pre-exposure prophylaxis

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."

/ENDS

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.

13 March 2024—A new report, HIV Prevention: From Crisis to Opportunity shows that HIV infections continue to decline in countries that are part of the Global HIV Prevention Coalition (GPC) faster than in the rest of the world.

Eleven GPC focus countries have reduced their annual number of new HIV infections by at least 66% since 2010. By comparison, the average reduction in new HIV infections since 2010 globally is 38%. The GPC is a coalition of 38 countries working together to accelerate declines in new HIV infections to achieve the target of having 95% of the people who are at risk of HIV accessing effective combination prevention options.

The GPC countries that have prioritised primary prevention and treatment and that have focused on reaching people most at risk have secured the strongest consistent declines in new HIV infections.

Globally, progress in HIV prevention has been highly uneven and a majority of the world’s countries are not currently on track to achieve the 2025 targets. Indeed, several countries are experiencing prevention crises with low access to services and face record rising new HIV infections.

“The findings of this report offer crucial lessons for action,” said Angeli Achrekar, Deputy Executive Director Programme, UNAIDS. “The report shows that sustained political leadership, investment in effective HIV prevention programmes, and an enabling policy environment are crucial to end AIDS as a public health threat by 2030.”

Declines in new HIV infections have been boosted by the cumulative impact of combination HIV prevention options and increased access to antiretroviral treatment which has also increased viral suppression in people living with HIV. People who are on treatment and are virally supressed cannot transmit HIV.

“It’s remarkable to see what has been achieved in the AIDS response in the past 20 years. But the progress to date has not been equitable and is not yet sustainable, and we must never confuse progress with being sure of success,” said Mitchell Warren, GPC co-chair and Executive Director, AVAC. “Our progress is fragile, and what we’ve achieved today could slip away even more quickly than it was achieved if we let complacency take hold.”

Key populations and adolescent girls and young women are still at high risk of new infections

HIV incidence remains unacceptably high among populations where gaps in HIV prevention investments persist. This includes key populations in all regions globally and adolescent girls and young women in parts of sub-Saharan Africa.

Around 3100 young women and girls aged 15-24 became newly infected with HIV every week in sub-Saharan Africa in 2022 and HIV incidence declined less rapidly than it has among young men. Only 43% of the sub-national areas in which there is elevated HIV incidence among young women are being reached with dedicated prevention programmes for young women.

Although GPC countries have shown solid gains in reducing new HIV infections, challenges remain worldwide in reaching key populations most at risk of new HIV infections including men who have sex with men, sex workers and people who inject drugs. Every week, more than 11 000 new HIV infections occur among key populations and their sexual partners globally.

Only 44% of sex workers, 28% of gay men and other men who have sex with men, and 37% of people who inject drugs accessed two or more HIV prevention services in the previous three months according to median values reported by GPC countries ––against a target of 90%.

HIV prevention is being obstructed by shortfalls in prevention financing, and by punitive laws. Social stigma, violence, discrimination and social exclusion are barriers to key populations’ access to health-care services and information, exacerbating their risk of acquiring HIV. Law reform is a crucial enabler of prevention programmes. Protecting the human rights of everyone is vital for protecting the health of everyone.

Investments in both condom and voluntary medical male circumcision programmes, which are both effective in preventing HIV, have fallen in some of the countries with the largest HIV epidemics. In addition, breakthrough HIV prevention options such as pre-exposure prophylaxis (PrEP), medicine to prevent HIV, are still only available to a small fraction of the people who need them.

There are unprecedented opportunities for HIV prevention in 2024. There is a growing array of prevention options including existing tools and new long-acting prevention technologies, as well as country examples of how to implement prevention at scale and increase choices available to communities.

HIV Prevention programmes need to be at scale, efficient and equitable. The actions that are needed for success and sustainability are known, have been shown to work, and have been agreed: collaborate, follow science, tackle inequalities, protect everyone’s rights, let communities lead, and invest in what is needed. Sliding back on resourcing or inclusion would hurt everyone. Solidarity will benefit everyone. Communities, countries and international partners can prevent new infections – together.

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, 31 March 2023 — UNAIDS welcomes the announcement by Medicines Patent Pool (MPP) and ViiV of three licenses signed with generic manufacturers Aurobindo, Cipla and Viatris for long-acting Cabotegravir for PrEP (Pre-exposure prophylaxis.) PrEP reduces risk of HIV transmission from sex or injecting drug use. UNAIDS also called for urgent action by ViiV to be taken to reduce the price and increase the production of CAB-LA now.

UNAIDS Deputy Executive Director for Policy, Advocacy and Knowledge, Christine Stegling said:

“UNAIDS applauds this announcement by the Medicines Patent Pool, and congratulates the companies on securing the licensing agreement. The generic production of affordable CAB-LA is essential to preventing millions of new HIV infections. The progress made is a testament to the power of campaigning communities who have mobilised to demand long-acting medicines, and to the determined efforts of access to medicines advocates. UNAIDS thanks ViiV for the commitment to tech sharing made through these agreements, and urges all patent holders of long-acting HIV medicines, including those still in development, to commit to share, and make their technology available, now. UNAIDS welcomes that this is only the first announcement of licensing, not the last, and urges ViiV to expand the geographic coverage of the licensing to all low and middle income countries. Because generic production will take several years to get to medicines being available for use, UNAIDS also urges ViiV to right now provide its own production of CAB-LA to procurers at an affordable price and in volumes that match need. We must all be driven by the fierce urgency of now.”

Progress in the global HIV response is slowing, and too many countries are seeing rising infections. The 2025 targets are in danger, and only bold actions can enable the curve of new infections to be pulled down. The deployment of new technologies such as long-acting CAB-LA at an affordable price is urgent and will help fill critical HIV prevention needs for people facing the highest HIV risks. It is also notably welcome that one of the sub-licenses (Cipla) plans to manufacture in South Africa, in addition to India. This is an important step in support of increased local manufacturing of medicines in Africa. 

UNAIDS acknowledges this concrete step towards generic production of needed innovative products but urges that short term solutions be put in place immediately and until generic products are widely available. UNAIDS is notably concerned with the recent announcements that current supplies of CAB-LA are not at all sufficient to meet growing demand, and are much less than procurers have said they could purchase. Transparency in sharing information on volumes and price by ViiV of long-acting CAB-LA is essential to help drive progress in increasing volumes.

It is vital and urgent that long-acting anti-retrovirals for PrEP be made available at an affordable price everywhere they are needed. Middle-income countries are now where the majority of new HIV infections occur and home to many of the key populations most at risk of HIV transmission and who most need access to long-acting ARVs. But many countries are not included in this license despite considerable need for affordable new health technologies.

The issuance of these three licenses should pave the way for sharing technology on other innovations for long-acting HIV prevention and for long-acting treatment. UNAIDS urges that licensing help develop a path for accelerated market entry of generic formulations of long-acting anti-retrovirals not only for prevention, but also for treatment, when normative guidance is established, and regulatory approvals are in place at country level.

UNAIDS calls on the private sector, governments and funders to ensure that everyone who needs long-acting antiretrovirals can access them. UNAIDS will continue working with the Coalition to Accelerate Access to Long-Acting PrEP that is jointly convened by the Global Fund on AIDS, TB and Malaria, PEPFAR, Unitaid and the World Health Organization (WHO) with AVAC as its Secretariat to find solutions and ensure equitable global access to pandemic-fighting technologies 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.

“This isn’t your mother’s clinic!” said one amazed visitor.

From banners to brochures, all promotional materials are slick and cheerful. Smiling faces and toned torsos are everywhere. A purple colour scheme covers the whole building. Even files and staff face masks are colour coordinated. A pair of Facebook Live hosts have the good looks and energy of K-pop stars. And the organization’s slogan is decidedly upbeat: “where community fulfills your happiness”.

Over almost two decades, Thailand’s Mplus Foundation has refined a unique approach to providing comprehensive HV services to key population clients including men who have sex with men and transgender women.

Their method goes far beyond a cool brand identity. Mplus has leveraged domestic and international partnerships to create a key population-led health service with impressive results. They dispense more than half of the PrEP in Thailand’s Chiang Mai province.

This year they tested 95% of the almost 8000 people they reached with face-to-face services. Of those who tested positive, 91% were placed on treatment while the other 9% are in follow-up case management. And 100% of their clients who received viral load testing were found to be virally suppressed.   

“Community organizations can best reach key populations to receive services. We find that people who do not want to get tested at the hospital are comfortable with peers who they know understand their  life,” explained Pongpeera Patpeerapong, Director of the Mplus Foundation.   

Since its formation in 2003 Mplus has evolved to deliver a full range of services. They now have health centres in four provinces, while their mobile testing units serve clients in another five districts. They support a local hospital in each province, linking people to care and helping them with adherence. Mplus provides rapid testing, CD4 and viral load monitoring, and is also authorized to dispense medication. A small fleet of motorcycles even makes PrEP deliveries to clients in remote areas.

Both their online and offline engagements are anchored by a peer-led strategy. Their social media presence is commanding—everything from Twitter to Tik Tok. There are closed Facebook groups and special applications for clients to connect with community. Offline, they go beyond information booths to host parties and sport meet-ups. These aren’t just bonding exercises. Clients book appointments online and face-to-face interactions usually result in receiving an HIV test.

Mplus also provides technical assistance to other countries. It has supported an organization in Laos with online interventions and helped community groups in Cambodia develop campaigns to promote PrEP.

They played a key role in advocating nationally for the accreditation of community health workers. All Mplus staff are certified by the Department of Disease Control following a rigorous programme of study, evaluation and practice.

The programme continues to progress.  Mplus is strengthening their mental and emotional health support offering, and is working towards becoming certified to provide HIV and sexually transmitted infection (STI) treatment.

While in the past the programme was more heavily funded by the U.S. President's Emergency Plan for AIDS Relief through the United States Agency for International Development, today half of their investments come from branches of the National Health Security Office.

“Domestic funding is very important to develop our systems,” Mr. Patpeerapong said. “Community-based organizations have to be able to access domestic funding to cover more issues, including stigma and discrimination.”

Empowering key population-led health services has been crucial in improving Thailand’s HIV programme results. One of five people living with HIV in Thailand were identified and referred by a key population-led health service under the domestic health financing scheme. Four out of five people on PrEP in the country are served by community-led organizations. These services play a critical role in Thailand’s  strategy of Reach, Recruit, Test, Treat, Prevent, Retain.

“Thailand is well-positioned to be a leader in addressing the need for a sustainable community-led response as a critical part of the health infrastructure,” said UNAIDS Country Director for Thailand, Patchara Benjarattanaporn. “By creating an enabling system for health outreach we can address the challenge of late diagnosis and better reach key population communities with services.”

Thailand has integrated HIV services into its Universal Health Coverage scheme and increased investments in key population- and community-led health services. UNAIDS Programme Coordinating Board (PCB) members visited Mplus and other community-led health services ahead of the 51^st PCB meeting in Chiang Mai, Thailand.

Two young men are sitting on a couch scrolling on their phones when May Oo, a famous makeup artist and lesbian, gay, bisexual, transgender, and queer (LGBTQ) activist in Myanmar, joins them wearing a face mask and carrying a bag of drinks. He announces that a friend who works at an HIV clinic in Yangon told him that pre-exposure prophylaxis, or PrEP, is now available in Myanmar. As one friend is unaware of PrEP, May Oo shares his knowledge, also informing anyone else wo would like to listen in.

This scene, from a video shared on the Facebook pages of implementing partners of the USAID HIV/AIDS Flagship (UHF) Project, is one of several to raise awareness and demand PrEP as a prevention tool for men who have sex with men and transgender women in Myanmar. In these videos by celebrated members of the LGBTQ community and other educational posts, questions covered include what PrEP is, why it should be taken, and where to get it. As May Oo’s friend in the video puts it, ‘PrEP is a drug that can prevent HIV.’

Since 2016, PrEP has been included as a priority intervention in Myanmar’s National Strategic Plan on HIV/AIDS following recommendation by the World Health Organization that it be used as an essential part of HIV prevention services. It was also an objective of the UHF Project to introduce PrEP in Myanmar and integrate it into existing HIV services, since the project’s inception in August 2017.

The UHF Project, overseen by UNAIDS Myanmar and the non-governmental organisation Community Partners International, aims to develop, implement, and scale up innovative, cost-effective approaches to the HIV care cascade in Myanmar. As one of the innovative HIV prevention activities under the National Strategic Plan IV (2020-2025), the initial 18-month PrEP demonstration project began in July 2020 at three clinics in Yangon for men who have sex with men and transgender people.

Along with the pilot was a plan to expand the project for people who inject drugs in Kachin State since the UHF Project’s overarching goal is to foster interventions such as PrEP for Myanmar’s four key populations at highest risk for HIV—people who inject drugs, men who have sex with men, transgender people, and female sex workers in the five states and regions with the highest burden of HIV—Kachin and Shan States and Mandalay, Sagaing, and Yangon.

Formative assessments conducted prior to the inception of these PrEP services indicated that PrEP awareness in Myanmar was very low. Fewer than a quarter of focus group participants—comprised of men who have sex with men, transgender women, and people who inject drugs—had heard of PrEP prior to the assessment. Service providers interviewed as part of the assessments also described low PrEP awareness among their clients.

Once educated about PrEP, however, most study participants agreed that PrEP would benefit their communities and that people at risk would be interested and willing to take PrEP. Awareness raising and community education have been one of the UHF Project’s focuses to increase PrEP uptake in Myanmar.

That is where videos such as May Oo’s are important. By using celebrities, private chat groups, and informational posts alongside interactive follow up by service providers for recruitment of PrEP clients, implementing partners not only educate people at risk for HIV on PrEP as a prevention option but also address the stigma around it.

Respondents to a midterm analysis conducted one year into the PrEP project reported that Facebook was the primary source of PrEP information and education, as the potentially more effective approach of fully-fledged in-person outreach is not feasible in the country’s current situation.

‘There are many in rural areas who do not have access to or use social media platforms,’ reports Ma Shin Thant, a PrEP client and activist currently based in Mandalay for her work with transgender women. As PrEP is currently only available in Yangon, Ma Shin Thant is fortunate that she can afford access to required testing and PrEP delivery in Mandalay.

‘The next chapter of PrEP in Myanmar calls for greater political commitment, more resources, a decentralised and simplified delivery system, and innovative community-centred approaches to ensure access by populations who need PrEP,’ concurs Rangaiyan Gurumurthy, UNAIDS Myanmar Country Director. ‘Moving from the demonstration phase to reaching scale with epidemic impact is now necessary.’

While the number of new HIV infections in Indonesia decreased by 3.6% in 2021 to around 27 000, the country remains one of the countries with the highest number of new infections in the Asia and the Pacific region. Pre-exposure prophylaxis or PrEP is a medication that is highly effective at preventing HIV infection so making it available to groups of people most vulnerable is a key priority.

“In the past, I independently searched for information about PrEP because a client asked about it. I am glad there is a PrEP training that allows me to receive comprehensive information that I can then share with other people,” said Temmy a community outreach worker who participated in a training course in Bekasi.

PrEP was rolled out in Indonesia in 2021 as a pilot project to provide a new HIV prevention option which may be more convenient for people at risk of HIV, and to reduce new HIV infections among key populations such as sex workers and gay men and other men who have sex with men. It began in 12 districts, before expanding to 21 districts in 2022, with the aim of getting 7000 people on to PrEP.

As part of the expansion, a second round of training sessions was conducted in August across nine cities in Indonesia: Bogor City, Bogor Regency, Depok, Bekasi, Tangerang, Batam, Balikpapan, Samarinda, and Sidoarjo. Over 120 services providers from 24 hospitals and 47 outreach workers from local communities took part.

The PrEP training for health providers and community outreach workers was conducted by the Ministry of Health of Indonesia in partnership with Kerti Praja Foundation, Padjajaran University, and the national MSM-TG Network (GWL-INA). It was supported by donors, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID-PEPFAR and the Government of Australia’s Department of Foreign Affairs and Trade (DFAT).

"With less than a decade to go before our goal of ending AIDS by 2030, we must prioritize efforts to scale up combination prevention programmes, such as PrEP. The piloting of PrEP is critical to kickstart policy and programme development on PrEP in Indonesia. The conduct of training for service providers and community outreach workers is an integral part of the pilot implementation to ensure adequate capacities to provide PrEP services to communities in need,” said Krittayawan Boonto, the UNAIDS Country Director for Indonesia.

The PrEP training sessions are held over two days and include discussions between service providers and outreach workers. The aim is to equip and improve the capacity of the service providers and outreach workers to provide good quality PrEP services.

“This PrEP training has increased my knowledge of the alternative methods to prevent HIV. After this training, our health service office can now offer this new method of HIV prevention to our clients. We hope that this will contribute to the reduction of new infection risk. Thanks to this training, I have become more confident in providing PrEP services in the future,” said Doctor Elly from Lambuk Baja, Batam Province.

Unlike the first series of training sessions, the second was conducted in person and engagement was much higher. The enthusiasm also led to more active follow up after the training. One of the health centres in Bogor City started to provide PrEP services a couple of days after the end of the course. They also directly approached communities about the benefits of PrEP and within a month PrEP uptake had increased by 15%.

“As with all aspects of the HIV response, communities play a key role in the success of PrEP implementation. Contribution from the community is especially vital in the context of the pilot implementation in Indonesia, as communities of key populations with a substantial risk of HIV infection are the main beneficiaries of the programme,” said Muhammad Slamet, National Coordinator of the MSM-TG network (GWL Ina).