New study is a breakthrough for preventing tuberculosis in people living with HIV
Geneva – A Unitaid-funded study has found that 3HP, a new, shorter preventive therapy for tuberculosis, is safe for people who also take the HIV drug dolutegravir. The results mark a critical milestone for countries and funding partners seeking to expand preventive TB therapy.
“These are the results we have all been waiting for,” Unitaid Executive Director Lelio Marmora said. “The evidence that 3HP is safe to use with dolutegravir, today’s most advanced HIV treatment, is critical for the scale up of short-course preventive therapy for TB. We now need to focus on affordable pricing for access.”
TB kills some 340,000 people living with HIV every year and accounts for about a third of HIV-related deaths. TB preventive therapy protects people already infected with TB bacteria from falling ill with the active disease and shields those at risk of exposure. A third of the world’s population is infected with latent TB, and HIV infection makes them much more likely to develop active TB.
The new therapy, a rifapentine-based regimen known as 3HP, requires only once-weekly treatment for 12 weeks, compared to the 6-to-36 month daily regimen required under the older standard of care, isoniazid preventive therapy (IPT). Patients are more likely to complete shorter treatments.
The study was carried out in South Africa by Unitaid grantee Aurum Institute and the Johns Hopkins University Center for TB Research as part of the IMPAACT4TB project.
Unitaid is investing US$ 59 million in the Aurum-led IMPAACT4TB (2017-2021) project, which seeks to establish rifapentine-based preventative regimens as affordable, quality-assured, less-toxic therapies suitable for wide introduction in countries most affected by TB.
The study also found that people who take 3HP do not require a higher dose of dolutegravir, and that all viral loads were suppressed while the patients were taking 3HP.
The findings were presented today in Seattle at the Conference on Retroviruses and Opportunistic Infections (CROI).
“Latent TB infection is the reservoir from which active cases develop, which in turn fuels transmission of the disease,” said Aurum Institute Group CEO Gavin Churchyard. “Scaling up new, safer, shorter prevention therapies, such as 3HP, is key to ending the TB epidemic.”
Today’s results allow IMPAACT4TB to move forward with activities to improve the affordability and feasibility of TB prevention using 3HP. This work is expected to pave the way for the scale-up of 3HP by key funders of TB prevention interventions, including the Global Fund, PEPFAR and Stop TB Partnership.
“The news that 3HP is safe for people being treated with DTG opens the door to healthy, productive lives for a vast number of people who would otherwise die of tuberculosis,” said Dr Tereza Kasaeva, Director of the Global Tuberculosis Programme at WHO. “With scale-up as recommended by WHO’s new guidelines on latent TB infection, 3HP has enormous potential as a tool to help achieve the target of reaching 30 million people with TB preventive treatment by 2022, as outlined in the political declaration of the first UN High Level Meeting on TB in September 2018.”
The project is being implemented in the following countries: Brazil, Ghana, Ethiopia, Kenya, Tanzania, Malawi, Zimbabwe, Mozambique, South Africa, India, Cambodia and Indonesia.
IMPAACT4TB stands for the full project name: Increasing Market and Public health outcomes through scaling up Affordable Access models of short Course preventive therapy for TB.
Unitaid seeks innovative, long-lasting technologies to help tackle diseases
Geneva – Unitaid is pleased to announce a call for proposals for projects speeding development of long-acting versions of medicines that could potentially revolutionize treatment and prevention of diseases including HIV, tuberculosis and malaria in low- and middle-income countries.
Safe and effective daily oral medicines are available for the prevention and treatment of major diseases, but they are not always taken consistently, resulting in worse health outcomes, the spread of illness and the development of drug-resistant superbugs.
Long-acting treatments include slow-release injectables, implants, patches or rings that can last more than a month, and oral medicines that can last more than a week. Delivering medicines this way frees patients from complex, daily regimens with many pills, and could also improve access and address stigma.
Unitaid is soliciting proposals that:
• Reformulate critical standard-of-care medicines into long-acting products.
• Enable sound plans to commercialize these products, including a scale-up strategy to introduce them on a large scale.
• Focus on products that can be introduced in the market within three to five years.
Through calls for proposals, Unitaid finds smart new ideas to help alleviate the burden of diseases, and conducts pilots that, if successful, are scaled up by partner organizations such as the Global Fund. An independent review committee of global health experts helps Unitaid choose the best proposals to fund through a competitive selection process.
Unitaid launches initiative to avert deaths from advanced HIV
Geneva – Unitaid is investing US$ 20 million in measures to avert hundreds of thousands of preventable deaths among people with advanced HIV.
The initiative seeks to forge a more effective global response to diagnosing and treating people whose immune systems are so weakened by HIV that they are at risk of infection by other life-threatening diseases.
The grant, to be implemented by Clinton Health Access Initiative (CHAI), will help make new, WHO-recommended medicines and testing tools affordable and available in lower-income countries.
“This promises to be an enormous benefit not only to individuals, but to the global HIV response,” Unitaid Executive Director Lelio Marmora said. “Addressing advanced HIV could prevent four out of ten HIV-related deaths every year.”
The intention is to create a model for tackling advanced HIV that can be scaled up by national governments and funding partners such as the Global Fund and PEPFAR.
The new investment builds on Unitaid’s 2016-2019 work with CHAI to expand access to the best available antiretrovirals.
The HIV virus weakens the immune system, increasing the risk of dangerous infection by bacteria, viruses and fungi. A person is said to have advanced HIV disease when his or her immune system can no longer fight off these opportunistic infections.
“Millions of lives have been saved by greater access to antiretroviral therapy, but many people with advanced HIV are still at risk of dying,” said Peter Sands, Executive Director of the Global Fund. “By taking on this challenge together, we can move toward our common goal of ending HIV.”
A third of the people who begin HIV treatment get started so late that they already have very weakened immune systems. They are at risk of death even after getting on antiretrovirals, the medicine used to suppress the virus.
Extraordinary progress has been made over the past two decades in expanding access to treatment for HIV and encouraging people to test and begin treatment earlier. However, deaths from HIV-related diseases have not decreased as much as expected; they stand at about one million annually.
Tuberculosis is the leading cause of death among people living with HIV, claiming 300,000 lives in 2017. About 180,000 people with HIV die every year from cryptococcal meningitis, a fungal infection of the lining of the brain and spinal cord.
Last year, Unitaid secured two landmark agreements to improve treatment for those with advanced HIV disease: An agreement with the Indian drug manufacturer Cipla Ltd. lowered the price of an innovative combination therapy for co-infections including TB, and an agreement with Gilead Science reduced the price of a more tolerable formulation of AmBisome®, a drug for cryptococcal meningitis. Lower prices will allow more people to access treatment for these life-threatening infections.
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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.
