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.
- Advancing Research, Securing Access
Now in its 20th year of publication, TAGline has long sought to inform its readers and TAG supporters of the myriad research and policy challenges we face as a community in the ongoing fight against HIV and two of its insidious comorbidities, viral hepatitis and tuberculosis. Many of these challenges are inextricably intertwined, as we highlight in this issue focusing on specific clinical research and treatment-access hurdles threatening progress for all three diseases.
- Ryan White at a Crossroads
Preparing to defend and reshape a still-critical program
An increasing demand for services, coupled with significant fiscal retrenchment among federal and state agencies, leaves the Ryan White HIV/AIDS CARE Act-funded program at a crossroads. But advocacy strategies are afoot, not only to work toward continuation of Ryan White funding past its September 30 expiration, but also to promote a long-overdue implementation-science agenda to maximize the effectiveness and efficiency of HIV services.
- The "G" Word
Gilead’s greed gives rise to a slew of advocacy priorities
Activists are decrying Gilead’s refusal to continue codeveloping a winning HCV drug combination with Bristol-Myers Squibb (BMS), opting instead to focus on co-formulations of its own promising agents. While a high-level petition continues to circulate, demanding that Gilead continue codevelopment with BMS, a much larger advocacy agenda remains to be addressed.
- TB Drugs for Children
Poor treatment options spur innovative research strategies
There is an old adage in pediatric medicine: children are not little adults. This is particularly true when it comes to tuberculosis, for which management strategies are largely the same, but dosing guidance and options leave a lot to be desired. Fortunately, a number of initiatives hope to remedy this situation in an effort to reduce global TB mortality among children—currently 100,000 deaths each year.
- Razing the House of Cards
The discovery of HAART and the push for evidence-based HIV treatment
This is the third in a series looking back at the first two decades of TAG’s work to speed up AIDS research. Here we look at the rise of highly active antiretroviral therapy (HAART) and the push for evidence-based HIV treatment.
- Preparing for Generics
The push for affordable HIV treatment doesn’t end with patent expirations
The United States is on course for some much-needed economic relief from the crippling cost of HIV treatment, with the anticipated arrival of generic versions of guidelines- preferred antiretrovirals. However, much preparation is required to maximize price competition, maintain patient choice, and ensure that savings are used to the advantage of people living with HIV.
- Undetectable Is Not Always Enough
Immunologic nonresponders face increased risk of illness, but lack therapeutic options
A subset of people on antiretroviral therapy (ART) experience limited or no recovery of CD4 T-cell counts despite achieving and maintaining undetectable viral loads. Various terms have been used to describe this phenomenon, with the most common being “immunological nonresponders” (INRs). Many studies have documented that INRs face an increased risk of illness and death compared with people with more robust CD4 T-cell gains. Yet there are no approved therapies to improve immune reconstitution, and clinical trials of potential candidates remain few and far between.
- Sanofi’s Double-Edged Sword
Rifapentine’s manufacturer helps to advance TB research while stalling accessSanofi-Aventis, manufacturer of the tuberculosis (TB) drug rifapentine (Priftin), can be credited for aiding research efforts to shorten and simplify treatment dosing for TB. However, the company’s pricing of the drug has hampered access to such regimens, even in resource-rich nations like the United States.
- A Necessary Transformation
Simultaneous, not sequential, evaluations of novel drug regimens needed to speed TB treatment research
New drugs, as components of novel regimens, are necessary to improve TB treatment. To expedite the development of these regimens, while simultaneously reducing the size, length, and cost of clinical trials, TB researchers, funders, and activists are working together to develop alternative study designs.
- Help Paying for HIV and Hepatitis Treatment
Health insurance co-payment (co-pay) programs and patient drug assistance programs (PAPs) are critical services for thousands of U.S. residents with HIV and/or viral hepatitis who face out-of-pocket expenses associated with their treatment. The Fair Pricing Coalition (FPC) has negotiated co-pay programs with virtually every major HIV and viral hepatitis drug manufacturer.
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.
Report of a Functional Cure in an HIV-Infected Infant
3/2/13 - On Monday March 4th at the Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, details were presented on a case of a potential “functional cure” of HIV infection in an infant. The story has already broken widely in the media due to a CROI press conference held on Sunday afternoon, during which the researcher describing the case, Deborah Persaud, gave a preview of the data. The webcast of Persaud’s talk is now available for viewing online (it is the 7th presentation in the session entitled “Is There Hope for HIV Eradication?”). READ MORE
In September 2012, Médecins Sans Frontières, the Open Society Foundations and Treatment Action Group, joined forces with activists, researchers, UN and government representatives to identify priority issues, share information and develop strategies to overcome the barriers that prevent access to HCV treatment in developing countries, both today and in the future.
Have a Heart, Save My liver!
February 14, 2013 - Today, on the occasion of Valentine's Day, Médecins du Monde and Treatment Action Group (TAG) are launching an action urging pharmaceutical giants Merck and Roche to drop their exorbitant prices for pegylated interferon, an effective hepatitis C (HCV) treatment. Send a Valentine’s Day card (download it at www.hepcoalition.org) to leadership at Merck and Roche and ask them to “Have a Heart, Save My Liver!”
Grief Is a Sword: A Eulogy for Spencer Cox
A brilliant HIV treatment activist, Spencer Cox directed TAG’s Antiviral Project from 1994-1999. He died of AIDS on December 18, 2012. Peter Staley delivered this eulogy at his memorial gathering in New York City on January 20, 2013.
by Peter Staley
A Global Plan to End AIDS Everywhere But at Home
The bold, aggressive new plan released by Hillary Clinton once again wildly surpasses in ambition what U.S. officials dare attempt in this country.
by Mark Harrington
On the Edge: Uncertainty Grows over HIV Budgets
The HIV community is bracing for impact as acrimonious federal budgetary battles rage on.
by Coco Jervis
Data Deluge at AASLD
It is difficult not to be dazzled by cure rates of up to 100% from interferon-free hepatitis C virus (HCV) trials presented at the American Association for the Study of Liver Diseases (AASLD) meeting in November 2012.
by Tracy Swan
Beyond ARVs: Advocacy for Non-AIDS Disease Management
Fact: If we’re going to make headway in preventing and treating non-AIDS-related health complications among people with HIV, which are very much on the rise and a serious risk to disease-free survival, we’re going to need the full-on cooperation of pharmaceutical companies manufacturing and developing drugs for non-HIV diseases.
by Tim Horn
TB Zeroes Campaign Achieves Big Win
The world has recently called for zero new TB deaths, infections, and suffering, and that voice has been heard.
by Erica Lessem
TAG Welcomes the FDA Approval of the First New Drug for TB in 40 Years
December 28, 2012, was a historic day for the one million people around the world with strains of tuberculosis (TB) that are particularly difficult to treat. For the first time in forty years, the United States Food and Drug Administration (FDA) approved a new drug, bedaquiline for TB.
by Erica Lessem
Help Support Inclusion of Pegylated Interferon on the World Health Organization’s Essential Medicines List
The current standard of care for HCV is pegylated interferon (PEG-IFN) and ribavirin. Yet in most countries, this treatment is unaffordable to all but the wealthiest people.
by Karyn Kaplan
GUIDE TO CLINICAL TRIALS FOR PEOPLE WITH HEPATITIS C
SECOND EDITION NOW AVAILABLE
Tracy Swan’s popular guide for people who are deciding to participate in a clinical trial for new hepatitis C treatment has been updated. This guide is avialable in both English and Spanish. To download PDFs or request printed copies by mail, free of charge, go to: www.treatmentactiongroup.org/hcv-clinical-trials-guide.
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.
Support Inclusion of Pegylated Interferon in the World Health Organization’s Essential Medicines List: Guidance for Civil Society Submissions
January 15, 2013 - Civil-society groups have an important but limited opportunity to advocate for the inclusion of pegylated interferon on the World Health Organization Essential Medicines List. Deadline Mid-February!
Guide to Clinical Trials for People with Hepatitis C (Second Edition)
January 2013 - There are many new hepatitis C drugs being studied in clinical trials. People with hepatitis C have many options to choose from. Whether you have hepatitis C or another medical condition, deciding to participate in a clinical trial can be complicated. Having more information can help you decide whether or not to participate in a clinical trial, and which trial, or trials, may be right for you. This guide is available in English and Spanish.
HOW TO SURVIVE A PLAGUE
2013 Academy Award Nominee for Best Documentary
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.
Patrick Spencer Cox
March 10 1968 - December 18 2012
HCV Treatment Pipeline Update
12 December 2012 - It is difficult to be anything other than dazzled by astounding cure rates of up to 100% from a multitude of interferon-free hepatitis C virus (HCV) clinical trials presented at the American Association for the Study of Liver Diseases (AASLD) meeting in November 2012. Proof of concept has been established: hepatitis C, a disease that claims more than 350,000 lives annually, can be cured with three months of oral antiviral drugs.
The December 2012 issue:
- Letter from Sara Rafsky
- How to Survive a Plague
- 2012 Fundraisers
- International AIDS Conference
- New Staff Members
- Reports from the Front
- In Memoriam: Peter Diffly
A Global Plan to End AIDS Everywhere But at Home
December 1, 2012 - Mark Harrington writing in the Atlantic online - The bold, aggressive new plan released by Hillary Clinton once again wildly surpasses in ambition what U.S. officials dare attempt in this country.
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.
Micardis Sign-on Letter to Boehringer Ingelheim
30 November, 2012 - Dear Dr. Piliero: We, the undersigned organizations and individuals, urge Boehringer Ingelheim Pharmaceuticals to reconsider its negative decision to provide free telmisartan (Micardis) and matching placebo to the AIDS Clinical Trials Group so that it may move forward with Study A5317, a multicenter trial evaluating the effects of telmisartan on fibrotic and inflammatory contributors to end-organ disease in HIV-infected patients well controlled on antiretroviral therapy.
- TAG at 20 - Part II: On a Darkling Plain—The Years of Despair
Before the Discovery of HAART
This is the second in a series looking back at the first two decades of TAG’s work to speed up AIDS research. In Part I: TAG’s early campaigns to reform the National Institutes of Health (NIH) AIDS research, boost the federal budget, and revitalize HIV basic science research. Here we look at the clinical science of AIDS before the discovery of highly active antiretroviral therapy (HAART) in 1995–96, and how TAG responded to the needs of people with AIDS.
- Only Stronger U.S. Leadership Can End the AIDS Epidemic
Existing treatment and prevention techniques could prevent millions of new HIV infections and deaths from AIDS—but only if Obama sustains funding.
This article was first published on 24 July 2012 in theAtlantic.com
- Cure-Related Research at AIDS 2012
At the recent International AIDS Conference in Washington, D.C. (AIDS 2012), the research effort to develop a cure for HIV infection attained a higher profile than it ever has in the past. At a press conference on July 19, the International AIDS Society (IAS) officially launched its Global Strategy “Towards an HIV Cure,” in conjunction with a two-day symposium that immediately preceded the main conference.
- The Future of TB in the United States: Going, or Growing?
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.
- Getting to Zero—Join the Movement!
In May 2012, a group of activists, researchers, clinicians, implementers, policy makers, and foundation and government staff working to stop TB met in Cambridge, Massachusetts. During their three-day meeting, the group gave birth to a global TB strategy focused on a new target: zero TB deaths, zero new TB infections, and zero TB suffering and stigma. To this end, they created the Zero Declaration, which has already been signed by 500 institutions and individuals.
- GeneXpert Rapid TB Test Price Reduced in Historic Agreement
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.
Tribute to Médecins Sans Frontières (MSF)
8 September 2012 - Médecins Sans Frontières (MSF)/Doctors Without Borders asked Treatment Action Group’s Mark Harrington to deliver a tribute to its work on September 8, 2012, when the Fulbright Association presented the 2012 J. William Fulbright Prize for International Understanding to MSF.
Previous recipients of the Fulbright Prize include Nelson Mandela (1993), Jimmy Carter (1994), Corazón Aquino (1996), Václav Havel (1997), Kofi Annan (2001), Bill Clinton (2006), Desmond Tutu (2008), and Bill and Melinda Gates (2010).
The Prize “recognizes and rewards outstanding contributions toward bringing peoples, cultures, or nations to greater understanding of others.” It is awarded to “individuals, groups, or organizations whose contributions have made a substantial impact in breaking through the barriers that divide humankind.”
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.
TAG Executive Director Mark Harrington Arrested at the White House - WE CAN END AIDS MARCH in Washington D.C. 24 July 2012 (photo credit: Colleen Daniels, TAG).
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
Washington Call for Access to HCV Diagnostics, Treatment and Care for All!
27 July 2012 - On the occasion of the XIX International Aids Conference in Washington, DC, USA, and the eve of World Hepatitis Day, the undersigned grassroots civil society groups and non-governmental organizations have formed an international coalition working towards universal access to HCV voluntary testing and treatment.
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.
TAG at AIDS 2012
Join TAG at the XIX International AIDS Conference in Washington D.C.
Sunday July 22 - Friday July 25
Come see TAG staff and board in conference sessions and join us at TAG affiliated events throughout the week.
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.