Nine quick facts about Unitaid’s investment in advanced HIV
Q&A
- What is advanced HIV disease?
People with advanced HIV disease have a very weakened immune system, putting them at high risk of deadly opportunistic infections such as tuberculosis (TB), cryptococcal meningitis, pneumocystis pneumonia and other bacterial and parasitic diseases. HIV destroys essential immune system cells (CD4) that protect the body from infections. Hence, the World Health Organization (WHO) defines advanced HIV disease as having a CD4 count below 200 cells/microliter or WHO clinical stage 3 or 4 of the disease.
- How big a problem is advanced HIV disease globally?
In lower-income countries, one in three people starting treatment have a very weakened immune system and are at risk of death even after getting on antiretrovirals, the medicines used to suppress the HIV virus. In sub-Saharan Africa, about 10 percent of those patients die within the first three months of enrollment.
- Why does advanced HIV prevail despite the increase in access to antiretroviral treatment (ART) in the last decades?
Advanced HIV disease prevails —despite the increase in access to antiretroviral treatment (ART)— due to delays in starting ART, treatment interruptions, and development of resistance to antiretrovirals.
- Why is Unitaid targeting advanced HIV disease?
The persistent and high burden of patients with advanced HIV disease leads to deaths from infections that are preventable and treatable; multiplies the costs to health systems; and increases the risk of transmission. Despite the massive scale-up of ART, decline in HIV mortality has plateaued in the last two years at around 1 million annual deaths.
There are now new medicines and screening tools to prevent, diagnose and treat advanced HIV disease, but demand- and supply-side challenges are stopping these products from reaching everyone who needs them.
- What exactly is Unitaid investing in?
Unitaid is investing US$ 20 million in measures to avert hundreds of thousands of preventable deaths among people living with HIV. Specifically, it intends to widen access to a package of live-saving medicines and diagnostics for opportunistic diseases in patients with advanced HIV disease. The grant, to be implemented by the Clinton Health Access Initiative (CHAI), builds on Unitaid’s work to expand access to the best available antiretrovirals and foster prompter treatment of HIV.
- How does Unitaid plan to make a difference?
Unitaid’s catalytic investment intends to make the WHO-recommended package of health products more affordable and accessible, and pave the way for governments and partners to make it widely available in countries. To that end, the grant will address bottlenecks on both the demand and supply-side of the market (e.g., high prices, low demand, regulatory obstacles). The ultimate goal is to avert hundreds of thousands of preventable deaths and improve the global response to HIV.
- What health products is Unitaid intending to widen access to?
Unitaid will target a package of WHO-recommended drugs and diagnostic tools for the management of advanced HIV disease, particularly TB, cryptococcal meningitis and severe bacterial infections. TB and cryptococcal meningitis account for half of HIV-related deaths. TB, the leading cause of death among people living with HIV, killed some 300,000 people in 2017, 86 percent of them in Africa. Cryptococcal meningitis, a fungal infection of the lining of the brain and spinal cord, takes 180,000 lives of people with HIV every year.
- With whom will Unitaid partner?
Lead grantee CHAI will partner with Doctors Without Borders (MSF) and the Elizabeth Glaser Paediatric AIDS Foundation (EGPAF) in key countries, and both Unitaid and CHAI will continue working with civil society, academia, governments, WHO and global health partners towards the elimination of HIV worldwide.
- Had Unitaid worked in advanced HIV disease before?
In related work last year, Unitaid struck two landmark agreements to improve treatment for those with advanced HIV disease: A deal with Indian drug manufacturer Cipla Ltd. lowered the price of the only combination pill aimed at preventing TB and other opportunistic infections; and another deal with Gilead Science reduced the price of a more tolerable formulation of a drug to treat cryptococcal meningitis.
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The Medicines Patent Pool and Unitaid publish intellectual property report on long-acting technologies
The Medicines Patent Pool (MPP) and Unitaid have jointly published a study into the patent landscape for long-acting technologies with the potential to have a major impact on preventing or treating HIV, hepatitis C, tuberculosis, and malaria in low- and middle-income countries.
The Intellectual Property Report on Long-Acting Technologies provides an overview of the intellectual property status of long-acting products under development or already on the market as of October, 2018.
The patent situation for long-acting products can be complex, the report finds, involving patent protection on the drugs themselves, on the technologies needed to manufacture them, and, in some cases, on the delivery devices.
In the case of nanoformulations, for example, there is high potential for overlapping patents. The delivery platforms are often applied to multiple products and are covered, as well, by extensive intellectual property protection. These factors and others summarised in the report may complicate adapting some long-acting products to the needs of low- and middle-income countries.
The report also finds that the geographical breadth of patent protection varies significantly among long-acting products, but that in general, products appear to have patents pending or granted for generic manufacturing in key countries.
The report, compiled by the MPP and Unitaid, provides a patent landscape of intellectual property protection for long-acting products marketed or under development for prevention and treatment of HIV, hepatitis C, tuberculosis, and malaria.
“There is huge potential for long-acting technologies to make a substantial difference to treatment adherence in low- and middle-income countries, for diseases including HIV, hepatitis C and tuberculosis. But this won’t happen by itself,” MPP Executive Director Charles Gore said. “Much collaboration is still required to develop them and then ensure affordable access. This report, by mapping the patent landscape for these technologies, will help accelerate this process.”
The report discusses the challenges of developing a healthy market for long-acting products in low- and middle-income countries. It also touches on the range of actors involved, where opportunities for partnerships might be found to speed development and widen access.
“To avoid the pitfalls of the past, when new medicines were introduced first in high-income countries and only much later in lower-income countries, we need to keep ahead of the curve to prepare for a healthy market and prompt access to these game-changing long-acting tools,” Unitaid Executive Director Lelio Marmora said.
For more information:
Long-acting technologies for infectious diseases in LMICs – The Lancet, October 2018
Unitaid to support new tools for P. vivax malaria and long-acting medical technologies to fight disease
MARRAKESH, Morocco – Unitaid’s Executive Board agreed to support innovative, long-acting medical technologies to prevent and treat infectious diseases in low- and middle-income countries, and to promote new tools for the diagnosis and treatment of Plasmodium vivax malaria.
In approving the two new areas in which it will target investment, the Board opened the way for Unitaid to invite relevant projects for funding.
In high-income countries, long-acting technologies have brought a shift from daily oral medication to monthly, or even less-frequent dosing for conditions ranging from schizophrenia to osteoporosis. Long-acting contraception has already transformed reproductive health in low-income countries.
Unitaid sees promise in quickly adapting long-acting technologies for major public health challenges in low- and middle-income countries — where introducing the latest health innovations requires operational, regulatory and administrative hurdles to be overcome. Long-acting products could be made available as long-acting injectables, implants, rings, patches, and weekly capsules.
“A rich pipeline is emerging in long-acting technologies, “ Unitaid Executive Director Lelio Marmora said. “Shortening the time to make these innovations a reality in low- and middle- income countries could significantly reduce illness and death from infectious diseases such as HIV, TB and malaria – and many other conditions.”
Long-acting medicines for treatment and prevention hold the promise of revolutionizing the management of major diseases. Daily doses of medicines might no longer be needed, making adherence to treatment or prevention regimens much easier.
Poor adherence to medicines is a major healthcare challenge. It not only leads to continued illness and the spread of diseases but can enhance drug-resistance, including in TB, HIV and malaria. Drug-resistance ranks among the biggest threats to global health.
The Board’s action today also allows for Unitaid to explore projects to fight Plasmodium vivax malaria. More than one-third of the world’s population lives in areas affected by this species of malaria. Those at high risk of Plasmodium vivax malaria include migrants, the rural poor, and children under five years old.
Specifically, Unitaid will explore opportunities such as piloting a new single-dose cure for Plasmodium vivax and supporting development of quality-assured paediatric treatments.
“Radical cure has the potential to avert millions of P. vivax cases and save tens of millions of dollars,” Marmora said. “There is a strong rationale for Unitaid to leverage its unique role and operating model to support the safe use of tafenoquine and other tools.”
Plasmodium vivax accounts for a small proportion of cases of malaria globally and is prevalent in Asian countries, such as India and Pakistan, Latin America and parts of Africa. If not treated effectively, patients may experience increasingly debilitating relapses that can eventually prove fatal.
The Hummingbird. Unitaid News – December 2018
Unitaid drives expansion in HIV self-testing to get more people to know their status
Geneva – Knowing their HIV status gives people the means to seek treatment, but one in four people living with HIV are not aware they have the disease. In response, Unitaid is investing in innovative diagnostics to bring that knowledge to those in greatest need and often hardest to reach with HIV testing, including key populations, men and young people in Africa.
A report launched jointly today with Population Services International (PSI), London School of Hygiene and Tropical Medicine and WHO unveils results of our HIV Self-Testing Africa (STAR) Initiative, which is generating the evidence for countries worldwide to scale up HIV self-testing and encouraging millions more people to find out their HIV status.
The report indicates an estimated 45 percent of people living with HIV in sub-Saharan Africa knew their status at the end of 2014, just before the STAR initiative was launched. It is now estimated 81 percent know their HIV status in sub-Saharan Africa.
“The brilliance of the Unitaid-funded STAR Initiative has been to take a recognized technology and find ways to get it into the hands of those we most need to reach if we are to control the HIV epidemic: men, highly stigmatized groups and those who have been left out of years of investment in HIV testing” said Karl Hofmann, President and CEO of PSI. “STAR has created new momentum, brought new actors onto the scene, unlocked new investments by governments and donors. STAR is opening a new chapter in the push to Know Your Status.”
The Unitaid-funded STAR initiative is the largest HIVST project globally. The evidence generated by this catalytic investment has directly informed WHO guidelines on HIV self-testing, released in December 2016, and led to the prequalification of two HIV self-testing products. As a result, 59 countries now have policies on HIV self-testing and 28 are actively implementing it, with an additional 53 reporting that a policy is under development.
“Unitaid has demonstrated bold leadership in increasing access to HIV testing through self-testing. WHO is privileged to be part of their successful work through STAR. The data and experience being generated by STAR continues to be critical in catalyzing HIV self-testing scale up in many other countries and regions” said Gottfried Hirnschall, Director of the HIV/AIDS Department and the Global Hepatitis Programme at WHO.
“Scale-up is the measure of our success, so we are immensely pleased by the results and promise of STAR,” said Unitaid’s executive director Lelio Marmora. “We will continue leveraging innovation to address shortcomings in the HIV response and accelerate efforts to fulfil global health targets.”
HIV self-testing offers a discreet and convenient way to test, with the potential to reach individuals in need of HIV testing services who may not otherwise seek a test. “Now, for many, testing for HIV does not have to mean travelling long distances, taking time from work, waiting in long lines or worrying about who might see them going for testing,” notes the report.
Unitaid’s HIV portfolio will reach $497 million in 2018 and continue to expand through 2020. Currently, we are investing in various projects that support the STAR Initiative in expanding HIV self-testing: the ATLAS project with Solthis is bringing HIV self-testing to West Africa; the TV drama series MTV Shuga, which is widely broadcast in Africa, will raise awareness of HIV self-testing among young people; and the ImPreP Project with Fiotec is implementing HIV self-testing to increase demand for preventive therapy (PrEP) in Brazil, Mexico and Peru.
DOCUMENTS
Knowing your status – then and now. Realizing the potential of HIV self-testing, STAR Initiative Report
Point-of-care early infant diagnosis. Getting babies born with HIV on treatment, earlier.
