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Expert Panels [ARCHIVED] New Medicines and Novel Approaches for MDR-TB

When: March 24, 2014 - March 28, 2014 | Where: Virtual, online panel at GHDonline.org Community: MDR-TB Treatment & Prevention

This Expert Panel is Archived.

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Panelists of New Medicines and Novel Approaches for MDR-TB and GHDonline staff

Drug resistant tuberculosis is a major public health concern. With the introduction of Xpert MTB/RIF and other technologies, early diagnosis is becoming possible. Through the intensive work of countries and partners, access to treatment has been scaled up in most settings.

Still, with the exception of a few settings, treatment success of multidrug resistant TB cases is suboptimal. Patients are often on long treatment regimens with various adverse events. Recently two new medicines, bedaquiline and delamanid were approved for use under specific conditions. A new short treatment regimen has been piloted in some settings and is showing promising results.

Joining us to discuss these new developments from March 24 – 28 are:

     • Dr Aung Maug, Bangeladesh
     • Dr Mamel D. Quelapio, The Philippines
     • Dr Dalene von Delft, South Africa
     • Dr Arnaud Trébucq, France
     • Dr Masoud Dara, Belgium

Please feel free to start sharing questions and thoughts now. We look forward to this discussion.

Thank you.

 
Samuel Kasozi
Replied at 8:10 PM, 18 Mar 2014

Dear Sir,

This to submit my request to join the above discussion.

Rgds

MD. SHAMIM HOSSAIN
Replied at 8:10 PM, 18 Mar 2014

Dear concerns,

I'm very much interested about it. Hope I'll be in touch.

Best regards
Shamim

Jude Beauchamp
Replied at 8:38 PM, 18 Mar 2014

My pleasure to participate on May 24th.

Jude

Asif Mahmud
Replied at 8:38 PM, 18 Mar 2014

Look forward to learning from the discussion. Thanks for the invitation.

Salman Siddiqi
Replied at 10:52 PM, 18 Mar 2014

I would like to be included in the electronic discussions.

Salem Barghout
Replied at 10:55 PM, 18 Mar 2014

Look forward to participation.

Maureen Kimenye
Replied at 10:57 PM, 18 Mar 2014

I will be very happy to join this discussion. The duration of treatment and particularly the injectable phase and the management of MDR TB in children are a big challenge. Monitoring patients for a long period and daily DOT is waring to patients, health care workers and the health system as a whole. It also requires a lot if resources which are not easy to come by especially in resource limited setting.

Kamene

Bipin Kumar
Replied at 11:51 PM, 18 Mar 2014

Willing to learn new things.
Thank you for the invitation!

sabira Tahseen
Replied at 12:28 AM, 19 Mar 2014

Look forward to participate in discussion

Dossegnaw Aragaw
Replied at 12:47 AM, 19 Mar 2014

Really I am happy to take part the discussion on new medicines and novel
approaches for MDR_TB.
Thank You
*Dossegnaw Aragaw(Bsc, Msc student )*
*Jimma University*
*Jimma,Ethiopia*
*Phone No *+251913970683
Alternative Email:

Thet Tin Tun
Replied at 12:50 AM, 19 Mar 2014

Dear colleagues,

I would like to join this conversation.

Omotayo Salau
Replied at 3:08 AM, 19 Mar 2014

Great! i will love to be part of the discussion.
many thanks

Mona Javaid
Replied at 3:31 AM, 19 Mar 2014

I would like to join the discussion.

Joaquim Da Silva
Replied at 3:55 AM, 19 Mar 2014

I would love to participate

Ernest Ruttoh
Replied at 3:57 AM, 19 Mar 2014

I would wish to be in the meeting.
Thanks

Ernest Ruttoh
Senior Technical Advisor, SPHLS
Management Sciences for Health
ACK Garden House, Nairobi-Kenya
P.O. Box 8700-00100
+254 - 722833768(mobile)
Email : <mailto:>
www.msh.org<http://www.msh.org/>
[Description: Description: Description: Description: MSH_.jpg]<http://www.msh.org/>
Stronger health systems. Greater health impact.
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Wessen Nega
Replied at 4:07 AM, 19 Mar 2014

Thanks for the information, I will be part of the discussion

Haluk Çalışır
Replied at 5:02 AM, 19 Mar 2014

I would like to join the discussion.  
Best regards.
Haluk Çalışır M.D.
Assoc. Prof. 
Chest Physician
Acıbadem Hospital
Istanbul

Rebecca Berhanu
Replied at 5:04 AM, 19 Mar 2014

Please include me in this discussion.

Dr Satish Kaipilyawar
Replied at 5:24 AM, 19 Mar 2014

Thanks for inviting me, I look forward to participate.

Nelly Solomonia
Replied at 6:09 AM, 19 Mar 2014

Dear Colleagues,

Thank you for giving us the opportunity to participate in discussion with such critical themes. For the beginning its will be interesting to know:
1. When final version of the WHOs’ Policy update about Xpert MTB/RIF system for the diagnosis of PTB and EPTB in adults and children will be available? (Still we have access to the pre-publication version only http://www.stoptb.org/wg/gli/assets/documents/WHO%20Policy%20Statement%20on%2...);
2. We were informed about WHOs conditional recommendation, that Bedaquiline (inhibitor of ATP synthase) may be added to a WHO-recommended regimen in adult patients with pulmonary MDR-TB. We know that EMA has approved Sirturo (Bedaquiline) for conditional use in EU for adults with Pulmonary MDR-TB. Of course we need more detailed information about bedaquilone (doses and duration, effective combinations with other II line drugs and etc.), but most critical to know when we will have recommendations for using of Delamanid (Nitroimidazole-OPC 67683 – inhibitor of M. tuberculosis cell wall synthesis and cell respiration)?

With kind regards,

Nelly

arnauld fiogbe
Replied at 6:21 AM, 19 Mar 2014

HEllo everyone,
With great interest I'll join the discussion on this hot topic.
Best regards
arnauld

Khairunisa Suleiman
Replied at 6:42 AM, 19 Mar 2014

Dear Sir/Madam,

This is to confirm interest in participating in the session.

Thank you.

Gemeda Abebe
Replied at 7:16 AM, 19 Mar 2014

Dear Wossen,

There are lots options that you can have to do the geneXpert training
without going abroad. You can come to Jimma University Laboratory of
Mycobacteriology to have the training. Hope this can help.

Gemeda


Wessen Nega via GHDonline writes:

--
Gemeda Abebe (PhD)
Assistant Professor
Director, Institute of Biotechnology
TB and HIV research group leader, VLIR IUC-Jimma University Program

Altaf Ahmed, MD
Replied at 7:18 AM, 19 Mar 2014

count me in. thanks

Wessen Nega
Replied at 7:37 AM, 19 Mar 2014

Dear Dr. Gemda,
Many thanks for the information. I will arrange and take the training in your institution laboratory.

With kind regards
Wessen Nega ( MLT, Mph)
Lab program advisor, Columbia University ICAP Ethiopia global Health action

Mohammed suaudi Hassen
Replied at 7:42 AM, 19 Mar 2014

Dear/sir Hi
I am very glad to participate on this fantastic event.


King regard

Mohammed SUAUDI
Medical Laboratory Science.
Mobile phone: +251911355221
Regional Reference TB Laboratory Expert
Oromia Public Health Research Capacity Building and Quality Assurance Laboratory,
P O Box 688
Adama ,ETHIOPIA

Appolinaire MANIRAFASHA
Replied at 7:49 AM, 19 Mar 2014

Thanks for this invitation, i have few comments;
Can you share with us the results of pilot project so that we can see the effectiveness of this
If we start this new protocol of short term treatment of MDR_TB what about the the patients who are already on this longterm regiments.
When do you suggest to start this new regiment.
Best regards
Appolinaire

ZAHOOR ZAHOOR
Replied at 8:30 AM, 19 Mar 2014

thanks for sharing. can u add my name in discussion.

Regards
Zahoor Ahmed

Jeroen van Gorkom, MD
Replied at 8:34 AM, 19 Mar 2014

I am interested to follow this discussion.
Best regards,

Jeroen van Gorkom
KNCV Tuberculosis Foundation

Christopher Gilpin, PhD, MPH
Replied at 9:29 AM, 19 Mar 2014

The final version of the Policy Update on Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children will be available online and in a printed version at the 6th Global Laboratory Initiative Partners' Meeting 30th April - 2nd May at WHO, Geneva

Indrajit Kumar
Replied at 9:51 AM, 19 Mar 2014

Respected Sir,
I am happy to participate in this disscussion.
Indrajit.

Anil Pokhrel
Replied at 9:52 AM, 19 Mar 2014

Thanks for information

Paul Abarca
Replied at 10:53 AM, 19 Mar 2014

Thanks for the invitation.

Alboren Shtylla
Replied at 10:58 AM, 19 Mar 2014

Hello,
Thank you for invitation.
I am very interested to be part of the discussions on the respective dates.

Anthony Okwuosah
Replied at 11:09 AM, 19 Mar 2014

Its great to hear there is a shorter regimen which also hopefully will be less toxic than existing ones. This will reduce the current challenges in following up patients in the ambulatory phase in the community resulting in improved outcomes.

Svetlana Doltu
Replied at 11:20 AM, 19 Mar 2014

Thanks for the invitation!

*Best regards, **Svetlana Doltu*


2014-03-18 23:27 GMT+02:00 Masoud Dara, MD via GHDonline <
>:

Trisha Finnegan
Replied at 11:59 AM, 19 Mar 2014

I look forward to participating.
Thank you,
Trisha Finnegan, Biometrac

Belayneh Dimah Taye
Replied at 12:00 PM, 19 Mar 2014

Many thanks for invitation!
Kind regards
Belayneh

Alena Skrahina, MD
Replied at 12:11 PM, 19 Mar 2014

I greatly appreciate the invitation.
Looking forward to hearing from you soon.
Best regards

Alena

Jesica Mazza-Stalder
Replied at 1:01 PM, 19 Mar 2014

I'will like to join you for the discussion. Many thanks for the invitation.

Kind regards

Jesica Mazza-Stalder MD
Senior consultant lung specialist
University Hospital of Lausanne (CHUV)
Switzerland

Degu Dare
Replied at 2:28 PM, 19 Mar 2014

Dear Dara,
Thank you for inviting me to participate in this interesting discussion. It
will be great if someone could kick-start this discussion by highlighting
key recent developments in the area.

spero HOUNDENOU
Replied at 2:58 PM, 19 Mar 2014

Looping Forgeard tous discussion

Heidi Linton
Replied at 3:20 PM, 19 Mar 2014

I would like to join this discussion,
Thank you,

Heidi Linton


--
Heidi Linton

Gunturu Revathi
Replied at 4:16 PM, 19 Mar 2014

Dear Dr Masoud,
Thank you very mcuh for this invite. I am happy to join this group discussion.
Revathi

Dr. Daniela Cirillo, MD, PhD
Replied at 7:35 PM, 19 Mar 2014

Happy to join
bw

NATALIA TAMAYO
Replied at 8:28 PM, 19 Mar 2014

Hi all! Happy to have this space for discussion. Natalia

Natalie Lorent
Replied at 9:57 PM, 19 Mar 2014

Hi all! Thanks for providing us the opportunity to learn more and share experiences on shorter/newer MDR-TB treatment regimens.
From my experience working in Cambodia, there is a dire need for shorter, less toxic and (hopefully more) effective regimens to treat MDR-TB. New diagnostics such as the Xpert TB/RIF assay have substantially increased MDR-TB diagnosis, as well as shortened time to start treatment. However, encouraging patients to start and - more importantly - adhere to a 2-year toxic and demanding treatment regimen can be challenging. Although, the team here tries to tailor it as much as possible to the patient’s needs by combining hospital-based with ambulatory treatment, the current regimen still puts an big strain on patients and an already overburdened (and low funded) tuberculosis programme. A shorter regimen would alleviate some of the burden. However, despite favourable reports from Bangladesh and the African experience with shorter treatment regimens, in many developing countries, the NTPs will only consider it once recommended/approved by WHO. I realise and fully agree it is important to gather enough evidence, especially when introducing newer drugs. I wonder whether using shorter regimens with existing drugs (such as used in Van Deun’s regimen and the slightly modified regimen used in the Union’s STREAM trial – end of 2016 ) could be supported sooner – eventually under strict conditions? I’m eager to learn about preliminary results or updates from other studies that might improve quality of life of our (MDR-)TB patients.
Natalie

Marybeth Maritim
Replied at 10:48 PM, 19 Mar 2014

Thank you for the invitation. I look forward to participate in the discussion.

Dato Chorgoliani
Replied at 10:56 PM, 19 Mar 2014

There are controversial opinions regarding usage of short regimens in high MDR burden countries. Would be interesting to hear if anybody has such experience in East European countries.

Mary Murugami
Replied at 4:23 AM, 20 Mar 2014

Thank you very much, i would be delighted to be part of the panel and discussion.

Gaël CLAQUIN
Replied at 6:42 AM, 20 Mar 2014

Dear all,
thanks to include me in the discussion.

While we expect better tolerated regimen we'll have to struggle with existing ones for a while.
This raise the issue of hearing toxicity management, linked to injectable AG in particular.

I heard about an audiometry test administered by lay personnel in Kwazulu Natal and transmitted over the internet to a distant proficient technician for interpretation. I'd like to know more about the experience as it could be one of the possible way to prevent severe impaired hearing.

Another issue of concern is the high occurrence of hypothyroidia in MDR/HIV population (India) but also in Lesotho and Botswana (landlocked countries: link to access to sea/iodized salt ?) MDR cohorts (not sure about the link with HIV there) : how to handle patients without access to TSH test ? Clinical diagnosis, cautious introduction of thyroxin supplementation, dosage adjustment based on the clinical response ?

I have the impression these issues are not highlighted enough: shouldn't funding for MDR be linked to side effect management component, for many reasons both at individual and public health levels ?

Thanks
Gaël Claquin
TB/HIV specialist
Mozambique

Alcade RUDAKEMWA
Replied at 10:29 AM, 20 Mar 2014

Dear sir,
Your idea is so great with regard to results.

Kind regard

Dossegnaw Aragaw
Replied at 11:33 AM, 20 Mar 2014

really nice idea.

Nini Tun
Replied at 12:02 PM, 20 Mar 2014

Thanks a lots for invitation!
Very much interested to participate....

Kedir Abdella Abdulsemed
Replied at 1:20 PM, 20 Mar 2014

Dear all,
It is known that long term treatment duration and less effectiveness of currently used chemotherapy for MDR-TB cases are potential treat to global or national TBCP for controlling MDR-TB. thus it is pleasure to hear this issue is requested for dissuasion and i would like to take part in discussion.

Yours

Isaya Jelly
Replied at 2:13 AM, 21 Mar 2014

Constructive and capacity building discussion.
Definitely will participate.


Isaya Jelly, MD
DR-TB Fellow SES/PIH

Nelly Solomonia
Replied at 3:58 AM, 21 Mar 2014

Dear Christopher,

Thank you very much for information about final version of the Policy Update on Xpert MTB/RIF assay.

Hope within discussion we will have opportunity to receive information about short regimens of MDR-TB treatment, especially about Delamaind. For detailed information about clinical trials I usually use the links below, maybe you can suggest more informative webs and links.

http://www.newtbdrugs.org
http://clinicaltrials.gov

Sincerely,

Nelly

Domingo Palmero
Replied at 6:36 PM, 22 Mar 2014

It will be a pleasure for me to participate in this panel.
Until soon.
Domingo Palmero

Masoud Dara, MD
Replied at 3:38 AM, 23 Mar 2014

Dear colleagues,

While preparing for the upcoming panel discussion, I thought to share with you the following information in case you are interested to follow the debates.

Member States, partners and WHO country offices have been organizing different activities to mark the World Tuberculosis Day. To this end, WHO Regional Office for Europe is organizing a high level event on 24 March 2014.

During the event, a panel including the Regional Director of the WHO Regional Office for Europe Zsuzsanna Jakab, ECDC director Marc Sprenger, UN Secretary General Special Envoy for HIV/AIDS in Eastern Europe and Central Asia professor Michel Kazatchkine, Ministry of Health and pharmaceuticals of Denmark, European Commission, ex MDR-TB patients and civil society representatives will discuss the progress, challenges and next steps in TB and MDR-TB prevention, control and care in WHO European Region. Ambassadors and diplomatic missions of Member States in Denmark and directors and high level representatives of partners' organization will also participate.

Via the below link you may find the joint WHO-ECDC press release, the updated factsheet (Tuberculosis in WHO European Region) and relevant PowerPoint presentations:

http://www.euro.who.int/en/media-centre/events/events/2014/03/world-tuberculo...

The event will be live webcasted in both English and Russian on the following link: http://streaming.uncity.dk/who/

You can also participate in a twitter discussion with the following hashtag #TBchat @WHO_Europe

Ejaz Qadeer
Replied at 2:55 PM, 23 Mar 2014

We are using two years regimen with almost 70 % TSR , However it is very difficult to manage in programmatic conditions. We are looking with interest to learn about shorter regimens

egh Eduardo Gotuzzo
Replied at 7:59 PM, 23 Mar 2014

dear masoura
I will partiipate in this panel
thanks
eduardo Gotuzzo
LIMA peru
2014-03-18 16:25 GMT-05:00 Masoud Dara, MD via GHDonline <
>:

--
************************
Dr. Eduardo Gotuzzo
Director
Instituto de Medicina Tropical
Alexander von Humboldt
UPCH
e-mail:

www.upch.edu.pe/tropicales
www.gorgas.org

Laura Gillini
Replied at 8:13 PM, 23 Mar 2014

Sorry unable to partecipate
Would it be possible to circulate later on the summary of the discussion?
Thank you very much and Happy World TB Day

Allen Bain
Replied at 8:16 PM, 23 Mar 2014

Clinical trials of our company's adjuvant immunotherapy products continue to show positive effects on MDR-TB. Immunitor products are approved in some countries and we are trying to accelerate the final testing of our products, eg V5 (eg see http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3031205/ ), V7 (oral form of M vaccae), or Immunoxel (herbal immunomodulator). We are open to suggestions for additional trials.

Veriko Mirtskhulava
Replied at 1:53 AM, 24 Mar 2014

I am interested in this topic. Thanks! Congrats on the World TB Day!

Regards,
Veriko

Anne Marie Hvid
Replied at 2:44 PM, 24 Mar 2014

Pakistan ranks fifth in terms of TB burden, at an alarming figure of 620,000 TB patients out of a total population of 177 million people. It is the world’s fourth highest multidrug-resistant tuberculosis burden country in the world. Although TB is a treatable disease, in Pakistan, pharmacies frequently stock out of the required medications.

Today, in honor of World TB Day, JSI's blog The Pump features an article about how assistance from the USAID | DELIVER PROJECT is helping Pakistan fight tuberculosis (TB). Since 2012, the USAID | DELIVER PROJECT has worked with Pakistan's National Tuberculosis Control Program to enhance the scope of the country's web-based Logistics Management Information System and the warehouse management system for TB Drugs. Read more about the success of this critical assistance at http://goo.gl/xPfbLK

Arnaud Trébucq
Replied at 3:43 PM, 24 Mar 2014

Hi
I am Arnaud Trebucq, and I am working for The Internatinal Union Against TB and Lung Disease, based in Paris.
With the NTPs of Benin, Cameroon and Niger, we have implemented a 12-month short-course regimen for MDR-TB in these countries, using the same drugs as Armand Van Deun in Bangladesh but prolonging the continuation phase for 8 months instead of 5. We have treated 238 proven MDR-TB patients with a 90% cure rate, no failure and no relapse so far.
Because of this preliminary success, since beginning of 2013, we are implementing a 9-month regimen (4KmMfxPtoHCfzEZ/5MfxCfzEZ) in 9 francophone countries in Africa: Benin, Cameroon, Niger, Cote d'Ivoire, Burundi, Central African Republic, DR Congo, Burkina Faso, Rwanda. In each country, the protocole has been approved by the National Ethics Committee. Drugs were bought by different partners, and already more than 200 patients have been enrolled. Since January 2014, we begin to buy the drugs also with the Global Fund money because we get the approval of WHO for this observational study. Still too early to have much results, but so far, patients convert very quickly and we do not have specific problems with the replacement of gatifloxacin by moxifloxacin.

Masoud Dara, MD
Replied at 6:12 PM, 24 Mar 2014

Thank you very much Arnaud for joining the panel and this important introduction, very good to hear about your preliminary results. Some of members of the community had asked our views on efficacy of short regimen in setting where resistance to first and second line medicines are high. I know MSF has been doing a trial in central Asia, not sure if preliminary results are available or if other colleagues would like to share their opinion.

Salem Barghout
Replied at 10:06 PM, 24 Mar 2014

Dear Dr. Arnaud

I would be very interested to learn more about your 12 month short-course regimen for MDR-TB with a 90% cure rate among the 238 proven MDR cases. Would it be possible to know 1) the inclusion criteria of these 238 cases (background history and DST Pattern) 2) the treatment regimen used. 3) Your protocol for discontinuation of injectables and understanding of “Cure” 4) The number of months of follow up so far post declaration of cure. This is indeed very encouraging to learn more about your experience and hope to learn more about it.

Dalene von Delft
Replied at 12:06 PM, 25 Mar 2014

Dear Nelly and colleagues,

I am pleased to share with you the link of the WHO interim guidance on the use of Bedaquiline for the treatment of MDR-TB. The link also provides access to the interim guidance document, Frequently Asked Questions and other background material: http://www.who.int/tb/challenges/mdr/bedaquiline/en/index.html

Full link to pdf: http://apps.who.int/iris/bitstream/10665/84879/1/9789241505482_eng.pdf?ua=1

The WHO also scheduled a meeting on development of an Interim Guidance for the Use of Delamanid in the treatment of Multidrug-Resistant Tuberculosis for April this year (next month).

With regards to the development of hypothyroidism in MDR TB patients:
It is a relatively common problem in MDR TB patients (especially as a side effect of Ethionamide therapy)
and therefore recommended to do routine TSH screening after 3 months of therapy.
I personally developed hair loss early during therapy and therefore tested already during my second month of therapy. I already had low TSH levels. Signs of hypothyroidism: hair loss, dry skin, fatigue, depression and impaired memory. Because the signs and symptoms are relatively non specific and common in TB patients, routine screening really is necessary.
I however recovered well after starting thyroxine supplementation at the usual dose of 50 micrograms a day. My levels were repeated every 3 months and my treating physician suggested tapering the eltroxin 1 month after stopping MDR TB treatment. My levels then stayed normal. Most patients recover normal thyroid levels after stopping therapy and should be reassured.

Please let me know if I could help in assisting any other questions, especially from a patient's perspective.

Mamel Quelapio, MD
Replied at 2:38 PM, 25 Mar 2014

I am Mamel Quelapio from the Philippines. I am happy to join this week's discussion. My work in MDR-TB started with being a clinic physician in 1999 in a public-private mix DOTS (PMMD) and MDR-TB clinic of an NGO, the Tropical Disease Foundation. In collaboration with the NTP, and under guidance by the Green Light Committee, we worked in the setting up, expansion and initial scaling up of the programmatic MDR management in the country until 2010. My work also involves providing PMDT technical assistance to neighboring countries. I will be happy to share my experience in whatever way, and, at the same time, learn from those who have experience with the new TB drugs.

Jay Achar
Replied at 5:50 PM, 25 Mar 2014

In response to Dr Dara, MSF started recruiting patients into an operational research study in Uzbekistan in late 2013. The study is being conducted in an established TB project (~15 years) in close collaboration with the MoH and has received institutional and national ethical approval. The context is one of high second line drug (SLD) resistance, a relatively sparsely populated region with extremes of weather, and medical teams well versed in the provision of WHO-endorsed DR and DS TB treatment.

The treatment protocol mirrors very closely the Bangladesh regimen with substitution of Moxifloxacin for Gatifloxacin, while using culture and smear results to guide treatment decisions. ECG monitoring, as well as standard protocolised side-effect management is being performed. In keeping with the aims of the project, almost all patients commence and continue treatment on an outpatient basis.

Given the high burden of DR-TB in this region, I hope this study will allow us to add a more tolerable, shorter, simpler and cheaper option for a sub-group of patients. Recruitment is ongoing, but my understanding is that other countries in the region are eagerly awaiting interim and final results.

Masoud Dara, MD
Replied at 6:01 PM, 25 Mar 2014

Thank you very much Jay for your inputs,
Yes indeed there are many similar settings eagerly waiting to see your interim results.

Masoud Dara, MD
Replied at 6:11 PM, 25 Mar 2014

Dear colleagues ,

There was a question regarding delamanid in new regimen. My colleagues from Geneva have informed me that WHO will host an expert group meeting mid-April to review the data on delamanid. It is expected that a WHO recommendation will be available not earlier than late June. I am not aware of any publication on drug-drug interaction of delamanid and bedaquline. Other panellists may add.

Masoud Dara, MD
Replied at 6:30 PM, 25 Mar 2014

Thank you Dalene,

One of the major concerns from the previous study on bedaquiline was QT prolongation and ventricular arrhythmia. Which measures were taken to detect arrhythmia when you were on bedaquline. How often you have had ECG?

Masoud Dara, MD
Replied at 6:48 PM, 25 Mar 2014

Dear colleagues,

An informative movie from Armenia by MSF on use of new medicines, with apologies for possible cross posting
http://www.youtube.com/watch?v=k4Ma1TMGPM8

You may also read Armenian experience to introduce bedaquiline on compassionate basis in our compendium of best practices, page 10 http://www.euro.who.int/__data/assets/pdf_file/0020/216650/Best-practices-in-...

Petros Isaakidis
Replied at 2:36 AM, 26 Mar 2014

Dear colleagues,
Even though the discussion is on new medicines and novel approaches we have noticed a thread on hypothyroidism and we would like to share with you some of our experiences, with HIV/MDR-TB co-infected patients.
Hypothyroidism is a very common adverse event (54% of patients in our Mumbai cohort, similarly frequent in a Lesotho cohort) but fortunately it is easy to early diagnose and manage. Therefore, it is a shame that in many programmes we only test for hypothyroidism when it gets symptomatic. We feel our patients have been suffering enough, both from their disease and their treatment; we should do our very best to aggressively prevent any AE and any additional suffering, that also compromises adherence.
We attach here a paper in which we discuss our experiences, including some suggestions on the frequency and intervals of screening, as well as some issues with point-of-care TSH diagnostics and the difficulties in resource limited settings.
Apologies for diverting from the main topic.

Attached resource:

Dalene von Delft
Replied at 8:00 AM, 26 Mar 2014

Dear colleagues

Please find attached a graph showing my QT times as measured during the first two weeks of bedaquiline therapy.
As you may know, the first two weeks is the loading phase where patients have to take 4 tablets daily, then thereafter they have to take only two tablets 3 times a week.

My husband is a doctor and we had an old ECG machine at home, therefore we measured and calculated my QT times almost daily during the loading phase and thereafter about weekly. We however did not measure it at the exact same time every day, therefore we think the variability in the curve may be from moxifloxacin peak and trough levels. Luckily my QT times never went above the "prolonged range".

I was the first patient to use moxifloxacin and bedaquiline together. I did experience palpitations at times and once had a halter ECG for 24 hours, which showed a normal sinus tachycardia of 130 beats per minute at night (at rest). The cardiologist suggested taking magnesium supplementation as it has a stabilizing effect on the heart. I also avoided stimulants (caffeine and vigorous exercise like jogging).

Attached resource:

Jesica Mazza-Stalder
Replied at 8:07 AM, 26 Mar 2014

Hello

It is possible that we might use Bedaquiline with an XDR patient soon. Does anybody know if we can monitor levels of Bedaquiline while on trial?

Many thanks

Jesica


CHUV
centre hospitalier universitaire vaudois
Dr. Jesica Mazza-Stalder
Médecin agréé
Service de Pneumologie
Bugnon 46 - 1011 Lausanne
Tél. +41 79 556 0294
Fax +41 21 314 1395


________________________________
De : []
Envoyé : mercredi 26 mars 2014 13:01
À : Mazza Stalder Jesica
Objet : Re: New Medicines and Novel Approaches for MDR-TB

Dalene von Delft<http://email.ghdonline.org/c/ZW1haWxfdHlwZT1wZXJfcG9zdCZpPTIwMTQwMzI2MTIwMDAxLjE0MTYxLjEyNi41NTA0NCU0MHd3dy5naGRvbmxpbmUub3JnJmg9ZTU2NzdmYmNkZDE1NmE3NGI3NWI1MWU1MTFmZDkyNGMmdXNlcnByb2ZpbGVfaWQ9MTc3OTQxMDEmbD1odHRwJTNBJTJGJTJGd3d3LmdoZG9ubGluZS5vcmclMkZ1c2VycyUyRmRhbGVuZS12b24tZGVsZnQlMkYlM0ZpZCUzRDE3Nzk0MTAxJTI2Zm9ybWF0JTNEaHRtbCUyNnR5cGUlM0RpbnN0YW50JmNvbW11bml0eV9pZD0xNzgxODI1NiZyPWplc2ljYS5tYXp6YS1zdGFsZGVyJTQwY2h1di5jaCZjb250ZW50X2lkPTE3ODE4NjE1JmQ9Mzc3Mw> replied to a discussion<http://email.ghdonline.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> in New Medicines and Novel Approaches for MDR-TB<http://email.ghdonline.org/c/ZW1haWxfdHlwZT1wZXJfcG9zdCZpPTIwMTQwMzI2MTIwMDAxLjE0MTYxLjEyNi41NTA0NCU0MHd3dy5naGRvbmxpbmUub3JnJmg9ZTE3NTkxYWI1OTBiMjBjY2E5NGFjZjIzYzg2NDMzZGQmdXNlcnByb2ZpbGVfaWQ9MTc3OTQxMDEmbD1odHRwJTNBJTJGJTJGd3d3LmdoZG9ubGluZS5vcmclMkZuZXctbWVkcy1tZHItdGIlMkYlM0ZpZCUzRDE3Nzk0MTAxJTI2Zm9ybWF0JTNEaHRtbCUyNnR5cGUlM0RpbnN0YW50JmNvbW11bml0eV9pZD0xNzgxODI1NiZyPWplc2ljYS5tYXp6YS1zdGFsZGVyJTQwY2h1di5jaCZjb250ZW50X2lkPTE3ODE4NjE1JmQ9Mzc3Mw>:

Dear colleagues

Please find attached a graph showing my QT times as measured during the first two weeks of bedaquiline therapy.
As you may know, the first two weeks is the loading phase where patients have to take 4 tablets daily, then thereafter they have to take only two tablets 3 times a week.

My husband is a doctor and we had an old ECG machine at home, therefore we measured and calculated my QT times almost daily during the loading phase and thereafter about weekly. We however did not measure it at the exact same time every day, therefore we think the variability in the curve may be from moxifloxacin peak and trough levels. Luckily my QT times never went above the "prolonged range".

I was the first patient to use moxifloxacin and bedaquiline together. I did experience palpitations at times and once had a halter ECG for 24 hours, which showed a normal sinus tachycardia of 130 beats per minute at night (at rest). The cardiologist suggested taking magnesium supplementation as it has a stabilizing effect on the heart. I also avoided stimulants (caffeine and vigorous exercise like jogging).

Attached resource:

* QT times.pptx<http://email.ghdonline.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>

Nelly Solomonia
Replied at 9:01 AM, 26 Mar 2014

Dear Masoud and Dalene,

Thank you very much for information about Delamanid, we will wait WHOs’ recommendations with great interest, we are waiting final results of studies and WHOs current position on shorter MDR-TB regimens too.

With kind regards,

Nelly

Caitlin Reed
Replied at 7:12 PM, 26 Mar 2014

RE: monitoring levels of Bedaquiline

We are using Bedaquiline for an XDR TB patient currently. I contacted Dr. Peloquin's lab at the University of Florida where we send our therapeutic drug monitoring for TB drugs:
idpl.pharmacy.ufl.edu

He said that they do not currently offer BDQ levels as a clinical test. However they do have an assay for research purposes. According to Dr. Peloquin, therapeutic ranges for BDQ are not known; normal ranges could be constructed but have not been to date. We will store some plasma just in case an assay becomes available.

For monitoring, we did daily EKGs for the first two weeks as the patient is also on other QT prolonging drugs (high dose IV Moxi, Clofazamine) and now are doing weekly EKGs. We are also using a Zoll LifeVest wearable automated cardiac monitor/defibrillator. This allows us to keep the patient monitored with immediate access to defibrillation in the event of an arrhythmia, while still allowing him to go outside of the hospital TB Unit and visit family.

Trisha Finnegan
Replied at 11:05 AM, 27 Mar 2014

For those providing medical care for TB patients, how is your work being documented today? I am interested in understanding if more paper-based or more automated systems are in place. For those using paper or technology, what are the key challenges you face that if resolved would make your work more effective in helping those in need?
I appreciate any responses you may share.
Thank you,
Trisha

Dalene von Delft
Replied at 4:16 AM, 3 Apr 2014

Dear colleagues

Thank you for taking part in this discussion. It was wonderful to hear about people’s interests, concerns and work all over the world. I hope that we can continue having these discussions in future and that there would be better options and outcomes for Drug Resistant TB patients in the near future. Please contact anytime if you need a patient's perspective on an issue or if you have patients in need of social support, please invite them to visit our website, www.tbproof.org, or facebook page, www.facebook.com/TBproof.

Best regards

Dalene

Mamel Quelapio, MD
Replied at 9:41 AM, 3 Apr 2014

Dear Trisha,
Thank you for your question regarding documentation. There are efforts to either initiate or expand electronic recording in some of the high-burden countries in the Western Pacific Region, but paper-based recording using Treatment Cards and Registers, remains to be the standard means of documenting programmatic care in TB for now. In the Philippines, the NTP uses both paper-based and electronic recording, the latter using the Integrated TB Information System (ITIS), a web-based system for both TB and MDR-TB data, that captures most of the information in the Treatment Cards. Its use is currently being expanded countrywide. Key challenges include the need for a dedicated person to do regular data entry in every site, and also for the system to be able to generate routine reports for notification and cohort analysis.

To everyone, let me take this opportunity to thank you for your interest and participation in this interesting panel discussion!

Shirin Kakayeva
Replied at 12:57 PM, 3 Apr 2014

Dear colleagues,

Speaking of new TB medicines and regimens, I thought it would be relevant to announce a new version of our TB pharmaceutical management tool for forecasting, quantification, and early warning tool designed to improve procurement processes and planning for TB treatment.

The new version of the tool and User Guide can be accessed at the QuanTB website, http://siapsprogram.org/quantb/.

Feedback and questions for QuanTB version 1.0.2 are very welcome; all comments can be shared through the new QuanTB forum at http://mshforums.org/forums/forum/quantb/ or here on GHD.

Best,

Shirin.

Dr Shanta Ghatak
Replied at 8:51 PM, 3 Apr 2014

Hi

I am so sorry as I never got to see these mails before !! It seems I
missed a great opportunity

Trisha Finnegan
Replied at 2:08 PM, 4 Apr 2014

Dr. Quelapio,
Thank you very much for taking the time to respond regarding documentation. As someone providing user-friendly electronic solutions to those in low-resource settings, I would also be interested in hearing what you feel are the key components to the most effective systems. We feel user input early on, systems that are designed for challenging environments and appropriate training are critical. What else would you include? What do you see as the biggest value to electronic systems (accuracy, reduction of administrative burden, better reporting, etc)?

Thank you all for this dialogue and for your work to improve the lives of so many. I am happy to be part of this community.
Trisha Finnegan, Biometrac

Mamel Quelapio, MD
Replied at 5:23 AM, 7 Apr 2014

Dear Trisha,


In my opinion, key in an effective electronic information system would be
accuracy, timeliness (ability to reflect real-time data), linked with the
ability to produce consolidated reports routinely. For large countries and
expanded programs, a web-based feature would be most beneficial. However,
all these have to be balanced with setting-specific conditions, e.g., staff
availability and internet connectivity. I hope that helps.

Trisha Finnegan
Replied at 12:36 PM, 8 Apr 2014

Dr. Quelapio,
I understand and agree. Thank you very much for taking the time to share your perspective, you hit on some important key points.
I wish you well in your work!
Trisha

Masoud Dara, MD
Replied at 4:22 AM, 16 Apr 2014

Dear Salem,

Arnaud from the UNION responded your question as follows:

Dear Salem
Some more about the 12month-short-course regimen. The treatment regimen used
was: 4KmGfxPtoHCfzEZ/8GfxCfzPtoEZ, with Gatifloxacin used at the normal
dosage: 400 mg per day. In Cameroon and Niger, the prothionamide was kept
during the continuation phase but not in Niger and the results were very
similar in the 3 countries. We used 12-month regimen instead of 9-month
because the opposition to short course regimen for MDR-TB was terribly
strong and we did not dare to go straight for 9-month. However, the
conversion of the sputum and of the cultures was so rapid that it is obvious
for us that 9-month is more than enough. There was no specific inclusion
criteria apart from known allergy to one of the product. In these three
countries the short regimen is the standard for MDR cases. Our definition of
“Cure was the international one, with 5 negative cultures after conversion,
but the cultures performed after the treatment was finished were also
counted. For all patients, the follow-up was minimum one year after stopping
the treatment. We should publish papers in the following months probably in
the International Journal of Tuberculosis and Lung Disease hopefully before
the end of the year and you will be able to find more details. Arnaud"

All the best

Arnaud TREBUCQ, MD, MPH
The Union

Helen Cox
Replied at 4:43 AM, 16 Apr 2014

Dear Arnaud,
These results are very impressive and we are all looking forward to seeing the results published. Would you be able to describe the model of care used in these settings? Ie. were patients hospitalised for treatment initiation or for a set period, and how was treatment supervised?

Masoud Dara, MD
Replied at 5:01 AM, 16 Apr 2014

Dear members of the DR-TB Community, Dear Panelists, Arnuad, Dalene and Mamel,

I am writing to thank you for an interactive dicussion on New Medicines and Novel Approaches for MDR-TB. We had 90 questions and answers on this topic. It is very difficult to summarize the discussion since there are ongoing studies on this topic and I understood some of our members could not provide further inputs due to the confidentiality arrangements they are currently bound to. New Medicines and shorter treatment regimen are promising, but we do need further evidence and their dissemination as soon as possible. I suggest we keep this discussion line open and share views and information as the new evidence arise. For your information, there are currently 3631 members from 149 countries in our community spanning a total of 1630 organizations.

I take the opportunity to wish Happy Easter to those who celebrate it.

All the best,
Masoud

Salem Barghout
Replied at 9:27 AM, 16 Apr 2014

Thank you so much Amoud for your very kind and helpful response which actually cleared number of questions but opened up for more queries. However, I would wait to see more details when the study is published later on. With this I cc. Dr. Caminero for further input from his side with many thanks.

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Panelists of New Medicines and Novel Approaches for MDR-TB and GHDonline staff