Tesamorelin Gets FDA Advisory Committee’s Unanimous Vote
Use of Lubricants with Anal Sex Could Increase Risk of HIV
Ford Foundation Grants $25 Million to Fight HIV in High-risk Populations
Visual AIDS Uses Art to Promote Men’s Health
Tesamorelin Gets FDA Advisory Committee’s Unanimous Vote
On May 27, Theratechnologies announced that the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee recommended by a 16 to 0 vote that tesamorelin, a growth hormone releasing factor, should be granted marketing approval by the FDA based on a favorable benefit-risk profile for the treatment of excess abdominal fat in HIV-positive patients with lipodystrophy.
Although advisory committees provide their recommendations to the Agency, the final decisions on marketing approvals are made by the FDA. The FDA has indicated that the target date for the FDA to complete its review of the tesamorelin New Drug Application will be July 27, 2010.
Mr. Yves Rosconi, President and Chief Executive Officer of Theratechnologies said, "The Advisory Committee recommendation is another important step forward for the company. It is especially significant for those patients who suffer from this serious metabolic complication, where today no treatment option exists."
Positively Aware editor Jeff Berry was one of three public speakers testifying to the committee on the importance this drug could play in the lives of people living with HIV.
Use of Lubricants with Anal Sex Could Increase Risk of HIV
As reported in ScienceDaily on May 25, “The risk of acquiring HIV through unprotected anal sex is at least 20 times greater than with unprotected vaginal sex and increases if other infections are already present in the rectal lining.” Now researchers are questioning whether or not the use of lubricants could be another risk factor among men and women who engage in receptive anal intercourse. Two studies presented at the International Microbicides Conference in Pittsburgh suggest the answer is yes.
According to the report, “In one study involving nearly 900 men and women in Baltimore and Los Angeles, the researchers found that those who used lubricants were three times more likely to have rectal sexually transmitted infections (STIs). Another study that subjected popular over-the-counter and mail-order lubricants to rigorous laboratory tests discovered that many of the products were toxic to cells and rectal tissue in rats. If in humans these products have the same effect, the cells might be rendered more vulnerable targets for HIV infection than they already are.”
Microbicides could potentially help prevent the rectal transmission of HIV, and some are being tested in early Phase 1 safety studies. Another approach called oral pre-exposure prophylaxis (PrEP) involves the use of antiretroviral drugs to reduce the risk of HIV in HIV-negative people.
Ford Foundation Grants $25 Million to Fight HIV in High-risk Populations
On June 2, the Ford Foundation announced a $25 million effort to “fight the disproportionate, yet largely hidden, impact of HIV/AIDS on marginalized communities in the United States.”
The initiative will target the District of Columbia and nine states in the South that rank among the highest in new AIDS cases. It will also support efforts to address the spread of HIV among African Americans, Latinos, and women. The effort will build upon investments made by Ford over the past several years to address the impact of HIV in these communities.
“This crisis is affecting the places and people that, as a country, we too easily ignore,” said Luis A. Ubiñas, president of the Ford Foundation. “This initiative aims not only to help stop the spread of HIV, but also to address the stigma and discrimination that allowed the epidemic to grow in these communities in the first place.”
Ford’s grants—at least $5 million a year for the next five years—will support organizations working to build strong coalitions of leaders among the affected communities who will then educate policymakers and the public about the impact of HIV in their neighborhoods; expand advocacy and litigation efforts to ensure a more effective response to HIV/AIDS; and fight the stigma and discrimination that contributes to the spread of the disease.
Ford’s announcement came on the same day that the White House held a conference on black men and HIV, bringing together grassroots and national organizations from across the country to develop strategies for decreasing the spread of HIV in the black community.
Visual AIDS Uses Art to Promote Men’s Health
According to their mission statement, “Visual AIDS utilizes art to fight AIDS by provoking dialogue, supporting HIV-positive artists, and preserving a legacy, because AIDS is not over.”
During June, Gay Pride month, Visual AIDS will be distributing free “Cover the Stump” tote bags designed by Steve DeFrank and Play Smart trading cards picturing Aaron Cobbett, inkedKenny, Greg Mitchell, and Slava Mogutin throughout the city of New York.
As stated on their web site, “Play Smart is an honest and straight-forward approach to promote harm reduction, HIV testing and post-exposure prophylaxis. Trading cards are packaged with a sticker, condoms and lube. The back of each trading card features information you need to know to Get Your Game On & Play Smart.”
To see the bag and the cards and learn more about Visual AIDS, go to: www.thebody.com/visualaids/current/broadsides2010.html.