TB/HIV Project News
2016 Pipeline Report
July 15, 2016 – HIV and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development
- The Tuberculosis Diagnostics Pipeline
- The Tuberculosis Prevention Pipeline
- The Tuberculosis Treatment Pipeline
- The Pediatric Tuberculosis Treatment Pipeline
Breathing Life into Flatlined U.S. Government Funding for Tuberculosis Research: FY 2017–2020 Allocations and Recommendations
June 2016 – This policy brief provides an overview of investments made by the U.S. government and explains how increasing TB R&D funding can catalyze the development of better vaccines, diagnostics, and treatments for TB. It is built upon resource tracking and reporting done by Treatment Action Group (TAG), and it recommends areas in which investments will not only fill research gaps but also provide clarity in the vision proposed by the National Action Plan and prevent the rising threat of multidrug-resistant TB (MDR-TB).
TAG Welcomes Delamanid’s Inclusion in the Stop TB Partnership’s Global Drug Facility
February 24, 2016 – Treatment Action Group (TAG) congratulates the Stop TB Partnership and Otsuka Pharmaceutical for arranging for the inclusion of delamanid, an important new medicine for treating some cases of multidrug-resistant tuberculosis (MDR-TB), in the Global Drug Facility (GDF). TB is the leading infectious cause of death globally, and new medicines to treat drug-resistant strains of TB are urgently needed. TAG commends the GDF and the Stop TB Partnership for their leadership in securing access to delamanid with minimal barriers and at a single flat price for all Global Fund-eligible countries.
TAG’s Response to the U.S. Action Plan for Combating Multidrug Resistant Tuberculosis
January 7, 2016 – Treatment Action Group (TAG) welcomes the release of the Obama Administration’s National Action Plan for Combating Multidrug-Resistant Tuberculosis. Strengthening the domestic and global and research efforts to address multidrug-resistant tuberculosis (MDR-TB) are critical to ending the suffering this preventable, curable disease needlessly causes. However, the targets set forth in this plan are not ambitious enough to effectively stop the spread of MDR-TB. The Administration and Congress must appropriate funding levels to ensure that the U.S. can effectively address MDR-TB.
An Activist’s Guide to Regulatory Issues: Ensuring Fair Evaluation of and Access to Tuberculosis Treatment
December 2015 – This guide explains different regulatory processes and terms and offers examples of how to use a variety of regulatory mechanisms to improve access to treatment. The guide also encourages activists to advocate for effective, efficient, transparent regulatory systems.
Tuberculosis Research Funding Crisis Imperils Elimination Goal
November 30, 2015, Cape Town, South Africa – Worldwide funding for tuberculosis (TB) research fell $1.3 billion short of global targets in 2014, according to a report released today by Treatment Action Group (TAG). Total funding of US$674,036,492 in 2014 amounted to barely one-third of the US$2 billion experts estimate the world must spend on TB research and development (R&D) each year to eliminate TB. Alarmingly, funding for TB drug research fell by US$25 million compared with 2013. Overall, funding for TB R&D fell by US$12 million.
Symposium: Scale Up to Get Down to Zero TB Deaths, New Infections, and Suffering
In conjunction with the 2015 Union World Conference on Lung Health Conference
Friday, December 4, 2015
18h00 – 20h30
Southern Sun The Cullinan, Protea 1 & 2
1 Cullinan Street Cape Town Waterfront
Cape Town, South Africa 8001
TAG Response to the Release of the World Health Organization’s 2015 Global Tuberculosis Report
October 28, 2015: Global leaders’ half-hearted response has enabled TB to overtake AIDS as the world’s leading cause of death from an infectious disease.
September 15, 2015: TAG signed on to an open letter to India’s Minister of Health and Family Welfare calling for the immediate scale-up of GeneXpert machines and MTB/RIF cartridges, which are capable of detecting TB disease and rifampicin resistance in just two hours. The letter highlights critical delays in procurement of these machines and cartridges, underutilization of available machines, cartridge stock-outs, and lack of access to this technology for people living with HIV.
September 3, 2015: On behalf of TAG, the TB CAB, and other allied organizations and individuals, Universities Allied for Essential Medicines (UAEM) presented the president of the Johns Hopkins University with a petition calling for transparency and assurances of non-exclusivity as the university negotiates a licensing agreement for the promising TB drug sutezolid.
August 12, 2015: TAG signed on to an open letter calling for Indian health and municipal authorities to urgently address increasing rates of occupationally acquired TB at Sewri Hospital in Mumbai—Asia’s largest TB hospital. Inadequate infection control measures and access to personal protective equipment have left health care workers at Sewri Hospital without means to protect their health and safety. The letter outlines several measures that health and local authorities can take to better protect health care workers from TB.
August 10, 2015: TAG signed on to an open letter calling for the prioritization of human rights in The Global Plan to Stop TB, 2016–2020. The signatories outline international instruments that establish legal rights for people with TB and encourage members of the Global Plan Development Task Force to more fully integrate a clearly developed human rights–based approach into the Global Plan.
2015 Pipeline Report
July 17, 2015 – HIV, HCV, and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development
- The Tuberculosis Treatment Pipeline: Moving Beyond “Making the Most of What We’ve Got”
- Momentum in the Pediatric Tuberculosis Treatment Pipeline
- The Tuberculosis Diagnostics Pipeline
- The Tuberculosis Vaccines Pipeline: A New Path to the Same Destination
2014 Report on Tuberculosis Research Funding Trends, 2005–2013. 2nd Edition
October 22, 2014 – Reader beware: funding data presented in this report may be less encouraging than they appear. A quick glance at Treatment Action Group’s ninth annual Report on Tuberculosis Research Funding Trends would suggest good news: funding for tuberculosis research and development (TB R&D) increased by US$37.9 million over 2012 to reach a total of $676.7 million in 2013. The foundation of the TB research enterprise, however, is shakier than at any other time since Treatment Action Group (TAG) began tracking funding levels in 2005.
2014 Symposium: Zero Accountability: When Action Doesn’t Match the Numbers (Video)
On October 30, 2014, in conjunction with the Union World Conference in Barcelona, Spain, Treatment Action Group (TAG), the Stop TB Partnership, Médecins Sans Frontières (MSF), Partners In Health (PIH), and the Harvard Medical School Department of Global Health and Social Medicine sponsored a symposium titled “Zero Accountability: when action doesn’t match the numbers.” The symposium began with an introduction highlighting inadequacies in the global response to the MDR-TB emergency. Two panels, with individual talks followed by panel-wide discussions, then convened around the current state of research and development for MDR-TB, including the complexity and duration of existing treatments, and key access issues, including pricing and the uptake of new drugs and regimens.
Letter to the South African Medicines Control Council
October 20, 2014 – TAG signed on to an open letter to the Medicines Control Council, urging them to register a generic version of linezolid to make it available for all patients with drug-resistant TB in need throughout South Africa. Brand-name linezolid is exorbitantly expensive, and out of the reach of most people who need this potentially lifesaving antibiotic. Without access to this quality-assured generic version of linezolid, many patients with difficult-to-treat forms of TB are denied treatment. See press coverage on the letter.
Activists Urge Otsuka to Provide Access to TB Drug – Only a handful of patients have received Otsuka’s new drug, delamanid –
October 30, 2014, Barcelona, Spain – Tuberculosis (TB) activists interrupted Otsuka’s symposium at the 45th Conference on World Lung Health, calling for widespread registration of and immediate broad compassionate use access to delamanid, Otsuka’s new drug to treat multidrug-resistant TB (MDR-TB).
Two New Activist Guides on Delamanid and Linezolid
September 23, 2014 – Delamanid (also called Deltyba), the newest drug to fight tuberculosis (TB) was approved in Europe and Japan in 2014. An Activist’s Guide to Delamanid explains what we know about the drug’s efficacy and safety. Linezolid, an older drug important for treating some cases of drug-resistant TB, is being used more and more, and An Activist’s Guide to Linezolid summarizes the information we have on linezolid’s safety and efficacy in TB treatment. Both guides describe what activists—including people with TB, researchers, and doctors who treat TB—can do to help ensure access, fair pricing, and further research.
SAVE THE DATE: Zero Accountability: When Action Doesn't Match the Numbers: Thursday, October 30, 2014, Barcelona
Please join us for a symposium at the 2014 International Union Against TB and Lung Disease World Conference. Keynote speaker Mark Dybul, Executive Director, Global Fund to Fight AIDS, Tuberculosis and Malaria, will talk about financing the emergency response.
September 10, 2014: TAG and a coalition of organizations and individuals working on TB sent an open letter to Janssen appealing to the company to lower bedaquiline's price for all non-high-income countries. They also requested a September 2014 meeting with the company, policy makers, and key funders of TB drug procurement to make bedaquiline accessible affordably.
2014 Pipeline Report
July 20, 2014 – HIV, HCV, and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.
Read the TB chapters online:
- The Tuberculosis Diagnostics Pipeline
- Tuberculosis Drug Development Hobbles Forward
- Playing Catch-Up: Pediatric Tuberculosis Treatment Pipeline
- The Tuberculosis Vaccines Pipeline
An Activist's Guide to Tuberculosis Drugs
May 29, 2014 – TB treatment must be shorter, simpler, less toxic, and more tolerable and affordable. Activists can contribute to the development and uptake of improved TB treatment by calling attention to research, quality of medications, and access priorities. This guide provides a brief summary of safety and efficacy data for those drugs currently in use for TB (many of which have been approved for other diseases but are used off-label for TB), and suggests advocacy points for activists.
TB in TAGline Spring 2014:
- Punked by Pharma: Public Funds for Private Products – Tax dollars are making it easier for the drug and diagnostics industry to develop and market essential TB products. Is the public getting a fair return on its investment?
- Fool’s Errand: The Sloppy Science of the MDR-TB STREAM Trial – Confirming the efficacy and safety of bedaquiline-inclusive regimens is a priority. Comparing them to unvalidated MDR-TB drug combinations in the planned STREAM study is not the way to go about it.
Falling Funding for Tuberculosis Research Threatens to Derail TB Elimination Efforts in the United States
Research Dollars Drop Just as Old Disease Grows More Difficult to Treat
March 24, 2014, Washington, D.C. – The goal of eliminating tuberculosis (TB) as a public health threat in the United States is under threat, a new policy brief released today by Treatment Action Group (TAG) shows. Analysis conducted by TAG reveals that spending on TB research and development (R&D) among U.S. government agencies declined from 2009 to 2012 in the face of budget instability, sequestration, and the rising costs of biomedical research.
Flatlined: U.S. Government Investments in Tuberculosis Research and Development, 2009–2012
March 2014 – The goal of eliminating tuberculosis (TB) as a public health threat in the United States is under threat. In 1989, the U.S. government committed to ending the TB epidemic through the formation of a national TB elimination plan. Since then, the heart of the U.S. strategy for domestic TB elimination has progressed through a combination of visionary research linked to bold implementation. As a result of this two-pronged strategy, there were only 9,951 new domestic cases of TB in 2012, the lowest level since reporting began in 1953. Yet falling funding for TB research threatens to roll back the hard-won achievements of the last two decades.
CRAG, TAG Welcome Sanofi U.S. Commitment to Reduce the Price of Tuberculosis Drug Rifapentine
December 12, 2013 – The Community Research Advisors Group (CRAG) and Treatment Action Group (TAG) welcome the Sanofi U.S. decision to lower the price of the tuberculosis (TB) drug rifapentine to $32 per 32-tablet blister pack. The company indicates that the new price will become effective in January 2014 under 340(b) Public Health Service pricing.
Treatment Action Group Applauds European Approval of New Drug to Fight Tuberculosis, Demands Expanded Access and Affordable Pricing –
November 22, 2013 – Approval of and access to delamanid are crucial while further research is pending —
New York, New York – Treatment Action Group (TAG) congratulates the Committee for Medicinal Products for Human Use (CHMP) for its recommendation to the European Medicines Agency (EMA) to grant marketing approval to delamanid, a new drug for multidrug-resistant tuberculosis (MDR-TB) now in phase III clinical trials. MDR-TB treatment options that do not include new drugs are long, toxic, difficult to tolerate, and often ineffective.
October 30, 2013 – Activists stormed the stage at the World Health Organization (WHO) sponsored Stop TB Symposium during the 44th Union World Conference on Lung Health. TAG's TB Project Director Colleen Daniels called for global action and a new global attitude in the fight against TB.
Tuberculosis: Behind the Numbers Video Series
November 1, 2013 – Treatment Action Group launches three-video series, produced by filmmaker Jonathan Smith and titledTuberculosis: Behind the Numbers, on PLOS Medicine’s Community Blog, Speaking of Medicine.
- Mike Frick and Audrey Zhang discuss the need to modernize directly observed therapy and move toward patient-centered care for both drug-sensitive and drug-resistant TB patients, highlighted in the video, A Walk to Work with Dr. Vivian Cox.
- Lindsay McKenna and Colleen Daniels describe the importance of access to timely diagnosis and appropriate treatment for patients with drug-resistant TB, and demand that urgency be returned to the global response, underscored in the video,Drs. Dalene and Arne von Delft.
- The third and final video, Breaking the Record with Dr. Bart Williams, illustrates the story of a South African doctor and his experience completing treatment for drug-sensitive TB.
A Double Blow: Private-Sector Funding for TB Research Drops Sharply Amid Severe Public-Sector Budget Cuts
As Threat of Drug-Resistance Grows, Big Pharma Decreases Investments in TB research by 22 Percent
October 29, 2013, Paris, France – The 2013 Report on Tuberculosis Research Funding Trends, 2005–2012 finds that funding for tuberculosis research and development (TB R&D) dropped by US$30.4 million compared with 2011—the first time funding has fallen since TAG began tracking investments in 2005. Funding declined for diagnostic, drug, vaccine, and operational research, increasing the likelihood that new tools to fight TB will remain out of reach for the 8.7 million people who develop TB each year.
TB in TAGline Fall 2013:
- U.S. TB Control: From Confidence to Crisis – funding cuts and shifting budgetary priorities threaten tuberculosis gains.
- An Obligatory Overhaul to Address Domestic TB Drug Shortages – bold strategies are required to remedy frequent stock-outs and supply interruptions.
Webcast: New Approaches to Drug-Resistant Tuberculosis
October 2013 – Mark Harrington, executive director of TAG, was featured in an online panel discussion about the global crisis of drug-resistant tuberculosis (DR-TB). The webcast was hosted by Doctors Without Borders/Médecins Sans Frontières (MSF) and New York Times science writer Denise Grady. The panel comprised health care workers and patient advocates working to improve treatment for people living with DR-TB, including Dr. Grania Brigden, TB advisor, MSF Access Campaign; Cathy Hewison, TB medical advisor at MSF; Mark Harrington, executive director of Treatment Action Group; and Evaline Kibuchi, senior TB advocacy manager at the Kenya AIDS NGO Consortium (KANCO).
First-Ever Targeted Roadmap Outlines Steps to End Childhood TB Deaths
Cost to end deaths from childhood TB estimated to be at least US$120 million annually
October 1, 2013, Washington, D.C. – The deaths of more than 74 000 children from tuberculosis (TB) could be prevented each year through measures outlined in the first ever action plan developed specifically on TB and children.
Treatment Action Group Criticizes European Refusal of New Drug to Fight Tuberculosis
— Approval of and access to delamanid is crucial while further research is pending —
July 29, 2013 – Treatment Action Group (TAG) is disappointed by the failure of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to recommend marketing approval for delamanid, a new drug in development for multidrug-resistant tuberculosis (MDR-TB).
2013 Pipeline Report Calls on Leaders to Get the Best HIV, Hepatitis C Virus, and Tuberculosis Drugs, Diagnostics, and Vaccines to the Most People as Quickly as Possible
June 30, 2013, Kuala Lumpur, Malaysia – HIV i-Base and Treatment Action Group (TAG) called on global and national leaders, research sponsors, and regulatory authorities to work together to make the best HIV, HCV, and TB drugs, diagnostics, and vaccines accessible as fast as possible, according to a report released today at the 7th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Kuala Lumpur, Malaysia.
TB in TAGline Spring 2013:
- TB Drugs for Children – poor treatment options spur innovative research strategies
- Sanofi’s Double-Edged Sword – rifapentine’s manufacturer helps to advance TB research while stalling access
- A Necessary Transformation – simultaneous, not sequential, evaluations of novel drug regimens needed to speed TB treatment research
Children with Drug-Resistant Tuberculosis Require Urgent Attention
—Research and access required to achieve zero deaths, new infections, and suffering—
March 21, 2013 – Treatment Action Group (TAG), in partnership with the Sentinel Project on Pediatric Drug-Resistant Tuberculosis (Sentinel Project) released today We Can Heal: Prevention, Diagnosis, Treatment, Care and Support: Addressing Drug-Resistant Tuberculosis in Children. This collection, released in anticipation of World TB Day on March 24, 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 12, 2013 – New drugs are urgently needed to get to zero deaths, zero new infections, and zero stigma and suffering from tuberculosis (TB). While TB has been curable for decades, existing drugs have to be taken for months or even years. Even then, cure rates can range from 30% to 80% for cases of drug-resistant TB, depending on the extent of resistance. 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 in TAGline Winter 2013:
- TB Zeroes Campaign Achieves Big Win – global call for zero new TB deaths, infections, and suffering has been heard
- TAG Welcomes the FDA Approval of the First New TB Drug for TB in 40 Years.
Treatment Action Group Lauds FDA Approval of First New Tuberculosis Drug in Half a Century
December 31, 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 multi-drug 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.
November 28, 2012 – TAG’s Executive Director Mark Harrington testifies at the FDA Anti-Infective Drugs Advisory Committee Hearing on the Use of Bedaquiline for Treatment of Multidrug-Resistant Tuberculosis.
November 13, 2012 – Aspiring to Zero TB Deaths, New Infections, and Suffering Symposium videos from the 43rd Union World Conference on Lung Health available online.
Treatment Action Group and the Stop TB Partnership Issue Update on 2011 Global TB R&D Investment Trends
— 2011 Funding Increases 3% to US$649.6 Million, but Annual US$1.35 Billion Funding Gap Remains —
November 14, 2012 | KUALA LUMPUR, MALAYSIA – For the seventh year, Treatment Action Group (TAG) and the Stop TB Partnership have published the latest investment data on the state of global tuberculosis (TB) research and development (R&D) funding. The 2012 Report on Tuberculosis Research Funding Trends: 2005–2011 finds 81 donors invested US$649.6 million in TB R&D, an 82% increase from the baseline year of 2005, but only a 3% increase over 2010 funding levels.
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—
August 7, 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.
HIV i-Base/Treatment Action Group 2012 Pipeline Report Reveals Deep Gaps between Scientific Promise and Program Delivery
—Recent Advances in Biomedical HIV, Hepatitis C Virus (HCV), and Tuberculosis (TB) Prevention and Treatment Are Not Reaching Those Who Need Them Most
Political Leaders Continue to Break Domestic, Global Health Commitments—
July 21, 2012 | WASHINGTON, D.C., USA–On the eve of the XIX International AIDS Conference in Washington, D.C., a new report by HIV i-Base (U.K.) and Treatment Action Group (TAG) (U.S.) reveals the deepening gulf between new scientific advances that make it possible to prevent, treat, and in some cases cure people living with HIV, hepatitis C virus (HCV), and tuberculosis (TB), and access to these where they are most needed.
Children with Drug-Resistant TB Make Up the Most Neglected Patient Population & Treatment Action Group Finds Global TB R&D Rose by Just 2% from 2009: Less than One-Third of the Global Need
March 22, 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.
Treatment Action Group Issues Latest Update on Global TB R&D Investment Trends
—2010 Funding Flat at $617 million, Less Than One-Third of the Global Need—
October 26, 2011 – LILLE, France – New data released by the Treatment Action Group (TAG) and the Stop TB Partnership finds that in 2010 the world spent just $617 million in tuberculosis (TB) research and development (R&D), or 0.3% less than 2009 funding levels—the first time TAG documents no growth since it began tracking TB research investments in 2005.