Innovations for Tackling Tuberculosis in the Time of COVID-19 Proceedings of a Workshop (2022) / Chapter Skim
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2 Current Tools and Challenges
2 Current Tools and Challenges
Pages 5-28
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From page 5... ...
Jim Yong Kim, vice president and partner at Global Infrastructure Partners, highlighted the critical role of leadership and the value of strong community-based public health systems. Salmaan Keshavjee, director of the Harvard Medical School Center for Global Health Delivery and chair of the Steering Committee of the Zero TB Initiative, discussed progress toward global TB elimination and presented a comprehensive epidemic control strategy with potential to bolster those efforts.
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From page 6... ...
,2 delved into the collective social value of infectious disease interventions. LEADERSHIP FROM PUBLIC HEALTH WORKERS IN ENDING TUBERCULOSIS -- PAST AND PRESENT Presented by Jim Yong Kim, Global Infrastructure Partners Kim opened by describing the value of strong community-based public health systems and the critical role of leadership in driving efforts to eliminate TB.
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From page 7... ...
Kim replied that his former colleagues at the World Bank are eager to support countries that are seeking to develop public health systems that are fully equipped for a range of infectious and noninfectious health threats. Development banks are looking for models of more horizontal health systems -- such as programs delivered by community health workers (CHWs)
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From page 8... ...
Thus, the challenge is to use the attention and new sources of capital associated with the COVID-19 pandemic to build better systems, including metrics, and establish strong baseline capacities that are resilient to changes in leadership. PROGRESS TOWARD GLOBAL TUBERCULOSIS ELIMINATION GOALS AND OPPORTUNITIES FOR MOVING FORWARD Presented by Salmaan Keshavjee, Harvard Medical School Keshavjee discussed the status of efforts to eliminate TB in the time of COVID-19 and opportunities to move those efforts forward.
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From page 9... ...
in 2018 and 2019 • TB preventive treatment in people living with HIV: goal of 6.0 million, reached 88 percent of goal in 2018 and 2019 • TB preventive treatment in household contacts under the age of 5: goal of 4.0 million, reached 20 percent of goal in 2018 and 2019 • TB preventive treatment in household contacts older than the age of 5: goal of 20 million, reached less than 1 percent in 2018 and 2019 • TB treatment in children: goal of 3.5 million, treated 1.04 million (30 percent) in 2018 and 2019 • Treatment for MDR or rifampicin-resistant (RR)
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From page 10... ...
Potential Pathway to the Elimination of Tuberculosis: Search-Treat-Prevent Strategy Despite acknowledging these concerning trends and stagnated progress toward global TB control targets, Keshavjee was resolute in his belief that TB elimination is possible and can be achieved by implementing a comprehensive epidemic control strategy -- "search-treat-prevent" -- that has existed since the 1960s but has yet to be implemented on a global scale, particularly in high-burden LMICs. Beyond addressing the global burden of TB, the strategy could also serve as a platform for controlling other infectious disease threats such as COVID-19.
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From page 11... ...
Keshavjee highlighted new tools and opportunities that have recently emerged or been expanded in the prevention domain, such as new short-course preventive treatment regimens for DS TB (e.g., 1 month of isoniazid or rifapentine, or 3 months of once weekly isoniazid and rifapentine) and new treatment regimens for MDR and XDR TB (e.g., bedaquiline, ongoing clinical trial using levofloxacin)
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From page 12... ...
Keshavjee ended by showing how being able to diagnose and treat diseases is not only good for TB and a number of other infectious and noninfectious diseases but is also an important frame for biosecurity, as we have seen recently with COVID-19. CHALLENGES AND INNOVATIONS Presented by Eric Rubin, New England Journal of Medicine Innovations and Translatable Lessons for TB Control from the COVID-19 Pandemic Rubin highlighted innovations and translatable lessons from the COVID-19 pandemic that are applicable to diagnostics, therapeutics, and vaccines for TB.
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From page 13... ...
Of the more than 200 clinical trials listed for COVID-19 therapeutics at the time of the workshop, many of them had been withdrawn, had repetitive trial designs, or had small sample sizes unlikely to yield useful results. These issues underscore the importance of coordination and thoughtfulness in the clinical trials enterprise to avoid redundancy and improve efficiency, especially for expensive and lengthy trials conducted across multiple groups.
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From page 14... ...
The use of easy-to-obtain samples, such as saliva, could transform TB and COVID19 diagnosis by improving access to decentralized testing with drive-through facilities, mobile testing sites, community health workers, pharmacies, schools, and workplaces. Pharmacy-available, single-use self-testing kits also hold promise as rapid diagnostic tools, she added.
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. It will not be possible to achieve TB elimination goals without more robust diagnostic tests, she warned.
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Summary of Innovations Swaminathan categorized emerging innovations from the COVID-19 pandemic into three major new domains: POC biomarkers in rapid diagnostic tests, multidisease platforms, and next-generation whole genome sequencing. She framed these efforts as being part of pandemic planning, preparedness, and coverage, thus warranting a focus on developing multidisease, multiplatform technologies and databases with crosscutting coverage across diseases.
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From page 17... ...
SOURCE: Presented by Soumya Swaminathan on July 22, 2021. IMPROVING TREATMENT REGIMENS AND VACCINE DEVELOPMENT Presented by Emilio Emini, Bill & Melinda Gates Foundation Emini explored challenges and opportunities related to developing and improving TB therapeutics and vaccines.
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From page 18... ...
Notably, the Tuberculosis Trials Consortium Study 31/AIDS Clinical Trials Group A53496 (TBTC Study 31/A5349) recently demonstrated noninferiority in 6 For more information on Tuberculosis Trials Consortium Study 31/AIDS Clinical Trials Group A5349, see https://clinicaltrials.gov/ct2/show/NCT02410772 (accessed December 15, 2021)
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From page 19... ...
protec 7 This is a recently completed clinical trial led by the Tuberculosis Trials Consortium at the U.S. CDC, with collaboration from the AIDS Clinical Trials Group funded by the National Institute of Allergy and Infectious Diseases.
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From page 20... ...
There are currently a number of candidate TB vaccines in the global clinical pipeline, including some using an mRNA platform, that are in preclinical development and at various stages of clinical trials. Like the development of new treatment regimens, however, TB vaccine development also requires significant sources of funding for large and expensive phase 3 trials.
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From page 21... ...
Broadening the Definition of Value for the Cooperative Production of Public Goods It can be challenging for models for the cooperative production of public goods -- such as treatments and interventions for infectious disease outbreak preparedness and response -- to adopt a strategic perspective, noted Outterson. To address this issue, he suggested an alternative approach of adopting a broader view in defining the value of these antimicrobial interventions.
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From page 22... ...
Major funding organizations typically support either basic research coupled with early discovery or latestage clinical development; CARB-X has tried to bridge that binary divide. He acknowledged that the TB drug development effort has the advantages of more coordinated pipelines and strategically set target product profiles to guide development, but there is an opportunity to work collaboratively across funding and research silos and reward the development of antimicrobials -- including TB drugs -- based on their social value.
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From page 23... ...
He noted that ARPA-H is likely to receive roughly $3 billion dollars in appropriations from Congress to fund health product development through a model similar to the Defense Advanced Research Projects Agency's model for funding technical and engineering innovation. He noted that efforts to break down silos between infectious disease disciplines will help to capitalize on future opportunities.
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From page 24... ...
Outterson acknowledged Emini's distinction between cost of goods and price, adding that the introduction of social value as a consideration further distinguishes that difference and, moreover, can shift a company's focus from deriving revenue from market mechanisms to other reimbursements for its activities, including research and development (R&D)
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From page 25... ...
Outterson added that the ultimate cost of goods is a consideration early on in the preclinical development life cycle at CARB-X; the optimizations for cost structure and adaptive research into product characteristics (e.g., stability, shelf life) are initiated closer to clinical trials.
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From page 26... ...
and the community in a way that people will want to get screened, and people will want to take treatments? " Paradigm Shift to Articulate the Biosecurity and Social Values of Tuberculosis Elimination Keshavjee made the case that the lack of community health care delivery capacity for diagnosis, screening, and treatment constitutes a biosecurity emergency.
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From page 27... ...
The latter case would be seen as a failure, but is actually similar to the approach taken for many other infectious diseases including TB. Outterson proposed that this type of health system strengthening could be thought of as broad-spectrum defenses against unknown or unknowable microbial threats.
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From page 28... ...
Cassell emphasized that determining the social value of ending TB is an important task that may require innovative economic research and policy making to be achieved.
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