scholarly journals Adverse Events among HIV/MDR-TB Co-Infected Patients Receiving Antiretroviral and Second Line Anti-TB Treatment in Mumbai, India

PLoS ONE ◽  
2012 ◽  
Vol 7 (7) ◽  
pp. e40781 ◽  
Author(s):  
Petros Isaakidis ◽  
Bhanumati Varghese ◽  
Homa Mansoor ◽  
Helen S. Cox ◽  
Joanna Ladomirska ◽  
...  
Keyword(s):  
Adverse Events ◽  
Second Line ◽  
Tb Treatment ◽  
Mdr Tb

scholarly journals Prevalence and Molecular Characterization of Second-Line Drugs Resistance among Multidrug-ResistantMycobacterium tuberculosisIsolates in Southwest of China

2017 ◽  
Vol 2017 ◽  
pp. 1-9 ◽  
Author(s):  
Y. Hu ◽  
L. Xu ◽  
Y. L. He ◽  
Y. Pang ◽  
N. Lu ◽  
...  
Keyword(s):  
Gene Mutations ◽  
Multidrug Resistant ◽  
Rapid Screening ◽  
Second Line ◽  
Tb Treatment ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Improper Use ◽  
Mdr Tb

This study aimed to investigate the prevalence of multidrug-resistant tuberculosis (MDR-TB) isolates resistant to the second-line antituberculosis drugs (SLDs) and its association with resistant-related gene mutations inMycobacterium tuberculosis(M.tb) isolates from Southwest of China. There were 81 isolates resistant to at least one of the SLDs among 156 MDR-TB isolates (81/156, 51.9%). The rates of general resistance to each of the drugs were as follows: OFX (66/156, 42.3%), KAN (26/156, 16.7%), CAP (13/156, 8.3%), PTO (11/156, 7.1%), PAS (22/156, 14.1%), and AMK (20/156, 12.8%). Therefore, the most predominant pattern was resistant to OFX compared with other SLDs (P<0.001). The results of sequencing showed that 80.2% OFX-resistant MDR-TB isolates containedgyrAmutation and 88.5% KAN-resistant isolates hadrrsmutations with the most frequent mutation being A1401G. These results suggest that improper use of SLDs especially OFX is a real threat to effective MDR-TB treatment not only in China but also in the whole world. Furthermore the tuberculosis control agencies should carry out SLDs susceptibility testing and rapid screening in a broader population of TB patients immediately and the SLDs should be strictly regulated by the administration in order to maintain their efficacy to treat MDR-TB.

scholarly journals The Impact of Concurrent Antiretroviral Therapy and MDR-TB Treatment on Adverse Events

2020 ◽  
Vol 83 (1) ◽  
pp. 47-55 ◽  
Author(s):  
Jonathan P. Smith ◽  
Neel R. Gandhi ◽  
N. Sarita Shah ◽  
Koleka Mlisana ◽  
Pravi Moodley ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Adverse Events ◽  
Tb Treatment ◽  
Mdr Tb ◽  
The Impact

scholarly journals Understanding how geographic, demographic and treatment history impact health outcomes of patients with multi-drug-resistant tuberculosis in Pakistan, 2014–2017

2020 ◽  
Vol 148 ◽  
Author(s):  
F. Iqbal ◽  
M. K. Defer ◽  
A. Latif ◽  
H. Hadi
Keyword(s):  
Large Family ◽  
Multidrug Resistant ◽  
Incidence Rates ◽  
Diagnostic Methods ◽  
Diagnosis And Treatment ◽  
World Health ◽  
Sociocultural Factors ◽  
Second Line ◽  
Tb Treatment ◽  
Mdr Tb

Tuberculosis (TB) is one of the top 10 leading causes of morbidity and mortality worldwide [1]. In 2017, approximately 10 million people were infected with TB and 1.3 million patients faced mortality [1]. Patients with active TB can infect up to 10–15 people over a year. There is a greater risk of transmission in overcrowded areas with limited air ventilation including large family units, prisons and slums [1, 2]. Without proper diagnosis and treatment, roughly 45% of non-HIV positive TB patients face mortality [1]. With the help of global organizations and national TB treatment and control programmes, the global incidence of TB is declining by approximately 2% each year [1]. The World Health Organization (WHO) TB-strategy aims to end the TB epidemic and encourages partners to fund national TB programmes to improve diagnosis and treatment of TB. The goal is to ultimately decrease death rates by 90% and decrease incidence rates by 80% [1]. To achieve these goals, the decline in TB incidence needs to reach approximately 4–5% per year [1]. The WHO 2018 TB report identified multidrug resistant TB (MDR-TB) as the leading factor hindering that goal [1]. The incidence and spread of MDR-TB has drastically increased, where approximately 558 000 new cases of MDR-TB were diagnosed in 2017 causing more than 230 000 deaths globally [1]. MDR-TB is identified by resistance to the two most powerful anti-TB treatment drugs including isoniazid and rifampicin [3]. Patients with MDR-TB are required to start second-line anti-TB drugs (SLDs), which are limited, expensive, less effective and more toxic [1,2]. Therapy duration is one of the major limitations of second-line treatments, which may require up to two years of consistent use. Since TB affects mostly developing countries, long treatment durations and associated costs become a major challenge. In 2015, 15% of new TB cases were reported as MDR-TB, which drastically increased to 24% by 2017 [1]. Even with significant improvements in molecular tests and diagnostic methods, MDR-TB is still on the rise where the success rate of treatments is between 50 and 60% [1]. Additional characteristics including socioeconomic and sociocultural factors need to be considered when targeting and treating patients with MDR-TB.

scholarly journals Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0255357
Author(s):  
Nguyen Bao Ngoc ◽  
Hoa Vu Dinh ◽  
Nguyen Thi Thuy ◽  
Duong Van Quang ◽  
Cao Thi Thu Huyen ◽  
...  
Keyword(s):  
Risk Factors ◽  
Adverse Events ◽  
Bayesian Model Averaging ◽  
Multidrug Resistant ◽  
Treatment Regimens ◽  
Tb Treatment ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Mdr Tb

Objective Management of multidrug-resistant tuberculosis (MDR-TB) is a significant challenge to the global healthcare system due to the complexity and long duration of the MDR-TB treatment. This study analyzed the safety of patients on longer injectable-based MDR-TB treatment regimens using active pharmacovigilance data. Method We conducted an observational, prospective study based on active pharmacovigilance within the national TB program. A total of 659 MDR-TB patients were enrolled and followed up at 9 TB- hospitals in 9 provinces of all 3 regions in Vietnam between 2014 and 2016. Patients received a treatment regimen (standardized or individualized) based on their drug susceptibility test result and their treatment history. Baseline and follow-up information was collected at the start and during treatment. Adverse events (AE) were defined and classified as serious adverse events (SAEs) or otherwise. Multivariate Cox regression following the Iterative Bayesian Model Averaging algorithm was performed to identify factors associated with AE occurrence. Results Out of 659 patients assessed, 71.3% experienced at least one AE, and 17.5% suffered at least one SAE. The most common AEs were gastrointestinal disorders (38.5%), arthralgia (34.7%), and psychiatric disorders (30.0%). The proportion of patients with nephrotoxicity and hearing loss or vestibular disorders were 7.4% and 15.2%, respectively. 13.1% of patients required modifications or interruption of one or more drugs. In 77.7% of patients, treatment was completed successfully, while 9.3% lost to follow-up, in 3.0% treatment failed, and 7.4% died. Some significant risk factors for nephrotoxicity included diabetes mellitus (HR = 8.46 [1.91–37.42]), renal dysfunction (HR = 8.46 [1.91–37.42]), alcoholism (HR = 13.28 [5.04–34.99]), and a higher average daily dose of injectable drugs (HR = 1.28 [1.14–1.43]). Conclusion While a majority of patients on the longer injectable-based regimens experienced non-serious AEs during MDR-TB treatment, one in six patients experienced at least an SAE. Active TB drug-safety monitoring is useful to understand the safety of MDR-TB treatment and explore the risk factors for toxicity. All-oral, shorter MDR-TB regimens might be able to reduce the inconvenience, discomfort, and toxicity of such regimens and increase adherence and likelihood of successful completion.

scholarly journals Tuberculosis control in Latvia: integrated DOTS and DOTS-plus programmes

2006 ◽  
Vol 11 (3) ◽  
pp. 17-18 ◽  
Author(s):  
V Leimane ◽  
J Leimans
Keyword(s):  
Drug Resistance ◽  
The State ◽  
Diagnostic Methods ◽  
Simultaneous Increase ◽  
Second Line ◽  
Tuberculosis Control ◽  
Tb Treatment ◽  
Number Of Patients ◽  
Mdr Tb ◽  
Cure Rates

From 1991 until the end of 1998, the number of patients with tuberculosis in Latvia increased 2.5 times with a simultaneous increase of drug resistant and multidrug resistant tuberculosis (MDR-TB). Descriptive analysis of different TB programme services, activities and strategies including Directly Observed Therapy Short-course (DOTS) for tuberculosis and treatment of MDR-TB, were performed. Data from the state tuberculosis registry, drug resistance surveillance, and the national MDR-TB database were used. The state-funded national tuberculosis control programme (NTAP, Nacionâlâ Tuberkulozes Apkarodanas Programma), based on WHO recommended DOTS strategy, was introduced in Latvia in 1996. The NTAP includes TB control in prisons. Treatment of MDR-TB using second line drugs was started in 1997. Cure rates for TB patients increased from 59.5% in 1996 to 77.5% in 2003. Between 1996 and 2003, more than 200 patients began MDR-TB treatment each year, and the cure rate was between 66% and 73%. Numbers of MDR-TB patients were reduced by more than half during this period. Treatment results including MDR-TB reached the WHO target, with cure rates 85% of newly diagnosed patients. These results demonstrate that MDR-TB treatment and management using the individualised treatment approach can be effectively provided within the overall TB programme on a national scale, to successfully treat a large number of MDR-TB patients. Rapid diagnostic methods combined with early intensified case finding, isolation and infection control measures could decrease transmission of TB and MDR-TB in hospitals and in the community. Highly important that MDR-TB management follows WHO recommendations in order to stop creating drug resistance to first and to second line drugs.

scholarly journals Adverse events among patients of multi drug resistant tuberculosis receiving second line anti TB treatment

2015 ◽  
Vol 1 (6) ◽  
pp. 253 ◽  
Author(s):  
Kishor B. Rathod ◽  
Mangala S. Borkar ◽  
Avinash R. Lamb ◽  
Sanjay L. Suryavanshi ◽  
Gajanan A. Surwade ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
High Protein Diet ◽  
Drug Resistant ◽  
Second Line ◽  
Drug Reactions ◽  
Drug Resistant Tuberculosis ◽  
Resistant Tuberculosis ◽  
Poor Treatment ◽  
Mdr Tb

<p class="abstract"><strong><span lang="EN-US">Background: </span></strong>As per WHO’s “Global Tuberculosis Report, 2012”, India accounts for an estimated 64000 patients out of 310000 cases of drug resistant TB estimated to have occurred amongst the notified cases of TB across the globe in a year. <strong> </strong><span lang="EN-US">MDR-TB is a man-made phenomenon– poor treatment; poor drugs, poor adherence lead to the development of MDR-TB. </span><span lang="EN-US"> </span><span lang="EN-US">Treatment of MDR-TB is difficult, much costlier, challenging and needs experience and skills. Reserve drugs are frequently associated with high rates of unacceptable adverse drug reactions, needing change of regimen. Therefore, it is imperative to monitor and treat adverse drug reactions. <strong></strong></span></p><p class="abstract"><strong><span lang="EN-US">Methods: </span></strong>The present prospective observational study was carried out at Drug Resistant Tuberculosis Centre at Govt. Medical College, Aurangabad, Maharashtra, to monitor patients for early detection of adverse events after starting treatment till the patients were admitted and later followed up personally or telephonically at regular intervals.</p><p class="abstract"><strong><span lang="EN-US">Results:</span></strong><span lang="EN-US"> We observed adverse drug reactions among </span>90/265 (33.96 %) patients of whom 90/265 (33.96 %) had gastro intestinal ADRs, followed by ototoxicity 15/265 (5.66%), psychiatric manifestations 14/265 (5.28%), injection site pain swelling 13/265 (4.90%), arthralgia 11/265 (4.15%), dermatological ADRs 7/265 (2.64%), peripheral neuropathy 5/265 (1.88%), renal dysfunction 3/265 (1.13%), <span lang="EN-US">change of therapy was only required in 13 psychiatric and 12 ototoxic ADRs.</span></p><p class="abstract"><strong><span lang="EN-US">Conclusions:</span></strong><span lang="EN-US"> ADRs are more common in MDR TB patients on second line anti tubercular treatment. Good counseling, spacing drugs, high protein diet helps patients to tolerate therapy better and default rate to drop.</span></p>

scholarly journals Determination of MIC Breakpoints for Second-Line Drugs Associated with Clinical Outcomes in Multidrug-Resistant Tuberculosis Treatment in China

2016 ◽  
Vol 60 (8) ◽  
pp. 4786-4792 ◽  
Author(s):  
Xubin Zheng ◽  
Rongrong Zheng ◽  
Yi Hu ◽  
Jim Werngren ◽  
Lina Davies Forsman ◽  
...  
Keyword(s):  
Treatment Outcome ◽  
Treatment Success ◽  
Multidrug Resistant ◽  
Classification And Regression Tree ◽  
Second Line ◽  
Cart Analysis ◽  
Tb Treatment ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Mdr Tb

ABSTRACTOur study aims to identify the clinical breakpoints (CBPs) of second-line drugs (SLDs) above which standard therapy fails in order to improve multidrug-resistant tuberculosis (MDR-TB) treatment. MICs of SLDs were determined forM. tuberculosisisolates cultured from 207 MDR-TB patients in a prospective cohort study in China between January 2010 and December 2012. Classification and regression tree (CART) analysis was used to identify the CBPs predictive of treatment outcome. Of the 207 MDR-TB isolates included in the present study, the proportion of isolates above the critical concentration recommended by WHO ranged from 5.3% in pyrazinamide to 62.8% in amikacin. By selecting pyrazinamide as the primary node (CBP, 18.75 mg/liter), 72.1% of sputum culture conversions at month four could be predicted. As for treatment outcome, pyrazinamide (CBP, 37.5 mg/liter) was selected as the primary node to predict 89% of the treatment success, followed by ofloxacin (CBP, 3 mg/liter), improving the predictive capacity of the primary node by 10.6%. Adjusted by identified confounders, the CART-derived pyrazinamide CBP remained the strongest predictor in the model of treatment outcome. Our findings indicate that the critical breakpoints of some second-line drugs and PZA need to be reconsidered in order to better indicate MDR-TB treatment outcome.

scholarly journals Phase 2b Open-label Randomized Controlled Trial to Evaluate the Efficacy, Safety and Tolerability of N-acetylcysteine in Reducing Adverse Drug Reactions among Adults Treated for Multidrug-resistant Tuberculosis in Tanzania. (Trial Acronym NAC Trial).

2021 ◽  
Author(s):  
Stellah George George Mpagama ◽  
Happiness C Mvungi ◽  
Peter M Mbelele ◽  
Hadija H Semvua ◽  
Alphonce A Liyoyo ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Multidrug Resistant ◽  
Second Line ◽  
Drug Reactions ◽  
Open Label ◽  
Randomized Controlled ◽  
Tb Treatment ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Mdr Tb

Abstract Background: Adverse drug reactions (ADRs) frequently occur in patients using second-line anti-tuberculosis medicine for treatment of multidrug resistant tuberculosis (MDR-TB). ADRs contribute to treatment interruptions which can compromise treatment response and risk acquired drug resistance to critical newer drugs such as bedaquiline, while severe ADRs carry considerable morbidity and mortality . N-acetylcysteine (NAC) has shown promise in reducing ADRs for medications related to TB in case series or randomized controlled trials in other medical conditions. We therefore designed a pilot clinical trial to study the protective effect of NAC among people treated for MDR-TB with second-line anti-TB medications. Methods: This is a phase 2b randomized open label clinical trial with 3 treatment arms including a control arm , an interventional arm of NAC 900mg daily , and an interventional arm of NAC 900mg twice-daily administered during the intensive phase of MDR-TB treatment. Patients initiating MDR-TB treatment will be enrolled at Kibong’oto National Center of Excellence for MDR-TB in the Kilimanjaro region of Tanzania . The minimum anticipated sample size is 66 ; with 22 participants in each arm. ADR monitoring will be performed at baseline and daily follow-up over 24 weeks including blood and urine specimen collection for hepatic and renal function and electrolyte abnormalities, and electrocardiogram. Sputum will be collected at baseline and monthly thereafter and cultured for mycobacteria as well as assayed for other molecular targets of Mycobacterium tuberculosis . Adverse drug events will be analysed over time using mixed effect models. Mean differences between arms in change of the ADRs from baseline (with 95% confidence intervals) will be derived from the fitted model. Discussion: Given that NAC promotes synthesis of glutathione, an intracellular antioxidant that combats the impact of oxidative stress , it may protect against medication induced oxidative damage in organs such as liver, pancreas, kidney and cells of the immune system. This randomized controlled trial will determine if NAC leads to fewer ADRs, and if this protection is dose dependent. Fewer ADRs among patients treated with MDR-TB may significantly improve treatment outcomes for multidrug regimens that necessitate prolonged treatment durations. Trial registration: PACTR202007736854169 Registered 03 July 2020 https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12163

Sign in / Sign up

Export Citation Format

Share Document