Comparison of different treatments for isoniazid-resistant tuberculosis: an individual patient data meta-analysis

Fregonese, Federica; Ahuja, Shama D.; Akkerman, Onno W.; Arakaki-Sanchéz, Denise; Ayakaka, Irene; Baghaei, Parvaneh; Bang, Didi; Bastos, Mayara Lisboa; Benedetti, Andrea; Bonnet, Maryline; Cattamanchi, Adithya; Cegielski, Peter; Chien, Jung-Yien; Cox, Helen; Dedicoat, Martin; Erkens, Connie; Escalante, Patricio; Falzon, Dennis; Garcia-Prats, Anthony J.; Gegia, Medea; Gillespie, Stephen H.; Glynn, Judith R.; Goldberg, Stefan; Griffith, David E.; Jacobson, Karen R; Johnston, James C.; Jones-López, Edward C.; Khan, Abdul Qadir; Koh, Won Jung; Kritski, Afrânio Lineu; Lan, Zhi Yi; Lee, Jae Ho; Li, Pei Zhi; Maciel, Ethel Leonor Nóia; Galliez, Rafael Mello; Merle, Corinne; Munang, Melinda; Narendran, Gopalan; Nguyen, Viet Nhung; Nunn, Andrew; Ohkado, Akihiro; Park, Jong Sun; Phillips, Patrick P. J.; C, George Priya Doss; Reves, Randall; Romanowski, Kamila; Seung, Kwonjune J.; Schaaf, H. Simon; Skrahina, Alena; Soolingen, Dick van; Tabarsi, Payam; Trajman, Anete; Trieu, Lisa; Velayutham, Banurekha; Viiklepp, Piret; Wang, Jann‐Yuan; Yoshiyama, Takashi; Menzies, Dick

doi:10.1016/s2213-2600(18)30078-x

Cited by 91 publications

(66 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Thankfully, some progress has been made in the last couple of years. In 2018, the World Health Organization (WHO) issued new treatment recommendations for Hr-TB, replacing the previous 9-month course of rifampicin, pyrazinamide, and ethambutol (RZE) with a 6-month regimen based on levofloxacin plus RZE [5,6]. This recommendation is reflected in the updated guideline for DR-TB jointly released in 2019 by the American Thoracic Society, Centers for Disease Control and Prevention, European Respiratory Society, and Infectious Disease Society of America, which also suggests reducing the duration of pyrazinamide to 2 months in case of noncavitary and lower-burden disease or if a high risk of pyrazinamideinduced toxic effects are anticipated [7].…”

mentioning

confidence: 99%

“…Whole-genome sequencing (WGS) data continue to shed light on the wide range of mutations associated with drug resistance, thus not only improving our understanding of transmission dynamics but also helping to refine therapeutic choices for the individual patient [13]. Importantly, a deeper examination of the genotypic diversity of INH resistance would be of great benefit to inform treatment guidelines that are currently based on low-quality evidence [6]. At present, nationwide scale-up of WGS for routine TB diagnosis may not seem within reach in most high-TB-burden countries owing to cost and infrastructure requirements.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Isoniazid-resistant tuberculosis: A problem we can no longer ignore

Sulis

Pai

2020

PLoS Med

View full text Add to dashboard Cite

For decades, people working in tuberculosis (TB) knew that monoresistance to isoniazid (INH) was common. INH has been in clinical use since the 1950s, and drug resistance was expected because its use became widespread. But this knowledge did not necessarily lead to testing for INH-resistant, rifampicin-susceptible TB (Hr-TB) or to the use of special drug regimens for this form of TB. Indeed, for decades, no drug-susceptibility testing (DST) for any drug was done unless patients failed first-line therapy or had risk factors for drug-resistant TB (DR-TB). Simply put, we chose to ignore the problem. When the TB world woke up to the need for universal DST and included it as a key goal in the End TB Strategy released in 2015, the focus became rapid testing for rifampicin resistance (RR) as a means of achieving universal DST. Novel technologies such as Xpert MTB/RIF (Cepheid, Sunnyvale, CA, USA) were rolled out in 2010, but the technology did not include INH-resistance testing [1]. Even today, access to any DST remains low, and when performed, DST is often limited to RR [2]. In 2020, we can no longer hide from this worrisome problem because Hr-TB is much more common than RR and could seriously jeopardize progress in the fight against TB. This is confirmed by an analysis of aggregated drug resistance data from 2003 to 2017 across 156 countries presented in the accompanying research study by Anna Dean and colleagues in PLOS Medicine, showing that-on average-7.4% (95% CI 6.5-8.4) of new cases and 11.4% (9.4-13.4) of previously treated patients have Hr-TB [3]. The overall prevalence of INH resistance (with or without concomitant RR) ranged between 10.7% (9.6-11.9) and 27.2% (24.6-29.9) depending on the treatment history and reached even more alarming levels in certain countries, particularly in the European and Western Pacific regions. The analysis by Dean and colleagues highlights major flaws in national surveillance systems, which go hand in hand with limited laboratory capacity. The small sample sizes available from some countries make national prevalence estimates imprecise. Furthermore, the diversity of detection methods employed across settings along with the widespread lack of quality control underscores the need for improved surveillance by countries. From a clinical standpoint, if INH resistance is not detected, new patients are managed as if they had pansusceptible TB, with a substantially increased risk of treatment failure or relapse and a greater propensity to acquire further resistance [4]. Yet, most research and policy efforts so far have been focused solely on RR as a proxy for multidrug-resistant (MDR)-TB. This means that hundreds of thousands of patients with Hr-TB are staying in the shadows, not receiving appropriate care, and all too often ending up developing MDR-TB.

show abstract

mentioning

confidence: 99%

mentioning

confidence: 99%

Isoniazid-resistant tuberculosis: A problem we can no longer ignore

Sulis

Pai

2020

PLoS Med

View full text Add to dashboard Cite

show abstract

“…drugs if not well tolerated or suggested to include in case of isoniazid resistance (3)(4)(5). In general, the toxicity profile of moxifloxacin is rather mild, though it includes concentration-dependent corrected QT interval prolongation and, rarely, tendinopathy (6)(7)(8)(9).…”

mentioning

confidence: 99%

Limited Sampling Strategies Using Linear Regression and the Bayesian Approach for Therapeutic Drug Monitoring of Moxifloxacin in Tuberculosis Patients

Elsen

Sturkenboom

Akkerman

et al. 2019

Antimicrob Agents Chemother

View full text Add to dashboard Cite

Therapeutic drug monitoring (TDM) of moxifloxacin is recommended to improve the response to tuberculosis treatment and reduce acquired drug resistance. Limited sampling strategies (LSSs) are able to reduce the burden of TDM by using a small number of appropriately timed samples to estimate the parameter of interest, the area under the concentration-time curve. This study aimed to develop LSSs for moxifloxacin alone (MFX) and together with rifampin (MFX+RIF) in tuberculosis (TB) patients. Population pharmacokinetic (popPK) models were developed for MFX (n = 77) and MFX+RIF (n = 24). In addition, LSSs using Bayesian approach and multiple linear regression were developed. Jackknife analysis was used for internal validation of the popPK models and multiple linear regression LSSs. Clinically feasible LSSs (one to three samples, 6-h timespan postdose, and 1-h interval) were tested. Moxifloxacin exposure was slightly underestimated in the one-compartment models of MFX (mean –5.1%, standard error [SE] 0.8%) and MFX+RIF (mean –10%, SE 2.5%). The Bayesian LSSs for MFX and MFX+RIF (both 0 and 6 h) slightly underestimated drug exposure (MFX mean –4.8%, SE 1.3%; MFX+RIF mean –5.5%, SE 3.1%). The multiple linear regression LSS for MFX (0 and 4 h) and MFX+RIF (1 and 6 h), showed mean overestimations of 0.2% (SE 1.3%) and 0.9% (SE 2.1%), respectively. LSSs were successfully developed using the Bayesian approach (MFX and MFX+RIF; 0 and 6 h) and multiple linear regression (MFX, 0 and 4 h; MFX+RIF, 1 and 6 h). These LSSs can be implemented in clinical practice to facilitate TDM of moxifloxacin in TB patients.

show abstract

“…Despite those problems, various studies have collected and pooled observational data, enabling individual patient meta-analyses (IPD-MAs). Since 2010, when WHO and other organizations started using GRADE for drug-resistant TB treatment guidelines (20), WHO recommendations on the type, composition, and duration of second-line TB regimens have been based largely on evidence from observational studies of patients treated under field conditions (21)(22)(23)(24)(25). Ahead of the WHO MDR/RR TB guideline update in 2018, a public call was made for contributors to report IPD conforming to certain criteria and a specific data dictionary (26).…”

Section: Online Reportmentioning

confidence: 99%