NEWS

Obama’s Global, Domestic & HIV Research FY 2013 Budget Backslides on Existing Commitments
Proposed Cuts to President's Emergency Plan for AIDS Relief (PEPFAR) Would Prevent 500,000 People from Starting on Life-saving HIV Treatment
— President’s 2013 Budget Weakens U.S. Leadership on Fighting HIV Globally and Domestically —

NEW YORK, NY —Thursday, 16 February 2012. Treatment Action Group (TAG) is deeply disappointed by President Obama’s proposed cuts to PEPFAR (President’s Emergency Plan for AIDS Relief) and bilateral TB funds, freezing of NIH (National Institutes of Health) research as well as the insufficient attention to the worsening domestic AIDS crisis in the administration's fiscal year 2013 budget plan. “This senselessly harsh budget will directly contribute to millions of preventable illnesses and deaths among people living with HIV, hepatitis C, and TB in the U.S. and around the world.” said Mark Harrington, Executive Director of TAG, “Why does President Obama want to turn his back on the most effective, life-saving global health and development program in history?"

Letter to Secretary Clinton on the Global Fund to Fight AIDS, TB, and Malaria
7 February 2011 - Dear Secretary Clinton, We write to ask for your leadership in ensuring The Global Fund to Fight AIDS, TB, and Malaria is “open for new business,” saving lives through expanding programming in 2012. We ask that you convene an emergency donor meeting in advance of the July International AIDS Conference to re-invigorate the U.S. three-­year commitment of $4 billion and use it to leverage commitments from other donors to the Global Fund. We also urge you and President Obama to use your political leadership — and the bipartisan support for The Global Fund — to achieve the U.S. pledge in 2013 without sacrificing any funding from essential bilateral AIDS, TB, and Malaria programs, which would undermine the game changing targets you and the president set at the end of last year.

Report and Commentary from the Fifth International Workshop on HIV Persistence During Therapy
February 2012 - Inaugurated in 2003, the bi-annual International Workshop on HIV Persistence during Therapy (aka “the persistence workshop”) is the brainchild of researcher Alain Lafeuillade. The meeting presaged the recent explosion of interest in pursuing a cure for HIV infection, a pursuit many had considered quixotic until the case of Timothy Brown came to light in 2008. As has been extensively documented, Brown’s apparent cure resulted from a debilitating odyssey of treatments required for the grim diagnosis of acute myelogenous leukemia, enhanced with a mix of insight and good fortune on the part of his doctor Gero Hütter, who was able to provide a stem cell transplant from a donor lacking the major HIV co-receptor CCR5. The sea change wrought by this fortuitous “proof of concept” was much in evidence at the 2011 persistence workshop this past December; the tentative forays into basic science that were once emblematic of the field are now mixed together with more ambitious plans for advancing ideas into the clinic. Perhaps most strikingly, two large pharmaceutical companies—Gilead and Janssen/Tibotec—described their use of industrial scale screening to search for compounds that are active against latent HIV. This represents an unprecedented expansion of efforts once confined to under-resourced academic labs.

Letter to Sangamo BioSciences on Development Plan for Gene Therapy SB-728-T
January 12, 2012 - Our concern is that while your press release highlights Sangamo BioSciences commitment to using zinc finger nuclease technology to address “unmet medical needs," it is silent on the status of further research for SB-728-T in the HIV-positive population with arguably the greatest unmet medical need: those who experience poor immune reconstitution despite suppression of HIV replication by antiretroviral therapy (ART).

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). Click here for presentation slides and advocacy links.

Letter Opposing a Proposed Low-dose Stavudine Trial
14 December 2011
Dear Mr. and Mrs. Gates, We write as people with HIV and community activists with serious and unresolved concerns about the proposed clinical trial comparing stavudine at 20 mg to tenofovir. Although we are broadly very supportive of dose optimisation strategies, we do not support this trial; we do not think that the Bill and Melinda Gates Foundation should support it; nor do we think it should proceed. Several of us have discussed this with your representatives both formally and informally over the past months. Those of us who met with your representatives on 19 July 2011 at the International AIDS Society conference in Rome received no response to the concerns we raised. We summarise our objections as follows:

TAG's 2011 Year-End Update
In this issue:

Demand Global Fund to Reverse Cancellation of New Programming
2 December, 2011 - The cancellation by the Global Fund to Fight AIDS, TB and Malaria of all new programming until 2014 is unacceptable. This decision will cost lives and cripple international efforts to deliver on health-related goals, breaking promises made to some of the world’s most vulnerable people, and punishing the Global Fund's success of the last ten years.

Let’s Redouble our Commitment to Cure AIDS!
1 December, 2011 - The debate over the federal budget and deficit reduction gets more heated each year. But on this World AIDS Day, the benefits of federal investment in research are incontrovertible. As documented earlier this year, for the first time in history, a cure for AIDS is possible. One man’s HIV infection has been eradicated using a HIV-resistant immune cell transplant—a concept based on discoveries first made by researchers supported by the National Institutes of Health (NIH) in the 1990’s. For millions around the world this discovery is incredibly encouraging, despite the fact that this type of treatment would be difficult, costly, and too dangerous for widespread implementation. With the new scientific breakthrough, some of the smartest, most experienced scientists and new young investigators are employing cutting edge technologies and working tirelessly to discover and develop a safe, effective, feasible, and scalable HIV cure. We need Congress to increase funding for NIH for AIDS research in order to build on this momentum.

We Need the Patent Pool to Work
A Joint Statement by Treatment Action Campaign, Treatment Action Group, HIV i-Base, European AIDS Treatment Group and SECTION27
16 November 2011 - The exorbitant price of AIDS medicines, especially antiretrovirals, has been one of the main barriers to people with HIV accessing them, especially in developing countries. As activist organisations we have been at the forefront of many of the struggles to make medicines affordable.

US Government HIV/AIDS Clinical Trial Sites to Accelerate Completion of Phase III TB Drug Trial
TB Alliance's REMox TB program leverages ACTG sites to advance testing of improved TB treatments
Durban, South Africa— 15 November 2011 The TB Alliance announces the launch of a collaboration with the National Institute of Allergy and Infectious Diseases' (NIAID) AIDS Clinical Trial Group (ACTG) to conduct and help complete a Phase III clinical trial testing potentially faster-acting tuberculosis (TB) treatments. Few clinical trials for TB have been conducted under modern GCP/GCLP standards in the past 40 years, and the infrastructure to support invigorated global TB drug research is lacking, especially in resource-limited settings where the majority of TB cases are found. The partnership between the NIAID's ACTG and TB Alliance joins available resources with the urgent need for TB clinical research capacity to accelerate testing of new therapies that can benefit both the HIV/AIDS and TB communities.

Time of Great Change in TB Drug Development
Speech Delivered to Critical Path to TB Drug Regimens Meeting, Washington DC
9 November 2011 - We are living in a time of great change and excitement in TB drug development. The last year has witnessed a number of epochal changes, including the approval and rollout of the most rapid test for TB ever discovered, the GeneXpert; the combination TB drug studies in the relapse mouse model of Eric Nuermberger and Jacques Grosset at Johns Hopkins with support from the TB Alliance; the progression of TMC207 into late phase II and of OPC67683 into phase III; and the first new regimen EBA study, NC-001 also from the Alliance.

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
26 October 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.

Strengthening the Role of the Stop TB Partnership in the Struggle Against Tuberculosis
11 October 2011 - Dear Professor Atun, We are writing to follow up on our letter of May 3, 2011, regarding the steps being taken by the Coordinating Board to reduce the conflict of interest in the Stop TB Partnership’s relationship with the World Health Organization (WHO), improve transparency and accountability in the operations and activities of the Partnership, and strengthen the Partnership’s ability to fulfill its mandate.

Treatment Action Group Mourns the Loss of Pioneering AIDS and TB Activist Winstone Zulu (1964-2011)
12 October 2011 - Not only was Winstone Zulu a hero in the fight against AIDS, but he was also a pioneer in bringing AIDS activism to the hitherto barren and civil society free zone of tuberculosis prevention, treatment, and care.

tagline: Fall 2011
In this Issue:

• A Golden Decade of Antiretroviral Drug Development
  Success rate for new ARVs entering phases II–III surpassed 32% from 2003–2011 - U.S. ADAP Prescribing Practices Closely Match Recent ARV Guidelines
  
  As we were putting together the 2011 Pipeline Report this summer, we decided to look back at the previous years' reports on anti-HIV drug development. Treatment Action Group (TAG) has been covering the antiretroviral (ARV) drug pipeline since our founding; in the past two years we have joined forces with HIV i-Base (UK) to deepen and broaden our coverage.

• Cure Research Momentum Accelerates
  The research effort to discover a cure for HIV infection continues to gain momentum, with several important developments having occurred since the last issue of TAGline.
   
• What We Need to Cure AIDS?
  A cure for HIV is possible: one man, the so-called Berlin patient, has already been cured of chronic HIV infection with an immune system transplant with cells genetically resistant to HIV. After four years, the man remains free of detectable HIV, and his HIV antibodies are disappearing. However, this approach is dangerous (potentially fatal), costly, and not scalable to the 34 million people currently living with HIV.
   
• Ending the Neglect of Childhood TB
  It is estimated that of the nine million new cases of tuberculosis (TB) each year, one million occur among children under the age of 15. Yet advocacy for prevention, diagnosis, and treatment of TB in children has been largely absent from the global public health agenda. In fact, the true global burden of TB in children is unknown because of the lack of child-friendly diagnostic tools, and inadequate surveillance and reporting of childhood TB cases. National TB programs and research efforts have ignored TB in children for a variety of reasons, among them that children are less likely to spread disease. However, the stark reality is that children with TB infection today represent the reservoir of TB disease tomorrow.

Cepheid Pricing Of The GeneXpert Machines And Cartridges For Public Sector Use In High TB Burden Areas

3 September 2011 - An open letter from the Treatment Action Campaign (TAC) and partners to Cepheid calling for affordable and expanded access to the GeneXpert® MTB/RIF TB diagnostic test. We remain concerned that there is little transparency around pricing, particularly as Cepheid is currently in negotiations with South Africa’s Department of Health regarding the procurement of these machines.