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14. Standard ganciclovir dosing results in slow decline of cytomegalovirus viral loads

Author

Märtson, Anne-Grete, Sturkenboom, Marieke G. G., Knoester, Marjolein, van der Werf, Tjip S., Alffenaar, Jan-Willem C., Hope, William, Edwina, Angela E., Burgerhof, Johannes G. M., Berger, Stefan P., de Joode, Anoek, Damman, Kevin, Verschuuren, Erik A. M., Blokzijl, Hans, Bakker, Martijn, Touw, Daan J., rtson, Anne-Grete Mä, and Microbes in Health and Disease (MHD)

Subjects
Pharmacology, Microbiology (medical), Antiviral Agents/therapeutic use, viruses, virus diseases, Cytomegalovirus, Viral Load, Antiviral Agents, Editor's Choice, AcademicSubjects/MED00290, Infectious Diseases, Ganciclovir/therapeutic use, AcademicSubjects/MED00740, Humans, Valganciclovir, Pharmacology (medical), AcademicSubjects/MED00230, Ganciclovir, Original Research
Abstract

Background Cytomegalovirus (CMV) can cause severe disease, including rejection in transplant recipients. Ganciclovir and its oral prodrug valganciclovir have been used as first-line therapy for CMV disease in transplant recipients. The exposure targets of ganciclovir are not exactly known, and toxicity and resistance have interfered with ganciclovir therapy. Objectives To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ganciclovir in transplant recipients. Methods We used patient data from a previous observational study on ganciclovir therapeutic drug monitoring (TDM) in prophylaxis and therapy. The ganciclovir concentrations and CMV viral loads were determined during routine clinical care. The PK/PD population modelling and simulations were done with non-parametric methodology using the Pmetrics program. Results Eighty-five patients were included in the PK modelling. The final PK model was a two-compartment model with first-order absorption and elimination. A subset of 17 patients on CMV therapy were included in the PD modelling. A median of 4 (range 2–8) viral loads were obtained per patient. A simulation of 10 000 patients showed that an approximately 1 log10 reduction of CMV viral load will be observed after 12.5 days at the current recommended dose. Conclusions The developed linked PK/PD population model and subsequent PD simulations showed slow decline of CMV viral load and it appears that dosing of (val)ganciclovir in this study might have been inadequate to achieve fast reduction of viral load. It is clear that further studies are needed to specify the PD effects of ganciclovir by performing systematic measurements of both ganciclovir concentrations and CMV viral loads.

Published
2022

15. Population pharmacokinetics of liposomal amphotericin B in adults with HIV-associated cryptococcal meningoencephalitis

Author

Stott, Katharine E, primary, Moyo, Melanie, additional, Ahmadu, Ajisa, additional, Kajanga, Cheusisime, additional, Gondwe, Ebbie, additional, Chimang’anga, Wezzie, additional, Chasweka, Madalitso, additional, Leeme, Tshepo B, additional, Molefi, Mooketsi, additional, Chofle, Awilly, additional, Bidwell, Gabriella, additional, Changalucha, John, additional, Unsworth, Jenny, additional, Jimenez-Valverde, Ana, additional, Lawrence, David S, additional, Mwandumba, Henry C, additional, Lalloo, David G, additional, Harrison, Thomas S, additional, Jarvis, Joseph N, additional, Hope, William, additional, and Märtson, Anne-Grete, additional

Published
2022
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17. Optimised administration of anti-infective drugs for prophylaxis and treatment in immunocompromised patients

Author

Märtson, Anne-Grete, Märtson, Anne-Grete, Märtson, Anne-Grete, and Märtson, Anne-Grete

Abstract

One of the major global threats is antimicrobial resistance. To prevent the development of antimicrobial resistance it is important to use anti-infectives at the right dose, at the right time and for the right duration. Every anti-infective can cause certain toxicity that can occur when the drug exposure is too high or resistance can develop when exposure is too low, both of which can affect the treatment outcome. The goal of this thesis was to investigate optimisation of anti-infective therapy in immunocompromised patients, such as transplant recipients, patients with hematological malignancies and critically ill patients. To achieve this, we explored the opportunities to improve the design of future studies; we conducted studies on therapeutic drug monitoring (TDM, measurement of drug concentrations and adjusting the dose accordingly); and we utilised data from previous clinical studies to develop population mathematic (pharmacokinetic) models to better guide drug dosing to improve drug exposure, thereby aiming to improve treatment outcome. We showed underexposure of anti-infectives in certain patient groups and designed dosing regimens that could be utilised in the clinic and further studies. Clearly, we have only just started the journey to optimise anti-infective therapy in immunocompromised patients. To further optimise outcomes, the future challenge will be to move on to patient-level personalisation using specific targets for individuals and potentially exploring drug exposure at the site of the infection.

Published
2021

18. TDM of Anti-infective Drugs: Implementation Strategies for Three Different Scenarios

Author

Kim, Hannah Yejin, Byashalira, Kenneth C., Heysell, Scott K., Märtson, Anne-Grete, Mpagama, Stellah G., Rao, Prakruti, Sturkenboom, Marieke G.G., and Alffenaar, Jan-Willem C.

Subjects
Anti-Infective Agents, Critical Illness, Humans, Drug Monitoring, Article, Software
Abstract

PURPOSE: Therapeutic drug monitoring (TDM) supports personalized treatment. For successful implementation, TDM must have a turnaround time suited to the clinical needs of patients and their health care settings. Here, the authors share their views of how a TDM strategy can be tailored to specific settings and patient groups. METHODS: The authors selected distinct scenarios for TDM: high-risk, complex, and/or critically ill patient population; outpatients; and settings with limited laboratory resources. In addition to the TDM scenario approach, they explored potential issues with the legal framework governing dose escalation. RESULTS: The most important issues identified in the different scenarios are that critically ill patients require rapid turnaround time, outpatients require an easy sampling procedure with respect to the sample matrix as well as sample collection times, settings with limited laboratory resources necessitate setting-specific analytical techniques, and all scenarios warrant a legal framework to capture the use of escalated dosages, ideally with the use of trackable dosing software. CONCLUSION: To benefit patients, TDM strategies need to be tailored to the intended population. Strategies can be adapted for rapid turnaround time for critically ill patients, convenient sampling for outpatients, and feasibility for those in settings with limited laboratory resources.

Published
2022

25. Ganciclovir therapeutic drug monitoring in transplant recipients

Author

Märtson, Anne-Grete, primary, Edwina, Angela E., additional, Burgerhof, Johannes G. M., additional, Berger, Stefan P., additional, de Joode, Anoek, additional, Damman, Kevin, additional, Verschuuren, Erik A. M., additional, Blokzijl, Hans, additional, Bakker, Martijn, additional, Span, Lambert F., additional, van der Werf, Tjip S., additional, Touw, Daan J., additional, Sturkenboom, Marieke G. G., additional, Knoester, Marjolein, additional, and Alffenaar, Jan W. C., additional

Published
2021
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27. Caspofungin Weight-Based Dosing Supported by a Population Pharmacokinetic Model in Critically Ill Patients

Author

Apotheek Klinische Farmacie, Märtson, Anne-Grete, van der Elst, Kim C M, Veringa, Anette, Zijlstra, Jan G, Beishuizen, Albertus, van der Werf, Tjip S, Kosterink, Jos G W, Neely, Michael, Alffenaar, Jan-Willem, Apotheek Klinische Farmacie, Märtson, Anne-Grete, van der Elst, Kim C M, Veringa, Anette, Zijlstra, Jan G, Beishuizen, Albertus, van der Werf, Tjip S, Kosterink, Jos G W, Neely, Michael, and Alffenaar, Jan-Willem

Published
2020

29. Coronavirus Disease-19: An Interim Evidence Synthesis of the World Association for Infectious Diseases and Immunological Disorders (Waidid)

Author

Abu-Raya, Bahaa, primary, Migliori, Giovanni Battista, additional, O'Ryan, Miguel, additional, Edwards, Kathryn, additional, Torres, Antoni, additional, Alffenaar, Jan-Willem, additional, Märtson, Anne-Grete, additional, Centis, Rosella, additional, D'Ambrosio, Lia, additional, Flanagan, Katie, additional, Hung, Ivan, additional, Lauretani, Fulvio, additional, Leung, Chi Chi, additional, Leuridan, Elke, additional, Maertens, Kirsten, additional, Maggio, Marcello Giuseppe, additional, Nadel, Simon, additional, Hens, Niel, additional, Niesters, Hubert, additional, Osterhaus, Albert, additional, Pontali, Emanuele, additional, Principi, Nicola, additional, Rossato Silva, Denise, additional, Omer, Saad, additional, Spanevello, Antonio, additional, Sverzellati, Nicola, additional, Tan, Tina, additional, Torres-Torreti, Juan Pablo, additional, Visca, Dina, additional, and Esposito, Susanna, additional

Published
2020
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31. Ethionamide Population Pharmacokinetic Model and Target Attainment in Multidrug-Resistant Tuberculosis

Author

Al-Shaer, Mohammad H., primary, Märtson, Anne-Grete, additional, Alghamdi, Wael A., additional, Alsultan, Abdullah, additional, An, Guohua, additional, Ahmed, Shahriar, additional, Alkabab, Yosra, additional, Banu, Sayera, additional, Houpt, Eric R., additional, Ashkin, David, additional, Griffith, David E., additional, Cegielski, J. Peter, additional, Heysell, Scott K., additional, and Peloquin, Charles A., additional

Published
2020
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32. Epidemic and pandemic viral infections: impact on tuberculosis and the lung

Author

Ong, Catherine Wei Min, primary, Migliori, Giovanni Battista, additional, Raviglione, Mario, additional, MacGregor-Skinner, Gavin, additional, Sotgiu, Giovanni, additional, Alffenaar, Jan-Willem, additional, Tiberi, Simon, additional, Adlhoch, Cornelia, additional, Alonzi, Tonino, additional, Archuleta, Sophia, additional, Brusin, Sergio, additional, Cambau, Emmanuelle, additional, Capobianchi, Maria Rosaria, additional, Castilletti, Concetta, additional, Centis, Rosella, additional, Cirillo, Daniela M., additional, D'Ambrosio, Lia, additional, Delogu, Giovanni, additional, Esposito, Susanna M.R., additional, Figueroa, Jose, additional, Friedland, Jon S., additional, Ho, Benjamin Choon Heng, additional, Ippolito, Giuseppe, additional, Jankovic, Mateja, additional, Kim, Hannah Yejin, additional, Rosales Klintz, Senia, additional, Ködmön, Csaba, additional, Lalle, Eleonora, additional, Leo, Yee Sin, additional, Leung, Chi-Chiu, additional, Märtson, Anne-Grete, additional, Melazzini, Mario Giovanni, additional, Najafi Fard, Saeid, additional, Penttinen, Pasi, additional, Petrone, Linda, additional, Petruccioli, Elisa, additional, Pontali, Emanuele, additional, Saderi, Laura, additional, Santin, Miguel, additional, Spanevello, Antonio, additional, van Crevel, Reinout, additional, van der Werf, Marieke J., additional, Visca, Dina, additional, Viveiros, Miguel, additional, Zellweger, Jean-Pierre, additional, Zumla, Alimuddin, additional, and Goletti, Delia, additional

Published
2020
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35. Posaconazole therapeutic drug monitoring in clinical practice and longitudinal analysis of the effect of routine laboratory measurements on posaconazole concentrations

Author

Märtson, Anne Grete, Veringa, Anette, van den Heuvel, Edwin R., Bakker, Martijn, Touw, Daan J., van der Werf, Tjip S., Span, Lambert F.R., Alffenaar, Jan Willem C., Märtson, Anne Grete, Veringa, Anette, van den Heuvel, Edwin R., Bakker, Martijn, Touw, Daan J., van der Werf, Tjip S., Span, Lambert F.R., and Alffenaar, Jan Willem C.

Abstract

Posaconazole is indicated for prophylaxis and treatment of invasive aspergillosis. Therapeutic drug monitoring (TDM) of posaconazole is used to optimise drug exposure. The aim of this study was to analyse and describe the TDM practices and exposure of posaconazole tablets. Patients who received posaconazole for treatment or prophylaxis of fungal infections were included in the study. The following therapeutic window was defined: if concentration was low (<0.7 mg/L for prophylaxis or < 1.5 mg/L for treatment) or high (>3.75 mg/L), the hospital pharmacist provided the physician with dosage advice, which implementation to patient care was analysed. A longitudinal analysis was performed to analyse if different confounding variables had an effect on posaconazole concentrations. Forty-seven patients were enrolled resulting in 217 posaconazole trough concentrations. A median of 3 (IQR 1-7) samples was measured per patient. The median concentration was 1.7 mg/L (IQR 0.8-2.7) for prophylaxis and 1.76 mg/L (IQR 1.3-2.3) for treatment. Overall, 78 posaconazole concentrations were out of the therapeutic window. For 45 (54%) of these concentrations, a dosage change was recommended. In the longitudinal analysis, the laboratory markers and patient baseline variables did not have an effect on posaconazole concentrations. Adequate posaconazole exposure was shown in 64% (affected 28 patients) of the measured concentrations. TDM practice of posaconazole can be improved by increasing the implementation rate of dose recommendation by a multidisciplinary antifungal stewardship team.

Published
2019

36. Posaconazole trough concentrations are not influenced by inflammation: a prospective study

Author

Märtson, Anne Grete, Veringa, Anette, Bakker, Martijn, van den Heuvel, Edwin R., Touw, Daan J., van der Werf, Tjip S., Span, Lambert F.R., C. Alffenaar, Jan Willem, Märtson, Anne Grete, Veringa, Anette, Bakker, Martijn, van den Heuvel, Edwin R., Touw, Daan J., van der Werf, Tjip S., Span, Lambert F.R., and C. Alffenaar, Jan Willem

Abstract

During inflammation, several cytochrome P450 enzymes are downregulated. Recently it was shown that voriconazole metabolism is reduced during inflammation. Posaconazole, another triazole with broad-spectrum antifungal activity, is metabolised only to a limited extent by cytochrome P450 enzymes and to a wider extent by phase 2 enzyme systems. The aim of this study was to investigate posaconazole concentrations during inflammation. Patients aged ≥18 years receiving posaconazole prophylaxis or treatment for fungal infections were enrolled in a prospective observational study. Samples for posaconazole and C-reactive protein (CRP) concentrations were collected routinely for each patient. Longitudinal data analysis was performed to analyse the correlation between posaconazole serum trough concentrations and CRP values, corrected for potential factors that could influence the posaconazole concentration. Between August 2015 and June 2017, 64 patients were recruited to this study. Data for 55 patients (511 posaconazole samples) were included in the final analysis. The overall median posaconazole concentration was 1.8 mg/L [interquartile range (IQR) 1–2.9 mg/L, range 0.1–7.94 mg/L] and the overall median CRP concentration was 23.5 mg/L (IQR 5–75 mg/L, range 0–457 mg/L). Longitudinal data analysis showed that only the posaconazole daily dose (in mg/kg body weight) had a significant influence on posaconazole concentration after correction for other factors (P < 0.0001). Posaconazole concentrations were not influenced by CRP concentrations (P = 0.77). Posaconazole concentrations are not influenced by inflammation, reflected by CRP concentration. Therefore, more frequent therapeutic drug monitoring of posaconazole during inflammation or after an infection subsides is not necessary.

Published
2019

40. From Therapeutic Drug Monitoring to Model‐Informed Precision Dosing for Antibiotics.

Author

Wicha, Sebastian G., Märtson, Anne‐Grete, Nielsen, Elisabet I., Koch, Birgit C.P., Friberg, Lena E., Alffenaar, Jan‐Willem, and Minichmayr, Iris K.

Subjects
DRUG monitoring, BETA lactam antibiotics, LINEZOLID, ANTIBIOTICS, CLINICAL pharmacology, EXPERIMENTAL design, MODEL validation
Abstract

Therapeutic drug monitoring (TDM) and model‐informed precision dosing (MIPD) have evolved as important tools to inform rational dosing of antibiotics in individual patients with infections. In particular, critically ill patients display altered, highly variable pharmacokinetics and often suffer from infections caused by less susceptible bacteria. Consequently, TDM has been used to individualize dosing in this patient group for many years. More recently, there has been increasing research on the use of MIPD software to streamline the TDM process, which can increase the flexibility and precision of dose individualization but also requires adequate model validation and re‐evaluation of existing workflows. In parallel, new minimally invasive and noninvasive technologies such as microneedle‐based sensors are being developed, which—together with MIPD software—have the potential to revolutionize how patients are dosed with antibiotics. Nonetheless, carefully designed clinical trials to evaluate the benefit of TDM and MIPD approaches are still sparse, but are critically needed to justify the implementation of TDM and MIPD in clinical practice. The present review summarizes the clinical pharmacology of antibiotics, conventional TDM and MIPD approaches, and evidence of the value of TDM/MIPD for aminoglycosides, beta‐lactams, glycopeptides, and linezolid, for which precision dosing approaches have been recommended. [ABSTRACT FROM AUTHOR]

Published
2021
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41. Therapeutic drug monitoring in patients with tuberculosis and concurrent medical problems

Author

Märtson, Anne-Grete, Burch, Gena, Ghimire, Samiksha, Alffenaar, Jan-Willem C., and Peloquin, Charles A.

Abstract

ABSTRACTIntroductionTherapeutic drug monitoring (TDM) has been recommended for treatment optimization in tuberculosis (TB) but is only is used in certain countries e.g. USA, Germany, the Netherlands, Sweden and Tanzania. Recently, new drugs have emerged and PK studies in TB are continuing, which contributes further evidence for TDM in TB. The aim of this review is to provide an update on drugs used in TB, treatment strategies for these drugs, and TDM to support broader implementation.Areas coveredThis review describes the different drug classes used for TB, multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), along with their pharmacokinetics, dosing strategies, TDM and sampling strategies. Moreover, the review discusses TDM for patient TB and renal or liver impairment, patients co-infected with HIV or hepatitis, and special patient populations – children and pregnant women.Expert opinionTB treatment has a long history of using ‘one size fits all.’ This has contributed to treatment failures, treatment relapses, and the selection of drug-resistant isolates. While challenging in resource-limited circumstances, TDM offers the clinician the opportunity to individualize and optimize treatment early in treatment. This approach may help to refine treatment and thereby reduce adverse effects and poor treatment outcomes. Funding, training, and randomized controlled trials are needed to advance the use of TDM for patients with TB.

Published
2021
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42. Precision Therapy for Invasive Fungal Diseases.

Author

Märtson, Anne-Grete, Alffenaar, Jan-Willem C., Brüggemann, Roger J., and Hope, William

Subjects
*MYCOSES, *INDIVIDUALIZED medicine, *IMMUNOCOMPROMISED patients, *PHARMACODYNAMICS, *PHARMACOKINETICS
Abstract

Invasive fungal infections (IFI) are a common infection-related cause of death in immunocompromised patients. Approximately 10 million people are at risk of developing invasive aspergillosis annually. Detailed study of the pharmacokinetics (PK) and pharmacodynamics (PD) of antifungal drugs has resulted in a better understanding of optimal regimens for populations, drug exposure targets for therapeutic drug monitoring, and establishing in vitro susceptibility breakpoints. Importantly, however, each is an example of a "one size fits all strategy", where complex systems are reduced to a singularity that ensures antifungal therapy is administered safely and effectively at the level of a population. Clearly, such a notion serves most patients adequately but is completely counter to the covenant at the centre of the clinician–patient relationship, where each patient should know whether they are well-positioned to maximally benefit from an antifungal drug. This review discusses the current therapy of fungal infections and areas of future research to maximise the effectiveness of antifungal therapy at an individual level. [ABSTRACT FROM AUTHOR]

Published
2022
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45. A systematic review of antibiotic drug shortages and the strategies employed for managing these shortages.

Author

Pandey AK, Cohn J, Nampoothiri V, Gadde U, Ghataure A, Kakkar AK, Kumar Gupta Y, Malhotra S, Mbamalu O, Mendelson M, Märtson AG, Singh S, Tängdén T, Shafiq N, and Charani E

Abstract

Background: There is a need to examine the impact of increasingly prevalent antibiotic shortages on patient outcomes and on the emergence and spread of antimicrobial resistance (AMR)., Objectives: To: 1) assess patterns and causes of shortages, 2) investigate the effect of shortages on health systems and patient outcomes, and 3) identify strategies for forecasting and managing shortages., Data Sources: PubMed/MEDLINE, EMBASE, Scopus, and Web of Science., Study Eligibility Criteria: Studies published in English during January 2000-July 2023., Participants: Healthcare, policy and strategic teams managing and responding to shortages. Patient populations (adult and children) affected by shortages., Interventions: Strategies, policies, and mitigation options for managing and responding to antibiotic drug shortages., Risk of Bias: Methodological quality of included studies was reviewed using the most appropriate tool from Joanna Briggs Institute critical appraisal tool for each study design., Methods: Data synthesis was qualitative and quantitative using descriptive statistics., Results: The final analysis included 74 studies (61/74, 82.4% high-income countries). Shortages were most reported for piperacillin-tazobactam (21/74, 28.4%) with most of the reported antibiotics being in the WHO Watch category (27/54, 51%). Frequent cause of shortages was disruption in manufacturing including supply of active pharmaceutical ingredient and raw materials. Clinical implications of shortages included increased length of hospital stay, treatment failure after using inferior alternative agents and negative impact on antimicrobial stewardship programmes (AMS). Robust economic impact analysis of shortages is unavailable. Successfully reported mitigation strategies were driven by AMS and infectious diseases teams in hospitals., Conclusions: Antibiotic shortages are directly or indirectly driven by economic viability and reliance on single source ingredients. The limited data on clinical outcomes indicates mixed effect with some infections becoming more difficult to treat, though there is no robust data on the impact of shortages on AMR. The mitigation strategies to manage shortages rely heavily on AMS teams., (Copyright © 2024 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Published
2024
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