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New PrEP Studies Show 86% Reduction In HIV Transmission Rates, Even As 'On-Demand' Treatment

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Truvada taken as an HIV preventative is shown to be an incredibly effective way of stopping the spread of HIV. In 2014 the iPrEx OLE study showed that when taken between 3 and 7 times a week, seroconversions were close to 0%. A new study from Britain called PROUD has come out with some slightly different numbers, but numbers that are still encouraging: 86% of the men studied were protected by a Truvada regimen. Not as great as 99.99%, but still a good notch better than the 76% offered by condoms alone. Naturally, the best results are achieved when multiple prevention tools are used in tandem, and condoms plus PrEP make for an even more solid barrier.

Here's where things get interesting: the IPERGAY study out of Canada and France showed that the 86% efficacy can be achieved even when taken "on-demand", which is defined here as once 2 to 24 hours prior to sex and once after.

These "on-demand" results could completely change everything, as both cost and potential side effects are some of the biggest concerns voiced against Truvada. The cost per pill is still somewhere in the neighborhood of $50, unsubsidized, so it's still not within everyone's reach, but being able to drop $100 without insurance for a preventative measure broadens the reach far beyond the standard of uninsured or underinsured people going without because they can't pony up $3k+ for a month's supply. Also, while the side-effects of the pill are minimal and typically reversible, just two pills could provide the needed benefit without being enough to make most of those side effects kick in.

Stand by for Michael Weinstein to rehash his accusation that Truvada is a party drug...though if Truvada is a party drug, does that make condoms party balloons?


PrEP Is Not The Problem, Perfection Is

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The Interplay is a special biweekly series exploring the intersections of sex, pop culture, and current events.

BY CHARLES PULLIAM-MOORE

Over the past few months Towleroad has extensively covered the development and deployment of pre-exposure prophylaxis (PrEP) and its use as an HIV preventative. The concept is fairly straightforward: If you’re HIV negative, you take a pill once a day that dramatically decreases your risk of contracting the virus. Like most drug treatments, PrEP is not 100% effective. Like most drug treatments, PrEP’s rate of efficacy is high enough to make it a legitimate guard against HIV infection.

12468795723_49cc5f73f7_zThere are times where explaining PrEP can feel repetitive, especially in writing. While the research and testing around newer versions of PrEP necessitate a fair amount of coverage, the core details of what the drugs do and how they work are the same. It’s easy to think that everyone understands PrEP, reads about it, and is talking about it with their doctors. It’s easy to think that Truvada opponents are overzealous fact-deniers that can’t be reasoned with. “Why bother engaging with them?”, one might ask. The thing is, though--walking away from an opportunity to talk about PrEP is almost as socially irresponsible as calling PrEP a threat to the gay community.

Figures like Zachary Quinto (most recently) and Larry Kramer (earlier this year) represent a side of the PrEP conversation that is couched in a very justifiable fear of sex. Hear me out: Regardless of who you are or how you do “it,” most every form of sex that we engage comes with a certain degree of risk. Part of being a sexually and socially responsible person is understanding that risk and making decisions with it in mind. For an entire generation of gay men, HIV/AIDS changed the way that people thought about that risk.

Experiencing a plague that spreads through sex brings the implicit danger associated with all sex acts into the sharpest relief. To that end, there’s a grain of truth to Larry Kramer’s ham-handed condemnation of today’s sexually active youth. I am a 24-year old millennial. Many of the men of my generation simply weren’t there for the initial outbreak. While the legacy of HIV/AIDS is a part of our collective cultural history, our generational relationships to it, and sex, are recognizably different. We are not so far removed from the early days of HIV/AIDS to have completely forgotten the lessons learned about safer gay sex. We are, however, primed for new, additional innovation.

CONTINUED, AFTER THE JUMP...

Continue reading "PrEP Is Not The Problem, Perfection Is" »


Research on Injectable, Longer-Lasting PrEP Moving Forward

Studies focusing on injectible pre-exposure prophylaxis as a means of preventing the contraction of HIV is moving forward as researchers have seen higher rates of efficacy using certain drug combinations. Currently Truvada, produced by Gilead Sciences, is one of the only currently commercially available forms PrEP. The pill must be taken daily in order to be effective, and is actually a combination of the two antiretroviral drugs tenofovir and emtricitabine.

Screenshot 2014-11-07 12.24.50The results of testing trials presented earlier this year showed that the drug cabotegravir proved to be effective as remaining within the bloodstream and preventing HIV infection. Two doses of the drug, then known as GSK744LA, prevented all eight of the test subjects provided with doses from contracting HIV, while the control group not given the drug all became infected. Following the success of initial simian test groups, researchers are proceeding with human efficacy test trials.

The potential benefits to using integrase inhibitors like cabotegravir could be significant in the advancement of PrEP use. Unlike Truvada, cabotegavir proved to be effective being taken much less frequently.Opponents of Truvada often cite the need for a constant, regular dosage as a reason not to advertise he drug as the end all be all protection from HIV infection.  An 800mg dosage of the drug injected into the soft tissue remained in the bloodstream for up to 12 weeks, meaning that future iterations of PrEP would only need to be taken quarterly.

While cabotegavir has shown promise rilpivirine, another HIV drug being tested that has been shown to have much lower side effects in those taking it, was shown to have lost its efficacy after about 18-21 days.


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

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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.”


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