Clinical standards for the dosing and management of TB drugs

Alffenaar, Jan-Willem; Stocker, Sophie L.; Forsman, Lina Davies; Garcia-Prats, Anthony J.; Heysell, Scott K; Aarnoutse, Rob E.; Akkerman, Onno W.; Aleksa, Alena; Altena, Richard van; Oñata, W Arrazola de; Bhavani, Perumal Kannabiran; Boveneind-Vrubleuskaya, Natasha van’t; Carvalho, Anna Cristina Calçada; Centis, Rosella; Chakaya, Jeremiah; Cirillo, Daniela María; Cho, J G; Ambrosio, Leire; Dalcolmo, Margareth Pretti; Denti, Paolo; Dheda, Keertan; Fox, Greg J.; Hesseling, Anneke C.; Kim, H Y; Köser, Claudio U.; Marais, Ben J.; Mărgineanu, Ioana; Märtson, Anne-Grete; Torrico, Marcela Muňoz; Nataprawira, Heda Melinda; Ong, Catherine W.M.; Otto-Knapp, Ralf; Peloquin, Charles A.; Silva, D R; Ruslami, Rovina; Santoso, Prayudi; Savic, Rada; Singla, Rupak; Svensson, Elin M; Skrahina, Alena; Soolingen, Dick van; Srivastava, Shashikant; Tadolini, Marina; Tiberi, Simon; Thomas, Tania A; Udwadia, Zarir F; Vu, Dinh Hoa; Zhang, W; Mpagama, Stellah; Schӧn, Thomas; Migliori, Giovanni Battista

doi:10.5588/ijtld.22.0188

Cited by 34 publications

(43 citation statements)

References 173 publications

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“…Monitoring to evaluate treatment response in patients with PTB is recommended; patients should have a repeat sputum for smear and culture at Month 2. 8 , 17 Duration of this regimen should be extended if delayed sputum smear and culture conversion occurs (confirmed or presumed DS-TB), and/or in case of extensive cavitary disease with slow clinical and/or radiological improvement, provided that an undetected or newly acquired drug resistance has been excluded. Ideally, 4 months of treatment after culture conversion should be administered.…”

Section: Standardmentioning

confidence: 99%

“… 19 Culture positivity at Month 2 should result in closer follow up, adherence check, repeat DST, repeat CXR, assistance with smoking cessation, review of illicit drugs and alcohol use, optimisation of concurrent medical conditions (e.g., initiating ART for people living with HIV/AIDS and better glucose control in DM patients) and therapeutic drug monitoring. 8 Duration of DS-TB treatment may be reduced to 4 months with the regimen from Study 31 (2HPZMfx/2HPMfx), 14 except in certain circumstances, e.g., complex forms of extrapulmonary TB and HIV-infected persons with CD4 <100 cells/ml. 14 , 68 In children with non-severe (i.e., intrathoracic TB confined to opacification of <1 lobe with no cavities, no signs of miliary TB, no complex pleural effusion and no clinically significant airway obstruction; or only peripheral lymph node TB), drug-susceptible, smear-negative TB, a shorter 4-month regimen of 2HRZ(E)/2HR has recently been shown to be non-inferior to 2HRZ(E)/4HR, and is now recommended by the WHO in children with non-severe PTB (See also Table 3 ).…”

Section: Standardmentioning

confidence: 99%

“… 93 , 94 With therapeutic drug monitoring (TDM), dosage is adjusted based on drug exposure to ensure therapeutic concentrations improve treatment success and reduce the possibility of toxicity and adverse events. 10 , 95 , 96 TDM is especially useful in patients at risk of altered drug exposure and severe disease, 3 , 8 , 97 , 98 and may also be useful in checking adherence. TDM is not currently recommended for all TB patients on treatment, mainly because of availability, time and financial costs, rather than its potential benefit.…”

Section: Standardmentioning

confidence: 99%

“… 3 Substantial variations in exposure to both isoniazid (INH, H) and rifampicin (RIF, R) have been shown in pharmacokinetic studies. 4 – 8 Inadequate exposure can be caused by malabsorption (malnutrition, severe state of disease, gastro-intestinal tract problems and HIV coinfection), delayed absorption due to diabetes mellitus (DM), increased clearance rate (smoking) and drug-drug interactions with INH, fast N -acetyl-transferase-2 acetylator status. 9 – 11 …”

mentioning

confidence: 99%

“…The IJTLD Clinical Standards for Lung Health complement existing WHO or other guidelines and integrate their recommendations to provide a specific clinical focus. 8 , 15 – 19 The standards are universal principles and might need to be adapted to specific settings and situations for future programmatic implementation for legal, organisational or economic reasons. Specific evidence in some areas is still limited.…”

mentioning

confidence: 99%

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Clinical standards for drug-susceptible pulmonary TB

Akkerman

Duarte

Tiberi

et al. 2022

int j tuberc lung dis

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BACKGROUND: The aim of these clinical standards is to provide guidance on ‘best practice´ for diagnosis, treatment and management of drug-susceptible pulmonary TB (PTB).METHODS: A panel of 54 global experts in the field of TB care, public health, microbiology, and pharmacology were identified; 46 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all 46 participants.RESULTS: Seven clinical standards were defined: Standard 1, all patients (adult or child) who have symptoms and signs compatible with PTB should undergo investigations to reach a diagnosis; Standard 2, adequate bacteriological tests should be conducted to exclude drug-resistant TB; Standard 3, an appropriate regimen recommended by WHO and national guidelines for the treatment of PTB should be identified; Standard 4, health education and counselling should be provided for each patient starting treatment; Standard 5, treatment monitoring should be conducted to assess adherence, follow patient progress, identify and manage adverse events, and detect development of resistance; Standard 6, a recommended series of patient examinations should be performed at the end of treatment; Standard 7, necessary public health actions should be conducted for each patient. We also identified priorities for future research into PTB.CONCLUSION: These consensus-based clinical standards will help to improve patient care by guiding clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment for PTB.

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Section: Standardmentioning

confidence: 99%

Section: Standardmentioning

confidence: 99%

Section: Standardmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Clinical standards for drug-susceptible pulmonary TB

Akkerman

Duarte

Tiberi

et al. 2022

int j tuberc lung dis

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Alternative Methods for Therapeutic Drug Monitoring and Dose Adjustment of Tuberculosis Treatment in Clinical Settings: A Systematic Review

et al. 2023

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Background and Objective Quantifying exposure to drugs for personalized dose adjustment is of critical importance in patients with tuberculosis who may be at risk of treatment failure or toxicity due to individual variability in pharmacokinetics. Traditionally, serum or plasma samples have been used for drug monitoring, which only poses collection and logistical challenges in high-tuberculosis burden/low-resourced areas. Less invasive and lower cost tests using alternative biomatrices other than serum or plasma may improve the feasibility of therapeutic drug monitoring. Methods A systematic review was conducted to include studies reporting anti-tuberculosis drug concentration measurements in dried blood spots, urine, saliva, and hair. Reports were screened to include study design, population, analytical methods, relevant pharmacokinetic parameters, and risk of bias. Results A total of 75 reports encompassing all four biomatrices were included. Dried blood spots reduced the sample volume requirement and cut shipping costs whereas simpler laboratory methods to test the presence of drug in urine can allow point-of-care testing in high-burden settings. Minimal pre-processing requirements with saliva samples may further increase acceptability for laboratory staff. Multi-analyte panels have been tested in hair with the capacity to test a wide range of drugs and some of their metabolites. Conclusions Reported data were mostly from small-scale studies and alternative biomatrices need to be qualified in large and diverse populations for the demonstration of feasibility in operational settings. High-quality interventional studies will improve the uptake of alternative biomatrices in guidelines and accelerate implementation in programmatic tuberculosis treatment.

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