I’m be in DC November 7-9 attending the FDA Clinical Investigator Course. It was the best meeting I attended last year and I’m excited to be included again this year. As I keep telling everyone… “The FDA is your FRIEND!”

APLA Treatment Education Training November 4, 2011 in RAncho Mirage at Eisenhower Medical Center. Speaking on “New Treatment Strategies in HIV”

Heading back home today from Seattle. Great trip up here. The weather was amazing yesterday. Its always sunny when I’m in Seattle. I think I bring a little of SoCal with me in my suitcase.

Had great meeting yesterday afternoon with Mari Kitahata who is an old friend of mine from residency. She has done amazing things and is the lead investigator for NA-ACCORD which is one of the largest and most valuable observational databases in the world. Her work there is one of the major reasons that the DHHS Panel changed the guidelines to recommend treatment for a broader group of HIV patients at higher t cell counts. It was great to see her. She looks amazing, has an incredible view from her office and, as I told her yesterday, everytime I see her, my heart sings.

Dinner meeting last night went very well. My great friends Peter Shallit and his partner Bob Clark are always so supportive and come to see me whenever I speak in Seattle. I am moved by their friendship and their passion for the amazing work they do here in Seattle with their patients. Hopefully, they will come to visit in LA or PS soon!!

Calling my flight, gotta go.

A clinical trial investigating the use of pre-exposure prophylaxis (PrEP) to prevent HIV infection among women has been canceled after early results suggested the approach would be ineffective, according to a statement issued by FHI, which implemented the study.

The findings are unexpected, to say the least. It was just a few months ago that a trial known as iPrEx gave us solid evidence to suggest that PrEP — the use of antiretrovirals by HIV-negative people to help prevent infection during high-risk sexual exposure — was successful in reducing the risk of HIV infection among men who have sex with men (MSM). In fact, iPrEx was so successful that the U.S. Centers for Disease Control and Prevention (CDC) quickly created interim guidelines to help health care professionals decide whether (and how) to prescribe PrEP to HIV-negative MSM.

In its own statement on the cancellation of the FHI study, the CDC wrote:

“These preliminary results are disappointing, especially given that this approach has already been shown to be effective in reducing HIV infection among men who have sex with men (MSM). The well-conducted study included nearly 2,000 women at high risk for HIV infection in three African nations and sought to determine if a once-daily pill containing oral tenofovir and emtricitabine (FTC/TDF or Truvada) could protect women from HIV infection. While PrEP with FTC/TDF was not shown to be effective in preliminary analyses of these study results, it cannot yet be definitely determined whether this drug combination works, or does not work, to prevent HIV among women.”

It’s uncertain where we go from here. Other ongoing PrEP research may support or refute these findings; only time will tell. And we can hope that a deeper analysis of the FHI study (known as FEM-PrEP) will provide a logical explanation as to why Truvada would be effective as a prevention tool for MSM but not for women. (Early theories include poor adherence to the HIV meds and the possibility that, for whatever reason, oral Truvada just doesn’t prevent sexual transmission of HIV vaginally as well as it prevents it anally.)

In the meantime, these findings are likely to make clinicians much more reluctant to prescribe Truvada to HIV-negative women at potentially high risk for HIV. Those who have been skeptical about the widespread use of PrEP will likely welcome this news; some feel the medical community has been too quick to embrace PrEP without fully accounting for its potential downsides. But you can’t help but mourn this potentially major setback for PrEP, which, just a couple of months ago, seemed like it might be a promising new tool for women who may not have the option of using condoms with their male sexual partner.

 

 

6th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011)

Oral Abstract Presentation- Maraviroc/atazanavir/ritonavir vs. tenofovir/emtricitabine/atazanavir/ritonavir in HIV treatment naive patients

Helios Salud International Symposium on HIV

The use of raltegravir in treatment naive and treatment experienced patients- Merck Global

ViralEd Dinner Program- Making Strategic Choices in Treating HIV

Gilead Canada- Role of Rilpivirine (TMC278) in treating HIV patients

Dinner Meeting- Tibotec

4th International HIV-Psychiatry Meeting- Neurologic and Psychiatric adverse events of rilpivirine vs. efavirenz in HIV treatment naive patients in Echo and Thrive

Lunch meeting – Tarzana Treatment Center

Dinner Meeting for medical professionals

Back in beautiful warm sunny California. Got back about 10pm last night. Great trip overall. Excellent meeting. Some great educational talks. Really amazing talk yesterday morning by Richard Wolitski. PhD from the CDC on HIV Prevention in the US .  We are still seeing 60,000 new infections in the US each year . There is a 32% increased rate of infection in gay men over the last 10 years. 32% INCREASED rate!  MSM (men who have sex with men) account for 53% of new HIV infections and 48% of people living with HIV. Heterosexual sex accounts for 31% of new infections and for 28% of people living with HIV.  African Americans and Latinos account for a disproportionate share of HIV infections relative to their overall presence in the population. He reviewed the National AIDS Strategy that the White House released in July last year and talked about the variety of ways that we might go about stemming the spread of the epidemic. To decrease the overall prevalence of HIV in the US we would have to get down to 16,000 new infections each year. A lofty goal considering that 60,000 number that seems unchanging. It was certainly motivating for me to work closer with my patients on HIV risk behaviors to try to decrease transmission risk.  The Canadian talk later in the day on Ending HIV in Canada by 2020 was interesting but focused more on political ideology and allocation of resources than on eradication. I was hoping to hear more on the scientific work going on behind eradication but that will have to wait for another day.

Here is a link to the CDC site for more complete updated info on HIV in the US:  http://www.cdc.gov/hiv/resources/factsheets/us.htm

I’m here in Toronto at the Canadian Conference on HIV/AIDS Research. If anyone thinks spring has come to Canada, think again. The wind is bitterly cold. Luckily everything is indoors. The meeting has been great. My poster presentation was well received. Great review yesterday of the state of the science for Hepatitis C management and the exciting future for Hep C treatments. I have another presentation today and then there is an exciting talk about ending HIV in Canada by 2020: Mission Possible? The meeting is smaller than most American meetings but its nice because its intimate and there is a great sense of collegiality amongst the attendees. And there are lots of young investigators here which bodes well for the future of HIV research. Home tonight to LA. Alvin Ailey tomorrow!!