The Hummingbird. Unitaid News – November 2019
Negotiation reduces price, expands access to tuberculosis treatment
Brasilia – The Government of Brazil announced today that 30,000 people will next year receive treatments of rifapentine, a key drug for tuberculosis prevention, following a nearly 70 percent discount negotiated by Unitaid, the Global Fund and the pharmaceutical company Sanofi. The National Committee for Health Technology Incorporation will assess the integration of the drug into the Brazil public system.
The lower price of the drug is expected to lead to TB prevention for millions of people in more than 100 countries where the disease is most prevalent.
In Brazil, 75,000 people suffered from active tuberculosis in 2018. The country’s roughly 900,000 people living with HIV are at high risk for developing active TB, as are their household contacts, estimated at three people per home.
“The price reduction of latent TB treatment is a step forward in tackling the disease, and in improving the lives of people who may be affected by the it. For the Brazilian government, it is an important advance towards reaching the international commitments to end TB,” Brazil Minister of Health Dr. Luiz Henrique Mandetta said.
A quarter of the world’s population is infected with latent TB, in which the bacteria is dormant. HIV infection makes people up to 25 times more likely to fall ill with the active disease. Preventive therapy stops latent TB from becoming active.
Rifapentine is part of an effective therapy for TB called 3HP, which requires only once-weekly treatment for 12 weeks, compared to the 6-to-9-month daily regimen. That means patients receive 12 doses in three months, versus the 180 doses in six months or 270 doses in nine months required under the older standard of care, isoniazid preventive therapy.
The Unitaid-funded IMPAACT4TB project (2017-2021) has been working in 12 high-burden countries, including Brazil, to establish 3HP as an affordable, quality-assured and less-toxic therapy for TB prevention. Led by the Aurum Institute, IMPAACT4TB is providing 6,700 patients in Brazil with the new treatment.
“Today’s announcement from Brazil is exemplary,” said Unitaid’s Executive Director Lelio Marmora. “Unitaid is eager to witness the first impact that this groundbreaking deal will have for thousands of people vulnerable to the disease.”
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Carol MASCIOLA, masciolac@unitaid.who.int
Unitaid introduces its newest tuberculosis-fighting projects at Union World Conference
Hyderabad, India – Unitaid and partners launched a trio of innovations today that will work together to fight tuberculosis through gene-based diagnosis, better treatments and ingenious technologies that help patients remember to take their medicines.
The US$ 50 million in new investments was presented at the Union World Conference on Lung Health in India, confirming Unitaid’s position as the world’s largest multilateral funder of TB research and development. Unitaid’s TB portfolio has nearly doubled over the past few years and is on track to reach US$ 300 million in 2020.
TB kills about 1.5 million people a year.
Unitaid’s new projects attack the epidemic on three important fronts: diagnosis, treatment, and adherence, while working against drug-resistant infections. Drug-resistant TB poses a threat to the world’s gains against the epidemic.
“India, with the highest burden of TB globally, represents a fitting backdrop for launching Unitaid’s latest investments in the global response to end TB,” said Robert Matiru, director of programmes at Unitaid. “By attacking TB from multiple angles, these innovations are a promising, holistic response to the pressing need for new tools in this ancient fight”.
The projects are:
- BENEFIT Kids: Led by Stellenbosch University in South Africa, the three-year, US$ 18.9 million project will increase access to quality-assured medicines for multidrug-resistant TB that are adapted for children.
“Children have been largely neglected to date in the global response to MDR-TB and they deserve better. We are excited that, through Unitaid’s investment in this innovative project, Stellenbosch University and its partners can contribute to reduced morbidity and mortality in children by improving access to better, more child-friendly MDR-TB treatment and prevention,” said Prof. Anthony Garcia-Prats project leader with the Desmond Tutu TB Centre, Stellenbosch University and the University of Wisconsin-Madison.
- ASCENT: This project uses mobile technology to help TB patients take their medicines on schedule, and healthcare workers to offer optimal support to patients who need it the most. It employs “smart” pill boxes that send a signal to a health care worker whenever patients open them to take a pill, medication sleeves with toll-free phone numbers to call or text after taking a dose and a mobile application to record video messages to be sent to the health care worker as soon as the patient takes the medication. The KNCV Tuberculosis Foundation leads the US$ 13.9 million project.
“Digital adherence technologies empower patients, allowing them to take their medication at a time and place that suits them best and seek advice when they need it. At the same time, these technologies allow health care workers to better prioritize patients that need additional support,” said ASCENT Project Director Kristian van Kalmthout. “The project, which runs through 2022, will generate evidence, create a global market and engage stakeholders, including patients, to facilitate a global scale up that will benefit TB patients worldwide. This can ultimately contribute to reducing global TB incidence, drug resistance and mortality,” he added.
- Seq&Treat: This project will pilot next-generation targeted genome sequencing, an innovation that provides fast, accurate diagnosis of drug-resistant TB. Better diagnosis enables patients to get the right treatment earlier. The technology also has the potential to be an effective tool against drug-resistant microbes, which develop when medicines are misused. The Foundation for Innovative New Diagnostics (FIND) leads the US$ 14.5 million project.
“The Seq&Treat project aims to help patients get a fast, reliable TB diagnosis, ensuring that they can be linked to the most appropriate treatment as soon as possible. Long term, this approach should lead to a decrease in the transmission of drug-resistant TB. Unitaid’s significant investment and FIND’s expertise will allow us to demonstrate sustainable and scalable sequencing models in high-burden TB countries – and serve as a pathfinder to expand sequencing applications to AMR and beyond,” said FIND CEO Catharina Boehme.
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Landmark deal secures significant discount on price of medicine to prevent TB
Hyderabad – A landmark agreement announced today by Unitaid, the Global Fund to Fight AIDS, Tuberculosis and Malaria and global biopharmaceutical company Sanofi will significantly lower the price of rifapentine, a critically important drug used to prevent tuberculosis (TB).
The deal will bolster efforts to treat latent TB infection – currently estimated to affect 1.7 billion people worldwide – by broadening access to better preventive therapy.
The volume-based agreement will discount the price of a three-month treatment course of rifapentine by nearly 70%, from approximately US$45 to US$15 (ex works) in the public sectors of 100 low- and middle-income countries burdened by TB and TB/HIV coinfection.
“Effective TB prevention will be a game-changer in the global fight to eliminate one of the major killer diseases,” said Unitaid’s Executive Director Lelio Marmora. “This lifesaving drug has, until now, been completely unaffordable in developing countries. This agreement will help transform political commitment to tangible action.”
Peter Sands, Executive Director of the Global Fund, warmly welcomed the new agreement. “Innovative partnerships can save lives,” said Sands. “At the discounted price, many people at risk of getting TB will have access to more effective treatment and can stay healthy, and that helps build more stable and prosperous communities.”
A quarter of the world’s population is infected with latent TB – they have no symptoms, are not contagious and most do not know they are infected. Without treatment, 5% to 10% of these people – 85 million to 170 million people globally – will develop active TB, the form which makes people sick and can be transmitted from person to person. HIV infection makes people up to 37 times more likely to fall ill with the active disease. Close to 1.5 million people die of TB every year.
Previously, preventive TB therapy took 6 to 36 months and uptake was low. A rifapentine-based regimen shortens treatment to 12 weekly doses in combination with another medicine, isoniazid. The World Health Organization (WHO) recommends the use of this regimen for treatment of latent TB infection in people living with HIV and contacts of TB cases of any age. Research shows that patients are far more likely to complete shorter treatment courses.
“The WHO Global TB Programme welcomes this significant development and congratulates the partners involved and early implementers of the 3HP regimen for their contributions to lower the price of rifapentine,” said its Director Dr. Tereza Kasaeva. “We hope that countries with the highest TB burdens can benefit from this price reduction and move swiftly towards the United Nations High-level Meeting target of providing TB preventive treatment to at least 30 million eligible individuals by 2022. Continued efforts to make medicines more affordable and patient-friendly will facilitate the task for national TB and HIV programmes and quicken their pace to scale up TB preventive treatment services appropriately.”
Sanofi’s rifapentine medicine, Priftin®, is already on the list of WHO prequalified products, registered in 11 countries and is in the process of being registered in many other countries.
“Sanofi is very pleased to have concluded this innovative agreement,” said Jon Fairest, Vice President, External Affairs Africa and Eurasia Middle East. “We believe that this sustainable commercial approach will widen access to the new standard of care for latent tuberculosis infection. Through this Global Health initiative, Sanofi remains at the forefront of the fight against Tuberculosis.”
The substantially lower cost of rifapentine will now allow the main development partners supporting TB prevention, such as the Global Fund, PEPFAR, USAID and the Stop TB Partnership’s Global Drug Facility, to make it much more widely available through their programs with governments in low- and middle-income countries. South Africa, one of the countries with a high-burden of TB, is expected to pioneer the scale-up of rifapentine-based TB preventive therapy in 2020 with a mix of domestic financing and support from the Global Fund and PEPFAR. This price discount will enable that scale-up, saving thousands of lives, and realize millions of dollars in savings.
“I congratulate the Global Fund, Unitaid, Sanofi and all parties involved in achieving this significant milestone, which will enable populations all over the world to be shielded from this deadly disease,” said Dr. Zweli Mkhize, Minister of Health of South Africa. “Hundreds of thousands of vulnerable people can be initiated on this new treatment regimen starting next year, thanks to this price agreement.”
The deal comes at a time when the Aurum Institute and its partners, through a Unitaid funded project, have already done extensive work to ensure rifapentine is safe to take alongside other treatments, particularly those used to combat HIV, and with national governments to ensure that they are prepared for introduction and scale-up of 3HP.
To ensure that there is sufficient rifapentine to meet growing demand, as well as establish greater supply security and competition, additional manufacturers will be required to enter the rifapentine market. Unitaid, in collaboration with other partners, is already at an advanced stage of negotiations with a generic manufacturer to initiate supply of a second, affordable rifapentine-containing regimen in 2020.
The announcement comes at the 50th Union World Conference on Lung Health 2019 in Hyderabad, India. Scale-up of affordable rifapentine stands to benefit over a million people in India alone, where more people suffer from TB than anywhere else in the world. The Indian government has set ambitious targets to eliminate TB by 2025.
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Unitaid greets Global TB Report, cites need for innovation to reach goals
Geneva – Unitaid welcomes new data from the World Health Organization’s Global TB Report showing a drop in tuberculosis cases and an increase in detection and treatment, but stresses that innovative tools, drugs and approaches will be indispensable to ending the epidemic by the UN’s 2030 target date.
“With this rate of progress we won’t reach the goals. We need to do better. We need to go faster,” Unitaid Executive Director Lelio Marmora said.
The Global TB Report, released on Thursday, showed that TB deaths fell from 1.6 million in 2017 to 1.5 million in 2018. The burden remains high among low-income and marginalized populations. Around 10 million people developed TB in 2018.
Unitaid is the world’s largest multilateral funder of TB research and development, with investments poised to hit US$ 300 million in 2020. Unitaid collaborates with partners to jump-start innovations in diagnostics, prevention, and treatment and to position new tools, medicines and approaches for wide introduction.
New Unitaid projects are developing child-friendly treatments and preventive therapy for multidrug-resistant tuberculosis, bringing in fast, accurate, gene-based diagnosis, and piloting technologies to help patients adhere to TB treatment.
For more information:
- Carol MASCIOLA, masciolac@unitaid.who.int
Unitaid thanks President Macron for support and leadership at the Global Fund’s successful replenishment conference
Lyon – Unitaid wholeheartedly thanks President Emmanuel Macron for France’s renewed three-year contribution, support that enables Unitaid to continue its push to bring about the innovations needed to reach the UN Sustainable Development Goals for global health.
“We maintain our full commitment to Unitaid,” President Macron said, speaking in Lyon today at the Global Fund’s Sixth Replenishment Conference. “I want to announce here the renewal of our support for the next three years.”
France is one of the founders of Unitaid, and its leading donor.
Unitaid also congratulates France for its leadership in the Global Fund’s successful replenishment, which met its goal Thursday afternoon by raising $US 14 billion for the next three years to accelerate the end of AIDS, tuberculosis and malaria as epidemics.
Unitaid works closely with the Global Fund to develop global health innovations that can be introduced on a large scale.
“France’s steadfast support of Unitaid can be directly credited with millions of lives saved and improved through better access to high-quality medicines, the latest tests and methods,” Unitaid Executive Director Lelio Marmora said. “President Macron is showing unprecedented, extraordinary leadership in pushing us to do more.”
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- Carol MASCIOLA, masciolac@unitaid.who.int
Health innovation is a major theme at the Global Fund’s 6th Replenishment Conference
Lyon – The Global Fund and Unitaid are celebrating innovation today, at a special gathering on the eve of the Global Fund’s 6th Replenishment Conference.
And for good reason: Without innovations supported and led by both organisations, it would take an estimated three extra years for the Global Fund to achieve its intended impact. Moreover, innovations supported by Unitaid and the Global Fund are projected to reach more than 100 million people every year from 2021 through 2023.
Tuesday’s gathering drew key figures from the global health community, countries, civil society, and donors including France, a major financier of global health. Speakers emphasized innovation’s essential role in achieving the UN Sustainable Development Goals.
The Global Fund and Unitaid have been working closely with countries and partners to ensure that the best innovations reach everyone, especially the most vulnerable. While Unitaid makes health products more suitable, effective, and affordable, the Global Fund and countries implement them on a large scale. Co-funded projects are introducing new-generation insecticide sprays and innovative bed nets to stop malaria-carrying mosquitoes.
“Innovation is essential if we are to end the epidemics,” said Peter Sands, executive director of the Global Fund. “We need to devise better diagnostics, prevention, treatment and delivery models and get them quickly to the people who need them.”
A Unitaid pilot proved that millions of paediatric malaria cases in the Sahel region of Africa could be prevented with four doses of oral medication per child. The Global Fund responded to the successful pilot by widely implementing the prevention method. Seasonal malaria chemoprevention is now protecting small children from malaria in 12 Sahel countries.
“Innovation is at the heart of Unitaid, and we have always worked hand in hand with the Global Fund,”Unitaid Executive Director Lelio Marmora said. “Together we have a moral obligation to guarantee that these innovations, when widely implemented, will improve the lives of all those in need.”
Together, #StepUpTheFight !
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- Carol MASCIOLA, masciolac@unitaid.who.int
- Sarah MASCHERONI, mascheronisa@unitaid.who.int