Nursing Guide for Managing Side Effects to Drug-resistant TB Treatment

This guide was developed by nurses with experience in the clinical care and programmatic management of TB and DR-TB in both high- and low-resource settings. Nursing and DR-TB literature were reviewed to establish best practice nursing assessment and intervention guidance. Nurses caring for patients with DR-TB field tested the job aid and provided feedback which was used to inform final content and format. A link to this guide online can be found here.

Citation: International Council of Nurses and Curry International Tuberculosis Center. Nursing guide for managing side effects to drug-resistant TB treatment. Geneva. 2018.

Revamped WHO Civil Society Task Force

The World Health Organization has revamped its Civil Society Task Force on TB to strengthen collaboration for accelerating progress towards ending TB. As countries are beginning to ramp up efforts to end TB following commitments made by Heads of State at the first-ever UN High-Level Meeting on TB (UN HLM) in September 2018, the role of civil society in driving action and accountability is more important than ever.

Find the full article here.

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.

ACTIVISTS URGE NATIONAL TB PROGRAMS AND TREATMENT PROVIDERS TO DISCONTINUE USE OF HARMFUL INJECTABLE AGENTS IN TB TREATMENT

Activists from around the world called on National TB Programs to discontinue routine use of harmful injectable agents in treatment regimens for drug-resistant tuberculosis, in favor of newer, safer World Health Organization (WHO)-recommended treatments. Second-line injectable agents (kanamycin, capreomycin, and amikacin)—previously considered essential medicines for the treatment of multidrug-resistant TB (MDR-TB)—have poor efficacy against TB and high toxicity, including irreversible hearing loss. Giving these medicines to people with MDR-TB exposes them to unnecessary pain and risk of disability—in the case of kanamycin and capreomycin, without any benefit.

The full article can be accessed and read here.

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.

————————————

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. 

——————————————————-
To join the webinar, please use the following link:
https://hms.webex.com/hms/onstage/g.php?t=a&d=711971099
——————————————————-