Severe outcomes among adults with TB during COVID-19.

BACKGROUND: The COVID-19 pandemic prompted strict public health measures to reduce SARS-CoV-2 transmission, potentially interrupting TB programmes in the Western Cape, South Africa. METHODS: We conducted a retrospective cohort study, estimating changes in new TB case rates and risk of death during TB-specific admissions within 6 months of TB first evidence, during the pre-pandemic (1 January 2019-26 March 2020) and after the implementation of public health and social measures (PHSM) periods (26 March 2020-30 September 2021), based on PHSM strictness. We used interrupted time series and logistic regression models to adjust for key characteristics. RESULTS: We found an average 22% reduction (95% CI 19-25) in monthly TB cases during the entire PHSM implementation period. Additionally, the risk of death during TB-specific admissions increased, with the adjusted odds ratio ranging across PHSM levels from 1.36 (95% CI 1.17-1.57) on Level 1 to 1.44 (95% CI 1.16-1.79) on Level 2 compared with the pre-pandemic period. CONCLUSIONS: There was a decline in the number of diagnosed TB cases and an increased risk of severe outcomes from 26 March 2020 to 30 September 2021 in the Western Cape. TB programme recovery strategies must be prioritised, and TB management programmes must be integrated into future pandemic responses.

CONTEXTE: La pandémie de COVID-19 a entraîné la mise en place de mesures de santé publique strictes afin de limiter la propagation du SRAS-CoV-2, ce qui risque de perturber les efforts de lutte contre la TB dans la province du Cap-Occidental, en Afrique du Sud. MÉTHODES: Une étude de cohorte rétrospective a été réalisée afin d'évaluer les variations des taux de nouveaux cas de TB et le risque de décès lors des admissions spécifiques à la TB dans les 6 mois suivant la première preuve de la maladie. Cette étude a été menée pendant deux périodes distinctes : la période prépandémique, allant du 1er janvier 2019 au 26 mars 2020, et la période post-mise en œuvre des mesures de santé publique et sociales (PHSM, pour l'anglais « public health and social measures ¼), allant du 26 mars 2020 au 30 septembre 2021. L'objectif était d'évaluer l'impact des PHSM sur ces indicateurs. Pour ce faire, des séries temporelles interrompues et des modèles de régression logistique ont été utilisés afin de prendre en compte les principales caractéristiques. RÉSULTATS: Au cours de la période de mise en œuvre des PHSM, nous avons observé une diminution moyenne de 22% (IC à 95% 19­25) des cas mensuels de TB. De plus, nous avons constaté une augmentation du risque de décès pendant les admissions pour TB, avec un rapport de cotes ajusté variant de 1,36 (IC à 95% ; 1,17­1,57) au niveau 1 des PHSM à 1,44 (IC à 95% ; 1,16­1,79) au niveau 2, par rapport à la période prépandémique. CONCLUSIONS: Entre le 26 mars 2020 et le 30 septembre 2021, il y a eu une baisse du nombre de cas de TB diagnostiqués dans la province du Cap-Occidental, mais le risque de résultats graves a augmenté pendant cette période. Les stratégies de rétablissement des programmes de lutte contre la TB doivent être prioritaires et les programmes de gestion de la TB doivent être intégrés dans les futures réponses à la pandémie.

A position statement and practical guide to the use of particulate filtering facepiece respirators (N95, FFP2, or equivalent) for South African health workers exposed to respiratory pathogens including Mycobacterium tuberculosis and SARS-CoV-2.

SUMMARY: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is transmitted mainly by aerosol in particles <10 µm that can remain suspended for hours before being inhaled. Because particulate filtering facepiece respirators ('respirators'; e.g. N95 masks) are more effective than surgical masks against bio-aerosols, many international organisations now recommend that health workers (HWs) wear a respirator when caring for individuals who may have COVID-19. In South Africa (SA), however, surgical masks are still recommended for the routine care of individuals with possible or confirmed COVID-19, with respirators reserved for so-called aerosol-generating procedures. In contrast, SA guidelines do recommend respirators for routine care of individuals with possible or confirmed tuberculosis (TB), which is also transmitted via aerosol. In health facilities in SA, distinguishing between TB and COVID-19 is challenging without examination and investigation, both of which may expose HWs to potentially infectious individuals. Symptom-based triage has limited utility in defining risk. Indeed, significant proportions of individuals with COVID-19 and/or pulmonary TB may not have symptoms and/or test negative. The prevalence of undiagnosed respiratory disease is therefore likely significant in many general clinical areas (e.g. waiting areas). Moreover, a proportion of HWs are HIV-positive and are at increased risk of severe COVID-19 and death. RECOMMENDATIONS: Sustained improvements in infection prevention and control (IPC) require reorganisation of systems to prioritise HW and patient safety. While this will take time, it is unacceptable to leave HWs exposed until such changes are made. We propose that the SA health system adopts a target of 'zero harm', aiming to eliminate transmission of respiratory pathogens to all individuals in every healthcare setting. Accordingly, we recommend: the use of respirators by all staff (clinical and non-clinical) during activities that involve contact or sharing air in indoor spaces with individuals who: (i) have not yet been clinically evaluated; or (ii) are thought or known to have TB and/or COVID-19 or other potentially harmful respiratory infections;the use of respirators that meet national and international manufacturing standards;evaluation of all respirators, at the least, by qualitative fit testing; andthe use of respirators as part of a 'package of care' in line with international IPC recommendations. We recognise that this will be challenging, not least due to global and national shortages of personal protective equipment (PPE). SA national policy around respiratory protective equipment enables a robust framework for manufacture and quality control and has been supported by local manufacturers and the Department of Trade, Industry and Competition. Respirator manufacturers should explore adaptations to improve comfort and reduce barriers to communication. Structural changes are needed urgently to improve the safety of health facilities: persistent advocacy and research around potential systems change remain essential.

Incorporating social justice and stigma in cost-effectiveness analysis: drug-resistant tuberculosis treatment.

Novel therapies for multidrug-resistant tuberculosis (MDR-TB) are likely to be expensive. The cost of novel drugs (e.g., bedaquiline, delamanid) may be so prohibitively high that a traditional cost-effectiveness analysis (CEA) would rate regimens containing these drugs as not cost-effective. Traditional CEA may not appropriately account for considerations of social justice, and may put the most disadvantaged populations at greater risk. Using the example of novel drug regimens for MDR-TB, we propose a novel methodology, 'justice-enhanced CEA', and demonstrate how such an approach can simultaneously assess social justice impacts alongside traditional cost-effectiveness ratios. Justice-enhanced CEA, as we envision it, is performed in three steps: 1) systematic data collection about patients' lived experiences, 2) use of empirical findings to inform social justice assessments, and 3) incorporation of data-informed social justice assessments into a decision analytic framework that includes traditional CEA. These components are organized around a core framework of social justice developed by Bailey et al. to compare impacts on disadvantage not otherwise captured by CEA. Formal social justice assessments can produce three composite levels: 'expected not to worsen…', 'may worsen…', and 'expected to worsen clustering of disadvantage'. Levels of social justice impact would be assessed for each major type of outcome under each policy scenario compared. Social justice assessments are then overlaid side-by-side with cost-effectiveness assessments corresponding to each branch pathway on the decision tree. In conclusion, we present a 'justice-enhanced' framework that enables the incorporation of social justice concerns into traditional CEA for the evaluation of new regimens for MDR-TB.

The devil we know: is the use of injectable agents for the treatment of MDR-TB justified?

For decades, second-line injectable agents (IAs) have been the cornerstone of treatment for multidrug-resistant tuberculosis (MDR-TB). Although evidence on the efficacy of IAs is limited, there is an expanding body of evidence on the serious adverse events caused by these drugs. Here, we present the results of a structured literature review of the safety and efficacy of IAs. We review the continued widespread use of these agents in the context of therapeutic alternatives-most notably the newer TB drugs, bedaquiline and delamanid-and from the context of human rights, ethics and patient-centered care. We conclude that there is limited evidence of the efficacy of IAs, clear evidence of the risks of these drugs, and that persons living with MDR-TB should be informed about these risks and provided with access to alternative therapeutic options.