Unitaid to incentivize generic production of life-saving medicine for people living with advanced HIV disease

Geneva – Cryptococcal meningitis is a severe fungal infection of the brain that causes around 15% of AIDS-related deaths globally. 75% percent of resulting deaths occur in sub-Saharan Africa, largely due to a lack of access to critical medicines. To fast-track commercialization of affordable, quality-assured supplies of a highly effective medicine used to treat cryptococcal meningitis, Unitaid has launched a call to generic manufacturers needing support to bring their product to market in low- and middle-income countries (LMICs).

Liposomal Amphotericin B (L-AmB) is the main drug used in the treatment of cryptococcal meningitis. Newly updated guidance from the World Health Organization now recommends treatment through a single high dose of L-AmB, making treatment simpler and causing fewer toxic side effects for the patient. However, new treatment guidance will only translate into lives saved if access to the drug is greatly improved.

Currently, although a 2018 agreement between Unitaid and the originator manufacturer Gilead secured access for the product in 116 LMICs at the price of US$ 16.25 per vial, uptake has been slow. So far, L-AmB is available at the negotiated price in 50 countries. Additional generic suppliers would help get vital, affordable, quality-assured products to countries more quickly.

With antigen screening methods adopted by many HIV programs in Africa and the prevalence of the infection now known in the key regions, access to simple, affordable treatments could significantly advance efforts to save lives threatened by the opportunistic infection.

“Cryptococcal meningitis is a leading cause of death among people with HIV. Recent advances in testing and treatment can only go so far if the medicine is unavailable in the places it is most needed. Through its work, Unitaid aims to quickly enable access to quality, affordable, life-saving medicine,” said Janet Ginnard, Director of Strategy at Unitaid.

Manufacturers with a generic formulation of L-AmB in advanced stages of development or ready for commercialization are invited to apply for technical, regulatory and/or financial support to quickly improve affordable, equitable access to life-saving medicine.


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Unitaid and the Government of Kenya strengthen collaborative partnership to advance global health goals 

Nairobi/Geneva – Global health agency Unitaid and the Government of Kenya are launching a newly reinforced cooperation, with a memorandum of understanding between the two parties signed in Nairobi.

Over its decade and a half history, Unitaid has worked closely with Kenyan partners to enable affordable, equitable, and rapid access to game-changing health innovations for those who need them. These include early infant HIV diagnostics, best-in-class antiretroviral drugs for adults and children with HIV, child-friendly tuberculosis (TB) medicines, cutting-edge screen-and-treat solutions for cervical cancer, indoor sprays to curb malaria, and access to COVID-19 tests and medical oxygen, among many others.

The agreement will further improve alignment between Unitaid investments and Kenyan health priorities, enable early access to innovations, and strengthen capacity of Kenyan health services, systems, research institutions and manufacturers.

“Unitaid’s collaboration with Kenya dates from its very beginnings 15 years ago. Nearly 80% of Unitaid’s US$1.5 billion currently invested supports work on the African continent. Kenya is a close partner in these efforts – both as one of the countries where the greatest number of Unitaid projects are running, and as one of the quickest countries to adopt and scale up critical health innovations,” said Dr Philippe Duneton, Executive Director of Unitaid. “This partnership will further advance our shared goals to improve health in Kenya and beyond.”

“Advances in health innovations hold game-changing potential when implemented widely and equitably, but ensuring products reach the last mile is far from guaranteed. This is why our partnership with Unitaid is so valuable: together we will design the most impactful solutions so no one is left behind,” “said Sen. Mutahi Kagwe, Cabinet Secretary for Health of the Republic of Kenya.

Joint efforts will focus on advancing sustainable approaches to reduce the burdens of HIV, TB, malaria, cervical cancer, hepatitis and COVID-19, improve the health of women and children, increase regional and domestic manufacturing of essential health products and strengthen pandemic preparedness and response efforts.


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Unitaid Strategy 2023-2027

Joint end of project evaluation – HIV Self-Testing (HIVST) area for intervention, Executive Summary

Unitaid HIV Self Testing (HIVST) area for intervention, Joint end of project evaluation, Supplementary Appendices

Unitaid HIV Self Testing (HIVST) area for intervention – Joint end of project evaluation

Unitaid to introduce new long-lasting injection to prevent HIV in Brazil and South Africa, as high-income countries begin deployment 

  • Unitaid will fund implementation of the latest innovation in HIV prevention – an injectable version of pre-exposure prophylaxis (PrEP) that has shown to be more effective than daily oral PrEP in reducing the risk of HIV infection, with just six injections a year. 
  • United Nations’ targets to reach three million people with PrEP by 2020 were missed by two-thirds. Long-acting cabotegravir provides a new alternative that addresses challenges associated with oral PrEP including inconsistent use and fear of stigma or discrimination, and could extend benefits to millions of people at risk of HIV infection.  
  • Unitaid, in partnership with Fiocruz in Brazil, Wits RHI in South Africa, and local health authorities in both countries, will integrate long-acting PrEP into national sexual health programmes and generate crucial real-world evidence that will underpin efforts for rapid global scale-up. 
  • Parallel action is urgently required to secure broader access for long-acting cabotegravir so 2025 UN prevention targets to reach 95% of people at risk of infection can be achieved  

Geneva – People at risk of HIV in Brazil and South Africa will be among the first to benefit from a highly effective, long-acting injectable HIV preventive treatment through two large-scale operational projects funded by global health agency Unitaid.  

Long-acting cabotegravir is a new HIV prevention method that provides eight weeks of continuous protection against HIV infection through a single intramuscular injection.  

This provides an alternative to oral pre-exposure prophylaxis (PrEP), which can reduce the risk of HIV infection by 99%, but only when taken as prescribed: either once a day, or before and after sex for cisgender men.  

Long-acting cabotegravir addresses challenges users face with regular pills that reduce the impact of oral PrEP in real-world settings. It also mitigates fears that pills will be misinterpreted for HIV treatment and cause the user to suffer stigma, discrimination, or intimate partner violence as a result. 

Unitaid will partner with Fiocruz in Brazil, Wits RHI in South Africa, and local health authorities in both countries to integrate long-acting cabotegravir into national sexual health programmes, generating some of the first real-world evidence that will support wide-scale global implementation. 

Despite the high protection oral PrEP can provide, uptake has been slow. United Nations targets to increase PrEP coverage and reduce new HIV infections by 2020 were both missed by two-thirds. And disparities in who is accessing treatment and prevention are growing.   

In Brazil, the programmes will aim to reach the two groups with the highest rates of HIV prevalence: an estimated 30% of transgender people and 18% of men who have sex with men in the country are living with HIV. 

Adolescent girls and young women, who will be the target of the Unitaid-funded efforts in South Africa, become infected at a disproportionately high rate. In sub-Saharan Africa, six in seven new HIV infections in adolescents occur among girls, and young women are twice as likely to be living with HIV as their male peers.   

“Unitaid recognizes the game-changing potential long-acting PrEP could have in making HIV prevention a more viable option for more people,” said Dr Philippe Duneton, Executive Director of Unitaid. “But we need urgent action to ensure people everywhere can benefit. We need adequate and affordable supply without delay. And we strongly encourage ViiV to develop a transparent access policy for long-acting cabotegravir that readily enables voluntary licenses through the Medicines Patent Pool to assure a generic pathway to broader access.” 

“Thanks to Unitaid’s investments, communities in Brazil with disproportionately high rates of HIV will be among the first in the world to benefit from this new preventive treatment,” said Marcelo Queiroga, Minister of Health of Brazil. “Working within our national health system, this project will not only integrate new PrEP options into existing services, it will also develop a model to scale up long-lasting PrEP so people across the continent and beyond can benefit.” 

The South African programme will include a second new long-acting HIV prevention product targeted at adolescent girls and young women. The dapivirine vaginal ring lasts 28 days, can be inserted at home, and is the first HIV prevention method a woman has complete control over.     

Supplies of long-acting cabotegravir and the dapivirine ring used in these projects have been donated by ViiV and the Global Fund through the South African Department of Health, respectively. 


ADDITIONAL QUOTES 

“It is exciting to see these bold investments by Unitaid in new long-acting HIV prevention options. To date there is little experience of offering these choices outside trial settings. These projects will provide invaluable information and evidence on how to deliver long-acting cabotegravir and the dapivirine vaginal ring in a safe and acceptable way, while answering many implementation questions critical to the development of future WHO guidelines,” said Dr Meg Doherty Director of the Global HIV, Hepatitis and Sexually Transmitted Infections Programme at WHO. 

“New HIV Prevention technologies have the potential to change the face of the HIV epidemic. But we know that access and use are not aligned unless research and planning is put into product introduction,” said Prof Helen Rees, Executive Director, Wits RHI. 

“This investment comes at a time when the field needs real-world evidence around the delivery of HIV prevention choices. We need innovative service delivery approaches to maximize public health impact of these promising new technologies through evidence-based strategies for introduction,” said Prof Saiqa Mullick, Director of Implementation Science, Wits RHI.  


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Landscape report launched on novel technologies for the prevention of HIV, STIs, and unintended pregnancy

Geneva – Emerging technologies that can prevent HIV, other sexually transmitted infections and unintended pregnancies through a single administration method have the potential to respond better to user preferences, simplify service delivery, alleviate stigma, and reduce health risks. Currently, over two dozen of these tools, called multipurpose prevention technologies, are in development, demonstrating the opportunity to accelerate health impact and help achieve global health targets, according to a new landscape report jointly launched today by Unitaid, the Children’s Investment Fund Foundation, and the Initiative for Multipurpose Prevention Technologies.

From 2018 to 2020, the number of new HIV infections per year showed limited decrease. Women and girls are at heightened risk of infection in many parts of the world, particularly in sub-Saharan Africa where they made up 63% of all new infections in 2020. In addition, more than 200 million women in low- and middle-income countries who want to avoid pregnancy do not have access to modern methods of contraception.

Innovations that better address user preferences are critical to respond to these challenges. Globally, the preference for interventions that respond to several needs versus single indication products prevails across populations and geographies. The preference for multipurpose products even appears to outweigh preference for a particular delivery type, such as intravaginal rings, gels, implants, and oral pills. However, preferences for specific attributes vary, highlighting the importance of advancing a robust pipeline that offers a range of choices.

The landscape report provides an overview of the current novel technologies in development and assesses their relevance and potential in low- and middle-income countries. While the pipeline is rich, the report calls out the need to involve key populations early in the design, introduction and scale-up of new products and proactively address potential market barriers. These considerations, as well as plans for adoption, manufacturing capacity, a broad supply base and an effective introduction strategy are crucial to developing solutions that are accessible, affordable, and acceptable and truly respond to people’s needs.

  • Access the multipurpose prevention technologies landscape here


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Maggie Zander

Communications officer

Mobile: +41 79 593 17 74

Email: zanderm@unitaid.who.int