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Research Toward a Cure
April 11, 2014 – A listing of clinical trials and observational studies related to the research effort to cure HIV infection.

TAGline Spring 2014: The April Fools' Issue

  • Fool Us Once…
    By Tim Horn
    We’re being duped by our government agencies. We’re being hoodwinked by the Affordable Care Act (ACA). We’re being bamboozled by pharmaceutical companies and research networks. In this April Fools’ issue of TAGline, we highlight several missteps in research and policy that have required some degree of advocacy to remedy and ensure that the jokes don’t remain on us.
     
  • Forgotten Negatives: The Limits of Treatment as Prevention
    The CDC’s High-Impact Prevention strategy takes aim at the stubborn HIV incidence rate in the United States. The only problem: it doesn’t include an ambitious plan for those at risk for the virus
    By Jeremiah Johnson
     
  • The White House’s Fuzzy Math
    An Office of National AIDS Policy progress report obscures the state of the domestic U.S. HIV/AIDS response

    By Mark Harrington
     
  • Marketplace Menaces: Discriminatory Practices by the ACA’s Qualified Health Plans
    Advocates scramble to stay ahead of coverage rejections, formulary concerns, and exorbitant out-of-pocket expenses facing people living with HIV

    By Kenyon Farrow
     
  • Better Late Than Never: Efavirenz Dose Optimization
    After a study suggests that we’ve been using too high a dose of efavirenz for a decade and a half, the move toward scaling up a lower and more cost-effective one faces some hurdles

    By Tim Horn and Polly Clayden
     
  • 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?

    By Lindsay McKenna
     
  • 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

    By Mike Frick


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.

Pharma Refuses to Ensure Access to Lifesaving Hepatitis C Treatment at Global Meeting
February 28, 2014, Bangkok, Thailand – Thirty-eight activists from 22 countries joined forces at the first-ever Hepatitis C Virus (HCV) World Community Advisory Board (CAB) to demand equitable access to treatment for hepatitis C virus (HCV) from six multinational pharmaceutical companies. Yet AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck, and Roche refused to provide a plan for equitable access to treatment for HCV, a curable infection that kills over 350,000 people each year.

Letter to Governor Cuomo on Ending AIDS in New York State
February 18, 2014, New York, New York – We write to follow-up on our January 14, 2014 letter regarding the development of a plan to end AIDS in New York State. In addition to creating a Task Force to End AIDS in New York to promptly develop a strategic blueprint and plan in collaboration with the community and the DOH AIDS Institute, we urge you to include the following items in your 30-day amendments to the 2014-2015 Executive Budget:

  • $10 million in new funding for the AIDS Institute to implement the plan developed by the above noted task force;
  • Article 7 language to eliminate the use of condoms as evidence of prostitution by police and prosecutors; and
  • Article 7 language to legalize the possession of syringes.

Treatment Action Group Remembers Marvin Shulman

Treatment Action Group mourns the death of TAG’s founding treasurer Marvin Shulman (May 17, 1932–January 15, 2014), who died Wednesday in Miami Beach, Florida. A beloved, compassionate, generous, and tireless AIDS activist, Marvin Shulman first joined the AIDS Coalition to Unleash Power (ACT UP)/New York at the time of its Wall Street II action on March 28, 1988, where he was arrested as a member of the ACT UP affinity group known as Wave 3. Marvin quickly became an active member of ACT UP/NY’s leadership, serving as ACT UP’s treasurer for several years.

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

In this issue:


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 Remembers Nelson Mandela
December 8, 2013 – Treatment Action Group salutes the achievements, life, legacy, and memory of Nelson R. Mandela, freedom fighter, prisoner at Robben Island, president of the African National Congress (ANC), from 1994 to 1999 South Africa’s first freely-elected President, and the man whose plea to his colleagues led to the establishment of South Africa’s public-sector HIV treatment program, now the world’s largest.

TAG Applauds $12 Billion Replenishment of Global Fund to Fight AIDS, Tuberculosis and Malaria, and Calls for Greater Flexibility to Support Middle-Income Countries Coping with Large HIV or TB Epidemics
December 3, 2013, 
New York, New York – Treatment Action Group applauds the donors who have helped make it possible to save more lives by raising a record-breaking $12 billion for the Global Fund to Fight AIDS, Tuberculosis and Malaria over the next three years. TAG also commends the Obama administration for its generous match of one dollar for every two dollars contributed by other donors, which helped to drive up funding commitments in the current replenishment round.

167 Organizations and 513 Individuals Sign on to Letter to Secretary Sebelius on the Allowance of Co-pay Assistance in the ACA Health Plans
December 2, 2013 – We, the undersigned organizations and individuals, are writing to urge that the HHS issue clear guidance on the allowance of drug industry–provided co-payment, co-insurance, or other out-of-pocket discount cards and coupons in the Affordable Care Act’s (ACA) Health Insurance Marketplaces. As people living with, and organizations serving people with, HIV, HCV, and other life-threatening and chronic health conditions, we are alarmed by the possibility of the prohibition of these critical financial lifelines in the ACA, just as affordable health insurance for people with preexisting conditions is finally becoming a reality in the United States, thanks to the ACA.

amfAR and Treatment Action Group Call for a Strategic Research Agenda Needed to End HIV/AIDS in the United States
December 1, 2013, New York, New York – Today, on World AIDS Day, amfAR, The Foundation for AIDS Research, and Treatment Action Group (TAG) called for a deliberate and expedited research agenda designed to begin to end the AIDS epidemic in the United States. Both organizations noted that in order to achieve this goal, Congress must end sequestration and work to ensure the full implementation of the Affordable Care Act (ACA). AmfAR and TAG’s new report, Filling the Gaps in the U.S. HIV Treatment Cascade: Developing a Community-Driven Research Agenda, outlines several recommendations for the Obama administration.

Treatment Action Group Applauds European Approval of New Drug to Fight Tuberculosis, Demands Expanded Access and Affordable Pricing
 — Approval of and access to delamanid are crucial while further research is pending
November 22, 2013, 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.

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.

135 Organizations Send Letter Urging UNITAID to Prioritize HIV/HCV Coinfection
October 10, 2013 – We commend UNITAID for addressing viral hepatitis in its 2013–2016 Strategic Objectives. We are writing to underscore the need for a swift response from UNITAID to hepatitis C virus (HCV) coinfection; delays will cost lives and impede scale-up when more effective and tolerable therapies are available.

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.

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

WASHINGTON, D.C. | October 1, 2013 – 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.

ROADMAP FOR CHILDHOOD TB: TOWARDS ZERO DEATHS
The World Health Organization, the International Union Against Tuberculosis and Lung Disease, the Stop TB Partnership, and other partners will launch a roadmap outlining the path towards zero deaths from childhood tuberculosis.
Tuesday, October 1, 2013
11:00 a.m. Press Conference
2:00 p.m. Workshop
PATH, 455 Massachusetts Ave, NW, Suite 1000
Washington, D.C. 20001   
Please join us for the launch.

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.
 
August 6, 2013 – Community advocates plea to the U.S. government partners of CROI to help restore access to the conference website, a vital HIV research resource. 
 
August 5, 2013 – Reported Pharmaceutical Association Efforts to Enlist Opposition to the Initiative Are Decried
HIV/AIDS advocates and advocacy organizations today issue a call to patient groups worldwide to sign up to support the AllTrials initiative (www.alltrials.net). 
 
Treatment Action Group Criticizes European Refusal of New Drug to Fight Tuberculosis
July 29, 2013 – Approval of and access to delamanid is crucial while further research is pending
NEW YORK, NY, U.S.A. – 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). The drug, one of the first new compounds to fight tuberculosis (TB) in over 40 years, has demonstrated safety and clinical benefit against multidrug-resistant TB (MDR-TB) in clinical trials to date. The decision by the CHMP was based on the duration of treatment (two months) in the phase IIb randomized controlled trial (Trial 204). It considered that the trial was too short to establish the effectiveness of delamanid in treating TB when added to other anti-TB medicines. Without new treatment options such as delamanid, treatment for people who have the disease will remain intolerable, toxic, lengthy, and ineffective, and patients—of which the European Union and its neighboring countries have many—will continue to die.
 

Petition Drive: Demand Leadership from the World Health Organization to Defuse the Hepatitis C Viral Time Bomb
July 8, 2013 –  Globally, approximately 185 million people are infected with the hepatitis C virus (HCV). Each year, 3-4 million people are newly infected, and  350,000 people die from HCV-related complications. The World Health Organization (WHO) has called hepatitis C a "viral time bomb," yet have done little to significantly address this global health crisis.

Press Release: 2013 Pipeline Report Calls on Leaders to Get the Best HIV, Hepatitis C Virus (HCV), 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.

Preexposure Prophylaxis (PrEP) Trial among Thai Injection Drug Users Marred by Lack of Response to Community Concerns
June 26, 2013 – On June 12, results from an efficacy trial of tenofovir as pre-exposure prophylaxis (PrEP) against HIV infection in individuals with a self-reported history of injection drug use were published in the Lancet. The trial was sponsored by the U.S. Centers for Disease Control and Prevention (CDC) and took place in Bangkok, Thailand (named the Bangkok Tenofovir Study). The publication was accompanied by a flurry of press releases and drew considerable news coverage due to the documentation of a statistically significant reduction in risk of HIV acquisition of 48.9%.

Letter to Gilead – Tenofovir Alafenamide Fumarate (TAF) (Final with 293 signatories)
June 24, 2013 – With a phase II clinical trial of tenofovir alafenamide fumarate (TAF) yielding encouraging preliminary results and regulatory planning for TAF-inclusive fixed-dose combinations (FDCs) under way, we are compelled to reach out to you regarding the need for a stand-alone formulation of the drug.

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.

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).
 

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.

TAGline Spring 2013

  • 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.