Online consultation to update the Global Plan to End TB

Online consultation to update the Global Plan to End TB

Posted on 07/11/19

The first online consultation is being launched by the Stop TB Partnership in order to update the Global Plan to end TB 2016 – 2020. This will align the The Paradigm Shift with the UN Political Declaration on TB targets and commitments in the next three-year replenishment cycle of the Global Fund covering 2021 and 2022.

FDA Antimicrobial Drugs Advisory Committee recommends approval of pretomanid

FDA Antimicrobial Drugs Advisory Committee recommends approval of pretomanid

Posted on 6/21/19

Investigational drug pretomanid is under regulatory review by FDA for treatment of XDR-TB and treatment-intolerant or non-responsive MDR-TB as part of a new investigational regimen. A decision regarding pretomanid approval is expected to be made by August of 2019.

For more news, click here.

BEAT TB: A ground breaking DR-TB program in South Africa

A ground breaking new programme, BEAT Tuberculosis, was launched in Port Elizabeth, South Africa. It is a world first in the fight against Drug Resistant Tuberculosis (DR TB) that is expected to slash treatment time-frames, make taking treatment far easier and minimise devastating side-effects. The program is supported by USAID in collaboration with the Wits Health Consortium.

It is a global first and will be conducted in Port Elizabeth, an area in South Africa which bears a disproportionally high burden of RR TB. It is expected to lead to a safer, more tolerable and more effective all-oral regimen for the treatment of DR TB.

Click here for the full article.

Click here for a informational video (~4 minutes).

World Tuberculosis Day 2019

Each year, we commemorate World Tuberculosis (TB) Day on March 24 to raise public awareness about the devastating health, social and economic consequences of TB, and to step up efforts to end the global TB epidemic. March 24 marks the day in 1882 when Dr. Robert Koch announced that he had discovered Mycobacterium tuberculosis, the bacterium that causes TB, which opened the way towards diagnosing and curing this disease.

It is a day to educate the public about the impact of TB around the world, sharing successes in TB prevention and control, and raising awareness of the challenges that hinder our progress toward the elimination of this devastating disease.

Click the following links to learn more about World TB Day 2019 (WHO, CDC)

CROI 2019 Presentations on the DELIBERATE Trial and the INHindsight Trial

On April 12th RESIST-TB hosted a webinar on two presentations from the 2019 Conference on Retroviruses and Opportunistic Infections (CROI):

EARLY BACTERICIDAL ACTIVITY OF HIGH-DOSE ISONIAZID AGAINST MULTIDRUG-RESISTANT TB

Presented by Kelly Dooley

High-dose isoniazid (INH) may be useful in treating multidrug-resistant tuberculosis (MDR-TB), particularly when INH resistance is mediated by inhA mutations. Although the World Health Organization (WHO) recommends ‘high-dose’ INH as part of the new shorter MDR-TB regimen, the optimal dose and its efficacy are not established.

AIDS Clinical Trials Group (ACTG) A5312 is a Phase 2A randomized, open-label trial in which individuals with smear-positive pulmonary MDR-TB with INH resistance mediated by an inhA mutation (Group 1) were randomized to receive INH doses of 5, 10 or 15 mg/kg daily for 7 days. Controls with drug-sensitive TB (Group 2) received the standard INH dose of 5 mg/kg/day. Sputum cultures were collected daily, beginning at baseline. The early bactericidal activity of INH, estimated as the average daily change in log10 colony forming units (CFU) on solid media (EBACFU0-7) or average daily change in time to positivity (TTP) in hours on liquid media (EBATTP0-7) over 7 days of treatment was estimated using nonlinear mixed effects models. Safety data were collected from study entry through Day 21.

 

Dr. Dooley’s webinar presentation: INHindsight Trial

 

QT EFFECTS OF BEDAQUILINE, DELAMANID OR BOTH IN MDR-TB PATIENTS: THE DELIBERATE TRIAL

Presented by Gary Maartens

Bedaquiline and delamanid are the first drugs of new classes approved for tuberculosis (TB) in 40 years. Both are oral, well-tolerated, and recommended for treatment of multidrug resistant (MDR) TB by WHO. However, these drugs and/or their metabolites have long half-lives, and each prolongs the QT interval with maximum effects weeks after drug initiation. The cardiac safety of these drugs given together as part of multidrug therapy has not been established.

AIDS Clinical Trials Group (ACTG) A5343 is a phase 2, open-label trial randomizing adults with MDR-TB receiving multidrug background treatment (MBT) 1:1:1 to receive bedaquiline (BDQ arm), delamanid (DLM arm) or both (BDQ+DLM arm) for 24 weeks. Patients with QTcF >450ms or CD4 count < 100 cells/mm3 were excluded. HIV-infected participants received dolutegravir-based ART. Clofazimine was not allowed, and levofloxacin was given in place of moxifloxacin. Three electrocardiograms (ECG) were performed at baseline, every two weeks for 24 weeks, then week 28. QTcF (in ms) was calculated by a core laboratory blinded to treatment. The mean QTcF change from baseline (averaged over weeks 8-24) was defined in each arm, and the QTcF change in the BDQ+DLM arm was compared to QTcF changes in the BDQ and the DLM arms. Grade 3 QTcF prolongation was defined as >500ms or >480ms with increase from baseline >60ms. Grade 4 was life-threatening dysrhythmia.

Dr. Maarten’s webinar presentation: DELIBERATE Trial

 

Due to technical complications during the webinar, the event was unable to be recorded.

We apologize for the inconvenience.

 

 

TB CAB statement on safety of using bedaquiline and delamanid together

The Global TB Community Advisory Board (TB CAB) welcomes the important finding from the AIDS Clinical Trials Group Deliberate Trial that newer drugs bedaquiline and delamanid are safe to use together. These findings should erase any remaining reluctance to use these two important drugs together, as the benefits of these safer drugs outweigh the risks–especially for patients with drug-resistant TB who have few other treatment options.

Click here to read the full article.

TB Medicine Pretomanid Enters Regulatory Review Process in the United States

TB Alliance’s new drug application (NDA) for the novel tuberculosis (TB) drug candidate pretomanid has been accepted for review by the United States Food and Drug Administration (FDA). The application is for the use of pretomanid as part of a new regimen, in combination with bedaquiline and linezolid, for the treatment of extensively drug-resistant (XDR) TB, treatment intolerant multidrug-resistant (MDR) TB, and treatment non-responsive MDR-TB.

The NDA for pretomanid has been granted Priority Review by FDA. The Prescription Drug User Fee Act (PDUFA) action date for an FDA decision is in third quarter 2019.

Statement by TB Alliance

Statement by Treatment Action Group (TAG)

Webinar: Introduction of the ICN/Curry Center Nursing guide for managing side effects to drug-resistant TB treatment (RECORDING AVAILABLE)

On January 16th, RESIST-TB and The Union’s Nurses and Allied Professionals Sub-Section (NAPS) hosted a webinar to discuss the ICN/CITC Nursing Guide for Management of Side Effects of DR-TB Treatment. Nurses are often the first to hear of a patient’s side effects during TB treatment, making them well positioned to intervene. The information presented in this guide, which is the topic of this webinar, was developed to help nurses assess for and respond appropriately to side effects related to anti-TB medications.

The ICN/CITC Nursing Guide for Management of Side Effects of DR-TB Treatment is available in English, Chinese and Russian.

For those of you who were unable to join the webinar, below is a recording. The slides used can be found here.

Key speakers: Bob Horsburgh, Carrie Tudor, Linette McElroy

*Speaking first is Bob Horsburgh (RESIST-TB), who introduces the key presenter Carrie Tudor (ICN)

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.

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.