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2013 TAG Update
TAG’S PROGRESS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS
December 2013
In this issue:


Filling the Gaps in the U.S. HIV Treatment Cascade: Developing a Community-Driven Research Agenda
December 1, 2013 – TAG and amfAR sponsored a workshop in Washington, D.C., on June 18–19, 2013, to develop a community-based agenda to improve implementation of effective service-delivery approaches and identify research priorities for improved management of HIV treatment and prevention, with a particular focus on filling the gaps in the United States HIV continuum of care (or treatment cascade). This document represents the outcomes from that meeting, attended by representatives from government, academia, and health care systems, along with community-based advocates and service providers.

TRAINING MANUAL FOR TREATMENT ADVOCATES: Hepatitis C Virus and Coinfection with HIV
November 2013 – The information here is written by and for people who are not medical specialists. We are treatment activists who learned about hepatitis C because it was a problem for people in our communities. We designed it to help you understand basic information about hepatitis C and coinfection with HIV: how it is transmitted, how to prevent hepatitis C, how a person can find out if he or she has hepatitis C, what happens to both HIV-negative and HIV-positive people who have hepatitis C, information used for making treatment decisions, and treatment options.

2013 Report on Tuberculosis Research Funding Trends, 2005–2012
November 2013 – Over the last eight years, Treatment Action Group (TAG) has tracked annual spending on tuberculosis research and development (TB R&D) and compared investments in six areas of research with the corresponding annual funding targets called for by the Stop TB Partnership’s 2011–2015 Global Plan to Stop TB (2011–2015 Global Plan). For the first seven years, TAG observed slow and unsteady increases in funding signaling slow progress toward the new tools needed to end the global TB epidemic. This year, for the first time, TB R&D investors reported a drop in spending that threatens to undermine the tenuous gains made since 2005.

TAGline Fall 2013: The Domestic Issue

  • Rising to the Domestic Challenge
    The past decade has brought astonishing developments in HIV disease management...Yet the U.S. epidemic continues unabated. We are at a stalemate.
     
  • U.S. TB Control: From Confidence to Crisis
    Funding cuts and shifting budgetary priorities threaten tuberculosis gains
    The United States is losing ground in its fight against the tuberculosis (TB) epidemic within its own borders.
     
  • An Obligatory Overhaul to Address Domestic TB Drug Shortages
    Bold strategies are required to remedy frequent stock-outs and supply interruptions

    Drug shortages, especially of tuberculosis (TB) drugs, have become increasingly common in the United States.
     
  • A Commitment to the HIV Continuum of Care
    President Obama orders multiagency cooperation to achieve National HIV/AIDS Strategy goals, but without required funding commitment

    If the United States is to effectively move toward the 2015 goals outlined in the National HIV/AIDS Strategy (NHAS), tighter collaboration between various federal agencies will be required.
     
  • Engagement in Care: A Final Frontier of HIV Medicine
    Getting more HIV-positive people linked to and retained in care requires innovation and research

    Far too many people living with HIV aren’t accessing the care they need to benefit from the personal and public health benefits of antiretroviral therapy.
     
  • Toward a Plan to End AIDS in New York State
    A coalition of community groups push to end AIDS at the epicenter of the U.S. epidemic
    A series of discussions to reenvision the state’s HIV/AIDS response to encourage the government to develop a New York State plan to end AIDS have begun.
     
  • HIV Prevention Is the Surest Way to Fight AIDS
    ACT UP/NY demands Department of Health accountability at the epicenter of the U.S. epidemic and commits to reinvigorate the national prevention agenda
    New York’s Mayor Michael Bloomberg has put his personal stamp on campaigns against guns, cigarettes, and big soft drinks. But HIV prevention has been neglected for years.
     
  • TAG’s Commitment to HIV Prevention
    Though the number of new HIV infections in the United States is down from its peak in the 1980s, incidence has refused to budge below its decade-long average.
     
  • Emerging Regulatory Issues in HIV Cure Research
    The science of discovery comes with ethical challenges in human clinical trials

    To prove their worth, potential curative strategies—whether based on a single approach or a combination—will need to be evaluated in human trials.


amfAR/TAG Issue Brief: The Cost of Flat Funding for Biomedical Research
August 12, 2013 – “The Costs of Flat Funding for Biomedical Research,” prepared by the Foundation for AIDS Research (amfAR) in collaboration with TAG, examines the declining purchasing value of public funding for health research at the National Institutes of Health (NIH) and the impact this has on public health, scientific progress, US productivity, and US science leadership.

The Immune System, HIV, and Aging
June 3, 2013 – Little more than a decade ago, it was almost inconceivable that the issue of aging with HIV infection would emerge as an important concern. But it has now become clear that combination antiretroviral therapy (ART) can suppress virus replication for many years—likely for life—in most people who can access the drugs, and the opportunistic infections that were once the primary causes of illness have largely evanesced everywhere treatment is available. Morbidity and mortality from HIV infection has plummeted, and the survival of HIV-positive individuals is edging ever closer to that of comparable HIV-negative people. With the specter of AIDS having finally been chased from the near horizon, attention has turned to health problems that may lie further down the road.

Pipeline Report
June 30, 2013 – HIV, Hepatitis C Virus (HCV), and Tuberculosis (TB) Drugs, Diagnostics, Vaccines, and Preventive Technologies in Development

June 3, 2013 – Research and treatment advocacy in 2012 for better prevention and treatment for people living with HIV and its two most common coinfections, hepatitis C virus (HCV) and tuberculosis (TB).

Revitalizing the U.S. National HIV/AIDS Strategy
Meeting Report and Action Plan
April 15, 2013 – On December 11–12, 2012, in Washington, D.C., Treatment Action Group (TAG) hosted a meeting of HIV advocates, service providers, and researchers from across the United States (U.S.) to review the current state of the national HIV response and discuss how to revitalize the National HIV/AIDS Strategy (NHAS). Meeting participants reviewed the latest data, discussed the changing landscape of the HIV response, and developed recommendations for continued and expedited progress. The Meeting Report summarizes the presentations and discussions, and outlines the key recommendations from participants. The Action Plan incorporates the recommendations from the meeting report.
 
  • 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 access
    Sanofi-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.

Hepatitis C and the IL28B Gene
April 2013 – This fact sheet describes how the genetic factor IL28B affects responses to hepatitis C treatment, including poorer efficacy among African Americans and people of African ancestry. Available in English and Spanish.

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.

Funding Scientific Innovation: Global Investments in HIV Treatment Research and Development in 2010 and 2011
March 6, 2013 – Advances in HIV treatment research in 2010 and 2011 saw improvement in treatment regimens and strategies, and reinvigorated optimism for finding a cure. In 2012, TAG and AVAC, with financial support from UNAIDS, put forth a collaborative effort to analyze investment trends in HIV treatment research and development (R&D) in 2010 and 2011.

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.