Tag Archives: AIDS

FDA panel approves FTC-TDF for HIV prevention

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Last night, the U.S. Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee recommended that emtricitabine/tenofovir disoproxil fumarate (FTC-TDF, marketed by Gilead Pharmaceuticals as Truvada) be indicated for use in preventing HIV, in what is known as pre-exposure prophylaxis (PrEP). The advisory committee’s recommendations will now be considered by the FDA, which is expected to issue a final decision on the matter by June 15, 2012.  The FDA usually accepts the advice of its advisory panels.

Kenneth H. Mayer, MD, Medical Research Director and Co-Chair of The Fenway Institute (Photo credit: Marilyn Humphries)

Fenway Health issued a statement commending the FDA panel’s decsion and Dr. Kenneth H. Mayer, Fenway’s Medical Research Director and Co-Chair of The Fenway Institute, was quoted in a Reuters story that was picked up by a number of major news outlets.

“Today is an exiciting day for HIV prevention. Although FTC-TDF for PrEP is not a panacea, this approach can prevent many new infections and could dramatically impact HIV transmission worldwide,” said Dr. Mayer.  “We at Fenway Health are gratified to have been involved with this field of research for several decades and are delighted to have helped to demonstrate the utility of this approach for prevention.”

You can read the full Fenway Health statement here. 

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FDA to review PrEP application today

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Today, the U.S. Food and Drug Administration (FDA) is reviewing a supplemental new drug application for emtricitabine/tenofovir disoproxil fumarate (FTC-TDF) to reduce the risk of acquiring HIV in men and women by pre-exposure prophylaxis (PrEP), offered as part of a comprehensive HIV-prevention package including risk reduction counseling.

FTC-TDF pills

FTC-TDF is an anti-HIV medication being reviewed by the FDA for use in preventing HIV infection.

PrEP has the potential to be a game-changer in the effort to curb HIV infection worldwide.  Fenway Health called on the FDA to approve PrEP use in at-risk populations in written comments filed on April 26.

“We believe that if the FDA looks closely at the science, it will see the merit of allowing PrEP to be added to our tool kit to prevent HIV infections,” said Kenneth Mayer, M.D., Medical Research Director and Co-Chair of The Fenway Institute at Fenway Health and a leading researcher in the field of biomedical HIV prevention. “We must deploy new tools to prevent new infections, which are affecting 50,000 Americans each year and more than 2 million people worldwide, most in Africa,” Mayer continued. “PrEP combined with sustained behavioral interventions and medical care to maintain adherence could help us finally begin to turn the tide with this virus.”

Earlier this year, The Fenway Institute issued a Policy Focus summarizing the state of PrEP and microbicides research as of January 2012, looking at willingness to use PrEP among various populations, addressing concerns about PrEP that could present obstacles to implementation, offering strategies for effective implementation, and examining policy issues related to cost and how to make PrEP accessible to those most vulnerable to HIV.

“PrEP has the potential to dramatically reduce HIV incidence among gay men, heterosexual women and men, and other populations,” said Sean Cahill, Director of Health Policy Research at The Fenway Institute and author of the report. “We look forward to action by the U.S. Food and Drug Administration and the World Health Organization this year to make PrEP available to those most vulnerable to HIV. PrEP could prove an invaluable new tool in the fight against HIV.”

Cahill has also authored a couple of op-ed pieces arguing for the approval of PrEP as an HIV prevention tool, first on March 26 on The Boston Globe’s Podium online opinion blog and then yesterday, May 9, on The Huffington Post.

We’ll be closely watching today’s hearing and will keep you posted about the FDA’s decision. 

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Educate Yourself to Protect Yourself: April is STD Awareness Month

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In honor of STD awareness month, here is a 1960s Ad Council public service announcement about venereal disease (The “V.D.” that cheerful voice is singing about):




Although how we understand and discuss sexually transmitted diseases (STDs) has changed a lot 40+ years since this PSA was produced, it is important as ever that we stay educated and empowered about our sexual health.

Each year, there are an estimated 19 million new sexually transmitted infections (STIs) in the United States. 

  • Young people are especially impacted. Even though youth age 15–24 make up only 25% of sexually active Americans, they acquire nearly half of all new STDs.
  • In 2008, men who have sex with men (MSM) accounted for 63% of primary and secondary syphilis cases in the United States.
  • People living with HIV experience more negative impacts of sexually transmitted infections, such as increased risk of neurosyphilis, HPV-related anal cancer in HIV-Positive MSM, and Pelvic Inflammatory disease in HIV-positive women.
  • Women had 2.7 times the reported chlamydia rate of men in 2009.
  • Transgender people experience HIV infection at up to four times the national level.

Here are five things we can all do to protect our sexual health:

  1. Stay Informed
    Most STDs are easily cured if they are caught early but often go untreated because people don’t recognize their symptoms as possible signs of a sexually transmitted infection. If you notice any changes in your health, don’t write it off! Ask your health care provider.
  2. Play Safe(r)
    Safer sex practices can help protect you from getting a sexually transmitted infection.  And safer sex isn’t limited to using condoms! There are other options you can explore to reduce your risk of catching an STD. Talk to your provider about your sexual practices and how you can cut your risk.
  3. Get Tested
    Some people don’t know they have an STD because they have no symptoms or have confused the symptoms for something else—a UTI, “jock itch,” etc. Make routine HIV/STD screening a part of your medical care. If you’re in the Boston area and want to know more about HIV/STD testing services, you can call Fenway’s referral line at 617.267.0159. For other areas, check National HIV and STD Testing Resources.
  4. Stop Playing the Shame Game
    STDs are a common occurrence with an uncommon level of stigma attached to them. Many people avoid getting tested because they are embarrassed—by their symptoms or because they fear judgment from others for getting tested. But getting tested is an important way to keep yourself and your sexual partners healthy—it’s nothing to be ashamed of!
  5. Start a Conversation
    Communication is one of the best tools we have to prevent the spread of sexually transmitted diseases.
    • Sexual partners can protect each other by disclosing their most recent test results or navigating safer sex practices.
    • Patients should feel able to openly discuss their sex lives with health care providers and counsellors, who can discuss risk reduction strategies and recommend testing when appropriate.
    • We can all encourage others to make healthier decisions by spreading information and awareness about STDs and testing.

To learn more about HIV and STD testing and counseling services at Fenway Health’s 1340 Boylston Street location, Fenway: South End, or Fenway: Sixteen, call 617.265.0159 or make a medical appointment at 617.927.6000. Young people ages 12–29 can access these services at the Sidney Borum, Jr. Health Center by calling 617.457.8140. 

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