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Major HIV News: 'On-Demand' PrEP Study Appears Successful

Prep

In major news in the fight against HIV, a second European study has concluded the "randomized" phase of its examination of the efficacy of pre-exposure prophylaxis (PrEP) due to the drug's high effectiveness at preventing HIV infection. All participants in this latest study--IPERGAY--including those who were previously receiving a placebo medication have now been given PrEP. What is perhaps most stunning about the new findings is that evidence seems to suggest that PrEP is effective not only when taken daily but when taken "on-demand", in other words, when sex is anticipated. AIDS Map reports:

6a00d8341c730253ef01a511e381fe970c-300wiThe investigators of the IPERGAY trial, which has six sites in France and one in Canada, announced today a “Significant breakthrough in the fight against HIV and AIDS” because IPERGAY had successfully demonstrated the effectiveness of its PrEP regimen.

IPERGAY’s early closure is significant not only because it adds confirmation that PrEP can be highly effective, but because it was testing an innovative, intermittent (“on-demand”) PrEP regimen. In this study, participants did not take PrEP daily, but only when they anticipated having sex. The regimen involved taking two pills of Truvada (tenofovir + emtricitabine) in the 24-hour period before anticipated sex and then, if sex happened, two separate one-pill doses in the two days following sex. This extends the versatility of PrEP and provides an alternative regimen to daily dosing.

The results from the IPERGAY trial mirrors those of a recent British trial, PROUD, which concluded its first phase early as well. The reports from both trials are still preliminary, however:

As with PROUD, no actual effectiveness figure or other quantitative data [from IPERGAY] were released, pending full analysis of the figures. The full results should be available early in 2015.

The trial will continue in non-randomised form for at least a year, as will PROUD, because of the need to demonstrate that “on demand” PrEP can have long-term benefit and to gather data on safety.

Principal investigator Professor Jean-Michel Molina said, "The biomedical concept of on-demand PrEP at the time of sexual exposure, in a broader prevention framework, is validated. We owe this to all trial volunteers without whom we could never have achieved these results". He adds that “condoms remain the cornerstone of HIV prevention. Combining all prevention tools that have proved to be effective will certainly allow us to better control the HIV epidemic.”

Professor Jean-François Delfraissy, Director of ANRS, commented, "This is a major breakthrough in the fight against HIV. The results of the ANRS IPERGAY trial should change national and international recommendations for HIV prevention".


HRC Endorses PrEP, Truvada: READ

On Saturday, the Human Rights Campaign endorsed Pre-Exposure Prophylaxis (PrEP) - an HIV prevention strategy that reduces the risk of infection by the use of antiretroviral drugs. The group also endorsed the use of Truvada, the pharmaceutical produced by Gilead, while making it clear that PrEP is more than just about taking a pill.

HRC writes:

Truvada pillHRC believes that everyone should have the opportunity to make an informed choice about their sexual health and about PrEP with an informed healthcare provider. PrEP should only be utilized in combination with other safer sex practices – including continued condom use – and patients need to stay on their medications. HRC believes that all PrEP users should be educated about their medications and the potential side effects, establish dosing routines that work for them, and work around financial or health needs that may impede adherence, as well as seek out social support.

The group is also calling on "insurers, regulators, and drug manufacturers to make PrEP available to all medically-qualified individuals, regardless of socioeconomic barriers."

Read the policy paper outlining HRC's new endorsement, AFTER THE JUMP...

The Associated Press adds:

Some doctors have been reluctant to prescribe the drug, Truvada, on the premise that it might encourage high-risk, unprotected sexual behavior. However, its preventive use has been endorsed by the Centers for Disease Control and Prevention, the World Health Organization, and many HIV/AIDS advocacy groups. [...]

The CDC says studies have shown that Truvada, when taken diligently, can reduce the risk of getting HIV by 90 percent or more. Research discussed at the International AIDS Conference in July found that use of the drug does not encourage risky sex and is effective even if people skip some doses.

Others, such as AIDS Healthcare Foundation President Michael Weistein have labeled Truvada a "party drug" and maintain it will erode condom culture. 

Continue reading "HRC Endorses PrEP, Truvada: READ" »


SF Supervisor Scott Wiener Comes Out of the PrEP Closet: 'Each Morning, I Take a Pill Called Truvada'

San Francisco Supervisor Scott Wiener decided to "come out of the PrEP closet" this week in order to educate the public and destigmatize 'pre-exposure prophylaxis', an HIV prevention strategy that reduces the risk of infection by the use of antiretroviral drugs. In a piece published Wednesday in the Huffington Post, Wiener says that he takes Truvada, the pharmaceutical produced by Gilead, daily.

WienerWrites Wiener:

I recently decided to be public about my use of PrEP in order to raise awareness about this relatively new tool for preventing HIV. It's important to encourage people at risk for HIV to talk to their medical providers about all the tools and methods available for preventing infection, including PrEP, and to choose the methods that are best for them.

As an elected official, disclosing this personal health decision was a hard but necessary choice. After all these years, we still see enormous stigma, shame, and judgment around HIV, and around sexuality in general. That is precisely why I decided to be public about my choice: to contribute to a larger dialogue about our community's health. I have the honor of representing a district that includes the Castro -- ground zero for the HIV epidemic. I represent a community that has been profoundly impacted by HIV, with a large number of HIV-positive people -- nearly one in four gay men in San Francisco is HIV-positive -- and an even larger number of people at risk of becoming positive. As an elected official in this role, I have an obligation to do everything in my power to support those living with HIV, increase public awareness about effective HIV prevention, and reduce stigma and shame.

Wiener notes that, like many in his generation, "I came of age associating sex with illness and death" yet he is bewildered by the fact that many young men and many he have known to be negative for decades still seroconvert.

"None of this is preordained. People don't need to continue to get infected, and we know that PrEP has the potential to help stop the epidemic in its tracks by ending new HIV infections," Wiener writes.

TruvadaWiener is introducing a resolution in San Francisco today hoping to begin a process that will allow PrEP to become more available, reports Josh Barro in the NYT:

On Thursday, the board will hold a hearing about increasing that number. David Campos, a supervisor who like Mr. Wiener is openly gay, will introduce a resolution directing the city’s health department to develop a plan by December that “addresses the educational and affordability issues” around Truvada. In particular, he and Mr. Wiener are focused on bringing down costs for people who would like to be on PrEP but can’t afford it.

PrEP is widely covered by health insurers, including Medi-Cal, California’s version of Medicaid. Medi-Cal covers PrEP’s entire cost and many high-quality private plans cover most costs. Mr. Wiener pays just a $15 monthly co-payment under his city-provided health plan. But health plans with high deductibles may leave patients “covered” yet unable to afford their share of the cost of Truvada, whose list price is over $1,000 per month. The price is also forbidding for the uninsured; federally funded programs provide free medication to H.I.V.-positive people without insurance, but they do not cover PrEP.

Wiener told Barro: “A much larger segment of gay men should be taking a close look at PrEP...I hope that my being public about my use of PrEP can help people take a second look at it.”


Andrew Sullivan and Rich Juzwiak Continue Their Discussion on Gay Sex, Truvada: AUDIO

Rich

Andrew Sullivan sat down with Gawker's Rich Juzwiak to continue their discussion of Pre-Exposure Prophylaxis (PrEP) and to dissect the thought processes behind the often-taboo idea that people prefer sex sans condoms.

“People aren’t necessarily that articulate about it, they maybe don’t even understand that exactly,” Juzwiak explained, laying out a description of the intimacy sometimes associated bareback sex. “I’m not culturally a barebacker [but if] I have to do monogamy or something like it, my compensation is we’re not using condoms.”

Listen to Juzwiak’s discussion of PrEP’s place in modern gay culture with On The Media AFTER THE JUMP...

Juzwiak has been one of the internet’s most vocal and high-profile proponents of Truvada, a brand of PrEP that, when used properly, drastically reduces a person’s risk of contracting HIV. Despite protestations from those arguing that PrEP poses more harms than potential benefits, Juzwiak has made a cause out of  the controversial drug.

“If you don't contract HIV from bareback sex, was it unsafe?” He wrote earlier this spring. “What does it even matter? Just do better next time and take solace in the personal rules—somewhat informed, somewhat arbitrary—that you suspect are keeping you protected.”

Juzwiak’s assertion is a rather straightforward one: gay men are having sex without condoms, and they might as well be doing it with at least a modicum of preventative protection:

"But what hasn't harmed you in the past, if you're one of the luckily negative like I am, could still harm you when you do it in the future. Owning up to this fact is a crucial step in choosing to take Truvada, the antiretroviral drug cocktail of tenofovir and emtricitabine that's manufactured by Gilead."

Continue reading "Andrew Sullivan and Rich Juzwiak Continue Their Discussion on Gay Sex, Truvada: AUDIO" »


Andrew Sullivan And Rich Juzwiak Talk The 'Brotherhood of Gay Sex': Audio

Gawker writer Rich Juzwiak recently guested on Andrew Sullivan's podcast and the two took part in a frank conversation about their feelings on gay men and sex. Sullivan describes their talk:

Juzwiak-banner1We actually talk about the sexual adventurism of gay men – a subculture where no women restrain sexual desire – as an often wonderful thing, regardless of the judgment that so many, including gay men, have made about it.

Juzwiak openly expressed his candid opinions:

"I know that there are consequences to being promiscuous, but I could never argue against it. I just really feel like its such a wonderful way to meet people and engender brotherhood, too. That's what I'm really into now. This feeling of brotherhood amongst gay men where I can go home with a guy and we can hang out in bed in the morning for hours naked fooling around talking, fooling around while we're talking. That I just think is just specific to gay sexuality."

Listen to a 2 1/2 minute clip, AFTER THE JUMP...

Sullivan also points out that Juzwiak, who had discontinued taking the drug Truvada earlier this year, published a new piece on Gawker Wednesday wherein he explains why he's not only taking the pill again but encourages "all sexually active gay men who are negative should go on it, at least those who are in the highly populated gray area."

From the Gawker piece:

I try to be as nonjudgmental as possible when it comes to the behavior of other gay men (though I cannot refrain from judging those who judge). We are all in different places in life; we all enjoy different things. That variety is, in fact, what makes gay culture so vibrant. The choices at the disposal of those who are privileged enough to live in areas where gay is OK and where same-sex marriage is legal—these are part what make being gay so wonderful. But if you cannot deal with taking a single pill every day, you need to get a grip and reevaluate your life. After you do that, then just take the fucking pill.

The full podcast episode of the Sullivan/Juzwiak conversation is available (by subscription only) here

Continue reading "Andrew Sullivan And Rich Juzwiak Talk The 'Brotherhood of Gay Sex': Audio" »


'New York Times' Explains Conflicting Truvada Effectiveness Stats

The New York Times has published an insightful, data-driven rundown clarifying the sometimes conflicting information concerning Truvada that’s in circulation.

IPrEx_OLE_logoThe primary point of contention, writes Josh Barro, is linked to Truvada users actually taking the drug consistently, the way it’s prescribed. iPrEx, the first large scale, randomized PrEP trial using human subjects, found that Truvada users were 44% less likely to test HIV positive at the end of the trial compared to participants given a placebo. Participants who didn’t consistently take the drug, however, did not display the same immunity:

Of 48 iPrEx subjects who were assigned to take Truvada and contracted H.I.V. anyway, just four had any detectable level of the drug in their system when they were diagnosed, indicating a 92 percent reduction in risk for people who were actually taking the medicine.

But wait, there’s more: Those four subjects who took Truvada and became infected had its active ingredients in their blood only at levels consistent with taking the drug twice a week. That is, in the study, there were zeroapparent cases of subjects taking their pills daily and contracting H.I.V.

iPrEx’s sample size was relatively small sample size of 2,500 people and the fact that only 18% of participants were shown to have taken the drug daily made it difficult for researchers to claim 100% efficacy.

But by looking at the handful of infections among people taking their pills less than daily, the iPrEx researchers were able to build a statistical model of how the risk of infection declines as the number of pills taken weekly rises. In 2012, they estimated that actually taking Truvada every day produces a 99 percent reduction in the risk of H.I.V. infection, despite not directly observing any such infections.

The general consensus within the HIV/AIDS research community is that Truvada is, in fact, helpful in the prevention of contracting the, but doctors remain wary of putting a precise percentage on current studies.


Read through a an in-depth iPrEx fact sheet AFTER THE JUMP...

Continue reading "'New York Times' Explains Conflicting Truvada Effectiveness Stats" »


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