PREVIOUS NEWS IN DR-TB
From our January 2020 Newsletter
Submit Feedback To Inform Overhaul of ClinicalTrials.gov
In February, ClinicalTrials.gov—the world’s largest public repository of clinical research registry and results database—will celebrate its 20th anniversary. Over the next few months, the National Library of Medicine (NLM) will be Engaging Users To Support the Modernization of ClinicalTrials.gov.
WHO announces updates on new molecular assays for the diagnosis of tuberculosis and drug resistance
Significant improvements to the diagnosis of tuberculosis (TB) and rifampicin resistance in adults and children are expected, following key updates on new molecular assays, announced by the World Health Organization (WHO). It's easy.
FROM OUR DECEMBER 2019 NEWSLETTER
WHO announces changes to the treatment of drug-resistant tuberculosis
Significant improvements in treatment outcomes and quality of life for patients with drug-resistant tuberculosis (TB) are expected, following key updates to treatment approaches, announced by WHO.
TB Alliance responds to questions raised by activists in relation to pretomanid
MSF, TAG and TB CAB raised a number of outstanding medical and research questions regarding pretomanid and the regimen BPaL.
Posted on 11/14/19
HYDERABAD, INDIA – The National Institute of Allergy and Infectious Diseases is investing $70 million in a phase III clinical trial assessing the use of tuberculosis treatments in preventing multidrug-resistant tuberculosis infection among high-risk individuals, including infected household contacts of MDR-TB patients and people living with HIV, institute officials announced here.
Posted on 11/14/19
With the government providing key drugs like bedaquiline to only public sector patients, doctors say private patients have equal right to treatment without spending out of pocket.
From our November 2019 Newsletter
New guideline emphasizes treatment of drug-resistant TB with all-oral regimens and provides recommendations for treatment of all contacts to multidrug-resistant TB patients.
Posted on November 14, 2019
Posted on 10/11/19
The 50th Union World Conference on Lung Health will be held from 30 October to 2 November 2019 in Hyderabad, India. RESIST-TB has summarized a list of symposia, oral abstracts, and workshops relating to drug-resistant tuberculosis (DR-TB) from the online programme in order to create this flyer. View the flyer in the PDF attachment below.
Posted on November 14, 2019
Posted on 10/15/19
This article reports the 2018 survey results regarding the assessment of access to treatment strategies for tuberculosis conducted by the International Union Against Tuberculosis and Lung Disease (The Union) drug-resistant TB Working Group in collaboration with RESIST-TB. Read the full article here.
From our October 2019 Newsletter
The WHO Global Tuberculosis Report 2019 is Out
The WHO 2019 Global Tuberculosis Report has recently been published. It was found that the global MDR-TB epidemic increased by approximately half a million new cases of rifampin-resistant TB (of which 78% had multidrug-resistant TB) in 2018. Check out the link to the full global TB report 2019 below, and other recent news in DR-TB.
1. Global Tuberculosis Report 2019
2. Global campaign launched urging Johnson & Johnson to reduce price of bedaquiline
3. TB drug delamanid must be more affordable and made available in more countries
4. DR-TB Drugs Under the Microscope, 6th edition
From our September 2019 Newsletter
Below is the most recent State of the Art article from IJTLD, which discusses the use of palliative care and symptom relief (PCSR) for people affected by MDR-TB.
1. Palliative care and symptom relief for people affected by multi-drug resistant tuberculosis
Below is the new 2019 Lancet tuberculosis series presenting how the diagnosis of MDR-TB can be improved, how drug regimens can best be used to treat and applied to different populations, and how MDR-TB can be managed in the future.
2. The Lancet Tuberculosis 2019
From our August 2019 Newsletter
Here are a few items that address the exciting news about the FDA approval of pretomanid in the BPaL regimen; describe concern about the standard of the research that led to its approval, the regulatory precedent it sets; and highlight uncertainty around its affordability and access.
Posted on 08/15/19
The FDA has approved a new drug for highly-resistant forms of drug-resistant tuberculosis. Developed by the non-profit TB alliance, Pretomanid has been approved to be used in a combination regimen with bedaquiline and linezolid for people with MDR-TB and XDR-TB.
Posted on 08/07/19
The World Health Organization (WHO) is developing new guidelines for the treatment of drug-resistant TB (DR-TB) by issuing a public call appealing to industry, researchers, national TB programs, and other agencies to provide appropriate datasets.
From our July 2019 Newsletter
1. NIH launches large TB prevention trial for people exposed to multidrug-resistant TBA large clinical trial is being conducted to assess the treatments available for individuals who are at high-risk for developing multi-drug resistant tuberculosis (MDR-TB).
Recommendations for the management of MDR-TB are discussed in this June issue of the State of the Art articles from IJTLD.
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.
From our June 2019 Newsletter
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.
TB advocates sent an open letter to TB alliance requesting the organization toshare their recent agreement with Mylan.
From our May 2019 Newsletter
1. Advocates raise serious concerns about errors in the WHO guidelines for the treatment of drug-resistant TB
On 23 April 2019, TB advocates sent an open letter to Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), expressing their serious concerns about the WHO Global TB Program’s ability to issue evidence-based guidelines for the treatment of drug-resistant TB.
2. Community capacity building modules to accelerate DR-TB response
Affected communities and community-based organizations can play a crucial role and work with national programmes in ensuring a person-centred and human rights-based approach in the management of drug-resistant TB in countries in the South-East Asia Region, provided their capacity is built with appropriate training to understand the science and management of DR-TB. This article explores the recent developments made at the WHO South-East Asia Regional Meeting of National TB Program Managers and Partners.
3. It’s Time to End Drug-Resistant Tuberculosis: The Case for Action
NEW BRUNSWICK, N.J., MAY 7, 2019 — A new report published today by The Economist Intelligence Unit (EIU), and with support from Johnson & Johnson, emphasizes the urgent need for focused global action to address the growing threat of drug-resistant tuberculosis (DR-TB). DR-TB is the leading contributor to deaths from antimicrobial resistance (AMR).
From our April 2019 Newsletter
In a brief report published in Clinical Infectious Diseases, researchers reported a case of drug resistance against 2 recently approved antitubercular medications: delamanid and bedaquiline. Researchers presented a patient with extensively drug-resistant tuberculosis (TB), and highlighted the potential for the emergence and transmission of resistant Mycobacterium tuberculosis complex strains with more frequent use of these relatively new drugs.
BEAT TB: A groundbreaking 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).
From our March 2019 Newsletter
1. WHO consolidated guidelines on drug-resistant tuberculosis treatment
These Consolidated guidelines include a comprehensive set of WHO recommendations for the treatment and care of DR-TB, derived from these WHO guidelines documents. The consolidated guidelines include policy recommendations on treatment regimens for isoniazid-resistant TB (Hr-TB) and MDR/RR-TB, including longer and shorter regimens, culture monitoring of patients on treatment, the timing of antiretroviral therapy (ART) in MDR/RR-TB patients infected with the human immunodeficiency virus (HIV), use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care.
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.
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.
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.
From our February 2019 Newsletter
1. TB activists for first time challenge TB drug patent in India
February 6, 2019 - Médecins Sans Frontières (MSF) is supporting a patent challenge filed in India this week by two tuberculosis survivors, to prevent pharmaceutical corporation Johnson & Johnson (J&J) from extending its monopoly on the tuberculosis drug bedaquiline.
The development of bedaquiline benefited from considerable public investment, and the evidence for its potential to improve cure rates with fewer side-effects was the result of a collective effort of the global TB community. MSF is urging J&J to refrain from attempts to extend its monopoly that will further delay the availability of quality-assured generic versions of bedaquiline in India, South Africa and other countries.
2. As patients challenge patent, J&J commits to tackling drug-resistant TB
February 17, 2019 - While Bedaquiline patent is contested, firm denies its monopoly would get extended.
Johnson & Johnson has tripled its commitment on tuberculosis drug Bedaquiline by offering 90,000 doseages to its global donation programme that ends in March, Paul Stoffels, J&J’s Vice-Chair of the Executive Committee and Chief Scientific Officer, said, on a programme that has given medicines to India as well.