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    Wednesday, January 25, 2006

    The Pill: Part II ?

    The Times magazine tackles anti-retrovirals for the "pre-positive" population:

    Of course, researchers have made progress in treating patients who already have H.I.V., developing powerful drug cocktails that can stave off disease. But when it comes to preventing the virus's spread, success is spotty. One of the few effective interventions involves the use of anti-H.I.V. drugs to keep a mother from infecting her baby. And an underappreciated facet to this story has far-reaching implications: both mothers and their uninfected babies receive the drugs.

    If anti-H.I.V. drugs can help uninfected babies dodge the virus, might the same approach work for uninfected adults? Could the sexually active take antiretrovirals to avoid contracting H.I.V. in the first place? Intrigued by the prospects, some gay men already have experimented with what's known as "pre-exposure prophylaxis" or PrEP: a recent survey conducted by the U.S. Centers for Disease Control and Prevention at gay-pride events in four U.S. cities found that 7 percent of those interviewed said they had tried it.

    A half-dozen studies are now under way that will determine whether these men are onto something. The trials all focus on tenofovir (marketed under the brand name Viread), a drug that appears safer than the other AIDS medications on the market. Placebo-controlled trials are enrolling 5,000 people on four continents who are in high-risk groups, including gay and bisexual men, sex workers and injecting drug users. ...

    If the intervention worked, she reasoned, then researchers could confront the problem of behavioral disinhibition head-on with education campaigns, much as they do with condom promotion efforts that simultaneously encourage monogamy or even abstinence. And if tenofovir PrEP fails to stop H.I.V. transmission or causes serious side effects, then people urgently needed that information too. ...

    New Aids Review says:

    ... For the immediate problem it suggests is, of course, side effects. Cohen recognizes this drawback by talking of a new drug which is supposed to have fewer side effects than the norm for HAART drugs, the standard regimen which gave Larry Kramer a liver transplant and is wont to render your appearance rather unpleasant with fatty deposits in the wrong places, before eventually killing you off.

    The trials all focus on tenofovir (marketed under the brand name Viread), a drug that appears safer than the other AIDS medications on the market. Placebo-controlled trials are enrolling 5,000 people on four continents who are in high-risk groups, including gay and bisexual men, sex workers and injecting drug users. All told, the experiments will cost more than $40 million, which is being paid for by the C.D.C. and the National Institutes of Health, as well as the Bill and Melinda Gates Foundation.

    In other words, the side effects of this "safe" drug remain to be seen. But there is one hint that tells us already what they are likely to be. The company which makes the drug says it has no interest in extending their beneficial influence to people without any sign of HIV,

    And if tenofovir PrEP fails to stop H.I.V. transmission or causes serious side effects, then people urgently needed that information too. (In part because the prospect of harming a healthy person raises formidable liability issues for Gilead Sciences, tenofovir's manufacturer, the company says it has no interest in marketing the drug as a prophylaxis, even if trials prove that it works.)

    This doesn't stop Cohen, of course, who believes that handing the stuff out in the gay community might cut new HIV infections by more than 80 percent, if it works "90 per cent of the time". All this is based on "mathematical models, ie is nothing but speculation.

    Optimistic mathematical models show that if tenofovir PrEP is effective 90 percent of the time and is used by 90 percent of the people who are at highest risk of becoming infected, it could cut new H.I.V. infections in a community by more than 80 percent in a few years. That is, if behavioral disinhibition does not undo the benefits.

    What he means by the last sentence is that if it works and people feel they are protected against catching HIV, then they will get up to even more mischief, sexually speaking. This is the concern of his source for the idea, the chief of San Francisco city AIDS research:

    Dr. Susan Buchbinder, head of the H.I.V. research section at the San Francisco Department of Public Health, runs one of those trials, known as Project T. Buchbinder says she initially had "big reservations" about the research, because she worried about what psychologists call "behavioral disinhibition": what if fear of H.I.V. declined in people who took the drug, and they then skipped using condoms or increased their number of sex partners? "It's scary as an investigator, as a public-health official and as a person who has worked with the community for many years to think about doing something that could paradoxically make the epidemic worse rather than better," she says.

    If this is the usual quality of logic brought to bear on the epidemic by the chief city researcher at the ground zero of the US AIDS epidemic, one can only say that the continuing confusion about HIV?AIDS and the flourishing survival of an apparently baseless paradigm in the medical community is no mystery.

    That is to say, if the premise is that the drug does protect against infection, why would it expand the epidemic if those protected against carrying HIV escalate their sexual antics? What Ms Buchbinder has to fear would be the expansion of hospital admissions for side effects, one would think, not new HIV positives. ...

    From Big Gay Picture:

    Should sexually active HIV-negative men (and some sexually active African American women) be put on an HIV anti-viral regimen, since there is some evidence that such a regimen can prevent HIV infection in these high-risk populations? Some models show that new HIV-infection rates could fall by as much as 80%. But what if the existence of such a pill causes gay and bi men to take greater sexual risks--more partners, and fewer condoms--screwing up the model projections and resulting in MORE infections, or more resistant strains of the virus? ...

    I like the idea of actively involving HIV-negative gay and bi men in their health, and in maintaining their negative status (much the same way every gay and bi man is, or definitely should be, vaccinated for heptatis B). And my God, anything that could keep more people from being infected with HIV is something that should be considered and researched.

    But this new strategy has the potential for much danger; anyone who doesn't acknowledge this is a fool. ...

    I ask my friend, Jay Gladstein, M.D., an infectious disease specialist who works with people with HIV, for his reaction:

    One of the advantages to a pill is that it provides a degree of protection--I must emphasize, a degree of protection--that is especially helpful to those who are not in a position to insist on condom use, namely women who are on unequal footing with men. I do not believe there have been studies of tenofovir pre-exposure prophylaxis among gay men, but, again, there could be a study(ies) underway that I am not aware of. If it has not been studied among sexually active, HIV-negative gay men in the industrialized world, especially in the US, then I would say that no sound conclusions can be drawn based on heterosexuals in the 3rd world or in countries where tenofovir is already widely used. ...

    Use as many tools as possible: condoms, low viral loads among positives, treat herpes, wash after sex, limit the number of one's sex partners, etc. I wouldn't put all my eggs in one basket with any of them. Getting into a sling at the local bathhouse and getting plowed by every guy who walks in is VERY risky, even if everyone wears a condom (though it might feel pretty good, if the person is on crystal). Similar thing goes for a pill. Even with the pill, that sling is extremely risky.

    "The reason is this. Any drug will only work against virus that is susceptible to it. For tenofovir, it takes only one mutation for the virus to become resistant, the K65R mutation. With more and more men on tenofovir in this country, I am sure that we will see an increasing prevalance of the K65R mutation among positive men. And what protection will tenofovir afford against HIV-laden cum that contains the K65R mutation? Little or none. But to really know that, we'd have to do a randomized, controlled study. Any volunteers?"

    I don't know much about medicine, so please take everything I say with a shaker of salt, as they say, but this whole thing really seems off. I'm all for preventing HIV infection, but it does seem like a recipe for resistance.

    I'm interested, however, in the idea that condoms are for people who don't want to think about taking something everyday, but just want to deal with it when sex comes up, whereas antivirals (and birth control pills) are for people that don't want to have to deal with remembering protection "in the heat of the moment", but are fine with taking something everyday. I like the idea that there should be different methods of protection for different kinds of people, but it does seem like one kind of people are likely to fuck things up for the rest of us. Just like with antibiotics, where a bunch of people who couldn't be bothered with being sick made it so that everyone had to deal with more and more horrible strains of illness. I could be wrong, perhaps the drug-resistant strain is not much of a possiblity for HIV, but the thought really, really scares me.

    There are some people that should definitely be testing this out, though. Despite the side effects, people who, for example, have positive partners might find it takes a load off their minds to use condoms, but not worry quite as much if one were to break. Same with people who are receptive and promiscuous. I hope that people will use them as backup. But I've seen how it works with women who are on the Pill and have sex with men. So many of them have unprotected sex because the pregnancy issue seems moot and most middle-class heteros don't take HIV very seriously. But it's not just HIV, it's tons of stuff you don't want to be exposed to.

    Since you can't go around ruling people's sex lives, I believe that anti-virals should be available (and affordable) to people who prefer to take them, just as women should have unlimited access to emergency contraception and abortions, even if we'd prefer they use regular contraception, even if we prefer they don't use EC and abortions regularly, because people should be able to do what they want with their own bodies and protect themselves at whatever level and whatever point in their sexual activity that they wish. But I truly hope that this won't further dilute the condom message.

    Again, especially as drug and alcohol use interact dangerously with sexual activity, forgetting or not caring to protect themselves and their partners, it is not a bad idea to have something that you can take at 9am when you still have the presence of mind to be concerned about the risks. But the side effects could be far worse than the serious hormonal weirdness that many women on the Pill experience.

    The other serious concern I have is the effectiveness if people don't take these anti-retrovirals everyday, as often happens with birth control. A lot of women I know feel very safe being on the Pill, despite using it rather haphazardly. To me personally, it seems a lot easier to remember protection when you're right about to have sex than everyday at the same time, but ... that's just me.

    A lot of folks commented, though, that this could potentially be the basis for a vaccine, which would be a tremendous breakthrough. I have to admit that, as much as I wish we had a vaccine on its way, I would worry about many of the same things there too. And I can't help but think it would be hard not to begin mandating such a vaccine were one to exist, which troubles me; I don't think anyone should be able to force you to put anything in your body.


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