Contact: Natalie Shure, natalie.shure@treatmentactiongroup.org
September 19, 2023 — Ahead of the United Nations General Assembly High-Level Meeting on the Fight Against Tuberculosis, the 1/4/6×24 Campaign is sounding the alarm that the political declaration commits neither the funding nor the actions needed to expand access to the best-available TB regimens and diagnostics. The political declaration sets the target that over the next five years, 90% of people with TB will be reached with quality TB prevention, diagnosis, and treatment. But it doesn’t include any indication of member state plans to make transformative investments in TB or to rally the political will needed to address critical issues with the affordability and availability of medicines and diagnostics. David Branigan, TB Project Officer at Treatment Action Group which is spearheading the 1/4/6×24 Campaign calls on country governments to “take bold leadership and action that goes beyond the text of the political declaration to fully unlock and scale up access to shorter TB regimens and essential diagnostics by the end of 2024, and to invest in strengthening the full healthcare infrastructure necessary to facilitate access to these TB innovations as a human right.”
“Providing access to the shorter, safer 1/4/6 regimens is an essential component of delivering person-centered TB care. The shorter duration of treatment increases adherence, retention and treatment completion. And therefore, confers a higher success rate and better treatment outcomes. It is also a vital opportunity to bridge the equity gap that prevents the least resourced and most TB impacted communities from accessing innovative treatments and effective interventions. The shorter duration also leads to health system savings that can be applied to other areas of the TB response, including needed investments to deliver better person-centered care by strengthening the 5 Ss: staff, stuff, space, systems, and support,” explained Dr. Maxo Luma, Executive Director of Partners In Health Liberia.
Last month, the Stop TB Partnership published alarming results in its Step Up for TB 2023 survey of high TB burden countries. This “snapshot” of progress on scaling up access to WHO-recommended shorter, safer TB regimens found only two of the 20 countries that responded to the survey have policies on the use of the shorter 4-month regimen for DS-TB in children and just one has a policy on the use of the 4-month regimen for adults. Despite the significant scientific progress to shorten DS-TB treatment from 6 to 4 months and WHO recommendations of the regimens since 2021, governments have not acted with any urgency to provide access to the benefits of these shorter regimens at the national level.
Further threatening progress toward ending TB is the affordability and accessibility of key health technologies, including drugs like bedaquiline and diagnostic tests like GeneXpert. A recent deal between Johnson & Johnson and the Stop TB Partnership Global Drug Facility expanded access to generics and made bedaquiline more affordable. But because Johnson & Johnson has refused to withdraw its secondary patents on bedaquiline, 10 countries in the Eastern European and Central Asian (EECA) region plus China and South Africa will not be able to access generic versions of the drug until 2027 or later. Meanwhile Danaher/Cepheid entered into an agreement this week with the Global Fund reducing the price of GeneXpert tests for TB and resistance to rifampicin (MTB/RIF Ultra) from $9.98 to $7.97 per test. This 20% price reduction is a significant step toward improving access to TB testing and providing more people with life-saving TB treatment, but does not extend to Xpert MTB/XDR – another GeneXpert test critical to scaling up access to shorter regimens. The 1/4/6×24 Campaign calls on Johnson & Johnson to guarantee that the $130 price available through the Global Drug Facility will be made available to countries procuring bedaquiline bilaterally, such as South Africa, and to urgently commit to nonenforcement of secondary patents on bedaquiline, especially in countries left out of the recent deal. The Campaign calls on Danaher/Cepheid to allow independent third party verification of their claim that the $7.97 price of Xpert MTB/RIF is “at cost” and to urgently expand this price reduction to Xpert MTB/XDR tests, currently priced at $14.90, which are critically needed to expand testing for resistance to isoniazid and the fluoroquinolones and to scale up access to the shorter regimens.
“Rather than taking further steps needed to improve access to these life-saving interventions, Johnson & Johnson and Cepheid are choosing to prioritize profit over people’s lives, exacerbating the unmet funding needs in the UN declaration. The development of both bedaquiline and GeneXpert was heavily subsidized by public funding, and these should be available as public goods for everyone who needs them,” said Sergiy Kondratyuk, member of the Global TB Community Advisory Board and manager of the Make Medicines Affordable campaign.
The 1/4/6×24 Campaign is outraged by the recent stockouts of essential TB medicines in India and condemns the lack of urgency of the Indian government and global health actors to address the ongoing crisis. People with TB unfairly bear the consequences of these failures. Thousands of people have been forced to interrupt their treatment because they cannot access key drugs. The result of inaction will be additional unnecessary suffering and death, and drug resistance. TB-affected communities in India report stockouts of medicines for drug-resistant TB, linezolid, clofazimine, cycloserine, and moxifloxacin, as well as recent shortages of core medicines for drug-sensitive TB, isoniazid and rifampicin. Meanwhile, reports of recent stockouts from other countries including Kenya point to a much larger issue of the fragility of TB drug supply as more countries transition toward bilateral rather than pooled procurement. This interruption of supply of essential TB medicines is entirely unacceptable and must be urgently remedied by country governments, including India and Kenya, global health actors, and national suppliers of TB medicines.
Richa Maheshwari, Communications & Advocacy Officer at Global Coalition of TB Advocates warned that “continued stockouts of lifesaving medicines in India threatens progress in the fight against TB. The government of India must take urgent action to end this immediate crisis and put in place measures to prevent the possibility of stockouts of essential medicines from happening again in the future.”
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About the 1/4/6×24 Campaign
After decades of scientific research, we can now prevent TB with one month or once weekly regimens, treat drug-sensitive TB in just four months, and treat drug-resistant TB in six months. Yet relatively few people around the world have access to these shorter, safer regimens, and instead continue to be treated with longer, more toxic regimens. This lack of access to the best available TB regimens is a human rights violation that should inspire outrage.
Formed in 2022, the 1/4/6×24 Campaign demands that country governments and other global health actors take urgent action to scale up access to the shorter, safer regimens for everyone, everywhere by the end of 2024. Doing so requires closing diagnostic gaps and putting in place the full healthcare infrastructure — what the late Dr. Paul Farmer called the “5 Ss”: the staff, stuff, space, systems, and support — necessary to facilitate access to the shorter regimens and high quality TB care.
The 1/4/6×24 Campaign Coalition is an international network of TB survivors, researchers, clinicians, activists, and civil society professionals who advocate for communities affected by TB. Their institutional affiliations include:
Treatment Action Group (TAG)
Partners In Health (PIH)
Médecins Sans Frontières (MSF)
Global Coalition of TB Advocates (GCTA)
Treatment Action Campaign (TAC)
Global TB Community Advisory Board (TB CAB)
Stop TB Partnership
Survivors Against TB
Results Canada
The Sentinel Project Against Pediatric Drug-Resistant TB
We Are TB
TBPPM Learning Network
Asia Pacific Counsel of AIDS Service Organizations (APCASO)
African Coalition on TB (ACT)
Sub-Saharan African Pharmaceutical Access to Diagnostics, Medical Devices and Medicines (SAPAM)
TB Europe Coalition (TBEC)
Lean on Me Foundation
O’Neill Institute for National and Global Health Law at Georgetown University
TB Women Global
Wote Youth Development Projects
Zambia Association for Prevention of HIV and TB (ZAPHIT)