Expanding access to lifesaving new TB tools

Expanding access to lifesaving new TB tools

Many settings with a high burden of drug-resistant tuberculosis (DR-TB) lack access to advanced diagnostics and to groundbreaking new treatments. The Collection linked below spotlights work by MSF and collaborators to analyze barriers, identify gaps, and accelerate the roll-out of these tools to people whose lives hang in the balance. Several reports examine price, regulatory, and patent obstacles that persist despite considerable public investment into developing many of these tools. Other authors examine critical remaining weaknesses in care pathways—especially in screening and diagnosis, and particularly in children. Several studies describe new strategies that could be part of the solution, from a pilot program in Tajikisttan that trains family caregivers to treat children with DR-TB at home, to a person-centered care model adapted to a conflict zone in Afghanistan. Lastly, initial findings demonstrate that pregnant women—another vulnerable population—can be effectively treated for DR- and multidrug-resistant TB, improving maternal outcomes without harming neonates.

10 result(s)
Journal Article > Short ReportFull Text
Clin Infect Dis. 2024 January 25; Volume 78 (Issue 1); 144-148.
Lotia Farrukh ILachenal NAdenov MMAhmed SMAlgozhin Y et al.
Clin Infect Dis. 2024 January 25; Volume 78 (Issue 1); 144-148.
Among 43 pregnant women receiving multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) treatment with bedaquiline and/or delamanid, 98% had favorable treatment outcomes. Of 31 continued pregnancies, 81% had live births with no reported malformations, and 68% of neonates had normal birth weights. Effective MDR/RR-TB treatment during pregnancy can improve maternal outcomes without harming neonates.
Journal Article > ResearchFull Text
PLOS One. 2024 January 19; Volume 19 (Issue 1); e0296952.
Tesfahun HMAl-Salihi LAbdulkareem Al-Ani NMankhi AAMohammed A et al.
PLOS One. 2024 January 19; Volume 19 (Issue 1); e0296952.
Since December 2019, the World Health Organization (WHO) has encouraged National Tuberculosis Programs to deprioritize the use of injectable-containing regimens and roll-out all-oral bedaquiline-containing regimens for rifampicin-resistant tuberculosis (RR-TB) treatment. Consequently, Iraq gradually replaced the injectable-containing regimen with an all-oral regimen, including bedaquiline. To assess treatment enrolment and outcomes of both regimens during a transitioning phase in Iraq, where health system services are recovering from decades of war, we conducted a nationwide retrospective cohort study using routinely collected programmatic data for patients enrolled between 2019–2021. We describe treatment enrolment and use logistic regression to identify predictors of unfavorable treatment outcomes (failure, death, or lost to follow-up), including regimen type. Nationwide, a total of 301 RR-TB patients started treatment, of whom 167 concluded treatment. The proportion of patients enrolled on the all-oral regimen increased from 53.2% (50/94) in 2020, to 75.5% (80/106) in 2021. Successful treatment was achieved in 82.1% (32/39) and 63.3% (81/128), for all-oral and injectable-containing regimens respectively. Moreover, the proportion of lost to follow-up was lower among those treated with the all-oral versus the long injectable-containing regimen; respectively 2.6% (1/39) versus 17.9% (23/128: p = 0.02). Unfavorable treatment outcome was associated with male gender (aOR 2.12, 95%CI:1.02–4.43) and age <15 years (vs 30–49 years, aOR 5.80, 95%CI:1.30–25.86). Regimen type (aOR 2.37, 95%CI: 0.91–6.13) was not significantly associated with having an unfavorable treatment outcome. In Iraq, the use of bedaquiline-containing all-oral regimen resulted in a high treatment success and reduced lost to follow-up.
Journal Article > CommentaryFull Text
Lancet Child Adolesc Health. 2023 September 11; Volume 7 (Issue 10); 675-677.
Deborggraeve SCasenghi MHewison CCHDitekemena JDitiu L et al.
Lancet Child Adolesc Health. 2023 September 11; Volume 7 (Issue 10); 675-677.
Journal Article > CommentaryFull Text
Lancet Microbe. 2023 July 31; Volume S2666-5247 (Issue 23); 00217-3.
Branigan DDenkinger CMFurin JHeitkamp PDeborggraeve S et al.
Lancet Microbe. 2023 July 31; Volume S2666-5247 (Issue 23); 00217-3.
Technical Report > Policy Brief
MSF Access Campaign
2022 November 8
TB was the leading cause of death from a single infectious agent until the COVID pandemic. The number of people newly diagnosed with TB in 2020 fell by 18% from the previous year due to disruptions to health systems and services caused by the pandemic, with only a partial recovery in 2021. As a result, in 2021, only one in three people with drug-resistant TB (DR-TB) received treatment for the disease.

However, since the onset of the pandemic, more effective and patient-friendly treatments and regimens for adults and children have become available to the TB community. Now more than ever there is a need to accelerate treatment and save more lives.

This Issue Brief – the eighth in this series – by Médecins Sans Frontières (MSF)’s Access Campaign, examines the current landscape and trends of DR-TB drug pricing and patents, and highlights challenges and opportunities to accelerate people’s access to lifesaving regimens that are shorter, all-oral and make use of the most effective medicines.
Journal Article > LetterFull Text
Int J Tuberc Lung Dis. 2022 August 1; Volume 26 (Issue 8); 792-794.
Rekart MLMorshed TMulanda WKKlieascikova JSitali N et al.
Int J Tuberc Lung Dis. 2022 August 1; Volume 26 (Issue 8); 792-794.
Other > Journal Blog
PLoS Blogs. 2022 May 10
Berry C
PLoS Blogs. 2022 May 10
Journal Article > CommentaryFull Text
BMJ Glob Health. 2022 April 19; Volume 7 (Issue 4); e007490.
Perrin CAthersuch KElder GMartin MAlsalhani A
BMJ Glob Health. 2022 April 19; Volume 7 (Issue 4); e007490.
Two drugs with novel mechanisms of action, the diarylquinoline bedaquiline and the nitroimidazole delamanid—as well as pretomanid from the same class of drugs as delamanid—have recently become available to treat drug-resistant tuberculosis (DR-TB) after many decades of little innovation in the field of DR-TB treatment. Despite evidence of improved efficacy and reduced toxicity of multidrug regimens including the two agents, access to bedaquiline and delamanid has been limited in many settings with a high burden of DR-TB and consistently poor treatment outcomes. Aside from regulatory, logistic and cost barriers at country level, uptake of the novel agents was complicated by gaps in knowledge for optimal use in clinical practice after initial market approval. The main incentives of the current pharmaceutical research and development paradigm are structured around obtaining regulatory approval, which in turn requires efficacy and safety data generated by clinical trials. Recently completed and ongoing clinical trials did not answer critical questions of how to provide shorter, less toxic treatment DR-TB treatment regimens containing bedaquiline and delamanid and improve patient outcomes. Voluntary generation of evidence that is not part of this process—yet essential from a clinical or policy perspective—has been left to non-sponsor partners and researchers, often without collaborative efforts to improve post-regulatory approval access to life-saving drugs. Additionally, these efforts are currently not recognised in the value chain of the research and development process, and there are no incentives to make this critical research happen in a coordinated way.
Journal Article > ResearchFull Text
Trop Med Int Health. 2022 January 3; Volume 27 (Issue 2); 207-215.
Mesic AIshaq SKhan WHMureed AMar HT et al.
Trop Med Int Health. 2022 January 3; Volume 27 (Issue 2); 207-215.
OBJECTIVES
To describe the effect of adaptations to a person-centred care with short oral regimens on retention in care for rifampicin-resistant TB (RR-TB) in Kandahar province, Afghanistan.

METHODS
The study included people with RR-TB registered in the programme between 01 October 2016 and 18 April 2021. From 19 November 2019, the programme implemented a trial investigating the safety and effectiveness of short oral RR-TB regimens. During the trial, person-centred care was adapted. We included the data from people living with RR-TB treated in the period before and after the care model was adapted and applied Kaplan-Meier statistics to compare rates of retention in care.

RESULTS
Of 236 patients registered in the RR-TB programme, 146 (61.9%) were registered before and 90 (38.1%) after the model of care was adapted. Before adaptations enhancing person-centred care, pre-treatment attrition was 23.3% (n = 34/146), whilst under the adapted care model it was 5.6% (n = 5/90). Attrition on treatment was 22.3% (n = 25/112) before adaptations, whilst during the study period none of the participants were lost-to-follow-up on treatment and 3.3% died (n = 3/90).

CONCLUSIONS
As person-centred care delivery and treatment regimens were adapted to better fit-specific contextual challenges and the needs of the target population, retention in care improved amongst people with RR-TB in Kandahar, Afghanistan.
Journal Article > ResearchFull Text
PLOS One. 2021 August 31; Volume 16 (Issue 8); e0256883.
Gotham DMcKenna LDeborggraeve SMadoori SBranigan D
PLOS One. 2021 August 31; Volume 16 (Issue 8); e0256883.
BACKGROUND
The GeneXpert diagnostic platform from the US based company Cepheid is an automated molecular diagnostic device that performs sample preparation and pathogen detection within a single cartridge-based assay. GeneXpert devices can enable diagnosis at the district level without the need for fully equipped clinical laboratories, are simple to use, and offer rapid results. Due to these characteristics, the platform is now widely used in low- and middle-income countries for diagnosis of diseases such as TB and HIV. Assays for SARS-CoV-2 are also being rolled out. We aimed to quantify public sector investments in the development of the GeneXpert platform and Cepheid's suite of cartridge-based assays.

METHODS
Public funding data were collected from the proprietor company's financial filings, grant databases, review of historical literature concerning key laboratories and researchers, and contacting key public sector entities involved in the technology's development. The value of research and development (R&D) tax credits was estimated based on financial filings.

RESULTS
Total public investments in the development of the GeneXpert technology were estimated to be $252 million, including >$11 million in funding for work in public laboratories leading to the first commercial product, $56 million in grants from the National Institutes of Health, $73 million from other U.S. government departments, $67 million in R&D tax credits, $38 million in funding from non-profit and philanthropic organizations, and $9.6 million in small business 'springboard' grants.

CONCLUSION
The public sector has invested over $250 million in the development of both the underlying technologies and the GeneXpert diagnostic platform and assays, and has made additional investments in rolling out the technology in countries with high burdens of TB. The key role played by the public sector in R&D and roll-out stands in contrast to the lack of public sector ability to secure affordable pricing and maintenance agreements.