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September 2006 NORA Bi-Monthly
Meeting Peg Willingham presented first. As she began her presentation entitled, “The Road to an AIDS Vaccine,” she stressed the importance of pairing treatment and prevention together as we fight the AIDS epidemic. She went on to explain that vaccines are an essential part of prevention. They are non-controversial prevention pieces in comparison to other methods. She said, “While finding a vaccine that is 100% effective, covers every transmission route, and would be easily accessible is ideal, it is a very difficult challenge. But is finding an HIV vaccine possible? Yes.” Ms. Willingham pointed out that Merck is currently the only pharmaceutical company actually investing shareholders’ dollars into research of an HIV vaccine. They are looking at a cell mediated vaccine, one which hopes to trigger the immune system to fight off infection. She said that Merck expects to release the data from this trial in 2008. IAVI and several other governments are continuing to research cell mediated vaccines as well as a traditional antibody vaccine. She feels that after the International AIDS Conference, political commitment to prevention and vaccine research is high. It is the hope of IAVI that the conference may stimulate more capital interest and investment into vaccine research. Currently the vast majority of investments in vaccines have come from the public sector, with little commercial support. She stated that funding is the critical issue. The nature and science of the HIV disease makes vaccine research extremely costly. She affirmed that there are currently 30 clinical vaccine trials taking place throughout the world, and only one has made it through Phase 3. While the vaccine did not prove effective, Ms. Willingham believes the trial itself proved to be a success. It showed that a clinical Phase 3 trial can take place in the developing world. She said, “IAVI has shown that these complicated scientific trials can take place in Africa and can have a skilled work force with world class facilities.” For more information on the work that IAVI does please visit www.iavi.org. Anna Forbes spoke next on Microbicides. She commented on how fitting it was to pair a conversation about microbicides and vaccines at the same NORA meeting. She believes they are two similar topics with new awareness and enthusiasm in the wake of Toronto. Ms. Forbes first shared some statistics. In Sub-Sahara Africa 77% of the 9 million HIV positive youth (ages 15-25) are women. In the United States 56% of all adolescent HIV infections reported are among girls. AIDS is the leading cause of death in African American women ages 24-34. She said, “In light of these statistics, women are in dire need of a prevention method they can control.” Ms. Forbes then gave an overview of products in the microbicide pipeline. There are currently 5 products in Phase 3 trials expecting to release their clinical data by 2008. The most promising is Carigard®, which may be available by 2010, but most likely not in the United States due to its 50-60% efficacy. Most of these first line products may have a contraceptive effect. There are currently 9 products in Phase 1 trials and 10-20 still being studied in the lab. The second and third generation microbicides in Phase 1 and 2 are products from anti-retrovirals which have the potential to have increased efficacy and decreased contraceptive capabilities. Ms. Forbes said that most of the funding for these trials is coming from small bio-technology companies, non-profits, and academic institutions. Big pharmaceutical companies have not invested in microbicides, and there is a serious lack of public funding for this research. She explained that microbicide trials are actually cheaper than the drug development process of many other medications; however they are far more difficult to conduct. She explained that because microbicide trials are prevention trials, they must prove a negative while enrolling very large numbers to do so. As of 2005, $140 million had been invested in microbicide research. She said, “An additional $106 million is needed for microbicide research to be adequately funded.” The Global Campaign for Microbicides promotes microbicide advocacy across organizations, demands the resources from Congress to make microbicides a reality, and encourages an increase in private investment for microbicide research. The Global Campaign for Microbicides is pushing passage of the Microbicide Development Act which could give increased money to NIH for microbicide research and require NIH to form a Microbicide Development branch to streamline the development research. This Act has been introduced in the last 6 Congresses without passage, but is gaining support each time. Please visit www.global-campaign.org/legislativeadvocacy.htm to find information you can use to urge your legislator to support the Microbicide Development Act. Lastly, Ms. Forbes spoke on the potential public health impact of microbicides. She shared the data analysis that if a microbicide that is only 60% effective was offered to 73 low income countries and used by 20% of the people in that country reached by the health care system during only 50% of their unprotected sexual acts, 2.5 million HIV infections could be averted over the next three years. This proves the enormous HIV prevention gap in the developing world. |
