Action needed to scale up access to shorter, safer TB prevention and treatment regimens
A push to include the latest WHO-recommended TB regimens in the current round of funding requests to the Global Fund.
All people affected by TB have a right to benefit from scientific progress and to access the shorter, safer WHO-recommended regimens for TB prevention and treatment. The 1/4/6x24 Campaign is pushing national governments and other global health actors to update policies and guidelines and put in place the staff, stuff, space, systems and support needed to make these regimens available for everyone, everywhere, by the end of 2024. The current Global Fund funding cycle presents a key opportunity to ensure that the shorter, safer regimens are included in funding requests to the Global Fund.
As COVID-19 fatalities continue to decline, tuberculosis (TB) has reclaimed its position as the world’s deadliest infectious disease – killing 1.6 million people in 2021, the highest toll in nearly two decades. Since early 2020, the coronavirus pandemic has disrupted TB programs and other essential services around the world, leading to rising numbers of people sick with TB and fewer diagnoses, interrupted and deferred treatment, increased drug resistance and more. This dramatic backslide in progress against TB not only results in immense suffering but also exacerbates already massive shortfalls of resources needed for an effective global TB response. Unless bold action is taken, the world will not be on course to end TB by 2030.
Hearteningly, communities affected by TB and stakeholders around the world – including TB survivors, researchers, clinicians, and civil society organizations – launched the 1/4/6x24 Campaign in 2022, uniting around a vision to rally the energy and funding necessary to get back on course and end TB once and for all. The 1/4/6x24 Campaign name comes from its central demand: the universal implementation of the shortest and best available TB regimens that can be completed in as little as one month (or once-weekly) for TB prevention, four months for drug-sensitive TB, and six months for drug-resistant TB – by the end of 2024. The 1/4/6x24 Campaign urges all TB advocates to hold governments, global health actors and other duty bearers accountable for taking steps to make these shorter, less toxic TB regimens available to everyone, everywhere. All people affected by TB have the right to benefit from the scientific progress that made these effective new preventive treatments and cures possible. The current Global Fund cycle of funding requests is a key opportunity to push for the resources needed to scale up access to the latest World Health Organization (WHO) recommended TB innovations, including shorter, safer regimens for TB prevention and treatment.
Advocacy to prioritize and include 1/4/6 regimens in Global Fund funding requests
Allies of TB communities everywhere should leverage the current Global Fund cycle of funding requests to bring 1/4/6 regimens to people who need them. The Global Fund is the main source of international donor funding for TB, providing 76% of all international financing. So, prioritizing the 1/4/6 regimens in the current funding cycle will be vital for introducing and ensuring equitable access to these regimens in low- and middle-income countries with high TB burdens. Since the Global Fund allocates just 18% of its funding for TB, which is not enough to meet TB program needs, advocates should push for increased ambition for TB in Global Fund requests (including as part of Prioritized Above Allocation Requests), and for increased domestic funding for TB.
The 1/4/6 regimens are WHO-recommended, and rolling them out is explicitly in line with the Global Fund’s commitment to equitable access to innovation and the universal implementation of “program essentials” that include the shorter regimens for TB prevention and treatment, detailed in the Global Fund Information Note on Tuberculosis. This also applies to access to best available diagnostic tools to find more people living with TB and connecting them with proper care.
The Global Fund Advocates Network (GFAN), the 1/4/6x24 Campaign, and TB AIMS (Ambition for Implementation, Money and Strategy) have all developed resources to support advocates to influence the current Global Fund cycle of funding requests and ensure that the shorter regimens and other critical tools and TB interventions are included:
- GFAN released a series of 1/4/6x24 advocacy briefs to support advocates to push for the prioritization and inclusion of the 1/4/6 regimens in National Strategic Plans and Global Fund requests. These include a guide on Achieving 1/4/6 by 24 in NFM4, and guides on each of the regimens: one month or once weekly for TB prevention, four months for drug-sensitive TB treatment, and six months for drug-resistant TB treatment.
- The 1/4/6x24 Campaign Coalition also released community campaign training materials composed of a set of slide decks with more information on the campaign and the evidence behind each of the regimens to further equip civil society and community based organizations with information to support advocacy for the 1/4/6 regimens and what Dr. Paul Farmer called “the 5 S's” necessary to deliver effective and equitable healthcare: stuff, staff, space, systems and support.
- TB AIMS, a focused campaign designed to break the cycle of low ambition and low funding in countries’ Global Fund TB proposals, developed a toolkit of resources for TB advocates to maximize funding requests for TB and ensure program essentials such as the 1/4/6 regimens are included.
Political will to address TB is non-negotiable
When it comes to TB, the demands of the community have been clear: decades of shameful neglect and underinvestment have taken a terrible toll on people at risk of and living with TB. Political will must be built to rectify that injustice.
Indifference toward TB is evident in longstanding standards of care across the world, which are mediocre at best. Until very recently, the only available TB treatments were highly toxic and difficult to endure, and could leave people with lasting side effects. Household and other close contacts of people with TB were less likely to take and complete TB preventive treatment (TPT) because it lasted for at least six months. Drug-sensitive TB treatment lasted six-to-nine months, and included drugs associated with worrisome side effects. Worst of all, drug-resistant TB treatment could last 18 to 24 months, including nine months of painful injections and drugs that leave many people with hearing loss, kidney failure, and more. These burdensome regimens are one reason why so many people continue to die of TB, even though it’s been curable for generations. Treatment difficulty and duration allow more opportunities for loss-to-follow up, access barriers, drug stockouts and more, and pose serious threats to the psychosocial and physiological wellbeing of people with TB. TB advocates have rightfully condemned the status quo, making the case that it’s unacceptable to be combating such a formidable disease with grossly outdated tools.
1/4/6x24 Campaign asks of national governments and other global health actors
The 1/4/6x24 regimens are the improved tools activists have been fighting for – but as any global health advocate knows, scientific advancement alone isn’t enough to change people’s lives. To ensure that people who need these cures actually benefit from the fruits of scientific research requires the coordinated commitment of powerful actors, held to account by TB-affected communities and their allies. Members of the 1/4/6x24 Campaign Coalition, including Treatment Action Group, Partners in Health, the Global TB Community Advisory Board, the Global Coalition of TB Advocates, We Are TB, Treatment Action Campaign, and others, have already outlined Campaign asks and actors that would lay the groundwork for effective implementation of and universal access to the 1/4/6x24 regimens everywhere in the world.
Governments and drug manufacturers must play their part
Chief among the entities whose decisive action is needed to achieve 1/4/6x24 are national governments. It is critical that TB advocates engage members of the Country Coordinating Mechanisms (CCMs) and urge country programs to swiftly update their national guidelines to include 1/4/6 regimens for TB prevention and treatment, to increase funding allocations for TB programming, and to make use of available legal mechanisms for expanding drug access. Moreover, they must make progress toward securing “the 5 S's” necessary to deliver effective and equitable healthcare: stuff, staff, space, systems and support, which the Global Fund can help them to put in place and strengthen.
Pharmaceutical and diagnostics manufacturers also have a role to play in addressing access barriers by making existing drugs and diagnostics more affordable and developing fit-for-purpose drug formulations and diagnostic technologies to make treatment easier and more convenient for key populations. These include fixed-dose combinations and pediatric formulations, and point-of-care molecular testing to detect TB and drug-resistance to facilitate prompt and appropriate treatment. There has already been some meaningful progress with respect to price reductions that will enable new regimens to be implemented widely while still maintaining resources for other components of TB programming. The TB Alliance announced a price reduction for pretomanid, a part of the six-month BPaL[M] regimen for which official guidelines were recently published by WHO, but there are still major supply challenges that need to be addressed. This comes on the heels of Unitaid’s deal with Lupin and Macleod last year which slashed the price of rifapentine, removing a major barrier to the scale-up of TB preventive treatment. The 1/4/6x24 Campaign Coalition has now set its sights on Johnson & Johnson, demanding withdrawal and nonenforcement of secondary patents filed on bedaquiline which will impede generic manufacturing, and Cepheid, calling for urgent action necessary to improve equitable access to GeneXpert TB diagnostics and achieve 1/4/6x24.
Building momentum behind the 1/4/6x24 Campaign presents a path forward for those determined to finally see history’s oldest pandemic draw to a close. It’s more urgent than ever for TB advocates everywhere to throw their weight behind bringing long-awaited scientific achievements to everyone who needs them. Ensuring the prioritization and inclusion of the shorter, safer regimens in National Strategic Plans and Global Fund funding requests is a key next step toward universal implementation and access to these regimens, and to helping pave the way for rapid uptake and implementation of future innovations necessary to end TB.
Further reading and resources:
- 1/4/6x24 Campaign: https://www.treatmentactiongroup.org/1-4-6-x-24/
- Nature Medicine Correspondence: The 1/4/6x24 campaign to cure tuberculosis quickly
- Global Fund Information Note on Tuberculosis: https://www.theglobalfund.org/media/4762/core_tuberculosis_infonote_en.pdf
- GFAN Advocacy Guides to 1/4/6x24 – Shorter Regimens for TB: https://www.globalfundadvocatesnetwork.org/resource/advocacy-guides-to-1-4-6x24-shorter-regimens-for-tb/
- 1/4/6x24 Community Campaign Training Materials: https://www.treatmentactiongroup.org/publication/1-4-6x24-community-campaign-training-materials/
TB AIMS toolkit of resources including:
- a Summary Guide on the Global Fund Grant Cycle 7 and Situation analyses for 13 countries
- the Global Fund TB info note that includes the Program Essentials (what the Global Fund requires countries to include or report on)
- a recording and presentations from a February 2023 TB AIMS Maximizing TB Global Fund Proposals webinar https://tinyurl.com/2p8utbf7