Reports from the Front
Focus on Hepatitis C
In 2011, HCV research has advanced by decades in a matter of months; in addition to the approval of two new direct-acting antivirals, there are more than 50 ongoing clinical trials looking at both new drugs and treatment strategies. Companies are collaborating on studies of their drugs, and interferon-free treatment is quickly becoming a reality. In the words of one researcher, it is “HIV drug development on crack.”
TAG’s Hepatitis/HIV Project has been front and center, working with regulators, the pharmaceutical industry, other activists and community members, researchers, clinicians, and service providers on these exciting new developments. Tracy Swan, our Hepatitis/HIV Project director, spoke at the Food and Drug Administration’s new drug application hearing, where she advocated for trials to address underrepresentation of populations with high hepatitis C rates, and stressed the urgent need for treatment and for studies on interactions between new medications and commonly used drugs.
Liver disease from HCV is now a leading killer among HIV-positive people. But new HCV drug trials in people coinfected with HIV have had to wait until the drugs are first approved for people with HCV alone. As a cofounder of the Hepatitis C Community Advisory Board (HCAB), an international activist group, TAG met with six pharmaceutical companies to discuss early access and clinical trials for people who are coinfected. This year, for the first time, a 300-person, phase III trial has opened exclusively for people with HIV and hepatitis C, and interim results from smaller trials in coinfected people are available.
TAG also co-organized Sitges IV, the fourth multi-stakeholder meeting with the European AIDS Treatment Group, guiding drug makers, regulators, and researchers on how best to provide early access to experimental HCV drugs for people who are not eligible for clinical trials.
The Hepatitis/HIV Project continued to draw from the successes in HIV, and worked closely with allies to broaden access to, and improve the quality of, hepatitis C care and treatment, domestically and globally. The Project brought the latest information to the community through publications, workshops, and presentations, including a stand-alone report on HCV Drug Development, released A Guide to Clinical Trials for People with HCV, conducted a two-day workshop in San Francisco, training counselor/ testers working in California’s correctional facilities, and presented at support groups, community forums, and public think-tank meetings.
Michael Palm Basic Science, Vaccines & Prevention (BSVP) Project
In addition to organizing the HIV Cure-Related Clinical Research Workshop in April, TAG’s BSVP Project and other sponsoring organizations sent a follow-up memorandum to the U.S. Food and Drug Administration and the NIH’s Office of AIDS Research (OAR) addressing cure-related regulatory and clinical research issues. The BSVP also supported and helped organize a smaller informal meeting on the same subject involving around 20 researchers and community advocates, which took place at the Conference on Retroviruses and Opportunistic Infections in Boston in March. BSVP created and maintained a cure-related research resource page on the TAG website featuring articles from the community and the popular and academic presses, and links to open clinical trials.
On the emerging issue of HIV and aging, BSVP worked with the TAG-initiated Coalition for HIV and Aging Research and Policy Advocacy (CHARPA) to recommend the creation of a working group at OAR. The group was created in early 2011, met several times during the year, and submitted research recommendations to OAR. BSVP also developed a report on the immunology of aging and HIV infection that will be published shortly. BSVP contributed a chapter on biomedical prevention, immune-based therapy, and cure-related research to the annual TAG pipeline report, which was distributed at the International AIDS Society conference in Rome in July. BSVP coordinator Richard Jefferys continued to maintain the program’s twitter feed, blog, and a web-based resource on clinical trials for individuals with poor immunologic responses to antiretroviral therapy.
The TB/HIV Project’s third grant from the Bill and Melinda Gates Foundation began in January of 2011; it supports TAG’s efforts to strengthen the voices of activists working on global TB/HIV policy and research advocacy.
TAG organized the first advocacy workshop in July with TB activists serving on the board of the Global Fund, UNITAID, WHO’s Strategic and Technical Advisory Group for TB, and the Stop TB Partnership. As the result of this workshop, for the first time, there will be a TB presession prior to the next Global Fund board meeting.
To ensure that global policy supports ambitious scale-up, TAG provided extensive input to the update of the WHO’s TB/HIV Collaborative Policy that will be launched in early 2012.
In November, TAG organized the first Global TB Community Advisory Board (CAB). The group was formed to meet with TB drug, diagnostics, and vaccine developers in order to provide a much needed patient-activist perspective. Critical issues of expanded access, compassionate use, the need to study drugs in combination, and the urgency of developing formulations appropriate for children were discussed. The issue of pediatric TB will also be a focus of TAG’s federal advocacy meeting in December.
U.S. and Global Policy Project
Based in Washington, D.C., TAG’s Policy Project has been advocating for increased AIDS funding for research and treatment despite the challenging fiscal and political environment. With uncertainty over the future of health care reform and Ryan White programs, a growing ADAP waiting-lists crisis, state and federal funding cutbacks, and the derailed National HIV/AIDS Strategy implementation, TAG’s senior policy associate Coco Jervis continues to work on behalf of the needs of the HIV community, including getting people into care and reducing new infections.
As the Research Working Group cochair of the Federal AIDS Policy Partnership, Coco organized monthly strategic planning calls to fight for the NIH’s AIDS research funding portfolio. She also submitted congressional testimony in support of greater NIH funding. In collaboration with amfAR, TAG updated our well-received AIDS research funding policy brief, AIDS Research: Broad Health & Economic Benefits, which has since been distributed to hundreds of congressional offices and Obama administration staffers.
Coco has also been taking a leadership role in HIV/TB appropriations advocacy, promoting better integration of TB/HIV services, addressing the multidrug-resistant TB treatment shortage in the U.S., and working toward building a greater global childhood TB advocacy community.