The International Journal of Tuberculosis and Lung Disease featuring RESIST-TB Steering Committee Members

The International Journal of Tuberculosis and Lung Disease has released its May publication featuring RESIST-TB Steering Committee Members C. Robert Horsburgh and Carole Mitnick as Guest Editors. This issue also features a supplemental publication by C. Robert Horsburgh and Amita Gupta titled, “MDR-TB in Children: Back to the Basics.”

The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

To view the IJTLD May issue, click here.

To read “MDR-TB in Children: Back to the Basics,” click here.

Interactive civil society hearing in preparation for the UN High-Level Meeting on TB

“Interactive civil society hearing to be held on 4 June 2018 in preparation for the UN High-Level Meeting on TB.”

April 2018 | Geneva: The President of the UN General Assembly has announced that the interactive civil society hearing will be held on 4 June 2018 at the United Nations in New York, as part of the preparatory process for the UN High-Level Meeting on TB (UN HLM). The hearing was requested in the modalities resolution for the UN HLM adopted by the UN General Assembly on 4 April 2018.

The hearing aims for the active participation of “appropriate senior-level representatives of Member States, observers of the General Assembly, parliamentarians, representatives of local government, relevant United Nations entities, non-governmental organizations in consultative status with the Economic and Social Council, invited civil society organizations, academia, medical associations and the private sector, as well as people affected by tuberculosis and broader communities, ensuring the participation and voices of women, girls and indigenous leadership as part of the preparatory process for the high-level meeting”. The World Health Organization and the Stop TB Partnership are supporting the President of the General Assembly in the organization of the hearing.

The accreditation process is now open for both the hearing and the UN High-Level Meeting. Kindly note that the deadline for applications for accreditation for attending either event is 27 April 2018.

Accreditation is required in order to be able to register and attend the hearing and/or the UN High-Level Meeting. Relevant non-governmental organizations, civil society organizations, academic institutions, medical associations and the private sector must seek accreditation. UN member states, UN entities, and non-governmental organizations in consultative status with the United Nations Economic and Social Council (ECOSOC), do not need to apply for accreditation.

For additional information on the UN HLM, please visit the President of the General Assembly page here. 

Presentation Announcement

Please join RESIST-TB on Thursday, April 5th from 08:00 – 09:00 EST (14:00 – 15:00 CET/SAST) for an exciting webinar about the current evidence and practices for the combined use of delamanid and bedaquiline for the treatment of MDR-TB. Dr. Cathy Hewison and Dr. Lorenzo Guglielmetti will be our presenters.

Two new drugs for tuberculosis, delamanid and bedaquiline, have shown to be effective and safe for the treatment of MDR-TB. Today, more and more clinicians around the world are experienced in using these drugs as part of a longer conventional MDR-TB regimen with good results. However, there is less experience in using delamanid and bedaquiline together in the same MDR-TB treatment regimen due to concerns about the common effects on the QT interval. Whilst there are studies ongoing to document the effect on the QT interval of these drugs in combination as well as clinical trials testing the safety and effectiveness of regimens including the combination, these results will not be available for the next 3-5 years. In the meantime, clinicians have used their best clinical judgement and have prescribed the combination of delamanid and bedaquiline as part of a longer conventional MDR-TB regimen, for individual patients in need.

This webinar will cover the current clinical practice and results of use of MDR-TBregimens containing the delamanid and bedaquiline combination from endTB, MSF and Europe, as well an overview of the latest publications and the ongoing studies and trials.

 

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To join the event as an attendee
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1. Go to https://hms.webex.com/hms/onstage/g.php?MTID=e5637abdd404713814ec0b217f31302f6
2. Click “Join Now”.

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To join the audio conference only
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Call-in toll number (US/Canada): 1-408-792-6300
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Access code: 710 073 887
Event password: MDRTB
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To contact your host, RESIST-TB, please send a message to smcanaw@pih.org

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WHO issues recommendations on management of isoniazid-resistant tuberculosis

“The emergence of drug-resistant TB is a major global health concern, which threatens the ambitious goals and progress set under the End TB Strategy. Isoniazid-resistant TB, which is present in 8% of TB cases worldwide, reduces treatment success in patients treated with the standard 6-month first-line regimen.

The new WHO recommendations for the treatment of isoniazid-resistant, rifampicin-susceptible TB are based upon a review of evidence from patients treated with such regimens by a Guideline Development Group in conformity with WHO requirements for evidence-based policies.”

Read the new guidelines here.

New Guide to Shorter Regimen for Treating DR-TB

DR-TB STAT + TAG brief: Is Shorter Better? Understanding the Shorter Regimen For Treating Drug-Resistant Tuberculosis

“Multidrug-resistant TB (MDR-TB) is a growing problem around the world, and is difficult to treat. In 2016, the World Health Organization (WHO) recommended a shorter regimen for treating MDR-TB. Now, data from a randomized controlled trial are available. The Drug-Resistant TB Treatment Scale-up Action Team (DR-TB STAT) and Treatment Action Group (TAG) released a new brief explaining what the shorter regimen is, who can receive it, and its advantages and disadvantages.”

Read the full brief here

ZeNix clinical trial announced

New trial evaluates whether the efficacy of the BPaL drug regimen can be maintained with reduced toxicity

“TB Alliance has announced the start of a clinical trial of a three-drug regimen to treat extensively drug resistant tuberculosis (XDR-TB)—one of the deadliest forms of tuberculosis (TB)—and those with pre-XDR-TB and multi-drug resident TB (MDR-TB) whose prior treatment has failed or who have not tolerated their treatment.

The trial, called ZeNix, will evaluate whether the efficacy of the BPaL (bedaquiline, pretomanid and linezolid) drug regimen can be maintained, while reducing toxicity by testing a lower dose and shorter duration of the drug linezolid. The first ZeNix patients have been enrolled in Georgia and South Africa, with sites in Russia joining later in 2018.

‘Too few people with XDR-TB are successfully cured with the current treatments,’ said Dr. Mel Spigelman, president and CEO of TB Alliance. ‘The present treatments take far too long and are made up of complex patchworks of drugs, many of which are toxic or ineffective—further contributing to TB drug resistance. With ZeNix, we are attempting to optimize a potentially safer, quicker and less complicated treatment to address this dire situation.’”

Read the full announcement here.

WHO issues a position statement on the use of delamanid for MDR-TB following an expedited review of phase III clinical trial results

This Position Statement by the World Health Organization (WHO) on the use of delamanid in the treatment of multidrug-resistant tuberculosis (MDR-TB) has been developed in response to the final data from the phase III, multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of delamanid (Trial #242-09-213, hereafter referred to as ‘Trial 213’). The final Trial 213 data were released in late November by the manufacturer (Otsuka Pharmaceutical, Japan) to WHO and to the European Medicines Authority (EMA) in compliance with EMA regulatory requirements. The original trial protocol and subsequent amendments are registered (#NCT0142670) in the US/NIH clinical trials register (https://clinicaltrials.gov/ct2/show/NCT01424670).

WHO conducted an expedited external expert review of the data on Trial 213 data in early December 2017 in order to assess the implications of the results on the 2014 and 2016 interim policy guidance. As data from ongoing observational studies using delamanid are not yet available for review, this document is focused on the results of Trial 213 and its immediate policy implications.

To download and read the position statement, click here.

Webinar Series: KNCV’s Patient Triage Approach

On Thursday, January 25th from 08:00 – 09:00 EST (14:00 – 15:00 CET; 15:00 – 16:00 SAST) Dr. Susan van den Hof presented on KNCV’s Patient Triage Approach.

KNCV Tuberculosis Foundation developed the Patient Triage Concept to ensure rapid diagnosis of TB and all forms of DR-TB (i.e. using rapid diagnostics) followed by early initiation of the most effective treatment regimen for every TB/DR-TB patient. KNCV team will present the methodology of the Right Diagnosis, Right Treatment Approach, and will share experiences with implementation of the shorter treatment regimen (STR) and individualized treatment regimens (ITR) containing new (bedaquiline, delamanid) and repurposed drugs in several countries under the Challenge TB project. During this webinar, KNCV will also share tools developed to assist countries in effectively introducing new drugs and regimens for DR-TB within their own context.

Webinar Series: New XDR-TB Regimens containing Pretomanid, January 11th

On Thursday, January 11, 2018 by Dr. Dan Everitt, Vice President and Senior Medical Officer at TB Alliance, presented on New XDR-TB Regimens containing Pretomanid.

Dr. Dan Everitt, MD, of the Global Alliance presented the results of an important study of a six-month treatment regimen for XDR-TB using bedaquiline, pretomanid and linezolid, the NiX-TB trial. In addition, the Alliance expects to launch the ZeNix trial in late 2017. This clinical trial, to optimize the use of linezolid with bedaquiline and pretomanid, is expected to be conducted across 10 trial sites in South Africa, Georgia, Belarus, and Russia. Study design and current status was presented on the Webinar.

A copy of the presentation slides will be made available shortly.

Health ministry approves new tuberculosis drug

“New Delhi: Perturbed by the increasing number of multi-drug resistant (MDR) and extensive drug resistant (XDR) tuberculosis cases in India, the health ministry has approved the use of a new drug in the treatment of such cases.
The technical group on tuberculosis in the ministry of health has given approval to Delamanid, which is in its phase 3 clinical trials.

“We are losing a lot of patients to XDR and MDR tuberculosis. We need more than one drug for treating patients in the backdrop of increasing drug resistance in patients. Delmanid proved to be a good alternative. We will initially conduct a trial with this drug on over 400 patients in a controlled manner,” said Jagdish Prasad, director general of health services in the ministry.

“Currently, around 50% of patients don’t respond to tuberculosis treatment. Delamanid has proved effective in many clinical trials in South Africa and Japan. Taking a cue from this, we are expecting that over 70-80% patients will respond to tuberculosis treatment,” he said.”

To read the full article click here.