Fleurs et Vin 2012
Dayton's Premier Wine and Gourmet Food Festival returns May 20, 2012! Read more
Our Stories
From time to time, clients, volunteers and friends share stories of how ARC Ohio has impacted their lives. Read more
Know Your Status!
Learn your HIV status by getting a free HIV test! Read more
FDA Committee Recommends Truvada as PrEP
The U.S. Food and Drug Administration (FDA) convened a hearing May 10, 2012 to review a supplemental new drug application for once-daily Truvada® to reduce the risk of HIV-1 infection among uninfected adults by pre-exposure prophylaxis (PrEP).
Through a series of votes, the FDA advisory panel recommended approval of the daily pill Truvada® for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-infected partner. Last week’s Advisory Committee recommendation is not binding. The FDA will take the recommendation into account as it makes its decision whether to approve Truvada® for prevention, a decision that is expected on or before June 15. If the FDA does follow the committee’s recommendation, PrEP will be the first new, non-surgical biomedical prevention tool against sexual transmission in nearly twenty years.
ARC Ohio believes that Biomedical prevention interventions such as PrEP have immense potential, especially if offered as part of a comprehensive HIV-prevention package including risk reduction counseling and coupled with traditional prevention approaches such as condom use, expanded testing, and linkage to treatment and care to ensure that any positive outcomes from PrEP or other innovative interventions are not erased by changes in risk behaviors.
PrEP is not meant to be the silver bullet in addressing the epidemic for all those at risk, but rather used in a targeted way for specific populations and in relatively short periods of time. The pill would be aimed at an estimated 415,000 Americans who are among those at high risk for contracting HIV, the Human Immunodeficiency Virus that leads to AIDS, from sexual activity, according to the Atlanta-based Centers for Disease Control and Prevention. These include people whose spouses or partners have the disease, as well as gay men who had more than two partners in the past year and didn’t wear condoms during sex.
ARC Ohio recognizes that it will be important to think beyond who will provide the tablet, to who’s going to provide the education and set of comprehensive wrap-around services necessary to effectively translate the intervention from clinical research into real-world public health practice.
For more information about PrEP visit www.prepwatch.org & www.avac.org/prep
RED Table Design Gala Raises Record $500,000
On Saturday, April 28th, more than 375 guests joined us at Ooh La Rouge, AIDS Resource Center Ohio’s 2012 RED Table Design Gala. A fabulous feast for the eyes was created by volunteer designers, as well as an incredible auction display of art, trinkets and treasures was on display. Perhaps most astounding was how the community came together to support ARC Ohio and raise funds for the critical need for continuous education and advocacy in our community.
Under the leadership of event chair Sue Spiegel, we raised a record-breaking $500,510 that will continue to support crucial programs for those infected, affected or at risk for HIV infection right here in the Miami Valley. These funds will help us continue to:
Reach thousands of individuals with scientifically-based prevention, testing, case management, care and support;
Empower clients to make healthy and positive decisions for their lives every day;
Dream of a World without HIV by tirelessly and relentlessly advocating on behalf of the HIV community.
It was a tremendous night for ARC Ohio, showing that the people in the Greater Dayton region and beyond truly care about the strength of our community.
To view photo's of the event, click here
U.S. FDA Grants Priority Review for Truvada® for
Reducing the Risk of Acquiring HIV Infection
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Gilead Sciences, Inc. announced this week that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada® for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States.
Last month, Los Angeles-based AIDS Healthcare Foundation began a campaign against the FDA to halt its review of the drug Truvada as a PrEP. PrEP is one additional tool being researched to prevent HIV transmission.
Many HIV leaders think that halting the FDA review is the wrong approach. Therefore, ARC Ohio was among agencies nationwide submitting a letter asking the FDA to expedite the review of the PrEP research. By granting priority review, we will know whether or not we have one more tool in our comprehensive prevention arsenal, including condoms, risk reduction education, and ARVs. Other initial signers of our letter included AIDS United, amfAR (The Foundation for AIDS Research), AIDS Foundation Chicago, Black AIDS Institute, Global Advocacy for HIV Prevention (AVAC), The Association of Clinical Trial Services, HIV Prevention Justice Alliance, National Minority AIDS Council, Project Inform, and San Francisco AIDS Foundation. The full letter and list of signers can be viewed at: http://www.avac.org/ht/a/GetDocumentAction/i/41807
The FDA grants priority review status to drug candidates that provide major advances in treatment or provide a treatment where no adequate therapy exists. Gilead submitted the Truvada for PrEP sNDA on December 15, 2011. The FDA has set a target review date for Truvada for PrEP under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012. The agency has also indicated that Truvada for PrEP will be discussed at the FDA Antiviral Drugs Advisory Committee meeting scheduled in May.
If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV. The sNDA is based on the results of two large placebo-controlled trials of Truvada as PrEP sponsored by the U.S. National Institutes of Health and the University of Washington. Several other clinical studies support the use of Truvada for HIV risk reduction. Click here for the official Gilead Press Release |
