HIV Prevention

UNAIDS response to ViiV’s announcement on increasing production of long-acting cabotegravir

08 October 2024

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.

UNAIDS response to Gilead’s announcement on signing voluntary licensing agreements on lenacapavir with six generic manufacturers

02 October 2024

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.

With new HIV infections rising in a growing number of countries and regions, urgent action is needed to turn the prevention crisis around

24 July 2024

GENEVA/MUNICH, 24 July 2024—An estimated 1.3 million people became infected with HIV in 2023, three times more than the target of fewer than 370 000 by 2025. While there has been marked progress in sub-Saharan Africa, for the first time, in 2023 more than half of the new HIV infections occurred outside of sub-Saharan Africa.

Rising new HIV infections are evident in several countries, particularly in countries where key populations including men who have sex with men, sex workers, transgender people and people who use drugs, are most affected, and investment in prevention was lower. Key populations and their sexual partners now represent the majority (55%) of new HIV infections globally, up from 44% to 2010.

The Global HIV Prevention Coalition (GBC), established in 2017, is addressing the HIV prevention crisis. Focusing on 40 countries the GPC, a coalition of United Nations Member States and partners including UNAIDS, donors, civil society and private sector organizations, is working to strengthen and sustain political commitment for HIV prevention.

“The HIV epidemic has evolved – now more than ever, we need resilient capacity to deliver and manage integrated, differentiated and equitable HIV prevention interventions,” said Prof. Sheila Tlou, GPC Co-chair and Former Minister of Health, Botswana.

There has been great variation in progress among GPC member countries; the biggest declines occurred in countries within eastern and southern Africa including Kenya, Malawi and Zimbabwe, where new HIV infections were reduced by more than 66% and which are on track to achieve the global target of 90% reduction by 2030 – and, to a lesser extent, in western and central Africa. Expansion of access to effective HIV treatment, combined with an ongoing focus on primary prevention, are driving those achievements.

“The moment of opportunity for HIV prevention is now,” said Angeli Achrekar, UNAIDS Deputy Executive Director for Programmes. “Today, we have a wider range of prevention options including new long-acting antiretroviral prevention—with the new results about lenacapavir—a twice yearly injection to prevent HIV—providing a promising game-changing option—and new opportunities to communicate about HIV prevention and health.”

Long-acting technologies like pre-exposure prophylaxis (PrEP) will play a major role in preventing new infections in the coming years. Access is increasing, but only in a few countries. Around 3.5 million people were accessing PrEP (antiretroviral medicine which prevents HIV) in 2023 up from just 200 000 in 2017, but this remains far short of the 10 million target set for 2025.

New HIV prevention products in the pipeline such as long-acting injectable cabotegravir (CAB-LA) and most recently, lenacapavir, are raising expectations due to their combination of convenience and high efficacy. However, the key is accessibility and affordability. The cost of the new long-acting injectable PrEP options, and the speed with which they are made available to potential users in the countries with the most need will be critical in expanding access to these life-saving technologies.

Persistent gaps remain in HIV prevention coverage (only 61% of areas with high incidence of HIV have programmes for young women, less than half of sex workers, and only about a third of gay men and other men who have sex with men and people who inject drugs regularly access prevention in GPC focus countries).

Condoms remain the most effective low-cost HIV prevention tool, however global condom procurement or distribution in low- and middle-income countries declined by an average of 27% between 2010 and 2022 and procurement by major donors fell by an average 32% in that period. Socially marketed distribution declined from a peak of about 3.5 billion condoms in 2011 to about 1.8 billion in 2022.

Condoms, PrEP, post exposure prophylaxis, antiretroviral therapy to ensure viral suppression thus preventing transmission of the virus, harm reduction and voluntary medical male circumcision are all HIV prevention options that should be real choices available for people at risk of HIV infection. Addressing structural and gender inequalities faced by these priority and key populations is essential in ensuring access to prevention services. The urgency to secure and sustain gains for HIV prevention cannot be overemphasized – programmes need to be community-led and country-led.

“No matter how good the science or community leadership, HIV will not end unless we have significant policy change to reverse criminalization and lessen stigmatization of affected populations. If we can’t protect human rights, then we can’t end HIV. This is never just about the virus—it’s about people, and the people must lead,” said Mitchell Warren, GPC co-chair and Executive Director, AVAC.

An enormous unmet need for resources for HIV prevention and societal enabler programmes in almost all regions persists. An estimated US$ 2.4 billion was available for primary prevention programmes in low- and middle-income countries in 2023 compared to the estimated need of USD 9.5 billion in 2025. Investing in HIV prevention now is essential to scale up programmes.

If 1.3 million people continue to acquire HIV every year, the response will become more challenging, more complex and more costly in 2030 and 2050. Increased investments in HIV prevention, strengthened political leadership, enabling legal and policy environments are urgently needed to effectively implement programmes. The time to act is now!   

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.

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