Study: Syphilis Ads Had no Impact on
Gay Health in Florida

This is a very interesting abstract, one that should be debated in San Francisco, as the issue of all the social marketing crap thrown at gay men will be placed back on the local community's agenda.

February 2008, Vol 98, No. 2 | American Journal of Public Health 337-343

Short-Term Impact Evaluation of a Social Marketing Campaign to Prevent Syphilis Among Men Who Have Sex With Men

William W. Darrow, PhD and Susan Biersteker, Drs

William W. Darrow is with the Department of Health Promotion and Disease Prevention at the Robert R. Stempel School of Public Health, Florida International University, Biscayne Bay Campus, North Miami. Susan Biersteker is with Behavioral Research and Evaluation Consultants, LLC, Miami Beach, Florida.

Correspondence: Requests for reprints should be sent to William W. Darrow, Florida International University, 3000 NE 151st St, TR–7, North Miami, FL 33181–3600 (e-mail darroww@).

Objectives. We carried out an independent short-term impact evaluation of a social marketing campaign designed to reduce syphilis infections among men who have sex with men in south Florida in 2004.

Methods. Venue-based surveys were conducted shortly after the campaign began and 6 months later to assess changes in exposure to campaign materials, awareness, knowledge about syphilis, perceptions of risk, sexual behavior, clinic visits, and testing and treatment for syphilis among participants.

Results. Exposure to social marketing campaign materials increased from 18.0% at baseline to 36.5% at follow-up (P< .001). Awareness of syphilis and perceptions of risk increased among Broward County residents but not among Miami–Dade County residents. Risky sexual practices and patterns of recreational drug use did not change. No significant increases in knowledge, clinic visits, or testing or treatment for syphilis among participants were detected over the 6-month study period.

Conclusions. None of the campaign objectives were fully met. The interventions were insufficient to produce a significant impact among men who have sex with men in south Florida.

No Proof SF DPH Serosorting Ads
Improved Gay Health

Silly me. I expected the dozens of staffers at the city's AIDS Office and Better World Advertising who created a particular ad campaign in 2006 could easily answer some basic questions regarding their ads. But they can't, illustrating to me how it's business, and a publicly well-funded business, as usual. Throw ads at the homosexuals, get 'em upset, fatten ad agency coffers, never show verifiable evidence gay health is improved.

-----Original Message-----
Sent: Thu, 14 Feb 2008 12:14 pm
Subject: SF DPH HIV serosorting ad campaign accomplishments requested

Eileen Shields
Public Information Officer
Department of Public Health

Dear Ms. Shields,

Please share my questions with Doug Sebesta, gay men's health coordinator for the DPH. -Michael


Dear Mr. Sebesta,

Over fifteen months ago you and the DPH launched a social marketing
campaign targeting gays with AIDS to serosort and disclose their HIV
status.

The campaign is ongoing and the web site for it is still operational:
http://www.disclosehiv.org/ .

I have some important follow-up questions that need answers.

1. What evidence do you have showing the ads led to more serosorting and disclosure?

2. Is there any proof your ads increased HIV antibody testing?

3. How about evidence HIV infections decreased because of the campaign?

4. Have you held any public meeting since November 2006, when the ads began, to discuss the merits and accomplishments of the ads?

5. Has a written report been issued to the community about the success or
failure of the serosorting campaign?

6. How have you interacted with critics of the campaign to insure diverse gay opinions were considered when evaluating the ads?

7. And finally, in your capacity as director of gay men's health issues for the DPH, when do you hold public meetings to seek community input into the gay health agenda of DPH?

I look forward to your thoughtful answers.

Best regards,
Michael Petrelis

A week later, the health department sent this email, full of red herrings, omitting any real answers to my simple questions:

In a message dated 2/20/2008 4:21:25 P.M. Pacific Standard Time, Eileen.Shields@:

Dear Mr. Petrelis:

Here is a response to your multitude of questions:

The Human Rights Commission held a forum on this issue at which Dr. Colfax presented.

The issue you are asking about is one image from a very broad multifaceted marketing, educational and training project that involved our network of Counseling and Testing and prevention providers. Better World Advertising is completing a report on the marketing component and staff is completing data analysis for the project on counseling and testing.

When the work is completed, DPH will share it.

Eileen Shields
Public Information Officer
San Francisco Department of Public Health

Good government advocates should be concerned that another city-funded HIV social marketing campaign targeting gays can't produce any results or a report on what the campaigns may have achieved. Between DPH and Better World Advertising, we have zero data to look at, 16 months after the serosorting ads were launched. Oh, and DPH can't even say date when the evaluation work will be completed. This is how DPH is accountability to the targeted community.

If someone can find an instance of DPH producing increased testing or lowered infection rates brought about through any one of the department's multi-million dollar social marketing efforts, please share tell me about it. The lack of any stats from the serosorting campaign is totally in keeping with established DPH policy for all such campaigns.

The stigmatizing attitude of DPH and Better World Advertising created through their endless barrage of ads, always peddling manufactured controversy and alarmism, has a detrimental influence on gay health. The message is always the same: You're doing something wrong and we need to provoke you. It is not enough for the city to spend millions annually on gay and HIV health social marketing, without producing tangible stats and beneficial results.

And just because Better World Advertising may soon show us proof their web sites for the campaigns received lots of hits, and the agency has lots of new press clippings for its archive, I want epidemiological and measurable health outcomes from the social marketing.

There's gotta be more accountability from DPH and its ad agency.

SF DPH Report:
Big Declines in 2007 Gay STD Numbers

In late January the SF DPH released the last monthly STD report for the city. The very encouraging preliminary year-end numbers for 2007 showed extremely welcome news of falling STDs across the board, except for HIV stats at the city's main STD testing site.

Then on February 21 DPH released the January monthly surveillance report, which included analysis of the raw figures for 2007.

"In 2007, declines were noted for all reportable STDs in San Francisco. Reported gonorrhea declined 19% from 2006 to 2007 from 2469 cases to 2008. Rectal gonorrhea among men also declined from 557 cases to 489 -- a 12% decline.

"Declines in syphilis were also found. Primary and secondary syphilis declined 17% in 2007 from 243 to 202; all early syphilis also declined by 16% in 2007. [...]

"Overall chlamydia declined from 4050 to 3937 (3%) while rectal chlamydia increased in 2007 from 512 to 592 for a 16% annual increase. We are exploring why rectal chlamydia cases increased in 2007 and rectal gonorrhea declined."

The monthly report omitted discussion about adult male shigellosis, which fell by 20%, from 99 to 78 cases; speed-related visits at SF General Hospital for males fell 17%, from 488 down to 402; for female visits there was a drop from 113 to 111.

The HIV figures from the primary STD testing site on Seventh Street, which are not the full numbers for the city but certainly represent a significant portion of the tests and results that comprise the city's overall HIV infection rate, increased by 12 percent, from 102 to 115.

However, the figure for number of antibody tests performed at this one clinic skyrocketed 58%; from 3,097 to 5,283. I think we can safely attribute the rise in HIV infections to the corresponding jump in tests.

The STD numbers, and probably the HIV stats too, are on a downward spiral in the double-digits, a positive development in the control and prevention of sexual infections, in a city where the overwhelming majority of STDs are seen in the gay and bisexual male communities.

But the double-digit drops are not of any particular interest to the many HIV and gay health groups in town, a judgment based after surveying their web sites and finding no mention of the plummeting figures.

You won't find a word about the falling infections at the site for the Stop AIDS Project, SF AIDS Foundation, SF Gay Men's Community Initiative, Magnet, UCSF Center for AIDS Prevention Studies, UCSF AIDS Health Project, UCSF AIDS Research Institute, or the Gay and Lesbian Medical Association.

Given the hopeful new stats illustrating lots of sexual safety and responsibility occurring among gay men, I would think especially after the worldwide media hysteria and gay community bashing generated by UCSF's staph infection study and press release, that HIV and gay health organizations would find a way to finally say something positive about gay men. But they all remain stonily silent about the decreasing 2007 STD numbers.

Actually, I wish someone would remind me of the last time these professional and well-financed health advocacy organizations said anything nice about gay men in San Francisco. Is there a commandment that says "Thou shall never offer positive reinforcement of responsible sexual practices of male homosexuals"?

I wish DPH and AIDS Inc would explain to me why they never offer a pat on the community's collective back for reductions in HIV and STDs, meth-related ER visits too. Here's a radical notion. DPH and its partners find ways to applaud the strengths of gay male health indicators in the near future.

It may be naive of me to say this, but I hope all the mainstream and gay news outlets that are on the DPH mailing list for STD reports soon cover the 2007 stats. Such media attention may be just the thing to force an end to the institutional complacency at HIV and gay health service groups.

SF DPH, CDC Rep: UCSF Gay Staph
Study Guilty of "Ascertainment Bias"

If the issue is gay men and communicable diseases in San Francisco, especially related to homo-sex, Jeffrey Klausner, the head of DPH's STD control unit, likes to rule over such issues like the queen bee controlling her territory. He just doesn't like anyone encroaching on his domain -- fags and diseases. This may be one motivating factor behind Klausner co-signing a letter to the Annals of Internal Medicine ripping into the UCSF gays and staph infections study recently published in the journal.

Klausner's stormy and stigmatizing campaigns have included social marketing campaigns equating people with syphilis with time-bombs, considering quarantine and closing gay sex venues, and demonizing gays and people with AIDS who use erectile dysfunction medications.

From the November 21, 2001, Washington Monthly:

Dr. Jeffrey Klausner [...] has suggested a number of measures, some coercive,which he thinks would slow the increase of new HIV infections among gay men. Among them: closing sex clubs and adult bookstores; enforcing no-sex ordinances in bars and clubs; enforcing no-drug policies in bars and clubs; and Internet-based outreach and education, particularly in chat rooms where many gay men meet new sexual partners.

Putting aside political realities when brainstorming on this subject, Klausner also raised the possibility of quarantining those who cannot control their infectivity---e.g., those barebackers who've infected 20 different people and still refuse to use condoms.

From the August 18, 2005, edition of the Bay Area Reporter:

AIDS czar Jeff Sheehy said the push by a city health official to make erectile dysfunction medications Schedule III drugs is AIDSphobic and homophobic. He has asked the city's Human Rights Commission to investigate the appropriateness of using city funds to advance the criminalization of Viagra use by gay men, particularly gay men with HIV. [...]

"Jeff Klausner wants the dicks of people with HIV in his back pocket and he wants us to ask him permission to use it. And I am not giving him my dick," said an outraged Sheehy, a gay HIV-positive man who volunteers as Mayor Gavin Newsom's adviser on HIV and AIDS policy. "Jeff Klausner is specifically targeting gay men with HIV. This is not what city funds should be used for. There is no science to justify this."

But today I will say something nice about Klausner, and that is I appreciate his letter in the Annals of Internal Medicine, calling into question what he says is the "ascertainment bias" of the UCSF research and findings.

What exactly is this bias? From Wikipedia:

In scientific research, ascertainment bias occurs when false results are produced by non-random sampling and conclusions made about an entire group are based on a distorted or nontypical sample. If this is not accounted for, results can be erroneously attributed to the phenomenon under study rather than to the method of sampling.

Published February 15, 2008, in the Annals of Internal Medicine:

In their population-based survey (1), Diep and colleagues report a higher incidence of a multidrug-resistant (MDR), community-associated (CA), methicillin-resistant Staphylococcus aureus (MRSA) clone USA300 infections in the ZIP code that includes the Castro district, compared with San Francisco overall (170 versus 26 cases/100,000 persons, respectively) during 2004–2005. We are concerned that this finding reflects, at least in part, ascertainment bias rather than a true difference in disease incidence.

Diep and colleagues defined cases as positive MDR CA-MRSA USA300 clinical cultures other than nasal swabs. Clinical considerations determined whether cultures were performed. Because all infections might not have been cultured, Diep and colleagues state that they might have underestimated the true incidence.

The magnitude of underestimation probably differed importantly among groups as a result of ascertainment bias. Bias likely stemmed from greater awareness of MRSA infections among gay men and other men who have sex with men (G/MSM) and their health-care providers.

In February 2003, articles in two widely read local newspapers — the San Francisco Chronicle and the gay-oriented Bay Area Reporter (BAR) — highlighted MRSA infections among G/MSM in San Francisco. In the San Francisco Chronicle, a prominent physician recommended culturing all infections; the front-page BAR article encouraged persons with suspected infections to seek treatment early. The San Francisco Department of Public Health issued frequently asked questions for the public and a Health Advisory for clinicians and, with community partners, hosted a forum, all focusing on MRSA infections among G/MSM. Additionally, journal articles published during 2003–2005 linked MRSA infections to G/MSM (2), including HIV-infected G/MSM (3).

All these factors increased the likelihood both that G/MSM sought health care for suspected MRSA infections and that clinicians cultured suspected MRSA infections among G/MSM San Franciscans. That bias, plus the fact that G/MSM in San Francisco (including HIV-infected G/MSM, who comprise a majority of HIV-infected city residents) are a large, geographically concentrated group (4), likely resulted in a relative overestimation of the incidence of infections in the Castro district, compared with other ZIP codes in San Francisco.

Additionally, Diep and colleagues provide evidence that among patients of a San Francisco HIV clinic who had an MRSA USA 300 infection, G/MSM were more likely to have an MDR strain of USA300 compared with non- G/MSM. However, G/MSM at that clinic are unlikely to be representative of G/MSM throughout San Francisco.

Kenneth A. Katz, MD, MSc, MSCE

Epidemic Intelligence Service, Centers for Disease Control and Prevention Atlanta, GA 30333 San Francisco Department of Public Health San Francisco, CA 94103

Kyle T. Bernstein, PhD, ScM

San Francisco Department of Public Health San Francisco, CA 94103

Jeffrey D. Klausner, MD, MPH

San Francisco Department of Public Health San Francisco, CA 94103

Note: The findings and conclusions in this report are those of the author(s) and do not necessarily represent the views of the Centers for Disease Control and Prevention.

This letter, and the authors' affiliations, should help generate additional coverage of the gay and staph story.

Video: Shredding SF DPH Rejection
of Swiss Paper

The author of the SF DPH rejection statement over the Swiss HIV transmission paper, Grant Colfax, was a last-minutes addition as co-chair of the CDC-mandated HIV prevention planning council on February 14.

Despite a request from me that DPH provide copies of the English version of the Swiss report to every member of the council, along with the DPH rejection statement, neither document was distributed at the council meeting.

Oh, well. So much for DPH/AIDS Inc meeting the needs of the local affected community, crying out for a public debate on the Swiss report.

The powers-that-be not only kept the report out of the hands of the council members, except for remarks during public comment, nothing of substance was said by Colfax or members. The man who made this YouTube video, Ken Hodnett didn't exclude comments by Colfax on the Swiss report because none were made.

By the way, pay attention to the fidgeting white man in a dark sweater on the panel behind me. That is Grant Colfax.

Don't you just love how "community planning" in San Francisco means DPH and AIDS Inc bureaucrats control the planning process, won't openly discuss their unilateral decisions made behind closed doors and would rather eat nails than say anything about the Swiss paper?


You can view more of Ken Hodnett's coverage of gay political life in San Francisco at his YouTube page.

Dr Sonnabend Weighs in on Swiss Report

[My friend and one-time health care provider, AIDS hero and visionary Dr. Joe Sonnabend, shared with me his thoughts on all the hoopla generated by the Swiss. Nice to have his voice added to the online debate over the report.]


Dear Michael,

Thanks for sending material on responses to the Swiss report.

It is a very reasonable, cautious and absolutely appropriate set of recommendations. They are based on studies that have been accumulating for about 8 years, some by US researchers. So the very interesting question is why was it left to the Swiss to make this absolutely reasonable comment on material that has been available to all of us? To me as well. Why did none of us, myself included, not see the important implications of the studies on which the Swiss report is based. Studies that have been in the literature for some time?

The Swiss did not make a discovery, they just saw something important in material that has been around for some time, and even if some of us had noticed the implications, as they did, we remained silent. Curiously we – that is US researchers did in fact pay attention to these implications, but in a very different context.

One of the justifications for starting treatment earlier was that, because of viral load reductions, transmission of HIV would be reduced. So they did get the point, but only in so far as using it to argue for an earlier start to treatment – with no interest in the implications regarding condom use.

I suppose I’m trying to say that all of us, myself obviously included, might have raised questions and initiated discussions on reconsidering the circumstances of condom use in response to studies we have seen for many years. I must admit that this lapse does make me wonder about my own ability to see important implications of study results. Again, why did we have to wait for the Swiss report?

The report is absolutely reasonable. There are caveats and cautions in it, and since I can see no reasonable objection to them, we have to look elsewhere to try and understand why the report has provoked such a furious response. I know it is a bit pedantic and pretentious but I’m going to add a quotation that is over 100 years old that recognizes that scientists can be as irrational as anyone else (especially about sex), Here it is:

In Man Adapting, Rene Dubos notes that:

“The presuppositions on which medicine operates are thus conditioned by the general philosophy of the social group as a whole” and adds the words of Oliver Wendell Holmes in 1860:

“The truth is that medicine, professedly founded on observation, is as sensitive to outside influences, political, religious, philosophical, imaginative, as is the barometer to the changes in atmospheric density”10

I would bet that some who have commented have not even read the cautious Swiss text, and have allowed their prejudices, and squeamishness about sex in general, maybe specially about gay sex, to surface at the very mention of sex without condoms.

The Swiss authors do deserve some recognition for their courage. There are circumstances in which it is not irresponsible to have sex without condoms. And even for those for whom these circumstances do not apply, the knowledge of the possibility of sex without condoms will be an encouragement, in at least two ways. To continue using condom use when this is necessary, and a support with treatment adherence and monitoring.

I say these things as someone who had something to do with the original introduction of condom use for gay men in 1983, and until now thought – as probably most did, that it would be forever.

Knowing that this is not necessarily so is a tremendous encouragement and I believe this thought alone will help our prevention efforts.

All the best, Joe

SF Chronicle:
Gays Still Angry Over Staph Stories

More than five weeks ago the San Francisco gay men's community was assaulted by researchers and PR staffers at UCSF with a staph study and a homophobic press release, leading to instantaneous outrage on Castro Street.

Gays were upset with coverage on the infectious outbreak from the Hearst-owned SF Chronicle, and oceans of anger flowed at community forums, in the gay and mainstream press and on countless blogs, bemoaning the rag.

And throughout the five-weeks of well-deserved hostile criticism directed at the Chronicle, the paper dogmatically refused to report on the anger.

But today, the reliable stenographer for UCSF/DPH/AIDS Inc, Sabin Russell, who wrote the original Chronicle stories on the epidemic of staph among gays, finally reports on the community anger.

Why did it take the paper so long to cover the local gay community's criticism?

Basic and decent journalism called upon the Chronicle to print a lengthy reaction piece, which they still could write, not just a few sentences buried in a larger article on developments with staph and its control.

The crumbs from the Chronicle today are duly noted and appreciated, but do not address the longstanding problems of the paper recycling AIDS Inc releases, publishing dozens of "gays = disease" stories that lack balance, and employing hysterics for practically everything on gay health.

From the paper this morning:

Last month, San Francisco General Hospital physicians reported in the journal Annals of Internal Medicine that a variant of USA 300, resistant to six antibiotics, was "especially common among men who have sex with men."

That report, and the subsequent media coverage of it around the world, deeply angered some members of the city's gay community. Ammiano denounced a report in The Chronicle about it as "irresponsible" and "homophobic," during a committee hearing Wednesday.

He joined with Supervisors Bevan Dufty and Aaron Peskin in a mock hand-washing demonstration, where the men soaped up their hands and rinsed them in an inflatable plastic swimming pool rolled into the City Hall supervisors' chambers.

Full 5-Page Swiss HIV Report Now in English

[I bestow much gratitude on veteran AIDS treatment and transparency advocate Mike Barr for providing the global HIV and gay communities with the original Swiss report, in French, finally translated in English. Let the debate about the report carry on. And check out Mike's fabulous Shill Factor site, and get the latest info on transparency advances. I like Mike! -Michael.]

(My apologies to the French Academy, the Alliance Française, the Université de Genève, Annie Hemingway-Gandon, the French Language Department of McGill University and all other French professors or schools where I have studied or that might recoil in horror at how I have butchered a famously mellisonant and erudite language. It is only in the interest of informed discussion and the open exchange of ideas that I rush this amateur effort at French to English medical translation to press. -Mike Barr; New York City.)

"HIV-infected persons on effective antiretroviral therapy (and free of other STDs) are sexually non-infectious" (download .pdf file here)

Original document, in both French and German, prepared and authored by: P. Vernazza, B. Hirschel, E. Bernasconi

Amateur English translation of the French text, “Les personnes séropositives suivant un TAR efficace ne transmettent pas le VIH par voie sexuelle,” as published in the Bulletin des médecins suisses 2008;89: No. 5.

Having taken into consideration all scientific evidence, the Expert Clinical Commission on HIV/AIDS Treatment of the Federal Office of Public Health, and after great deliberation, the federal committee for issues related to HIV/AIDS has arrived at the following conclusion:

HIV-seropositive individuals on antiretroviral therapy with a fully suppressed HIV viral load (hereafter referred to as “fully suppressive antiretroviral therapy”) and no additional sexually transmitted infections do not transmit HIV by sexual means.

This assertion is contingent on the following conditions:

• That the HIV+ individual is under the care of a treating physician and that s/he takes the medication exactly as indicated;
• The viral load must be below the limit of detection (<40 copies m/l) for a minimum of 6 months;
  
• That the HIV+ individual is not currently experiencing any other sexually transmitted infections.

Introduction
One of the tasks of the Committee consists of making public new information about the infectious nature of HIV+ individuals who are being successfully treated with antiretroviral therapy. The Committee would like to assuage the fears of both HIV+ and HIV- individuals in order to permit as many as possible of the estimated 17,000 HIV+ individuals living in Switzerland to live as close as possible a “normal” life.

Scientific basis and evidence
“Fully suppressive antiretroviral therapy” is defined as antiretroviral therapy (ART) that achieves a stably undetectable (<40> viral load in the blood. “Stable” viral suppression and antiretroviral therapy are defined as having an HIV viral load below the limit of detection for 6 months or greater.

The Committee is cognizant of the fact that, from a strictly scientific point of view, biological and medical principles available to date have been unable to prove that effective antiretroviral therapy can prevent all instances of HIV infection (in effect, it is simply not possible to prove the non-existence of an improbable but theoretically imaginable event).

Be that as it may, it remains the point of view of the Committee and interested organizations that data available to date is sufficient to justify our message. The situation is comparable to that of 1986, when it was publicly communicated that HIV could not be transmitted by a kiss. Even though this assertion could never be irrefutably proven, more than 20 years of experience with HIV have nevertheless permitted us to support its very strong plausibility.

Moreover, the facts and scientific criteria supporting the assertion that HIV+ individuals on fully suppressive antiretroviral therapy and not suffering from other sexually transmissible infections do not transmit HIV by sexual routes are clearly more favorable than those of 1986. Therefore, the Committee and interested organizations are of the opinion that currently available data are sufficient to justify this message.

Epidemiologic underpinnings
In the case of serodiscordant couples (one HIV+ and the other HIV-), the risk of HIV transmission depends on the viral load of the HIV+ persons [1] (fig. 1).

A longitudinal study of 393 serodiscordant heterosexual couples has shown that over 14 years of follow-up, none of the HIV- partners was infected by his or her HIV+ partner on a fully suppressive antiretroviral regimen, whereas among couples where the HIV+ sexual partner was not on treatment, the cumulative rate of HIV transmission approached 8.6% [2].

In a second longitudinal study of 93 serodiscordant couples, among whom 41 HIV+ partners commenced antiretroviral therapy, 6 individuals became HIV infected; the 6 sexual partners of HIV+ individuals not on antiretroviral therapy and with a plasma HIV viral load of 1,000 copies/ml or greater [3].

Of the 62 serodiscordant couples that had unprotected sexual relations in order to procreate (HIV+ man on fully suppressive antiretroviral therapy), not one woman became infected [4].

Mother-to-child HIV transmission also depends on the maternal viral load and can be avoided by means of effective antiretroviral therapy [5-8].

According to the San Francisco Men’s Health Study, the incidence of HIV in the homosexual community (men who have sex with men, or MSM) between 1994 and 1996 was 0.12 (infections per couple). Fully suppressive antiretroviral therapy has been available since 1996. From 1996 to 1999, the incidence of HIV fell to 0.0048, even though far from all HIV+ men had been treated with antiretroviral therapy [9].

The HIV transmission rate is clearly more likely during the acute phase of infection (“primary infection”). Several studies have demonstrated that a large percentage of new HIV infections can be linked to a sexual partner who has only recently become HIV-infected [10-12].

Sexually transmissible diseases (STDs) aggravate the risk of HIV transmission (in the absence of fully suppressive antiretroviral therapy). Certain mathematical models, for example, show that in this context, syphilis infection, notably, plays an important role in the epidemiologic picture [13].

Within only a few days or weeks after treatment interruption, HIV viral load rises rapidly. At least one case of HIV transmission has been documented to have occurred under such circumstances [14].

Biological underpinnings
Antiretroviral therapy leads to a diminution of the concentration of HIV RNA in genital secretions to levels below the limit of detection [15-17].

As a general rule, the concentration of HIV RNA detected in vaginal secretions is lower than that detected in the blood; moreover, it is no longer detectable in vaginal secretions once effective antiretroviral therapy has produced its effect. In principle, the HIV viral load in blood plasma rises before the viral load in genital secretions [18].

By contrast, HIV DNA in cells of genital secretions can still be detected despite the presence of suppressive antiretroviral therapy [15, 19-21]. This, however, is not indicative of infectious virus in itself. HIV-infected cells in semen fail to incorporate DNA at the long terminal repeat (LTR), signifying that this virus is not actively propagating [22].

The risk of transmission is related to the concentration of HIV RNA in the sperm: when the presence of HIV RNA is undetectable, the risk of transmission is nearly zero [23] (fig. 2). Referring back to the biological underpinnings enumerated above, fully suppressive antiretroviral therapy significantly reduces the risk of transmission by this route.

During primary HIV infection, the level of HIV in genital secretions soars [24], which would explain the heightened risk of transmission during this early phase.

Presence of an additional STD (urethritis, genital ulcers) increase the HIV viral load present in genital secretions (but not in the blood) for several weeks; thereafter, when the STD is effectively treated, the HIV viral load in genital secretions falls [25]. HIV viral load in semen can, nevertheless, slowly rise even if the person experiencing an STD (urethritis) is following an effective antiretroviral regimen. This progression remains very low and is clearly inferior to that which would be the case in the absence of antiretroviral therapy [26].

Conclusion
In the presence of effective antiretroviral therapy, no free virus is detectable in the blood or genital secretions. All epidemiologic and biologic evidence indicates that the successful use of antiretroviral therapy allows us to rule out any significant risk of HIV transmission.

In the case of full virologic suppression, the relative risk of HIV transmission by sexual contact in the absence of condom use is clearly inferior to 1 in 100,000.

If the relative risk cannot be entirely eliminated from a scientific point of view, the Committee and interested organizations judge this risk to be negligible.

Importance and field of application of the message according to which: “STD-free, successfully antiretroviral treated HIV-positive individuals do not transmit HIV by sexual routes”.

Implications for physicians & other HIV care providers
This information aimed at treating physicians is designed to help establish whether or not the seropositive patient is at risk transmitting HIV via sexual routes. The patient will not transmit HIV by sexual routes provided that:

• That the HIV+ individual is under the care of a treating physician and that s/he takes the antiretroviral medication exactly as indicated;
• That the HIV viral load is below the level of detection of common viral load tests (“undetectable”) and has been for at least 6 months;
• That the HIV+ individual is not currently experiencing any other sexually transmitted infection.

The decision to initiate treatment with antiretroviral therapy must still be made according to current treatment guidelines. At this time, it is not expected that the initiation of antiretroviral therapy with the sole goal of preventing transmission: in addition to the costs of such an approach, it is also uncertain that HIV+ individuals not in need of antiretroviral therapy will be sufficiently motivated over the long term to adhere to the strict requirements of such therapy.

Treatment interruptions and misuse run the risk of the development of drug resistant viral strains. For this reason, it would not only raise the possibility of creating a public health threat but also would jeopardize the health of the patient. For this reason, the initiation of antiretroviral therapy for the sole reason of prevention could only be indicated in cases of highly motivated seropositive patients. It is therefore not recommendable to try to convince a patient to initiate antiretroviral therapy solely for reasons of prevention.

Implications for suppressed HIV+ individuals on effective antiretroviral therapy with no concurrent STDs
For HIV+ individuals on fully suppressive antiretroviral therapy who are in a longtime, stable relationship with an HIV- partner and have no other (active) sexually transmitted diseases, it is important that they know that they do not put their partner in danger of becoming HIV-infected so long as they are strictly adherent to their antiretroviral therapy regimen and are regularly followed by their treating physician. Once having fully understood these conditions and criteria, it is up to the seronegative partner to decide whether or not the couple would like to suspend other measures of protection.

Implications for individuals not in a stable relationship
For HIV+ individuals on fully suppressive antiretroviral therapy, it is important that they know that they cannot transmit the virus to their sexual partners so long as they are strictly adherent to their antiretroviral therapy regimen, have no other (active) sexually transmitted diseases, and are regularly followed by their treating physician.

Implications for HIV/AIDS prevention efforts
The message contained here within (that HIV+ individuals with full viral suppression on antiretroviral therapy cannot transmit HIV through sexual acts) in no way changes the HIV prevention strategies in place in Switzerland. In fact, with the exception of monogamous seropositive couples on fully suppressive antiretroviral therapy regimens, the standard measures of protection must be followed at all times. Individuals not in a stable relationship must, above all else, protect themselves: a seronegative individual must never fail to take preventive measures during a sexual encounter. If s/he comforts himself/herself with the oral declaration of his/her partner such as, “I am HIV negative” or “I am HIV positive but have an ‘undetectable’ viral load,” s/he courts the risk of becoming infected with HIV because there is no way (in that moment) of verifying these facts. It is in exactly these types of situations that the responsibility for his or her own health cannot and must not be relegated to altruism.

In the case of stable relationships where one partner is HIV+ and the other HIV- (“serodiscordant”), the decision whether or not to suspend the use of other protective measures is incumbent on the seronegative partner. For it is s/he who, if against all odds becomes infected with HIV, will suffer the consequences.

Legal implications
Courts and other legal bodies must take into account that “HIV+ individuals with full viral suppression on antiretroviral therapy cannot transmit HIV through sexual acts” when ruling on cases of the reprehensible aspect of intentional HIV infection. From the point of view of the Committee, a non-protected sexual encounter between an HIV- individual and an HIV+ individual on fully suppressive antiretroviral therapy who is adherent to his/her treatment and not suffering from another STD cannot be said to be willingly attempting to spread a dangerous disease, according to article 231 of the Swiss Penal Code, nor to be willingly inflicting grave bodily harm, according to articles 122, 123 or 125 of the same code.

Medical management of patients on antiretroviral therapy
At the time of the next consult, the treating physician would raise the issue with fully suppressed patients on antiretroviral therapy about the intransmissibility of HIV in HIV+ patients adherent to a fully suppressive antiretroviral therapy regimen, and counsel them according to the current state of their relation. The sexual partner of the patient should be present during this discussion, who must also bear in mind the current legal situation.

The medical consult
Medical discussion with a stable, serodiscordant couple (both partners must be present and participate) should explain in detail the conditions by which a seropositive person is deemed non-infectious:

• The HIV+ persons must consistently adhere to the antiretroviral therapy regimen and the effectiveness of the therapy be monitored at regular intervals by his or her treating physician according to officially accepted guidelines;
• The viral load must be below the limit of detection (<40>
• The HIV+ person must not be suffering from any other sexually transmitted infections.

Over the course of the consultation, the couple must understand that from the moment they decide to suspend other protective measures against HIV transmission, adherence to the prescribed antiretroviral therapy becomes of utmost important in their relationship. At the same time, the couple must also understand the importance of avoiding any additional STDs and must establish rules regarding sexual contact outside of their relationship.

Heterosexual couples who decide to suspend protective measures with condoms must additionally think about other means of contraception they might want to employ if they do not wish to conceive. They must therefore consider:

• The possible drug-drug interactions between hormonal contraceptive measures and anti-HIV medications that may risk weakening the effect of the contraceptive medicines;
• The teratogenic potential (possibility of damage to fetus) of some of the antiretroviral medications; specifically, the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (trade name Sustiva in the U.S.; trade name Stocrin outside the U.S.; India-produced generic equivalent known as Efavir; but also one of the constituent components of the increasingly popular once-a-day pill Atripla) should be avoided if the couple wishes to conceive.

Artificial insemination via sperm “lavage” (sperm washing) is no longer indicated in the presence of fully suppressive antiretroviral therapy where the only goal is to avoid transmission of HIV.

The medical interview between treating physician and couple should give each of the partners the opportunity to ask follow-up questions. The physician must also understand that it is up to the HIV-negative partner (and not the HIV+ partner!) to decide whether or not s/he would like to suspend the use of condoms; the interview should help the couple to define together how they will manage adherence to antiretroviral therapy, sexual contacts outside of the relationship (risk of STDs) and, where appropriate, the desire for a child. The physician should review these agreed upon ground rules and the success or failure at adhering to them at each subsequent clinic visit.

HIV+ individuals on fully suppressive antiretroviral therapy with no other (active) STDs with no stable partner should be informed by their treating physician that they cannot transmit HIV so long as they adhere to their antiretroviral therapy regimen. This could come as a great relief to them. Many studies show that the fear of infecting sexual partners makes the sexual lives of HIV-positive very difficult. In the interest of public health, however, physicians have continued to recommend that HIV+ individuals protect themselves (“safer sex”) during occasional and/or anonymous sexual encounters in order to minimize the risk of acquiring other STDs. Depending on the frequency of these contacts, agreed upon regular spot-checking and testing for the possible acquisition of additional STDs might also be reasonable. The parties in question should be sensitized/educated about the presenting symptoms of the various STDs.

Internet sites and brochures are available for treating physicians who would like to seek further advice from AIDS service organizations. The Committee encourages them not to hesitate to take advantage of these resources.


Authors
P. Vernazza
Prof. Dr méd., président de la Commission fédérale pour les problèmes liés au sida (CFS) et responsable de la Division des maladies infectieuses et de l’hygiène hospitalière de l’Hôpital cantonal de St-Gall

B. Hirschel
Prof. Dr méd., membre de la Commission d’experts clinique et thérapie VIH et sida de l’OFSP et responsable de l’unité VIH-SIDA des Hôpitaux Universitaires de Genève

E. Bernasconi
Dr méd., membre de la Commission d’experts clinique et thérapie VIH et sida de l’OFSP et responsable de la Division des maladies infectieuses de l’Ospedale Regionale Sede Civico à Lugano


References

1. Quinn TC, Wawer MJ, Sewankambo N, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group [see comments]. N Engl J Med 2000; 342: 921-929.
2. Castilla J, del Romero J, Hernando V, Marincovich B, Garcia S, Rodriguez C. Effectiveness of highly active antiretroviral therapy in reducing heterosexual transmission of HIV. J Acquir Immune Defic Syndr 2005; 40: 96-101.
3. Melo M, Varella I, Nielsen K, Turella L, Santos B. Demographic characteristics, sexual transmission and CD4 progression among heterosexual HIV-1 serodiscordant couples followed in Porto Alegre, Brazil. 16th International AIDS Conference, Toronto, 13-18 August 2006, TUPE0430.
4. Barreiro P, del Romero J, Leal M, et al. Natural pregnancies in HIV-serodiscordant couples receiving successful antiretroviral therapy. J Acquir Immune Defic Syndr 2006; 43: 324-326.
5. Garcia PM, Kalish LA, Pitt J, et al. Maternal Levels of Plasma Human Immunodeficiency Virus Type 1 RNA and the Risk of Perinatal Transmission. N Engl J Med 1999; 431: 394-402.
6. Rousseau C, Nduati R, Richardson B, et al. Longitudinal analysis of human immunodeficiency virus type 1 RNA in breast milk and of its relationship to infant infection and maternal disease. J Infect Dis 2003; 187: 741-747.
7. Kilewo C, Karlsson K, Massawe A, et al. Prevention of mother-to-child transmission of HIV-1 through breastfeeding by treating mothers prophylactically with triple antiretroviral therapy in Dar es Salaam, Tanzania - the MITRA PLUS study. 4th IAS Conference, Sydney, July 2007. Abstract TUAX 101.
8. Arendt V, Ndimubanzi P, Vyankandondera J, et al. AMATA study: effectiveness of antiretroviral therapy in breastfeeding mothers to prevent post-natal vertical transmission in Rwanda. 4th IAS Conference, Sydney, July 2007. Abstract TUAX 102.
9. Porco TC, Martin JN, Page-Shafer KA, et al. Decline in HIV infectivity following the introduction of highly active antiretroviral therapy. AIDS 2004; 18: 81-88.
10. Yerly S, Vora S, Rizzardi P, et al. Acute HIV infection: impact on the spread of HIV and transmission of drug resistance. AIDS 2001; 15: 2287-2292.
11. Yerly S, Race E, Vora S, et al. HIV drug resistance and molecular epidemiology in patients with primary HIV infection. 8th Conference on Retroviruses and Opportunistic Infections, Chicago, 4-8 February 2001. Abstract 754.
12. Brenner BG, Roger M, Routy JP, et al. High rates of forward transmission events after acute/early HIV-1 infection. J Infect Dis 2007; 195: 951-959.
13. Chesson HW, Pinkerton SD. Sexually transmitted diseases and the increased risk for HIV transmission: implications for cost-effectiveness analyses of sexually transmitted disease prevention interventions. J Acquir Immune Defic Syndr 2000; 24: 48-56.
14. Bernasconi E, Vernazza PL, Bernasconi A, Hirschel B. HIV transmission after suspension of highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2001; 27: 209.
15. Vernazza, P. L., Troiani, L., Flepp, M. J., Cone, R. W., Schock, J., Roth, F., Boggian, K., Cohen, M. S., Fiscus, S. A., Eron, J. J., and and the Swiss HIV Cohort Study. Potent antiretroviral treatment of HIV-infection results in suppression of the seminal shedding of HIV. AIDS 2000; 14: 117-121.
16. Cu-Uvin S, Caliendo AM, Reinert S, et al. Effect of highly active antiretroviral therapy on cervicovaginal HIV-1 RNA. AIDS 2000; 14: 415-421.
17. Vettore MV, Schechter M, Melo MF, Boechat LJ, Barroso PF. Genital HIV-1 viral load is correlated with blood plasma HIV-1 viral load in Brazilian women and is reduced by antiretroviral therapy. J Infect 2006; 52: 290-293.
18. Cu-Uvin S, Snyder B, Harwell JI, et al. Association between paired plasma and cervicovaginal lavage fluid HIV-1 RNA levels during 36 months. J Acquir Immune Defic Syndr 2006; 42: 584-587.
19. Vernazza PL, Kashuba DM, Cohen MS. Biological correlates of sexual transmission of HIV: practical consequences and potential targets for public health. Reviews in Medical Microbiology 2001; 12: 131-142.
20. Neely MN, Benning L, Xu J, et al. Cervical shedding of HIV-1 RNA among women with low levels of viremia while receiving highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2007; 44: 38-42.
21. Kovacs A, Wasserman SS, Burns D, et al. Determinants of HIV-1 shedding in the genital tract of women. Lancet 2001; 358: 1593-1601.
22. Nunnari G, Otero M, Dornadula G, et al. Residual HIV-1 disease in seminal cells of HIV-1-infected men on suppressive HAART: latency without on-going cellular infections. AIDS 2002; 16: 39-45.
23. Chakraborty H, Sen P, Pranab K, et al. Viral burden in genital secretions determines male-to-female sexual transmission of HIV-1: a probabilistic empiric model. AIDS 2001; 15: 621-627.
24. Cohen MS, Hoffman IF, Royce RA, et al. Reduction of concentration of HIV-1 in semen after treatment of urethritis: implications for prevention of sexual transmission of HIV-1. Lancet 1997; 349: 1868-1873.
25. Sadiq ST, Taylor S, Kaye S, et al. The effects of antiretroviral therapy on HIV-1 RNA loads in seminal plasma in HIV-positive patients with and without urethritis. AIDS 2002; 16: 219-225.
26. Pilcher CD, Tien HC, Eron JJ, Jr., et al. Brief but Efficient: Acute HIV Infection and the Sexual Transmission of HIV. J Infect Dis 2004; 189: 1785-1792.

Figures & illustrations

(Copies of original figures are not yet available to post here, but here are the titles and medical citations from which the figures were either replicated or derived.)

Figure 1
Viral load and risk of transmission
Quinn et al. New England Journal of Medicine 2000, 342:921-9.

Figure 2
HIV viral load in sperm and the risk of transmission
Chakraborty et al. AIDS 2001, 15:621-7.

Posted by Mike Barr at 3:55 PM

NYC HIV Expert:
Public Debate Needed on Swiss Study

Dear Michael,

I applaud you for your reporting and commentary on the recent release of the Swiss study and the way it has been handled so far by public health officials. I also greatly appreciate Walter Armstrong's insightful commentary that's posted on your blog. I would like to highlight some of the points that each of you has made and perhaps add a few of my own.

My gut reaction was that this study was one of the most important study done since the beginning of the AIDS epidemic. The Swiss Study both has the potentially enormously positive public health implications to reduce new infections and as Walter so poignantly points out to "acknowledge what it means to sexually, emotionally and even spiritually to people who have been living with the shame and fear of sex as infectious-all the while longing for the day when natural sex could return."

While it is understandable that the public health implications of the Swiss Study are carefully examined by public health authorities and the public at large before any formal changes in safe sex guidelines are made regarding risks for HIV transmission, I agree with Michael and Walter that the kind closed door deliberations that are going on in the SF Department of health seem inadequate.

The question of why there are 40,000 new HIV infections in America well into the era of HAART undoubtedly has a multifacted answer but at the bottom line reflects a failure of public health. Stigmatization, discrimination, disempowerment, poverty, and lack of access to real information about HIV infection risks are in my opinion responsible for many of these 40,000 new infections. In addition a real commitment by public health officials to reducing these new infections appears to be lacking given the institutionalization of discriminatory policies of the Bush administration by the public health service.

To my knowledge there is no publicly funded NIH study examining whether or not in men who have sex with men what the risk of HIV transmission is in monogamous serodiscordant couples if the positive partner has an undetectable viral load. It seems that this study should have been done long ago and if not urgently needs to be done now.

In my own practice, I am seeing about one newly HIV infected patient every 1-2 months. Approximately, 4/5 had been carefully following safe sex practices as such as advised by the SF department of health regarding condom use and had tested negative for many years. Whether as a result of a condom break, an unprotected oral sex encounter or some unidentifiable risk factor each of these individuals seroconverted. In no situation to my knowledge, extending back over many years did the negative partner in a serodiscordant monogamous relationship similarly seroconvert.

In fact I regard it of great public health importance that in each patient of mine who has recently seroconverted they generally had no knowledge of their partners HIV status or if they knew or considered that there partner might be positive they had no knowledge of their viral load. Each of my patients was relying on adhering to their own understanding of safe sex practices which had served them well, well until it didn't. Current safe sex recommendations do not include trying to obtain specific info regarding a partners viral load status.

I appreciated David Wilton's comment on Michael's blog about the focus of AIDS public health officials on male circumcision as prevention but all but ignoring the Swiss Study.

Michaels analysis of the SF Health Dept's communique about the Swiss study goes point by point over problems with that communique and should be the focus of a vigorous discussion and debate by public health officials, clinicians and researchers, the community of HIV infected individulas and the public at large.

One last point.

"HIV patients who carefully follow there treatment regimens may develop resistance." Certainly, if a patient who is undetectable is nonadherent then viral rebound and viral resistance can and usually will occur and change the status of that patient from undetectable and increase their infectivity.

However, it is rare for viral rebound and resistance to occur on a predictably excellent suppressive regimen such as those in the DHHS Guidelines in an adherent patient. I haven't seen it!

Patients including adherent patients do have viral blips as they must have had in the Swiss Study. Apparently in the Swiss Study blips didn't lead to infections.

It seems important to establish whether in men who have sex with men blips in well suppressed patients could result in new infections in unprotected sexual encounters. While this is of theoretic concern and should be aggressively investigated I again want to reinforce the importance of what I am observing in my practice.

The newly infected MSM patients in my clinical practice generally have been adhering to safe sex guidelines but have not been aware of the viral load status of their contacts. No serodiscordant MSM's have seroconverted in my practice who are in monogamous relationships.

I hope this note stimulates more discussion and debate and in particular an opening up of the dialogue between public health officials, clinicians, the HIV infected community gay community and public at large.

Sincerely,
Dr. Paul Bellman
New York, NY

CDC Panel Debates Swiss HIV Report on Thursday

I called numerous people today at the Department of Public Health requesting open forums to discuss the closed-door decision made last week by Grant Colfax, head of HIV prevention programs for the city, to reject an important study from Switzerland.

To my surprise, Tracy Packer, from the HIV prevention section of DPH who is also co-chair of the CDC's local HIV prevention planning council, left a message this afternoon about my request. (See below.)

It's a small step in the right direction that Colfax will make short remarks at the prevention council on Thursday afternoon, but it will not be the full discussion the San Francisco gay men's community needs with him about his rejection statement.

We very strongly must require wide and open debate first on the Swiss study and has value for HIV prevention in San Francisco, in addition to learning how DPH arrived at its dismissal of the study with no public comment.

Some background. Colfax has also been repeatedly asked to hold town hall meetings with the gay community regarding ineffective and offensive HIV social marketing campaigns, the presentations he and others from DPH made in Boston last week at the CROI AIDS meeting, and generally start a public and respectful engagement with gay men. He has steadfastly refused to do of any this.

I've also learned that Colfax wrote the DPH rejection statement while in Boston, so I guess only people at the CROI meeting may have had influence over the statement.

Colfax seems to be going so out of his way to not organize and host his own much-needed public dialogs that I'm beginning to think he's allergic to sunshine and is afraid to be accountable to his gay brothers.

The HIV prevention council meets on February 14 at 3 PM at the Quaker Meeting House, located at 65 Ninth Street. CDC rules require that members of the public are allowed three minutes of comment time, at the start of the meeting.

Here's the transcript of Ms. Packer's message:

"Hi Michael. It's Tracy Packer from HIV prevention returning your call.

"I just want to say I think that your suggestion that Grant talk about the Swiss study at the council meeting is a very good one. And I will pass that on to him.

"I believe that we're writing something about the Swiss study for the co-chairs report and then Grant can give a brief presentation as to the group that came together to respond to what the study said.

"Thank you for that suggestion. If you have any further comments, please call me."

Full Text:
Swiss HIV Report v SF DPH Rejection Statement

January 30, 2008
Communicated by the Federal Commission for HIV/AIDS.

HIV-infected persons on effective anti-retroviral therapy are sexually non-infectious

P. Vernazza, B. Hirschel, E. Bernasconi

Summary.

The Federal Commission for HIV/AIDS, following the proposal of the Sub-commission on Clinical and Therapeutic Aspects, and after review of the medical literature and extensive discussion, resolves that:

An HIV-infected person on anti-retroviral therapy with completely suppressed viremia („effective ART“) is not sexually infectious, i.e. cannot propagate HIV through sexual contact.

This statement is valid if

· this person is compliant with ART, whose effect must be evaluated regularly by the treating physician, and

· the viral load has been suppressed (non-detectable) since at least six months ago, and

· there are no other sexually transmitted diseases

a) Transmission depends on the viral load.

We define „effective ART“ as fully suppressive, stable treatment, with a viral load below the limits of detection in plasma (< style=""> Treatment is considered "stable" once the viral load has been undetectable for at least six months.

The Commission realizes that medical and biologic data available today do not permit proof that HIV-infection during effective ART is impossible, because the non-occurrence of an improbable event cannot be proven. If no transmission events were observed among 100 couples followed for two years, for instance, there might still be some such events if 10'000 couples are followed for 10 years. The situation is analogous to 1986, when the statement “HIV cannot be transmitted by kissing” was publicized. This statement cannot be proven, but after 20 years’ experience its accuracy appears highly plausible.

Concerning the statement "an HIV-infected person on anti-retroviral therapy with completely suppressed viremia („effective ART“) cannot propagate HIV through sexual contact” however, the evidence is much better than what was available in 1986 regarding kissing.

1) In sero-discordant couples (one person seropositive, the other seronegative), the risk of transmission depends on the viral load of the HIV-infected partner, see Figure 1 from reference (1).

2) In a prospective study of 393 heterosexual sero-discordant couples there were no infections among partners of persons on ART, compared to a rate of transmission of 8.6% among partners of untreated patients (3).

3) In another prospective study of 92 sero-discordant couples, where in 41 cases the HIV-positive partner had started therapy, there were 6 infections. All these occurred in partners of untreated patients (3).

4).Among 62 sero-discordant couples, where the male partner was HIV positive and on ART, with unprotected sex in order to conceive, there was no transmission (4).

5) Transmission from mother to newborn also depends on the maternal viral load, and did not occur in pregnancies where the maternal viral load was below 1000 copies per ml. If the maternal viral load is higher, transmission can be prevented by ART (5-8).

b) Effective ART eliminates virus from genital secretions

HIV-RNA, measured in sperm, declines below the limits of detection during ART (15-17). The viral load (HIV-RNA) in female genital secretions is, as a rule, below the plasma VL and below the limits of detection during effective ART. As a rule, it rises after, not before, an increase in plasma VL (18). Cell-associated viral genomes are present in genital secretions, even during ART (15, 19-21). But these are not functional virions. HIV-containing cells in sperm lack markers of viral proliferations such as circular LTR-DNA (22).

The concentration of HIV RNA in sperm (sperm VL) correlates with the risk of transmission. Transmission risk declines towards 0 with falling sperm VL, see Figure 2. These data indicate that the risk of transmission is greatly decreased by ART.

c) Exceptions and caveats

· After a few days or weeks of discontinuation of ART, plasma viral load rises rapidly. There is at least one case report of transmission during this rebound (14)

· In patients without ART, sexually transmitted diseases (STDs, for instance urethritis or genital ulcer disease) increase the genital VL; it falls again after treatment of STD (24). In a patient with urethritis, sperm VL can rise slightly even while patient is receiving effective ART. This rise is small, however, much smaller that the rise observed in patients without ART.

d) Conclusion

· During effective ART, free virus is absent from blood and genital secretions. Epidemiologic and biologic data indicate that during such treatment, there is no relevant risk of transmission.

· Residual risk can not be scientifically excluded, but is, in the judgment of the Commission, negligibly small

References

1 Quinn TC, Wawer MJ, Sewankambo N, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group [see comments]. N Engl J Med 2000; 342: 921-929.

2 Castilla J, del Romero J, Hernando V, Marincovich B, Garcia S, Rodriguez C. Effectiveness of highly active antiretroviral therapy in reducing heterosexual transmission of HIV. J Acquir Immune Defic Syndr 2005; 40: 96-101.

3 Melo M, Varella I, Nielsen K, Turella L, Santos B. Demographic characteristics, sexual transmission and CD4 progression among heterosexual HIV-1 serodiscordant couples followed in Porto Alegre, Brazil. 16th International AIDS Conference, Toronto, 13-18.August 2006, TUPE0430. 2006.

4 Barreiro P, del Romero J, Leal M, et al. Natural pregnancies in HIV-serodiscordant couples receiving successful antiretroviral therapy. J Acquir Immune Defic Syndr 2006; 43: 324-326.

5 Garcia PM, Kalish LA, Pitt J, et al. Maternal Levels of Plasma Human Immunodeficiency Virus Type 1 RNA and the Risk of Perinatal Transmission. New England Journal of Medicine 1999; 431: 394-402.

6 Rousseau C, Nduati R, Richardson B, et al. Longitudinal analysis of human immunodeficiency virus type 1 RNA in breast milk and of its relationship to infant infection and maternal disease. J Infect Dis 2003; 187: 741-747.

7 Kilewo C, Karlsson K, Massawe A, et al. Prevention of mother-to-child transmission of HIV-1 through breastfeeding by treating mothers prophylactically with triple antiretroviral therapy in Dar es Salaam, Tanzania - the MITRA PLUS study. 4th IAS Conference, Sydney, July 2007 TUAX 101. 2007.

8 Arendt V. AMATA study: effectiveness of antiretroviral therapy in breastfeeding mothers to prevent post-natal vertical transmission in Rwanda. 4th IAS Conference, Sydney, July 2007 Abstract TUAX 102. 2007.

9 Porco TC, Martin JN, Page-Shafer KA, et al. Decline in HIV infectivity following the introduction of highly active antiretroviral therapy. AIDS 2004; 18: 81-88.

10 Yerly S, Vora S, Rizzardi P, et al. Acute HIV infection: impact on the spread of HIV and transmission of drug resistance. AIDS 2001; 15: 2287-2292.

11 Yerly S, Race E, Vora S, et al: HIV Drug Resistance and Molecular Epidemiology in Patients with Primary HIV Infection. 8th Conference on Retroviruses and Opportunistic Infections, Chicago, 4.-8.Feb.2001 2001; Abstract 754(Abstract)

12 Brenner BG, Roger M, Routy JP, et al. High rates of forward transmission events after acute/early HIV-1 infection. J Infect Dis 2007; 195: 951-959.

13 Chesson HW, Pinkerton SD. Sexually transmitted diseases and the increased risk for HIV transmission: implications for cost-effectiveness analyses of sexually transmitted disease prevention interventions. J Acquir Immune Defic Syndr 2000; 24: 48-56.

14 Bernasconi E, Vernazza PL, Bernasconi A, Hirschel B. HIV transmission after suspension of highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2001; 27: 209.

15 Vernazza, P. L., Troiani, L., Flepp, M. J., Cone, R. W., Schock, J., Roth, F., Boggian, K., Cohen, M. S., Fiscus, S. A., Eron, J. J., and and the Swiss HIV Cohort Study. Potent antiretroviral treatment of HIV-infection results in suppression of the seminal shedding of HIV. AIDS. 2. 2000.

16 Cu-Uvin S, Caliendo AM, Reinert S, et al. Effect of highly active antiretroviral therapy on cervicovaginal HIV-1 RNA. AIDS 2000; 14: 415-421.

17 Vettore MV, Schechter M, Melo MF, Boechat LJ, Barroso PF. Genital HIV-1 viral load is correlated with blood plasma HIV-1 viral load in Brazilian women and is reduced by antiretroviral therapy. J Infect 2006; 52: 290-293.

18 Cu-Uvin S, Snyder B, Harwell JI, et al. Association between paired plasma and cervicovaginal lavage fluid HIV-1 RNA levels during 36 months. J Acquir Immune Defic Syndr 2006; 42: 584-587.

19 Vernazza PL, Kashuba DM, Cohen MS. Biological correlates of sexual transmission of HIV: practical consequences and potential targets for public health. Reviews in Medical Microbiology 2001; 12: 131-142.

20 Neely MN, Benning L, Xu J, et al. Cervical shedding of HIV-1 RNA among women with low levels of viremia while receiving highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2007; 44: 38-42.

21 Kovacs A, Wasserman SS, Burns D, et al. Determinants of HIV-1 shedding in the genital tract of women. Lancet 2001; 358: 1593-1601.

22 Nunnari G, Otero M, Dornadula G, et al. Residual HIV-1 disease in seminal cells of HIV-1-infected men on suppressive HAART: latency without on-going cellular infections. AIDS 2002; 16: 39-45.

23 Chakraborty H, Sen P, Pranab K, et al. Viral burden in genital secretions determines male-to-female sexual transmission of HIV-1: a probabilistic empiric model. AIDS 2001; 15: 621-627.

24 Cohen MS, Hoffman IF, Royce RA, et al. Reduction of concentration of HIV-1 in semen after treatment of urethritis: implications for prevention of sexual transmission of HIV-1. Lancet 1997; 349: 1868-1873.

25 Sadiq ST, Taylor S, Kaye S, et al. The effects of antiretroviral therapy on HIV-1 RNA loads in seminal plasma in HIV-positive patients with and without urethritis. AIDS 2002; 16: 219-225.

26 Pilcher CD, Tien HC, Eron JJ, Jr., et al. Brief but Efficient: Acute HIV Infection and the Sexual Transmission of HIV. J Infect Dis 2004; 189: 1785-1792.

-

February 7, 2008

SFAF/SFDPH Statement on the Swiss Natl. AIDS Commission's Report on HIV Transmission

There are nearly 1,000 new HIV infections in San Francisco and an estimated 40,000 to 60,000 new infections nationally every year. The San Francisco AIDS Foundation and San Francisco Department of Public Health urge individuals living with or without HIV infection to continue to use appropriate HIV prevention measures, specifically, to use male latex condoms correctly and consistently during sex. A recent Swiss AIDS Commission report demonstrating that, in some cases, HIV-positive partners did not transmit the virus to their partners in the absence of condoms, is insufficient evidence to abandon safer sex practices for several reasons.

The report reviewed data from four studies conducted among heterosexual couples alone. One, involving 393 serodiscordant couples, found that as long as the HIV-positive partner adhered to a treatment regimen, had an undetectable viral load for at least six months, and did not suffer from any other sexually transmitted infections, the HIV-negative partner did not become infected. But another study that was part of the same report found that 6 out of 43 HIV-negative partners did become infected—a rate of nearly 14%—due to the fact that the HIV-positive partner was not always faithful to a treatment regimen.

Neither the San Francisco AIDS Foundation nor the Department of Health endorse the Swiss AIDS Commission statement, because:

• all of the studies involved heterosexual intercourse and may have little bearing on intercourse among men who have sex with men;
• HIV-positive people with apparently undetectable viral loads can experience occasional spikes in viral load;
• HIV-positive people who carefully follow their treatment regimen may develop viral resistance;
• people with other sexually transmitted infections can be asymptomatic yet still capable of transmitting or contracting HIV; and
• the Swiss report, since it did not use randomized, controlled studies, has not yet verified its causal conclusions.

Even the Swiss commission acknowledges that the data they reviewed do not assume a total absence of risk. In short, HIV-positive people cannot be entirely certain that they meet these criteria or that the criteria themselves are an indication of safety. The San Francisco AIDS Foundation and Department of Public Health advise everyone to continue to use appropriate, evidence-based measures to prevent sexual HIV transmission.