A movement to promote and conduct research on the treatment and prevention of drug-resistant tuberculosis, with a commitment to address the substantial existing gaps in our knowledge and to help provide access to an effective cure and prophylaxis of drug-resistant tuberculosis throughout the world.

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Nearly nine million people will develop tuberculosis (TB) in the world this year; at least 500,000 of these cases will have multidrug-resistant tuberculosis (MDR-TB). Some will receive treatment. However, we know little about the best ways of treating drug-resistant TB (DR-TB) and preventing tuberculosis in people who come in contact with DR-TB patients. Lacking a strong scientific basis in prescribing treatment regimens, existing TB treatments are often ineffective. TB control efforts require new evidence-based knowledge about optimal treatment regimens, prophylaxis, and, possibly, regimens involving new TB drugs, in order to address the growing health threats of MDR-TB and extensively drug-resistant (XDR) TB.

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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. 

Recent News and Announcements

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 […]

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 […]

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.  ——————————————————- To join the webinar, please use the following link: […]

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 […]

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 […]

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