Webinar: TREAT TB

TREAT TB will hosted a capacity building webinar on community engagement in MDR-TB clinical trials.

It will feature a presentation from Ezio Tavora dos Santos Filho, STREAM Community Engagement Coordinator from REDE-TB, followed by a question and answer session.

The presentation will highlight the importance and objectives of community engagement in clinical research, how to implement community engagement before a trial begins, as well as how to bring community engagement into an existing trial. To join the webinar, click here. To join by phone, please dial +1 855 880 1246 US Toll-free or +1 877 853 5257 US Toll-free. For international numbers, click here. Meeting ID: 912 316 884

A recording of the webinar and slides will be available on the TREAT TB website approximately one week after (available around (12/12/18)) the webinar.

TREAT TB’s MDR-TB clinical trial capacity building webinar series will continue over the coming months, with webinars scheduled for January, March, and May 2019. Future topics to be addressed include regulatory requirements, institutional review boards and ethics approval, as well as laboratory strengthening.

Has compassionate use ever sunk a drug?

Click here to read a recent International Union Against Tuberculosis and Lung Disease Editorial by RESIST-TB members, Sarah McAnaw, Carole Mitnick, and Bob Horsburgh.

“New treatments for a serious disease generate understandable excitement among patients with life-threatening conditions. As pharmaceutical companies consider compassionate use of experimental drugs, one factor is commonly cited as a barrier to such use: fear that adverse events incurred by patients during Compassionate Use/Expanded Access (CU/EA) will impede regulatory approval of the drug. Such concerns stem from the obligation to report adverse events—that are serious, unexpected, and suspected to be related to the investigational drug— experienced by patients during treatment under CU/ EA programs.1 Such reports, it is feared, will damage the future of the drug, particularly since adverse events may not be related to the experimental drug and patients taking such drugs are typically sicker than the average patient.2 Existing evidence, however, does not support the notion that such events jeopardize regulatory approval.” Click here to read the article in full. 

Unitaid extends key research grant as part of a strong counterattack on tuberculosis

Unitaid is intensifying its commitment to fighting tuberculosis with a US$ 21 million investment in extending endTB, a global research project that is improving treatment regimens for patients with multidrug-resistant tuberculosis (MDR-TB). This project has been piloting bedaquiline and delamanid in 17 countries with the goal of providing countries and funding agencies with effective drugs to tackle MDR-TB on a large scale. 

Long-used treatments for MDR-TB can take up to two years, succeed in only about half the cases, and can cause major side effects. With endTB’s extension, a new clinical trial will be added to develop a treatment regimen for patients with fluoroquinolone-resistant MDR-TB. These regimens have the potential to cure 119,000 more patients, save 56,000 more lives and avert 239,000 drug-resistant infections from 2019 to 2027.

The endTB project’s original term was 2015-2019 and its budget US$ 60 million, but with the extension it will run through the end of 2022, with Unitaid support of up to US$ 81 million. 

To read the full article, click here.

TREAT TB Clinical Trial Capacity Building Webinar Series

RESIST-TB invites you to join TREAT TB for the second webinar in its series to promote capacity building for high quality clinical trials for MDR-TB.

On September 28th at 8 AM EST, Dr. Jan Komrska, senior pharmacist at Vital Strategies, will present a webinar on supply chain management for MDR-TB trials.

Connection details below.

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For more information about connection details and future webinars, click here.

To join the webinar from a PC, Mac, Linux, iOS or Android, click here.

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

For international numbers, click here.

Meeting ID: 912 316 884

Complete makeover in fight of MDR-TB

An international collaborative study led by Dr. Dick Menzies at McGill University has shown that several new medicines, including bedaquiline, linezolid, and the later generation fluoroquinolones, have produced consistently better cure rates for MDR-TB patients and have been proven to be more effective at treating XDR-TB than currently used treatments. 

The World Health Organization (WHO) has already responded to this study’s findings by announcing landmark changes in line with this MDR-TB regimen and, also, positioning fully oral regimens over injectable agents. “The guidelines committee simply erased the old treatment recommendations and started over. They gave the treatment guidelines a complete make-over,” says Dr. Menzies.

To read the full article, click here.

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.