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Publications 2008

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Accelerated Approval and Post-marketing Commitments: A Delicate Balance
December 2008 - AIDS activists have focused on HIV drug development for more than two decades. In 1992, in part due to pressure from AIDS activists and pharmaceutical deregulators, FDA instituted Accelerated Approval regulations, allowing earlier approval of drugs for serious, or life-threatening diseases, based on unmet need and a surrogate endpoint. Clinical benefit and questions about optimal use are determined in subsequent trials, known as post-marketing commitments (PMCs).

From Rhetoric to Action: Making TB/HIV Collaboration Effective
TB/HIV Programs: Working together to achieve Universal Access to HIV and TB Prevention, Care, and Treatment
Report and presentations from the TB/HIV Satellite organized by the STOP TB Partnership (STBP), AIDES and Treatment Action Group (TAG) prior to the 39th Union World Conference on Lung Health held in Paris on October 14, 2008. The session brought together national TB and AIDS control program personnel, researchers, policy makers, funding agencies, and TB/HIV community advocates. Discussions at the Satellite session centered on the challenges faced and lessons learnt by the TB and HIV programs and their partners as they worked together to implement TB/HIV collaborative services.

TB/HIV Community Activism, 2008
Symposium on Activist Generated Solutions, International Union against TB and Lung Disease (IUATLD) 2008
Treatment Action Group, International Community of Women Living with HIV (ICW) - East Africa, Open Society Institute and the Stop TB Partnership are a few of the organisations that are supporting the integration of TB into community-based activism that has been focused on HIV through funding and capacity building. This panel will provide examples of different strategies of TB-HIV activist engagement in policy, research, monitoring and programme implementation to strengthen TB and TB-HIV programmes efforts and the impact that the strategies have had on these efforts.  Speakers presented perspectives on the strategies and their impact and the lessons learnt.

National AIDS Programme & National TB Programme
Notes and Presentations from the Special Session from the International Union against TB and Lung Disease (IUATLD), 2008

TB/HIV Monitoring & Advocacy: Experiences & Leadership by AIDS Activists
2008 - The Open Society Institute’s Public Health Watch (PHW) and Treatment Action Group (TAG) began working together through a common desire to enhance the capacity of community-based AIDS organizations to address the growing burden of TB/HIV coinfection in their communities. PHW brought experience in monitoring and advocacy and a mission of promoting the participation of civil society in the development of government policies that impact the lives of affected communities. TAG brought close partnerships with AIDS organizations and experience in providing advocacy skills training, treatment, policy and research literacy to community-based groups.

TAG-ICW TB/HIV Advocacy Project: Battling the Dual Epidemic through Community Action
TB/HIV: What Every HIV/AIDS Activist Should Know
August 2008 - I have always wanted to make a difference. My activism took root in my home province, Nyanza. My activism has always been focused on alleviating the burden of poverty and promoting health. I have always had an intense inner feeling that something needed to change; in fact, I was probably born an activist!

2008 Pipeline Report
HIV, Tuberculosis, Hepatitis B, and Hepatitis C: Drugs, Diagnostics, Vaccines, and Microbicides in Development
July 2008 - Treatment Action Group’s annual pipeline report is a review of medical technologies that stand a good chance of benefiting people with HIV within the next few years. It also covers those that may take longer to develop but represent innovation within the field.

TB  R & D Report 2005 - 2006 - Second Edition
A Critical Analysis of Funding Trends, 2005–2006: An Update

July 2008 - The report finds that while funding for TB research increased from 2005 it fell far short of the need. The report also finds that although funding from philanthropic sources rapidly increased from 2005 to 2006, public sector spending did not keep up; the proportion of total investment derived from public sources actually declined in 2006.

TAG's Response to NIAID 'Request for Information' on Priorities in Basic HIV Vaccine Research
June 4, 2008 - It is of great concern to TAG that many of our recommendations echo many of those made by TAG eight years ago, which in turn echoed those of the Levine Report almost four years prior to that. Given this observation, we hope that NIAID can understand why we greet this undoubtedly well-intentioned RFI with a certain amount of skepticism and cynicism.

PAVE Gives Pause: Position Statement on the Proposed PAVE100A Vaccine Trial
May 30, 2008 - The failure of Merck's adenovirus serotype 5 (Ad5)-based HIV vaccine to protect against infection or reduce post-infection viral load, combined with the evidence of potentially enhanced susceptibility to HIV acquisition among a subset of trial participants, has inevitably cast a cloud across the Ad5 candidate slated for use in the proposed PAVE100A Phase IIb efficacy trial. TAG recognizes and appreciates the work and commitment of researchers at NIH's Vaccine Research Center (VRC) who have developed the DNA and Ad5 HIV vaccine constructs, and their colleagues involved in PAVE100 who have collaborated in an effort to redesign the trial to ensure safety in the light of the data that emerged from the Merck vaccine trial (STEP/HVTN 502, hereafter referred to as STEP).

Hepatitis C: New Treatments in the Pipeline
April 2008 - Hepatitis C virus (HCV) is a serious global health problem. According to the World Health Organization (WHO), which describes HCV as a “viral time bomb,” 130 million people have chronic hepatitis C, and 3 to 4 million more become infected each year. If untreated, or unresponsive to treatment, chronic HCV leads to cirrhosis in 20–30% of people. Each year, ~4% of people with hepatitis C-associated cirrhosis develop liver cancer, and ~6% will experience liver failure. WHO estimates that up to 75% of liver cancer and ~65% of liver transplants occurring in the developed world are attributable to chronic HCV infection.