TB/HIV PROJECT NEWS
Treatment Action Group (TAG), the Global TB Community Advisory Board, and civil society in India call for Qiagen to stop unethical, off-label marketing and use of QuantiFERON-TB Gold for diagnosing active TB. (14 May 2013)
A SILENT CRISIS: Tuberculosis Drug Shortages in the United States (Video)
April 24, 2013 - On January 18, 2013, in Washington, D.C., TAG held a consultation on the domestic TB drug shortage crisis. The meeting was cosponsored by PATH, RESULTS, the Center for Global Health Policy, and the American Thoracic Society.
We Can Heal: Prevention, Diagnosis, Treatment, Care, and Support:
Addressing Drug-Resistant Tuberculosis in Children
March 21, 2013 - This collection calls for urgent attention to the global problem of pediatric drug-resistant tuberculosis (DR-TB). The stories of 30 children with DR-TB in 30 countries are a testament to the need for improved programs, policies, and tools to reach the goal of zero TB deaths, new infections, and suffering.
An Activist’s Guide to Bedaquiline (Sirturo)
March 11, 2013 - People with drug-resistant TB must resort to second-line drugs, which are more toxic, less effective, and more expensive. However, in December 2012, a new drug called bedaquiline was approved for the treatment of multidrug-resistant TB (MDR-TB). Bedaquiline (also known by its trade name, Sirturo, or as TMC207) is the first new drug from a new drug class to treat TB to be approved by the United States Food and Drug Administration (FDA) in over 40 years. This guide highlights important safety and efficacy data reported thus far and offers advocacy recommendations for activists to take forward.
TB and MDR-TB Advocacy List for Survivors and Patients
Treatment Action Group, together with the website Take That TB, has created a listserv for TB and MDR-TB survivors and patients interested in conducting advocacy and connecting with others in this community. The listserv provides a platform for TB patients and survivors from around the world to share experiences, support one another, and strategize on advocacy. To join the group, please visit https://groups.google.com/forum/#!forum/take-that-tb or contact email@example.com.
Aspiring to Zero TB Deaths, New Infections, and Suffering Symposium
Video presentations from ZERO TB Symposium at the 2012 International Union Against TB and Lung Disease World Conference in Kuala Lumpur.
Treatment Action Group Lauds FDA Approval of First New Tuberculosis Drug in Half a Century
31 December 2012 – Treatment Action Group (TAG) applauds the accelerated approval today of bedaquiline, the first new approved drug to treat tuberculosis (TB) in over forty years, by the U.S. Food and Drug Administration (FDA). The drug has the potential to improve the treatment for multidrug-resistant (MDR) TB, a particularly deadly and hard-to-treat form of TB that affects over a million people worldwide, and from which only about half of patients who are treated recover.
Treatment Action Group Welcomes FDA Review of First New Tuberculosis Drug in Half a Century
New drugs to fight TB, especially its drug-resistant forms, are urgently needed
November 29, 2012 - Treatment Action Group (TAG) welcomes the U.S. Food and Drug Administration (FDA) review of bedaquiline. Bedaquiline is the first new drug from a novel drug class to be reviewed by the FDA for its potential to fight tuberculosis (TB) in nearly 50 years.
Tuberculosis Research and Development: 2012 Report on Tuberculosis Research Funding Trends, 2005-2011
November 14, 2012 - Now in its seventh year, TAG's Tuberculosis Research and Development: 2012 Report on Tuberculosis Research Funding Trends: 2005-2011 builds on seven years of investment data to report on annual funding trends and gaps among the leading TB R&D donors. The report analyzes current spending levels across six research areas to assess how they compare to the Stop TB Partnership’s Global Plan to Stop TB 2011-2015 R&D funding targets.
Reaching Zero TB Deaths and Zero New TB Infections Satellite Symposium
04 October 2012 - You are invited to attend the “Reaching Zero TB Deaths and Zero New TB Infections’” satellite symposium in Kuala Lumpur, Malaysia, on Tuesday, November 13, 2012. The symposium will be held from 18:30-21:30 at the Prince Hotel & Residence (a short walk from the conference center) followed by refreshments and snacks. A draft agenda can be downloaded above. Treatment Action Group, the Stop TB Partnership, the Sentinel Project on Pediatric Drug-Resistant Tuberculosis, Partners In Health, and the Harvard Medical School Department of Global Health and Social Medicine are hosting the symposium at the 2012 International Union Against TB and Lung Disease World Conference in Kuala Lumpur, Malaysia.
The Future of TB in the United States: Going, or Growing?
3 October 2012 - This summer, Treatment Action Group (TAG) and its partners in fighting tuberculosis (TB) issued a call for zero TB deaths, zero new TB infections, and zero suffering from TB. Yet the U.S., long a leader in TB elimination efforts, is in jeopardy of losing ground in the struggle to get to zero. Drug shortages, coupled with financial obstacles, are threatening the success of TB programs nationwide. TB, long forgotten by the general public and by many policy makers, still affects the U.S., with over 10,000 new cases in 2011.
GeneXpert Rapid TB Test Price Reduced in Historic Agreement
3 October 2012 - After months of political wrangling, in early July 2012, an agreement to reduce the price of the GeneXpert MTB/RIF rapid test for tuberculosis (TB) was reached between the manufacturer, Cepheid, and pooled purchasers UNITAID, PEPFAR, USAID, and the Bill & Melinda Gates Foundation. GeneXpert was codeveloped by Cepheid, the Foundation for Innovative New Diagnostics (FIND), and the University of Medicine and Dentistry of New Jersey (UNMDJ). It accurately diagnoses both TB and some common rifampin drug-resistance mutations within two hours.
Treatment Action Group and European AIDS Treatment Group Applaud UNITAID Agreement to Reduce the Cost of GeneXpert Rapid TB Test
Call for Further Price Cuts on Cartridges and Machines to Realize Goals of Zero TB deaths
7 August 2012 – Treatment Action Group (TAG) and the European AIDS Treatment Group (EATG) welcome the announcement that a deal has been reached among PEPFAR, USAID, UNITAID, and the Bill & Melinda Gates Foundation to reduce the price of the GeneXpert® MTB/RIF rapid test for tuberculosis (TB). The partners to this collaborative market intervention have taken an important first step towards accelerating market entry to the molecular diagnostic system, which accurately diagnoses both TB and some common drug-resistance mutations, within two hours. But the still high cost of the machines and cartridges and the lack of private sector access greatly limit the reach and impact of this historic agreement.
THE ZERO DECLARATION: Join the Movement!
ZERO TB DEATHS – ZERO NEW TB INFECTIONS – ZERO TB SUFFERING
July 22, 2012 - We are a group of activists, clinicians, researchers, implementers, foundation and government officials, and policy makers. We commit to zero TB deaths, zero new TB infections, and zero TB suffering and stigma, because:
- TB is preventable and curable.
- The main driver of today’s unnecessary TB deaths, new TB infections, and suffering and stigma is lack of political will.
- Every country in the world has the potential to reach the goal of zero TB deaths, zero new TB infections, and zero TB suffering and stigma.
2012 PIPELINE REPORT
HIV, Hepatitis C Virus (HCV), and Tuberculosis (TB) Drugs, Diagnostics, Vaccines, and Preventive Technologies in Development
22 July 2012 - Visit our new website www.PipelineReport.org to:
- Read the report online
- Download individual chapters as PDFs
- Browse for specific information by agent
Global TB Community Advisory Board Advocacy Campaigns
24 May 2012 - The Global TB Community Advisory Board (TB CAB) urged regulators and drug developers to take action on four important issues:
- harmonizing European and US regulatory guidance on accepted endpoints to streamline and accelerate drug development, and
- conducting drug-drug interaction studies of bedaquiline and delamanid (the two most advanced candidates in clinical development for TB) to ensure they are safe to use together, as they likely will be once approved.
- enabling pre-approval access to these drugs for select providers to administer them to patients with no other treatment options; and
- lowering the price of the GeneXpert cartridges and machines to expand access to rapid TB diagnosis.
The TB CAB calls on the European Medicines Agency, the U.S. Food & Drug Administration, the South African Medicines Control Council, Otsuka, Janssen, and Cepheid to enable safe and effective treatment to fight TB to reach those who urgently need it as quickly as possible. Please see the full letters below.
- Letter to FDA: Crucial Regulatory Harmonization on Endpoints and Pharmacokinetic Studies for Tuberculosis Drug Development
24 May 2012 - As a group of concerned advocates for people infected and affected by tuberculosis (TB) worldwide, we urge the US Food and Drug Administration (FDA) to adopt two important measures to expedite research and development for desperately needed novel combinations of new drugs for TB.
- Letter to EMA: Conducting drug-drug interaction studies for bedaquiline (TMC207) and delamanid (OPC6783)
24 May 2012 - We wish to draw to your attention our deep concern at development of two new products extremely important for tackling the growing epidemic of drug resistant tuberculosis (TB). Those arebedaquiline (TMC207) by Janssen and delamanid (OPC6783) by Otsuka.
- Letter to Janssen: Pharmacokinetic Studies, Paediatric Studies, and Compassionate Use of Bedaquiline
24 May 2012 - The TB CAB remains concerned that the two new investigational tuberculosis (TB) drugs which are farthest along in development, bedaquiline and the Otsuka agent delamanid (OPC6783) -- both of which are being studied in people with MDR-, pre-XDR, and XDR-TB, and both of which are entering phase III studies and have or are likely to be submitted to regulatory authorities this year -- have not been studied together in the pharmacokinetic (PK) studies that will tell us how they interact and whether they are safe to use together.
- Letter to Otsuka: Pharmacokinetic Studies, Paediatric Studies, and Compassionate Use of Delamanid
24 May 2012 - The TB CAB remains concerned that the two new investigational tuberculosis (TB) drugs which are farthest along in development, delamanid and the Janssen investigational agent bedaquiline (TMC207) -- both of which are being studied in people with MDR-, pre-XDR, and XDR-TB, and both of which are entering phase III studies and have or are likely to be submitted to regulatory authorities this year -- have not been studied together in the pharmacokinetic (PK) studies that will tell us how they interact and whether they are safe to use together.
- Open Letter to Cepheid on Pricing of GeneXpert
16 April 2012 - We write to follow up on our previous communications regarding the price of Cepheid’s GeneXpert MTB/RIF machines and cartridges....We remain deeply disappointed that despite unprecedented momentum and global rollout of the Xpert MTB/RIF system, prices have failed to budge either for the machines or for the cartridges.
- Open letter to the Medicines Control Council and Ministry of Health on urgent need for compassionate use of bedaquiline for XDR-TB and pre-XDR-TB in South Africa
11 April 2012 - We urge you to take action to expedite compassionate use access for bedaquiline (TMC207) for persons with drug-resistant strains of tuberculosis in South Africa. Access to improved medicines to treat extensively drug resistant tuberculosis (XDR-TB) and pre-XDR-TB is essential given the enormous public health threat that the drug-resistant TB epidemic exemplifies.
PRESS RELEASE: Children with Drug-Resistant TB Make Up the Most Neglected Patient Population
— Treatment Action Group Analysis Finds Global TB R&D Rose by Just 2% from 2009: Less than One-Third of the Global Need —
Thursday, 22 March 2012 - In recognition of World Tuberculosis day on March 24th, Treatment Action Group (TAG) calls for the re-focusing of attention on the tremendous burden that tuberculosis (TB) plays around the world. TB is a disease of the poor – more than 80% of TB cases worldwide arise in the global south. According to the World Health Organization, nearly 4,000 people die every day because of TB. There were 8.8 million people newly diagnosed with TB in 2010, including 1.1 million cases among people with HIV – which, coupled with the emergence of drug resistant TB, including some untreatable strains – creates a deadly synergy. Despite this reality, investment in TB research has remained very low compared to the worldwide burden.
BEING BRAVE: Stories of children with drug-resistant tuberculosis
March 2012 - When it comes to drug-resistant tuberculosis (DR-TB), the global community is failing to “get it right.” Millions of people around the world suffer from this dangerous, yet treatable, infectious disease. Yet, in over a decade, less than 1% of those with DR-TB have been diagnosed and treated. Children bear a disproportionate burden of this disease, and are far less likely than adults with DR-TB to have access to appropriate care. This collection gives voice to the children from around the world featured in it, and to the thousands more like them who face the challenges of fighting DR-TB every day. It is also a global call to action. These stories invite all of us to join children with DR-TB and their families and caregivers in the struggle for better diagnosis and treatment. It is the first step toward “getting it right” for children with TB.
Forgotten But Not Gone: Childhood TB Advocacy Meeting
On Thursday January 5, 2012, TAG held a Childhood TB Federal Advocacy Meeting in Washington, D.C. The meeting was co-sponsored by STOP TB, RESULTS/ACTION, the Center for Global Health Policy and the American Thoracic Society (ATS). Some of the highlights of the meeting included an incredibly moving personal account of the struggles and hardships a young mother living in Texas who has a toddler son that was diagnosed with drug resistant TB meningitis over a year ago. There were also presentations from leading childhood TB clinicians and researchers and advocates on pediatric TB basics - epidemiological data, diagnosis, treatment and care issues as well as on TB research needs and gaps. At the end of the meeting there was also a quick discussion on the 2012 fiscal and political advocacy outlook, action items and next steps. Following all of the presentations, the speakers fielded many challenging questions from the audience. Click here for presentation slides and advocacy links.