CDC Responds To End Of African PrEP

The CDC writes us this morning to note their response to the early halting of an African HIV PrEP study, which I mentioned yesterday. Pre-exposure prophylaxis (PrEP) involves taking an HIV medication as a preventive to infection. The CDC expresses disappointment with the cessation of the African study, as "this approach has already been shown to be effective in reducing HIV infection among men who have sex with men."

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. FEM-PrEP study investigators will be conducting additional analyses in the coming months to better assess potential reasons for the results in this study – including examining factors such as adherence and differential risk behavior between the two trial arms -- that may account for the lack of demonstrated efficacy in this trial. Investigators from other PrEP trials, including CDC, will be working closely with FHI to review all available data and determine any implications for ongoing research. Given today's results, CDC cautions against women using PrEP for HIV prevention at this time. We will not know if PrEP is effective for women, couples, or injection drug users until the conclusive results of this and other trials are reported.

African HIV PrEP Study Halted

Citing poor early results, researchers have halted an African study in which women were given the HIV medication Truvada as a preventive to infection. Pre-exposure prophylaxis (PrEP) has been considered one of the more promising advances against AIDS.

Women taking Truvada, made by Gilead Sciences Inc., are just as likely to get HIV as other women who have been given dummy pills, an interim analysis of the study found. Even if the study were to continue, it would not be able to determine whether the pills help prevent infection, since the results are even this far along, researchers said. The finding is disappointing because another study last fall concluded that Truvada did help prevent infections in gay and bisexual men when given with condoms, counseling and other prevention services. Many AIDS experts view that as a breakthrough that might help slow the epidemic.

Last month the U.S.-based AIDS Healthcare Foundation denounced a similar study for gay men, saying, "There is no magic pill." Truvada costs as much as $14,000/year in the United States, but is available in generic form overseas for as little as $140/year.

AIDS Healthcare Foundation Denounces PrEP Study: There Is No Magic Pill

The AIDS Healthcare Foundation is denouncing the study of using existing HAART medications as a daily preventive for HIV infection. From their website, No Magic Pills:

AIDS Healthcare Foundation takes the matter of HIV prevention very seriously. We are concerned about the implications of a recent study of pre-exposure prophylaxis (PrEP) using Gilead Sciences, Inc.’s drug Truvada using 2,500 gay men and showing a 44% effectiveness rate in preventing HIV transmission. AHF supports continued research on HIV prevention, but opposes quick fixes that run the risk of contributing to the spread of HIV and drug-resistant viruses. Our community must consider these issues if we are going to offer up hundreds of thousands of gay men for this totally misguided experiment.

Jeff Berry, editor of Positively Aware, responds to a full-page ad published by AHF in this week's edition of the Windy City Times.

Of course there is no magic pill. There has never been, and never will be, a one-size-fits-all method to prevent the spread of HIV. And for those populations who may be at higher risk, or who may not have the luxury of having all of the tools at their disposal (for example men or women whose partners are unwilling or unable to use a condom or other form of protection), if they could use a microbicide gel or even a pill to lessen their risk, why would we not want that?

Oral PrEP (if proven safe and effective), vaginal and rectal microbicides, condoms, risk-reduction and adherence counseling, treatment as prevention—all of these and other methods must be allowed to be fully explored and studied. We owe it to ourselves, our partners, our families, our friends, and to future generations. We cannot and must not allow politics or fear tactics to trump science—we are better than that. To do any less is a disservice to those whom we purport to serve.

VIDEO: Positively Aware writer Keith Romell explains PrEP.

CDC Issues Interim PrEP Guidance

Last last year researchers announced some success in preventing HIV among gay men who were taking a daily dose of the HIV medication Truvada. The concept of warding off infection by pre-dosing with a medication is known as pre-exposure prophylaxis (PrEP.) But alarmed by the prospect for abuse, yesterday the CDC issued some interim PReP guidance as studies continue.

CDC says it wanted to fend off improper use of pre-exposure prophylaxis (or, more catchily, PrEP) as it and other agencies work on more detailed guidelines, which will take “several months.” It says that the drug should only be used in men who have sex with men, since studies in other high-risk groups such as IV drug users are still underway. And it should be used only in high-risk men (with multiple partners or partners from an area with a high prevalence of HIV infection), who are most likely to benefit. Also, the drug isn’t the equivalent of the morning-after pill for HIV; it’s meant to be taken daily. “Support for adherence to the prescribed medication regimen must be a routine component” of PrEP, the CDC says. (In the study, the risk of HIV infection was reduced just 21% in men whose adherence was less than 90%, compared to a 73% lower risk of infection for those with adherence of 90% or better.) And other preventive measures, such as condom use, should continue to be taken.

The wholesale cost of Truvada in the United States is $1000 for a month's supply, a cost unlikely to be covered by insurance when the drug is used as a preventive. In some countries, Truvada costs as little as $12/month.

Quote Of The Day - Michael Weinstein

"Recent headlines that heralded taking medication as a means of preventing transmission of HIV among gay men were applauded by many AIDS experts. The news came in a study of nearly 2,500 men in six countries that found that an average man taking the medication was 44 percent less likely to become infected than a control group taking a placebo.

"How very sad that we have come to this point. The applause for this approach shows just how disposable we consider the lives of gay men. If we were talking about protecting the general population with a treatment that was only 44 percent effective, would we be celebrating? Yet that is how the media and most of the public interpreted this study. [snip]

"I applaud efforts to find new ways to prevent HIV transmission. However, far too often baby steps forward are interpreted as huge leaps in scientific knowledge. We must consider this if we are going to offer up hundreds of thousands of gay men for this misguided experiment." - AIDS Healthcare Foundation head Michael Weinstein, writing for the San Jose Mercury-News.

Study Claims Using HIV Meds As Preventive To Infection Is Safe For Negative Gay Men

A study released at the AIDS 2010 conference in Vienna claims that using widely-prescribed HIV medications as a preventive for new infections (PrEP) is safe for HIV-negative men who have sex with men. Please note that effectiveness in preventing infection results have not yet been released on this study.

Pre-exposure prophylaxis (PrEP) with tenofovir (found in Viread, Truvada and Atripla) is safe for men who have sex with men (MSM), according to a U.S. study presented Friday, July 23, at the XVIII International AIDS Conference (IAC) in Vienna. PrEP is one of the most promising prevention tools on the immediate horizon. With PrEP, HIV-negative individuals take antiretroviral drugs to prevent becoming infected with the virus. The first PrEP studies are testing tenofovir alone (Viread), while several later studies are testing tenofovir plus emtricitabine (Truvada). Currently, all studies are looking at daily ongoing use of the drugs, but future trials are planned with intermittent dosing. The first efficacy results are expected later this year, but researchers from the Centers for Disease Control and Prevention (CDC) in Atlanta presented findings from a safety study at this year’s IAC.

As always, it's important to look at the size and the methodology of this study before making any decisions about your own health care.

RELATED: An unrelated NYC-based survey released last month indicated that the wide availability of PrEP would cause a high percentage of the most at-risk gay men to abandon safer sex practices.