Treatment FAQ

who pre final text of who tb treatment guidelines

by Dayna Mitchell Published 2 years ago Updated 2 years ago
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What is the who guidance for the management of tuberculosis in children?

Since the publication of the WHO Guidance for national tuberculosis programmes on the management of tuberculosis in children – second edition in 2014, new recommendations have been published in WHO guidelines and other policy documents on TB prevention, screening, diagnosis, treatment, management and models of care.

Who has the legal authority to control tuberculosis (TB)?

Because of the public health implications of prompt diagnosis and effective treatment of tuberculosis, most low-incidence countries designate a government public health agency as legal authority for controlling tuberculosis [12, 13].

Where can I find the latest recommendations for TB treatment?

The new recommendations are also available on the WHO Global Tuberculosis Programme’s Knowledge Sharing Platform. Tuberculosis (TB) is a preventable and curable disease, but it continues to impact the lives and development of millions of children and adolescents.

What are the who treatment guidelines for multidrug-/rifampicin-resistant tuberculosis?

The 2018 World Health Organization (WHO) treatment guidelines for multidrug-/rifampicin-resistant tuberculosis (MDR/RR-TB) give preference to all-oral long regimens lasting for 18–20 months. The guidelines strongly recommend combining bedaquiline, levofloxacin (or moxifloxacin) and linezolid, supplemented by cycloserine and/or clofazimine.

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What is the WHO recommended treatment protocol for TB?

The preferred regimen for treating adults with TB remains a regimen consisting of an intensive phase of 2 months of isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and ethambutol (EMB) followed by a continuation phase of 4 months of INH and RIF.

WHO latent TB treatment guidelines?

Preferred RegimensThree Months of Weekly Isoniazid Plus Rifapentine. ... Four Months of Daily Rifampin. ... Three Months of Daily Isoniazid Plus Rifampin.

WHO pre XDR-TB definition?

The new definition of pre-XDR-TB is: TB caused by Mycobacterium tuberculosis (M. tuberculosis) strains that fulfil the definition of multidrug resistant and rifampicin-resistant TB (MDR/RR-TB) and which are also resistant to any fluoroquinolone. The definition of MDR-TB* remains unchanged.

WHO guidelines TB prevention?

The World Health Organization has updated its guidelines on tuberculosis preventive treatment. Among the 18 recommendations, the group now conditionally recommends shorter regimens as alternative treatment options: 1 month of daily rifapentine and isoniazid, or 4 months of daily rifampicin.

WHO latent TB guidelines 2020?

Key RecommendationsThe first of three preferred regimens is once-weekly isoniazid plus rifapentine, for 3 months. ... The second preferred regimen, daily rifampin for 4 months, is also strongly recommended, especially for HIV-negative persons, and has perhaps the lowest toxicity.More items...•

WHO consolidated guidelines on tuberculosis Module 3 diagnosis?

WHO consolidated guidelines on tuberculosis Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection. The political declaration of the first United Nations (UN) high-level meeting on tuberculosis (TB) calls countries to diagnose and treat 40 million people with TB globally between 2018 and 2022.

What is the difference between MDR and XDR-TB?

Multidrug-resistant tuberculosis (MDR-TB) is practically incurable by standard first-line treatment. However, extensively drug-resistant tuberculosis (XDR-TB) is resistant to both first- and second-line drugs due to drug misuse and mismanagement. Therefore, XDR-TB treatment becomes even harder.

What is MDR-TB and XDR-TB Slideshare?

Multi drug and extensive drug resistant tuberculosis. Manju Pilania.

What is the full form of dots?

The full form of DOTS is the Directly Observed Therapy, Short-course. It is also known as TB – DOTS. It refers to a strategy aimed at curing and reducing the risk of TB (tuberculosis) cases.

WHO TB update?

Every year, 10 million people fall ill with tuberculosis (TB). Despite being a preventable and curable disease, 1.5 million people die from TB each year – making it the world's top infectious killer. TB is the leading cause of death of people with HIV and also a major contributor to antimicrobial resistance.

What are the 3 types of tuberculosis?

Tuberculosis: TypesActive TB Disease. Active TB is an illness in which the TB bacteria are rapidly multiplying and invading different organs of the body. ... Miliary TB. Miliary TB is a rare form of active disease that occurs when TB bacteria find their way into the bloodstream. ... Latent TB Infection.

What does the CDC and Prevention currently recommend for health care workers who care for TB infected patients?

The following measures can be taken to reduce the risk for exposure: Implementing a respiratory protection program; Training health care personnel on respiratory protection; and. Educating patients on respiratory hygiene and the importance of cough etiquette procedures.

How long does a RR-TB treatment last?

The 2018 World Health Organization (WHO) treatment guidelines for multidrug-/rifampicin-resistant tuberculosis (MDR/RR-TB) give preference to all-oral long regimens lasting for 18–20 months . Injectable agents are no longer among the priority medicines. The guidelines recommend that long MDR-TB regimens should include at least four agents likely to be effective in the first 6 months, and three agents thereafter. The guidelines strongly recommend the use of bedaquiline, levofloxacin (or moxifloxacin) and linezolid, supplemented by cycloserine and/or clofazimine [1].

What are the two core drugs used in TB treatment?

The new long WHO regimen uses two core drugs in a single regimen: a newer generation fluoroquinolone plus bedaquiline [1]. Besides rifampicin, these are likely to be the only two anti-TB drugs currently known to have both the necessary high bactericidal and sterilizing power to drive the effectiveness of a TB treatment regimen [6]. The use of two core drugs in one regimen may result in a considerable level of treatment success. However, like any treatment regimen, it cannot be successful in every patient. Acquired resistance to bedaquiline may develop, particularly in patients with undetected resistance to fluoroquinolones. The WHO guidelines indicate that, ideally, all MDR-TB patients should have – as a minimum – the isolate tested for fluoroquinolone susceptibility before the start of treatment, but they also acknowledge that capacity for DST may be lacking [1]. Given that DST capacity in resource-limited settings is insufficient and resistance to fluoroquinolones may not be detected, the risk of acquired bedaquiline resistance in fluoroquinolone-resistant pre-extensively-drug-resistant TB cannot be ignored. Indeed, high proportions of acquired bedaquiline and linezolid resistance were observed in patients treated with the combination (group A drugs plus cycloserine) that is now recommended [13].

Why is individualized treatment regimen effective?

In high-income settings, an individualized treatment regimen can be most effective because it can be applied under ideal conditions [40]. This will rarely be the case in low-income countries. The composition of the new long WHO regimen will need to fit many preconditions and will require adaption to frequent – and often serious – adverse events, so ‘standardized regimen’ may lose its meaning. The recommended long regimen, with which not a single patient has been reported to have been treated to date, is likely to cause more serious adverse events than the one it is intended to replace. This may very well result in a lower-than-expected level of effectiveness. The conditions for its use are too complex to be met in low- and middle-income countries, where it may not be any better than the currently used long regimens with a reported success rate of 55% [39]. This would be disastrous because of the introduction of resistance to not one but two core drugs, leaving almost no further treatment options in resource-limited settings.

Is a short regimen optional?

The WHO guidelines make the short regimen optional (leaving the choice to the individual patient and physician), and questionably present it as a less effective treatment compared with the long regimen [2].

What is the decision to initiate combination chemotherapy for tuberculosis?

The decision to initiate combination chemotherapy for tuberculosis is based on clinical, radiographic, laboratory, patient, and public health factors (Figure 1). In addition, clinical judgment and the index of suspicion for tuberculosis are critical in making a decision to initiate treatment.

What are the objectives of tuberculosis treatment?

The objectives of tuberculosis therapy are (1) to rapidly reduce the number of actively growing bacilli in the patient, thereby decreasing severity of the disease , preventing death and halting transmission of M. tuberculosis; (2) to eradicate populations of persisting bacilli in order to achieve durable cure (prevent relapse) after completion of therapy; and (3) to prevent acquisition of drug resistance during therapy.

What is DOT in chemo?

Among these, directly observed therapy (DOT), the practice of observing the patient swallow their antituberculosis medications, has been widely used as the standard of practice in many tuberculosis programs, and deserves special emphasis (see PICO Question 2 and Supplementary Appendix B, Evidence Profile 4). The systematic review conducted to obtain evidence in support of this practice guideline did not find any significant differences between self-administered therapy (SAT) and DOT when assessing several outcomes of interest, including mortality, treatment completion, and relapse. However, DOT was significantly associated with improved treatment success (the sum of patients cured and patients completing treatment) and with increased sputum smear conversion during treatment, as compared to SAT. Because DOT is a multifaceted public health intervention that is not amenable to the conventional clinical trial approaches to assessing benefits, and because participation in DOT can be advantageous for early recognition of adverse drug reactions and treatment irregularities, for allowing providers to establish rapport with the patient and for addressing treatment complications expeditiously, DOT remains the standard of practice in the majority of tuberculosis programs in the United States [33–35] and Europe [15] (Table 5). To be consistent with the principles of patient-centered care noted previously, decisions regarding the use of DOT must be made in concert with the patient [14–16]. For example, DOT can be provided in the office, clinic, or in the “field” (patient's home, place of employment, school, or any other site that is mutually agreeable) by appropriately trained personnel [32].

What is the ATS guideline?

The American Thoracic Society (ATS), Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America (IDSA) jointly sponsored the development of this guideline on the treatment of drug-susceptible tuberculosis, which is also endorsed by the European Respiratory Society (ERS) and the US National Tuberculosis Controllers Association (NTCA). This guideline provides recommendations on the clinical and public health management of tuberculosis in children and adults in settings in which mycobacterial cultures, molecular and phenotypic drug susceptibility tests, and radiographic studies, among other diagnostic tools, are available on a routine basis. Nine PICO (population, intervention, comparators, outcomes) questions and associated recommendations, developed based on the evidence that was appraised using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology [1, 2], are summarized below. A carefully selected panel of experts, screened for conflicts of interest, including specialists in pulmonary medicine, infectious diseases, pharmacokinetics, pediatrics, primary care, public health, and systematic review methodology were assembled and used GRADE methods to assess the certainty in the evidence (also known as the quality of evidence) and strength of the recommendations (see Supplementary Appendix A: Methods and Table 1). This executive summary is a condensed version of the panel's recommendations. Additional detailed discussion of the management of pulmonary and extrapulmonary tuberculosis is available in the full-text version of this guideline.

What is the responsibility of a tuberculosis patient?

The responsibility for successful treatment of tuberculosis is placed primarily on the provider or program initiating therapy rather than on the patient. It is well established that appropriate treatment of tuberculosis rapidly renders the patient noninfectious, prevents drug resistance, minimizes the risk of disability or death from tuberculosis, and nearly eliminates the possibility of relapse [95]. Provider responsibility is a central concept in treating patients with tuberculosis, no matter what the source of their care.

What is the role of public health in treating tuberculosis?

Because of the public health implications of prompt diagnosis and effective treatment of tuberculosis, most low-incidence countries designate a government public health agency as legal authority for controlling tuberculosis [12, 13]. The optimal organization of tuberculosis treatment often requires the coordination of public and private sectors [14–16]. In most settings, a patient is assigned a public health case manager who assesses needs and barriers that may interfere with treatment adherence [17]. With active input from the patient and healthcare providers, the case manager, together with the patient, develops an individualized “case management plan” with interventions to address the identified needs and barriers [18–20] (see PICO Question 1 and Supplementary Appendix B, Evidence Profiles 1–3). The least restrictive public health interventions that are effective are used to achieve adherence, thereby balancing the rights of the patient and public safety. Given that tuberculosis treatment requires multiple drugs be given for several months, it is crucial that the patient be involved in a meaningful way in making decisions concerning treatment supervision and overall care. International standards have been developed that also emphasize the importance of using patient-centered approaches to the management of tuberculosis [14–16].

How to select empiric regimens for relapse?

The selection of empiric treatment regimens for patients with relapses is based on the prior treatment scheme. For patients with relapse who were treated for drug-susceptible tuberculosis using DOT, experts recommend retreatment using the standard intensive phase regimen until the results of susceptibility tests are known. For patients who did not receive DOT or had irregular treatment, it is prudent to infer a higher risk of acquired drug resistance. Whenever feasible, rapid molecular and phenotypic diagnostics for detection of drug resistance should be used to inform regimen selection. When immediate treatment initiation is necessary, consider the use of an expanded empiric regimen in consultation with experts in the treatment of drug-resistant disease. If started, an expanded empiric regimen is administered until the results of susceptibility tests are known and commonly consists of the standard intensive phase regimen of daily INH, RIF, PZA, and EMB, plus a later-generation fluoroquinolone, an injectable, and depending on the severity of disease or the anticipated extensiveness of resistance, an additional second-line drug [404]. All drugs are administered using DOT. An expanded regimen is indicated especially in patients with impaired immunity, limited respiratory reserve, CNS involvement, other life-threatening circumstances, or any other situation in which treatment with an inadequate regimen could have severe consequences to the individual or the community.

What was the first treatment for TB?

Before the development of effective chemotherapy, TB treatment was essentially palliative care in sanatoriums with fresh air and sunlight. The age of TB chemotherapy began with the discovery of anti-tuberculosis compounds, beginning with streptomycin and para-aminosalicylic acid (PAS) in 1944.

What is the recommended treatment regimen for TB?

WHO 2019 guidelines now recommend an all oral, bedaquiline-containing regimen to replace injectable agents as the preferred treatment regimen. 23 24 WHO’s move toward shorter and all oral regimens for MDR-TB is also reflected in the ongoing MDR-TB clinical trials. Almost all experimental regimens being tested (except for Opti-Q, which began in 2015) are six to nine months long, and most of the experimental arms are completely oral (except for Opti-Q and STREAM stage 2 six month arm intensive phase; table 1 ). The change in the recommended WHO SOC regimen in duration and composition has implications for ongoing trials using the now obsolete 20-24 month regimens for their control arm (Opti-Q, MDR-END, NEXT, endTB, and TB-PRACTECAL). If enrollment is ongoing, these trials face the decision of whether to update their control arm treatment regimen or duration mid-trial.

What is stage 2 of STAT-TB?

Stage 2 of the StAT-TB trial will evaluate pravastatin as an adjunct to HRZE against time to sputum culture conversion as well as the secondary endpoint of improvement of pulmonary function among individuals with drug sensitive pulmonary TB ( NCT03456102 ). Relevant study populations and biomarkers will also depend on the targeted intervention. HDTs targeted to modulate detrimental inflammatory responses, such as dexamethasone ( NCT03092817 ), may include or target individuals with TB meningitis where uncontrolled inflammation is closely associated with morbidity and mortality.

When was pretomanid approved?

On 14 August 2019, the US Food and Drug Administration approved pretomanid, its second novel anti-tuberculous drug in 40 years (bedaquiline was approved in 2012). While additional agents against drug resistant TB are critically needed, the basis on which pretomanid was approved is somewhat controversial. 26 27

How long does RR-TB treatment last?

The landscape of RR-TB and MDR-TB treatment was, for many years, defined by prolonged treatment (20-24 months) with older drugs that had substantial side effects and required daily injections for the initial eight months. This began to change with the publication of the “Bangladesh regimen” in 2010, which touted a successful nine month treatment regimen with daily injections only for the initial four months. 21 However, because the trial was an uncontrolled observational study of sequential treatment arms, questions were raised about the validity of these results.

How many people have TB in the world?

According to WHO estimates, in 2018 10 million people developed TB globally, for an incidence of 132/100 000 people. This global average, however, hides the vast disparities between developed and developing countries. Almost all cases are concentrated in South East Asia (44%), Africa (24%), and the western Pacific (18%) regions.

How long does it take to treat TB?

The current poor global control of TB is due in part to the lack of research innovation over the past few decades; current DS-TB treatment guidelines have been essentially unchanged for 35 years and treatment still takes a minimum six months.

What is the 2021 consolidated guidelines on HIV?

The 2021 consolidated guidelines on HIV are an important step in supporting the goals of universal access to ARV drugs for preventing and treating HIV and ending the HIV/AIDS epidemic as a major public health threat by 2030. Subscribe to our newsletters →. Related.

What is the goal of the 2021 guidelines?

The 2021 consolidated guidelines on HIV are an important step in supporting the goals of universal access to ARV drugs for preventing and treating HIV and ending the HIV/AIDS epidemic as a major public health threat by 2030.

What were the first guidelines for treatment of tuberculosis?

These were evidence based and peer reviewed, but were “pre-SIGN” and so did not have evidence categories given to recommendations. 10 They allowed the fourth drug in the initial phase, ethambutol (E), to be included for those at higher risk of isoniazid resistance. The recommendations for non-respiratory disease had to be based largely on general principles. However, the results of national studies on lymph node tuberculosis, which accounts for 50% of all non-respiratory tuberculosis, published shortly afterwards, confirmed that a 6 month short course of chemotherapy gave as good results for this form of disease as 9 month regimens. 11 12 The publication of national treatment recommendations did allow the first national criterion based audit of tuberculosis treatment to be carried out on those cases treated in the 1993 notification survey. 13 This showed, among other things, that although there had been a substantial move to pyrazinamide containing regimens, treatment durations remained too long in a significant minority of patients. The publication of this audit “completed the loop”, with guidelines, then criterion based audit and then feedback.

How long is the Singapore Tuberculosis trial?

Clinical trial of 6-month and 4-month regimens of chemotherapy in the treatment of pulmonary tuberculosis. The results up to 30 months. Tubercle 1981;61:95–102.

What is the best antituberculosis drug?

Each of the antituberculosis drugs vary in their abilities to kill organisms, to sterilise lesions and to prevent the emergence of drug resistance. 3 Isoniazid is the best drug for killing rapidly dividing organisms, followed by rifampicin and then streptomycin and ethambutol. Rifampicin is best for dormant organisms with occasional spurts of metabolism, and pyrazinamide is best for organisms in an intracellular (acid) environment. Multiple controlled clinical trials have been carried out in a number of countries. 3 These show that a 6 month regimen comprising a 2 month phase of rifampicin (R), isoniazid (H), pyrazinamide (Z) and ethambutol (E), followed by a 4 month continuation phase of rifampicin and isoniazid, designated 2RHZE/4HR, gives a greater than 95% cure rate, and a relapse rate of less than 5%. This applies whether the drugs are given daily throughout treatment, daily in the initial phase with an intermittent (thrice weekly) continuation phase or fully intermittent throughout. 3 If the regimen is shortened to 4 months by a shortened continuation phase, relapse rates rise to over 10%. 4 The 6 month short course regimen also performs well in the presence of a proportion of isoniazid and/or streptomycin resistance, but much less well if there is initial rifampicin resistance. 5 The fourth drug in the initial phase, ethambutol, is included to cover the possibility of drug resistance. Six month short course regimens have performed well in England and Wales in both clinical trial conditions, with relapse rates of 1–3%, 6 and in routine clinical practice with relapse rates of 0–4%. 7 8 Monitoring of the treatment used in patients with pulmonary disease in the 1983 and 1988 national surveys showed a big change towards pyrazinamide containing regimens, but this was not accompanied in many cases by the appropriate reduction of treatment duration to 6 months that this change allowed. 9

How many cases of tuberculosis are there worldwide?

Globally, it is estimated that there are at least 7.96 million (95% confidence interval 6.3–11.1) clinical cases, with 3.52 million (2.8–4.1) sputum microscopy positive cases, and 1.87 million (1.4–2.8) deaths. 1 This gives a case fatality rate of 23%. In addition, 32% of the world’s population (1.86 billion) are infected, as judged by a positive tuberculin skin test. 1 In England and Wales after a nadir of 5000 cases per year, numbers have reached over 8000. 2

When was the last quinquenial survey?

In 1998, the final quinquenial national survey was carried out, over a 12 month period, which was also the pilot for continuous enhanced surveillance. This allowed, in 1999, the re-audit of the treatment of pulmonary and lymph node tuberculosis, again using a criterion based audit. At the same time, European outcome criteria had been agreed which allowed for the first time comparison at the national level with other countries management and outcome for tuberculosis. 17

How do stem cells help with tuberculosis?

This chapter describes the role of stem cells in the treatment of multidrug-resistant TB. Mesenchymal stem cells play an important immunomodulatory role in the pathogenesis of tuberculosis in patients that are affected by multidrug-resistant and extremely drug-resistant bacteria. Isolated from the host, autologous stem cells used in clinical trials have been shown to be safe and less toxic than current treatment regimens used against tuberculosis. Failed treatment regimens, poor patient compliance, and mutations by MTB have led to drug resistance, and these issues are also discussed. Several clinical trials have shown that stem cell therapy provides a safe alternative treatment that is better tolerated with fewer toxic side effects than current treatment regimens and will assist in slowing the global spread of TB. However, stem cell therapy is still in its early stages and much more intensive investigations are required to elucidate the role of stem cells in the treatment of drug-resistant TB.

How long is the Bangladesh regimen?

About ten years ago, the first results of the so-called “Bangladesh regimen”, a short regimen lasting nine months instead of 20 months, revolutionized multidrug-resistant tuberculosis (MDR-TB) treatment. Similar short regimens were studied in different settings, relying for their efficacy on a later generation fluoroquinolone, either gatifloxacin, moxifloxacin, or levofloxacin. We review the published material on short MDR-TB regimens, describe their different compositions, their results in national tuberculosis programs in middle- and low-income countries, the risk of acquiring resistance to fluoroquinolone, and the occurrence of adverse events. With over 80% success, the regimen performs much better than longer regimens (usually around 50%). Monitoring of adverse events allows adapting its composition to prevent severe adverse events such as deafness. We discuss the current applicability and usefulness of the short injectable-containing regimen given the 2019 recommendation of the World Health Organization (WHO) for a new long all-oral regimen. We conclude that the most effective fluoroquinolone is gatifloxacin, currently not listed as an essential medicine by WHO. It is a priority to restore its status as an essential medicine.

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