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Article ; Online: Treating children with tuberculosis-Using pharmacometrics to do better.

McIlleron, Helen

British journal of clinical pharmacology

2022 Volume 88, Issue 3, Page(s) 894–896

MeSH term(s)	Antitubercular Agents/adverse effects ; Child ; Humans ; Tuberculosis/drug therapy
Chemical Substances	Antitubercular Agents
Language	English
Publishing date	2022-01-18
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15220
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Article: Pharmacokinetics of antitubercular drugs in patients hospitalized with HIV-associated tuberculosis: a population modeling analysis.

Abdelgawad, Noha / Chirehwa, Maxwell / Schutz, Charlotte / Barr, David / Ward, Amy / Janssen, Saskia / Burton, Rosie / Wilkinson, Robert J / Shey, Muki / Wiesner, Lubbe / McIlleron, Helen / Maartens, Gary / Meintjes, Graeme / Denti, Paolo

Wellcome open research

2024 Volume 7, Page(s) 72

Abstract: Background: Early mortality among hospitalized HIV-associated tuberculosis (TB/HIV) patients is high despite treatment. The pharmacokinetics of rifampicin, isoniazid, and pyrazinamide were investigated in hospitalized TB/HIV patients and a cohort of ... ...

Abstract	Background: Early mortality among hospitalized HIV-associated tuberculosis (TB/HIV) patients is high despite treatment. The pharmacokinetics of rifampicin, isoniazid, and pyrazinamide were investigated in hospitalized TB/HIV patients and a cohort of outpatients with TB (with or without HIV) to determine whether drug exposures differed between groups. Methods: Standard first-line TB treatment was given daily as per national guidelines, which consisted of oral 4-drug fixed-dose combination tablets containing 150 mg rifampicin, 75 mg isoniazid, 400 mg pyrazinamide, and 275 mg ethambutol. Plasma samples were drawn on the 3rd day of treatment over eight hours post-dose. Rifampicin, isoniazid, and pyrazinamide in plasma were quantified and NONMEM Results: Data from 60 hospitalized patients (11 of whom died within 12 weeks of starting treatment) and 48 outpatients were available. Median (range) weight and age were 56 (35 - 88) kg, and 37 (19 - 77) years, respectively. Bioavailability and clearance of the three drugs were similar between TB/HIV hospitalized and TB outpatients. However, rifampicin's absorption was slower in hospitalized patients than in outpatients; mean absorption time was 49.9% and 154% more in hospitalized survivors and hospitalized deaths, respectively, than in outpatients. Higher levels of conjugated bilirubin correlated with lower rifampicin clearance. Isoniazid's clearance estimates were 25.5 L/h for fast metabolizers and 9.76 L/h for slow metabolizers. Pyrazinamide's clearance was more variable among hospitalized patients. The variability in clearance among patients was 1.70 and 3.56 times more for hospitalized survivors and hospitalized deaths, respectively, than outpatients. Conclusions: We showed that the pharmacokinetics of first-line TB drugs are not substantially different between hospitalized TB/HIV patients and TB (with or without HIV) outpatients. Hospitalized patients do not seem to be underexposed compared to their outpatient counterparts, as well as hospitalized patients who survived vs who died within 12 weeks of hospitalization.
Language	English
Publishing date	2024-03-01
Publishing country	England
Document type	Journal Article
ISSN	2398-502X
ISSN	2398-502X
DOI	10.12688/wellcomeopenres.17660.3
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Article: A model-based approach for a practical dosing strategy for the short, intensive treatment regimen for paediatric tuberculous meningitis.

Wasmann, Roeland E / Masini, Tiziana / Viney, Kerri / Verkuijl, Sabine / Brands, Annemieke / Hesseling, Anneke C / McIlleron, Helen / Denti, Paolo / Dooley, Kelly E

Frontiers in pharmacology

2023 Volume 14, Page(s) 1055329

Abstract: Following infection ... ...

Abstract	Following infection with
Language	English
Publishing date	2023-04-25
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2023.1055329
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Article ; Online: Pharmacometrics in tuberculosis: progress and opportunities.

Wilkins, Justin J / Svensson, Elin M / Ernest, Jacqueline P / Savic, Radojka M / Simonsson, Ulrika S H / McIlleron, Helen

International journal of antimicrobial agents

2022 Volume 60, Issue 3, Page(s) 106620

Abstract: Tuberculosis (TB) remains one of the leading causes of death by a communicable agent, infecting up to one-quarter of the world's population, predominantly in disadvantaged communities. Pharmacometrics employ quantitative mathematical models to describe ... ...

Abstract	Tuberculosis (TB) remains one of the leading causes of death by a communicable agent, infecting up to one-quarter of the world's population, predominantly in disadvantaged communities. Pharmacometrics employ quantitative mathematical models to describe the relationships between pharmacokinetics and pharmacodynamics, and to predict drug doses, exposures and responses. Pharmacometric approaches have provided a scientific basis for improved dosing of anti-TB drugs and concomitantly administered antiretrovirals at the population level. The development of modelling frameworks including physiologically based pharmacokinetics, quantitative systems pharmacology and machine learning provides an opportunity to extend the role of pharmacometrics to in-silico quantification of drug-drug interactions, prediction of doses for special populations, dose optimization and individualization, and understanding the complex exposure-response relationships of multi-drug regimens in terms of both efficacy and safety, informing regimen design for future study. This short, clinically focused review explores what has been done, and what opportunities exist for pharmacometrics to impact TB pharmacotherapy.
MeSH term(s)	Antitubercular Agents/therapeutic use ; Drug Interactions ; Humans ; Models, Theoretical ; Tuberculosis/drug therapy
Chemical Substances	Antitubercular Agents
Language	English
Publishing date	2022-06-17
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	1093977-5
ISSN	1872-7913 ; 0924-8579
ISSN (online)	1872-7913
ISSN	0924-8579
DOI	10.1016/j.ijantimicag.2022.106620
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Article ; Online: Quantitative assessment of the activity of antituberculosis drugs and regimens.

Chirehwa, Maxwell T / Velásquez, Gustavo E / Gumbo, Tawanda / McIlleron, Helen

Expert review of anti-infective therapy

2019 Volume 17, Issue 6, Page(s) 449–457

Abstract: ... ...

Abstract	Introduction
MeSH term(s)	Animals ; Antitubercular Agents/administration & dosage ; Antitubercular Agents/pharmacokinetics ; Antitubercular Agents/pharmacology ; Dose-Response Relationship, Drug ; Drug Therapy, Combination ; Humans ; Tuberculosis/drug therapy
Chemical Substances	Antitubercular Agents
Language	English
Publishing date	2019-05-30
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2181279-2
ISSN	1744-8336 ; 1478-7210
ISSN (online)	1744-8336
ISSN	1478-7210
DOI	10.1080/14787210.2019.1621747
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Article ; Online: Current research toward optimizing dosing of first-line antituberculosis treatment.

McIlleron, Helen / Chirehwa, Maxwell T

Expert review of anti-infective therapy

2018 Volume 17, Issue 1, Page(s) 27–38

Abstract: Introduction: Drug concentrations in tuberculosis patients on standard regimens vary widely with clinically important consequences. Areas covered: We review the available literature identifying factors correlated with pharmacokinetic variability of ... ...

Abstract	Introduction: Drug concentrations in tuberculosis patients on standard regimens vary widely with clinically important consequences. Areas covered: We review the available literature identifying factors correlated with pharmacokinetic variability of antituberculosis drugs. Based on population pharmacokinetic models and the weight, height, and sex distributions in a large data base of African tuberculosis patients, we propose simplified weight-based doses of the available fixed dose combination(FDC) for adults with drug susceptible tuberculosis. Emerging studies will support optimized weight-based dosing for children. Other sources of important pharmacokinetic variability include genetic variants, drug-drug interactions, formulation quality, and methods of preparation and administration. Expert commentary: Optimized weight band-based dosing will result in more equitable distribution of drug exposures by weight. The use of high doses of isoniazid in patients with drug-resistant tuberculosis would be safer and more effective if a feasible test was developed to allow stratified dosing according to acetylator type. There is an urgent need for more suitable formulations of many second-line drugs for children. The adoption of new technologies and efficient FDC design may allow further advances for patients and treatment programs. Lastly, current efforts to ensure adequate quality of antituberculosis drug products are not preventing the use of substandard products to treat patients with tuberculosis.
MeSH term(s)	Adult ; Animals ; Antitubercular Agents/administration & dosage ; Antitubercular Agents/adverse effects ; Antitubercular Agents/pharmacokinetics ; Child ; Dose-Response Relationship, Drug ; Drug Interactions ; Female ; Humans ; Male ; Models, Biological ; Tuberculosis/drug therapy ; Tuberculosis/microbiology ; Tuberculosis, Multidrug-Resistant/drug therapy ; Tuberculosis, Multidrug-Resistant/microbiology
Chemical Substances	Antitubercular Agents
Language	English
Publishing date	2018-12-12
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2181279-2
ISSN	1744-8336 ; 1478-7210
ISSN (online)	1744-8336
ISSN	1478-7210
DOI	10.1080/14787210.2019.1555031
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Article ; Online: Leveraging physiologically based pharmacokinetic modeling to optimize dosing for lopinavir/ritonavir with rifampin in pediatric patients.

Salerno, Sara N / Capparelli, Edmund V / McIlleron, Helen / Gerhart, Jacqueline G / Dumond, Julie B / Kashuba, Angela D M / Denti, Paolo / Gonzalez, Daniel

Pharmacotherapy

2022 Volume 43, Issue 7, Page(s) 638–649

Abstract: Study objective: Treatment of HIV and tuberculosis co-infection leads to significant mortality in pediatric patients, and treatment can be challenging due to the clinically significant drug-drug interaction (DDI) between lopinavir/ritonavir (LPV/RTV) ... ...

Abstract	Study objective: Treatment of HIV and tuberculosis co-infection leads to significant mortality in pediatric patients, and treatment can be challenging due to the clinically significant drug-drug interaction (DDI) between lopinavir/ritonavir (LPV/RTV) and rifampin. Doubling LPV/RTV results in insufficient lopinavir trough concentrations in pediatric patients. The objective of this study was to leverage physiologically based pharmacokinetic (PBPK) modeling to optimize the adjusted doses of LPV/RTV in children receiving the WHO-revised doses of rifampin (15 mg/kg daily). Design: Adult and pediatric PBPK models for LPV/RTV with rifampin were developed, including CYP3A and P-glycoprotein inhibition and induction. Setting (or data source): Data for LPV/RTV model development and evaluation were available from the pediatric AIDS Clinical Trials Group. Patients: Dosing simulations were next performed to optimize dosing in children (2 months to 8 years of age). Intervention: Exposure following super-boosted LPV/RTV with 10 and 15 mg/kg PO daily rifampin was simulated. Measurements and main results: Simulated parameters were within twofold observations for LPV, RTV, and rifampin in adults and children ≥2 weeks old. The model predicted that, in healthy adults receiving 400/100 mg oral LPV/RTV twice daily (BID), co-treatment with 600 mg oral rifampin daily decreased the steady-state area under the concentration vs. time curve of LPV by 79%, in line with the observed change of 75%. Simulated and observed concentration profiles were comparable for LPV/RTV (230/57.5 mg/m Conclusions: Super-boosted LPV/RTV with 15 mg/kg rifampin achieves therapeutic LPV troughs in HIV/TB-infected simulated children.
MeSH term(s)	Adult ; Humans ; Child ; Lopinavir/adverse effects ; Ritonavir ; Rifampin/therapeutic use ; Drug Interactions ; HIV Infections/drug therapy ; Anti-HIV Agents ; HIV Protease Inhibitors/therapeutic use
Chemical Substances	Lopinavir (2494G1JF75) ; Ritonavir (O3J8G9O825) ; Rifampin (VJT6J7R4TR) ; Anti-HIV Agents ; HIV Protease Inhibitors
Language	English
Publishing date	2022-06-08
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	603158-4
ISSN	1875-9114 ; 0277-0008
ISSN (online)	1875-9114
ISSN	0277-0008
DOI	10.1002/phar.2703
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Article ; Online: Bedaquiline exposure in pregnancy and breastfeeding in women with rifampicin-resistant tuberculosis.

Court, Richard / Gausi, Kamunkhwala / Mkhize, Buyisile / Wiesner, Lubbe / Waitt, Catriona / McIlleron, Helen / Maartens, Gary / Denti, Paolo / Loveday, Marian

British journal of clinical pharmacology

2022 Volume 88, Issue 8, Page(s) 3548–3558

Abstract: Aims: We aimed to explore the effect of pregnancy on bedaquiline pharmacokinetics (PK) and describe bedaquiline exposure in the breast milk of mothers treated for rifampicin-resistant tuberculosis (TB), where there are no human data available.: ... ...

Abstract	Aims: We aimed to explore the effect of pregnancy on bedaquiline pharmacokinetics (PK) and describe bedaquiline exposure in the breast milk of mothers treated for rifampicin-resistant tuberculosis (TB), where there are no human data available. Methods: We performed a longitudinal PK study in pregnant women treated for rifampicin-resistant TB to explore the effect of pregnancy on bedaquiline exposure. Pharmacokinetic sampling was performed at 4 time-points over 6 hours in the third trimester, and again at approximately 6 weeks postpartum. We obtained serial breast milk samples from breastfeeding mothers, and a single plasma sample taken from breastfed and nonbreastfed infants to assess bedaquiline exposure. We used liquid chromatography-tandem mass spectrometry to perform the breast milk and plasma bedaquiline assays, and population PK modelling to interpret the bedaquiline concentrations. Results: We recruited 13 women, 6 of whom completed the ante- and postpartum PK sampling. All participants were HIV-positive on antiretroviral therapy. We observed lower ante- and postpartum bedaquiline exposures than reported in nonpregnant controls. Bedaquiline concentrations in breast milk were higher than maternal plasma (milk to maternal plasma ratio: 14:1). A single random plasma bedaquiline and M2 concentration was available in 4 infants (median age: 6.5 wk): concentrations in the 1 breastfed infant were similar to maternal plasma concentrations; concentrations in the 3 nonbreastfed infants were detectable but lower than maternal plasma concentrations. Conclusion: We report low exposure of bedaquiline in pregnant women treated for rifampicin-resistant TB. Bedaquiline significantly accumulates in breast milk; breastfed infants receive mg/kg doses of bedaquiline equivalent to maternal doses.
MeSH term(s)	Breast Feeding ; Child ; Diarylquinolines/therapeutic use ; Female ; Humans ; Infant ; Milk, Human/chemistry ; Pregnancy ; Rifampin/pharmacology ; Rifampin/therapeutic use ; Tuberculosis, Multidrug-Resistant/drug therapy
Chemical Substances	Diarylquinolines ; bedaquiline (78846I289Y) ; Rifampin (VJT6J7R4TR)
Language	English
Publishing date	2022-05-26
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15380
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Article ; Online: Clinical outcomes in children living with HIV treated for non-severe tuberculosis in the SHINE Trial.

Chabala, Chishala / Wobudeya, Eric / van der Zalm, Marieke M / Kapasa, Monica / Raichur, Priyanka / Mboizi, Robert / Palmer, Megan / Kinikar, Aarti / Hissar, Syed / Mulenga, Veronica / Mave, Vidya / Musoke, Philippa / Hesseling, Anneke C / McIlleron, Helen / Gibb, Diana / Crook, Angela / Turkova, Anna

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2024

Abstract: Background: Children living with HIV(CLWH) are at high risk of tuberculosis(TB) and face poor outcomes, despite antiretroviral treatment(ART). We evaluated outcomes in CLWH and HIV-uninfected children treated for non-severe TB in the SHINE trial.: ... ...

Abstract	Background: Children living with HIV(CLWH) are at high risk of tuberculosis(TB) and face poor outcomes, despite antiretroviral treatment(ART). We evaluated outcomes in CLWH and HIV-uninfected children treated for non-severe TB in the SHINE trial. Methods: SHINE was a randomized trial that enrolled children aged <16 years with smear-negative, non-severe TB who were randomized to receive 4 vs 6 months of TB treatment and followed for 72 weeks. We assessed TB relapse/recurrence, mortality, hospitalizations, grade ≥3 adverse events by HIV status, and HIV virological suppression in CLWH. Results: Of 1204 enrolled, 127(11%) were CLWH, of similar age (median(IQR) 3.6(1.2, 10.3) vs. 3.5(1.5, 6.9)years, p= 0.07), but more underweight (WAZ; -2.3(-3.3, -0.8) vs -1.0(-1.8, -0.2), p<0.01) and anemic (hemoglobin 9.5(8.7, 10.9) vs 11.5(10.4, 12.3)g/dl, p<0.01) compared to HIV-uninfected children. 68(54%) CLWH were ART-naïve; baseline median CD4 count 719(241-1134) cells/mm3, CD4% 16(10-26)%). CLWH were more likely to be hospitalized (aOR=2.4(1.3-4.6)) and die (aHR(95%CI) 2.6(1.2,5.8)). HIV status, age <3 years (aHR 6.3(1.5,27.3)), malnutrition (aHR 6.2(2.4,15.9)) and hemoglobin <7g/dl(aHR 3.8(1.3,11.5) independently predicted mortality. Among children with available VL, 45% and 61% CLWH had VL<1000copies/ml at weeks 24 and 48, respectively. There was no difference in the effect of randomized treatment duration (4 vs 6 months) on TB treatment outcomes by HIV status (p for interaction=0.42). Conclusions: We found no evidence of a difference in TB outcomes between 4 and 6 months of treatment for CLWH treated for non-severe TB. Irrespective of TB treatment duration, CLWH had higher rates of mortality and hospitalization than HIV-uninfected counterparts.
Language	English
Publishing date	2024-04-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciae193
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Article ; Online: Recent advances in the treatment of tuberculosis.

Motta, Ilaria / Boeree, Martin / Chesov, Dumitru / Dheda, Keertan / Günther, Gunar / Horsburgh, Charles Robert / Kherabi, Yousra / Lange, Christoph / Lienhardt, Christian / McIlleron, Helen M / Paton, Nicholas I / Stagg, Helen R / Thwaites, Guy / Udwadia, Zarir / Van Crevel, Reinout / Velásquez, Gustavo E / Wilkinson, Robert J / Guglielmetti, Lorenzo

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases

2023

Abstract: Background: Tuberculosis (TB) is a global health challenge and one of the leading causes of death worldwide. In the last decade, the TB treatment landscape has dramatically changed. After long years of stagnation, new compounds entered the market ( ... ...

Abstract	Background: Tuberculosis (TB) is a global health challenge and one of the leading causes of death worldwide. In the last decade, the TB treatment landscape has dramatically changed. After long years of stagnation, new compounds entered the market (bedaquiline, delamanid, and pretomanid) and phase III clinical trials have shown promising results towards shortening duration of treatment for both drug-susceptible (Study 31/A5349, TRUNCATE-TB, and SHINE) and drug-resistant TB (STREAM, NiX-TB, ZeNix, and TB-PRACTECAL). Dose optimization of rifamycins and repurposed drugs has also brought hopes of further development of safe and effective regimens. Consequently, international and WHO clinical guidelines have been updated multiple times in the last years to keep pace with these advances. Objectives: This narrative review aims to summarize the state-of-the-art on treatment of drug-susceptible and drug-resistant TB, as well as recent trial results and an overview of ongoing clinical trials. Sources: A non-systematic literature review was conducted in PubMed and MEDLINE, focusing on the treatment of TB. Ongoing clinical trials were listed according to the authors' knowledge and completed consulting clinicaltrials.gov and other publicly available websites (www.resisttb.org/clinical-trials-progress-report, www.newtbdrugs.org/pipeline/trials). Content: This review summarizes the recent, major changes in the landscape for drug-susceptible and drug-resistant treatment, with a specific focus on their potential impact on patient outcomes and programmatic TB management. Moreover, insights in host-directed therapies, and advances in pharmacokinetics and pharmacogenomics are discussed. A thorough outline of ongoing therapeutic clinical trials is presented, highlighting different approaches and goals in current TB clinical research. Implications: Future research should be directed to individualize regimens and protect these recent breakthroughs by preventing and identifying the selection of drug resistance and providing widespread, affordable, patient-centred access to new treatment options for all people affected by TB.
Language	English
Publishing date	2023-07-22
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1328418-6
ISSN	1469-0691 ; 1470-9465 ; 1198-743X
ISSN (online)	1469-0691
ISSN	1470-9465 ; 1198-743X
DOI	10.1016/j.cmi.2023.07.013
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