 to purchase an estimated 150 000 dapivirine vaginal rings for use as PrEP in the Global Fund grant implementing countries. This would increase accessibility to one of the most discreet HIV prevention options for women and adolescent girls.

The World Health Organization (WHO) PrEP Implementation Tool Provider Module for Oral and Long Acting PrEP, launched in July 2024, integrates clinical service delivery  guidance for the three WHO recommended PrEP products (oral PrEP, the dapivirine vaginal ring and long-acting injectable cabotegravir) by a range of different providers in clinical or community settings and emphasizes the importance of access and choice.

These strategic advancements align to the HIV Prevention Choice Manifesto For Women and Girls in Africa that calls for prevention options to be made choices and urges that research and development of new HIV prevention options actual choices, thereby empowering women and girls to take control of their health and bodies. It also emphasizes the importance of ongoing research and development of innovative HIV prevention methods.

“Adolescent girls and women are gaining access to an increasing range of safe and effective options. Scale-up of HIV prevention will depend on supporting access to choice, strong country leadership and an enabling environment. An HIV free future for girls is possible, but only if the global community comes together with ambitious plans to make this range of PrEP options available with speed, scale and equity,” says Mitchell Warren, Executive Director, AVAC and GPC, Co-chair.

The GPC co-convened, by UNAIDS and UNFPA, will continue to work with its partners to accelerate HIV prevention to achieve the global target of less than 370 000 new HIV infections annually by 2025.

About the GPC

In 2017, a global coalition of United Nations Member States, donors, civil society organizations, and implementers was established to support global efforts to accelerate HIV prevention.  Membership includes 38 of the highest HIV-burden countries, UNAIDS Cosponsors, donors, civil society, and private sector organizations. The overarching goal of the Global HIV Prevention Coalition is to strengthen and sustain a political commitment to primary prevention by setting a common agenda among key policymakers, funders, and program implementers.

GENEVA, 8 October 2024—Responding to ViiV’s announcement on long-acting cabotegravir , UNAIDS Executive Director Winnie Byanyima said:

“New HIV prevention medication, in the form of a long-acting injection, could transform the lives of people who struggle to take daily pills. The option of an injection that only needs to be taken once every few months is vital for people who face stigma when seen with pills, and those who are driven underground by criminalizing laws.

The people most in need of this long-acting option include adolescent girls, LGBTQ+ people, sex workers, and people who use drugs.

The arrival of long-acting injections is truly a game-changer – it can help prevent millions of new HIV infections.

But this will only happen if everyone who would benefit has access. When medicines are lifesaving, delays are fatal.

To ensure affordable pricing and worldwide availability for everyone who needs these medicines, enabling access to generic versions in all low- and middle-income countries is essential. But ViiV continues to lock out many low- and middle-income countries from this possibility. Shockingly, the company has even launched a legal challenge against Colombia for trying to access a generic version of another lifesaving HIV medicine, dolutegravir.

ViiV's announcement on increasing production of long-acting cabotegravir  is a welcome first step, but their next steps must follow fast. It is not enough for ViiV to increase the number of doses up for sale.

I urge ViiV to show leadership on access to medicines now by announcing an affordable not-for-profit price, dropping its harmful legal challenge, and enabling all low and middle-income countries to access generic versions of its medicines.

That is how they can help ensure this scientific breakthrough fulfils its potential and how they can help bring an end to the AIDS pandemic."

/ENDS

Note: ViiV’s announcement can be read on their site at https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/triple-annual-supply-of-long-acting-hiv-prep-for-low-and-middle-income-countries/

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

GENEVA, 2 October 2024—Responding to today’s announcement by Gilead on lenacapavir, UNAIDS Executive Director Winnie Byanyima said:

“We welcome Gilead’s announcement of licensing the break-through HIV medicine lenacapavir for generic production. To stem the tide of new infections, and protect people most at risk from HIV, including young women and people from marginalised communities, long-acting HIV medicines are vital. Lenacapavir, which requires only two injections per year, could be game changing – 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.  At UNAIDS we commit to doing all we can to speed up this process.

Including an African producer in Egypt is also very welcome.

Much more work is still urgently needed to ensure that no one who needs lenacapavir is left behind and that Gilead’s commitment to rapid, affordable access is fulfilled.

The exclusion of many middle-income countries from the licenses is deeply worrying and undermines the potential of this scientific breakthrough.

HIV prevention products need to be deployed where new HIV infections are highest – and right now, forty-one percent of new infections are in upper-middle income countries. UNAIDS urges Gilead to secure further licenses for access in all low and middle-income nations.

We welcome Gilead’s statement of commitment to non-profit pricing, but we had been waiting eagerly for a specific price. We urge Gilead to disclose it, and to provide full transparency on their costs. Respected researchers have shown it is possible to produce and sell lenacapavir for $100 per patient per year, falling to as little as $40.

Manufacturing this medicine in African countries with the highest HIV rates is crucial for sustainability and Gilead should include manufacturers in countries like South Africa where there is strong production capacity. We at UNAIDS stand ready to assist.

UNAIDS urges Gilead to secure further licenses for access in all low and middle-income nations.

We urge Gilead also to do all it can to make lenacapavir viable for treatment in low- and middle-income countries, including working together with researchers to test new combinations. Over 30 million people worldwide taking HIV treatment every day deserve long-acting options. We recognize that Gilead has included treatment use in the license, where some companies have not, but we urge that they remove the current limitation in the license to “heavily treatment-experienced patients.” To support scientists and manufacturers worldwide, licenses should not be limited to specific uses.

Leaving no one behind is how to unlock lenacapavir’s full potential, fulfil Gilead’s promise, protect a generation from HIV and bring forward the end of the AIDS pandemic."

Note: Gilead’s announcement can be read on their site at https://www.gilead.com/news/news-details/2024/gilead-signs-royalty-free-voluntary-licensing-agreements-with-six-generic-manufacturers-to-increase-access-to-lenacapavir-for-hiv-prevention-in-high-incidence-resource-limited-countries
 

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

GENEVA, 10 July 2024— UNAIDS has welcomed the release of Gilead Sciences’ trial results on the injectable long-acting HIV medicine Lenacapavir for HIV prevention. The result “provides hope of accelerating efforts to end AIDS”, UNAIDS says, “but only if Gilead ensures that all people who need it can have access to this game-changing medicine.”

The recent trial of the medicine among cis-gender women in Uganda and South Africa was so successful that it was halted early. Twice-yearly injections of Lenacapavir showed overwhelming efficacy for preventing HIV infections compared to standard oral preventative HIV medicines, known as pre-exposure prophylaxis (PrEP). Additional trials are ongoing in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.

UNAIDS has welcomed the “exciting development,” and urged the company to allow generic production of Lenacapavir to all low- and middle-income countries by negotiating voluntary licensing agreements through the Medicines Patent Pool (MPP). The MPP is a UN-backed programme with extensive experience negotiating generics agreements between originators and generic pharmaceutical companies.

Gilead has not yet announced its plans for low and middle-income countries. However, UNAIDS is concerned that Gilead’s latest statement regarding its access strategy for low and middle-income countries mentions only “high incidence countries and resource limited countries” and makes no specific mention of upper-middle-income countries or the Medicines Patent Pool. Upper middle-income countries account for 41% of new HIV infections and 37% of all people living with HIV. These countries are home to millions who cannot afford the prices Gilead charges high-income countries.

“The success of Gilead’s recent Lenacapavir trial is an exciting development. While we still await regulatory approvals, normative guidance and results from the other ongoing trials, this news offers hope that we can enable everyone who would benefit, including especially the most marginalised communities, to have access to the help they need. Enabling equitable global access to new technologies can help get the world on track to end AIDS as a public health threat by 2030,” said Winnie Byanyima, Executive Director of UNAIDS. "However, it is concerning that Gilead’s latest announcement seems to mention neither upper-middle income countries, where people cannot afford anything like Lenacapavir’s current $42,250 price tag, nor a commitment to work with the UN-backed Medicines Patent Pool. Without these safeguards, it cannot be assured that this game-changing medicine will reach all those who need it."

Notes

Data in this press release comes from UNAIDS 2023 Epidemiological estimates (aidsinfo.unaids.org)

The UNAIDS Executive Director joined more than 300 experts and activists calling for a generic version of Lenacapavir to be licensed to all low and middle-income countries through the MPP, in a letter coordinated by the People’s Medicines Alliance: https://peoplesmedicines.org/wp-content/uploads/2024/05/Gilead-Open-Letter_May-2024.pdf

The AIDS Vaccine Advocacy Coalition provides an overview of the Lenacapavir for PrEP trials: https://avac.org/resource/infographic/an-overview-of-lenacapavir-for-prep-trials/ 

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.