SimpliciTB clinical trial launched with first patients in Tbilisi, Georgia

TB Alliance has started a new, four month clinical trial, SimpliciTB, to test the efficacy of the BPaMZ treatment regimen consisting of bedaquiline, pretomanid, moxifloxacin, and pyrazinamide in people with drug-sensitive TB against the standard six-month treatment regimen. SimpliciTB is looking to see if this regimen can shorten the duration of treatment by one third. BPaMZ was previously studied in a Phase 2b study, NC-005, in which MDR-TB patients saw improvement three times faster than those enrolled on the standard treatment. SimpliciTB is currently enrolling patients in Tbilisi, Georgia at the at the National Center for Tuberculosis and Lung Disease. 150 of the total 450 patients that will be enrolled are expected to have MDR-TB across 26 centers in 10 countries. 

To read the full article, click here.

RESIST-TB Webinar

Please join RESIST-TB on September 6, 2018 from 8:30 – 9:30am EST for a special webinar on Adequate and Well – Controlled Studies in the TB Regimen Development: An FDA Perspective. Hosted by Dr. Carole Mitnick, this webinar will feature the expertise of FDA mathematical statistician, Karen Higgins.

Connection details below. 

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To join the webinar, please use the following link:
https://hms.webex.com/hms/onstage/g.php?t=a&d=711971099
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WHO Rapid Communication: Key Changes to Treatment of MDR/RR-TB

The World Health Organization (WHO) released a rapid communication ahead of updated, more detailed guidelines on treatment of multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB) later in 2018. These improved guidelines are expected to lead to major improvements in treatment and quality of life of MDR-TB patients. The rapid communication announces a priority ranking for medicines available for treatment. This aims to improve access to more effective drugs in countries that currently have low treatment success rates. WHO also announced the forthcoming establishment of a multi-stakeholder Task Force to support national TB programs through the transition of the improved 2018 guidelines. 

Click here to read the full communication.

endTB Interim Analysis: BEDAQUILINE AND DELAMANID CONTAINING REGIMENS ACHIEVE EXCELLENT INTERIM TREATMENT RESPONSE WITHOUT SAFETY CONCERNS

Each year, there are about 600,000 new cases of RR- or MDR- TB and the global cure rate for MDR-TB is just 54%. Two new drugs were introduced, bedaquiline an delamanid, but the uptake of these treatments has been surprisingly slow despite the dire need for treatment. endTB was established to address barriers to access of these two drugs, and in this interim report presents three analyses as a part of the largest cohort study of patients receiving these treatments in the world.

The Safety Analysis focuses on adverse events patients on multidrug regimens like bedaquiline and delamanid may experience, with an emphasis on QT prolongation. The Delamanid Analysis focuses on patients receiving this treatment, many of whom have comorbidities such as HIV, diabetes, and Hepatitis C. Injectible Analysis examined patients who were susceptible to injection and those who were infected with injectable-resistant strains.

The interim analysis concluded that, similar to previous studies, delamanid is an effective drug to treat MDR-TB. Neither it nor bedaquiline poses major safety issues, but it is important for patients and clinicians to weigh the benefits and risks of replacing injectable treatments with these drugs before doing so. The data in the endTB study supports elevating bedaquiline and delamanid to the top of the MDR-TB drug hierarchy. 

Read full analysis here.

SOUTH AFRICAN STUDY FINDS LOWER DEATH RATES WITH BEDAQUILINE

In a retrospective cohort study, South African researchers found that bedaquiline was more effective at reducing mortality among MDR/RR/XDR-TB patients than the standard regimen.

By analyzing 24,014 cases from national vital statistics registries from July 2014 to March 2016, researchers found that only 12.6% of patients on bedaquiline died compared to 24.8% of patients treated with the standard regimen. Bedaquiline is also associated with reduced risk in all cause mortality in MDR/RR/XDR-TB.

Currently, The WHO only recommends bedaquiline for RR-TB treatment when there is resistance to second line drugs. However, these results show that there is significant evidence that this drug shortens the duration of treatment for DR-TB and reduces the side effects that are often found with standard treatments. While there are limitations to this study and results need to be confirmed in phase 3 trials, the results could have an impact for wider use of bedaquiline. 

Read the full article here.

South Africa Announces Reduction in the Price of Bedaquiline

The Minister of Health of South Africa has announced that the price of bedaquiline will drop to just 400 USD for a 6 month treatment course effective immediately. South Africa became the first country to recommend an injection-free, bedaquiline based treatment regimen for MDR-TB patients. Originally 750 USD, this significant price drop for treatment will result in over 36 million USD in savings for the South African government over the next 8 months. 

His Excellency Aaron Motsoaledi also called upon the World Health Organization to update the MDR-TB treatment guidelines in support of the evidence available to recommend bedaquiline as the new standard of treatment. This is the first step of many in ending TB.

Please click here to read the full article.

Advocates unite in call for injection-free DR-TB treatment regimens

In June of 2018, South Africa began recommending bedaquiline as a routine treatment for rifampin-resistant and multidrug-resistant TB (RR/MDR-TB) patients becoming the first country to implement an injection-free treatment regimen. Now, advocates in other countries aim to follow the steps of the South African Department of Health in support of injection-free regimens. 

Injectable treatments are associated with serious side effects, including irreversible hearing loss, and their efficacy against DR-TB has not been confirmed in clinical trials. TB affected communities are calling on their Ministries of Health to thus recommend bedaquiline as the standard RR-TB treatment regimen. Specifically, individuals and organizations are calling on the Indian Ministry of Health to be the next country to recommend bedaquiline. 

Please click here to read the recommendations created by The Desmond Tutu Tuberculosis Centre (DTTC), the Sentinel Project on Pediatric Drug-Resistant Tuberculosis and Treatment Action Group (TAG).

Please click here to view a list of all countries where bedaquiline is currently registered.

TAG, TB CAB, DR-TB STAT WEBINAR

RESIST-TB invites you to register for TAG, TB CAB, and DR-TB STAT’s webinar on Implementing a bed aquiline-based, injectable free regimen for drug-resistant tuberculosis.

On August 1, 2018 at 10AM EST, these organizations will host a critical discussion led by Dr. Nobert Ndejka from the National Department of Health in South Africa about roll-out of the unique, less toxic regimen, as his country is the first in the world to do so. Dr. Maureen Kamene from the Ministry of Health in Kenya will be talking about practical considerations when implentined BDQ-based injectable free regimens. The webinar will also include the perspective of a DR-TB survivor and other civil society members.

Please click here to register. Login information available after registration.

Closed captioning available.

REMINDER: endTB Webinar

Please join us this Thursday, July 12, 2018 from 09:30 – 11:00 EDT (15:30 – 17:00 CEST) for an exciting webinar presented by the endTB team, BDQ- and DLM-containing multidrug-regimens achieve excellent interim treatment response without safety concerns.

This webinar will be presented by Drs. Molly Franke (Partners in Health), Cathy Hewison (Médecins Sans Frontières) and Palwasha Khan (Interactive Research and Development). They will report on the endTB interim analyses of more than 1200 patients who started MDR-TB treatment regimens containing bedaquiline and/or delamanid between 1 April 2015 and 30 June 2017 in 15 countries. They will present preliminary efficacy analyses of delamanid and injectables used in multidrug regimens. Safety results will bedaquiline and delamanid (particularly QT interval prolongation), linezolid and injectables will also be shared. 

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To join the event as an attendee
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Reminder: TREAT TB Clinical Trial Implementation Webinar

RESIST-TB invites you to join an exciting discussion on July 10, 2018 from 7-10 am EST as TREAT TB hosts a webinar on Challenges with MDR-TB Clinical Trial Implementation- Sponsor and Site Perspectives.

This is the first in a series of webinars by TREAT TB to address challenges with implementing clinical trials of new treatments for MDR-TB in high burden settings. Over the next year, the series will address these challenges to strengthen capacity and increase stakeholder coordination. 

Connection details for the July webinar can be found below.

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To join the webinar from a PC, Mac, Linux, iOS or Android
follow the link below:
https://VitalStrategies.zoom.us/j/912316884

To join by phone, please dial:
US(toll free): +1 855 880 1246
or  +1 877 853 5257

International numbers available:
https://zoom.us/u/yzUOvv3Q
MeetingID: 912 316 884
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For more information about the future webinars in this TREAT TB series,
please visit:
www.treattb.org/capacitybuilding