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Archive for March, 2008

AIDS Activist Honored For Leadership

Posted by pozlife on March 27, 2008


by 365Gay.com Newscenter Staff

Posted: March 27, 2008 – 1:00 pm ET

(Los Angels, California) AIDS advocate Gregg Gonsalves has been selected as the first-ever recipient of the $100,000 John M. Lloyd AIDS Leadership Award. 

An AIDS activist for 17 years, Gonsalves has played a major role in international efforts to accelerate AIDS research and improve access to lifesaving drugs. He is currently based in Cape Town, South Africa, where he coordinates a regional AIDS and TB treatment advocacy program.

Gonsalves coordinates regional AIDS and TB treatment literacy and advocacy programs for the AIDS and Rights Alliance of Southern Africa, a network of African AIDS and human rights organizations. He is also a founding member of the International Treatment Preparedness Coalition, a network of more than 1000 people from 125 countries advocating for universal access to HIV/AIDS and TB treatment.

Gonsalves was formerly Director of Treatment and Prevention Advocacy for Gay Men’s Health Crisis (GMHC) and co-founder of the Treatment Action Group, both in New York City. Prior to that, he was a member of the Boston and New York chapters of ACT UP.

The John M. Lloyd Foundation was established in 1991 by John Musser Lloyd to seek creative, compassionate, and courageous solutions to the root causes of the AIDS epidemic. Each year, the foundation awards approximately $400,000 in small grants to groups and organizations.

This is the first leadership award it has given/

“We created this award to recognize and support the ‘unsung heroes’ of AIDS activism, and Gregg certainly fits the bill,” said Melanie Havelin, Executive Director of the John M. Lloyd Foundation. “Gregg’s visionary work on behalf of people living with HIV has had a major global impact.”

Zackie Achmat, founder and chairman of the Treatment Action Campaign in South Africa, said, “Gregg Gonsalves is one of the most remarkable leaders and activists I have met in the HIV epidemic … He is comfortable speaking to presidents, international agencies, and community leaders. Gregg assisted the Treatment Action Campaign in conceptualizing our national treatment literacy campaign and continues to support its work together with major advocacy efforts in the Southern African region.”

Gonsalves also received kudos from Dr. Anthony Fauci, Director of the U.S. National Institute of Allergy and Infectious Diseases.

“Gregg Gonsalves is a most distinguished HIV/AIDS and human rights activist. His impact on the HIV research and public policy agenda in the United States has been profound,” he said.

Larry Kramer, celebrated author and AIDS activist, said that Gonsalves is “the absolutely best person in this world to exemplify leadership and activism and brains and talent and expertise, certainly in the field of HIV/AIDS but in anything.”

Gay News From 365Gay.com


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Health Officials Issue Apology to Gay Community for MRSA Scare

Posted by pozlife on March 25, 2008


Article Date: 02/01/2008

By Dylan Vox

Over the last few weeks, the subject of Methicillin Resistant Staphylococcus Aureus (MRSA) has hit the media making a big impact in the gay community. Several reputable news agencies including the New York Times and the San Francisco Chronicle published detailed studies about the spread of the disease between men who have homosexual relations. While the risk of the” superbug” does have a higher rate of infection among men who have sex with men, the University of California San Francisco, who first reported the problem, issued a public apology to the gay community for singling them out as major contributor of this potentially deadly disease.

A new strain of MRSA, named USA300, which is particularly resistant to front line antibiotics, began to appear in the gay communities of San Francisco, New York and Los Angeles, and the quick rate of infection seemed to alarm health officials. Often referred to in the media as the ‘superbug’, MRSA is generally transmitted from skin to skin contact and can also be spread by touching contaminated surfaces, but the germ appears to be transmitted most easily through intimate sexual contact.

The germ typically causes boils and other skin and soft-tissue infections. Though staph infections are treatable in many cases, MRSA can be serious enough to force amputation of infected limbs or lead to death. If MRSA infects the lungs, the infection can cause severe pneumonia that kills within hours, according to the original article in the San Francisco Chronicle.

While it is true that MRSA has been identified among men who have sex with men, it has also been found in areas where people share close quarters, such as military barracks and prisons and hospitals and athletes are highly at risk.

According to the New York Times, “In 1998, The Archives of Internal Medicine published a report on MRSA among high school wrestlers, and The Clinical Journal of Sports Medicine published a report calling MRSA “the latest sports epidemic.”

While the spread of the disease is preventable by thorough washing with regular soap and water, the scare prompted many news-reporting agencies to refer to it as a “new gay disease.”

Early last week, the UCSF Dept of Public Affairs issued an apology stating: “We regret that our recent news report (1-14-08) about an important population-based study on MRSA USA300 with public health implications contained some information that could be interpreted as misleading. We deplore negative targeting of specific populations in association with MRSA infections or other public health concerns, and we will be working to ensure that accurate information about the research is disseminated to the health community and the general public.”

Although rates of MRSA are 13 to 15 times higher in men who engage in homosexual behavior, it is a disease that can affect the entire population, and gay advocacy groups felt that targeting the gay community could have negative repercussions.

“The way they keep targeting gays as if gays alone are responsible for it, it’s like H.I.V./AIDS all over again,” Colin Thurlow told the New York Times.

The Centers for Disease Control and Prevention in Atlanta, also released a statement last week that said it was not a sexually transmitted disease and could be contracted through skin-to-skin contact. They reiterated that MRSA is widespread in hospitals and among hospital workers. “These infections occur in men, women, adults, children and persons of all races and sexual orientations,” the statement read, adding that while the particular strain identified in the report had been found in gay men, it had also been found in people who were not gay,” the statement explained.

Some religious groups, however, have suggested that the CDC and the University are down playing the role that homosexual activity has on the spread of the disease in order to be politically correct.

Matt Barber, director of cultural policy for Concerned Women of America (CWA), told the Catholic News Agency, “After ‘pretty solid’ initial reporting of the outbreak, news coverage began to change when conservative groups like CWA began noting the microbe was spread primarily through male homosexual activity.”

He explained in his column in The Bulletin, Philadelphia’s family newspaper, “the actual study left little room for rationalization. It determined that the spread of MRSA “among men who have sex with men is associated with high-risk behaviors, including use of methamphetamine and other illicit drugs, sex with multiple partners, participation in a group sex party, use of the Internet for sexual contacts, skin-abrading sex and history of sexually transmitted infections.”

Ultimately, the study warned, “having male-male sex seems to be a risk factor for [MRSA].

While the reporting controversy continues to rage, more outbreaks have surfaced throughout the United States and abroad including a neonatal unit at Leeds General Infirmary in the UK and Coshocton Opportunity School in Ohio.

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Mr. Gay Ph.D, or Mr. Gay Porn Star?

Posted by pozlife on March 25, 2008


Article Date: 11/14/2007

By Dylan Vox

It’s a competition set up to establish “future leaders of the gay community,” open to anyone who wants to participate (as long as they are able to provide two to four pictures for consideration) and can fill out some basic statistical information.

It’s the Mr. Gay competition, and this week, Argentina announced their representative in the 2008 international event that takes place early next year.

The winner is none other than sexy porn star Max Schutler, who has appeared in films like Rush and Release and Bang that Ass.

The question of one’s past hardly seems relevant in a competition like this, but it does raise the issue: What exactly constitutes a representative of the gay community, and how well do we as a community accept ourselves?

Technically, the Latin hottie who won the prize is named Jorge Schmeda, but he is probably just as well known by his nom de porn.

The competition is produced by the Noble Beast Foundation, which has created the competition to “raise the visibility of non-stereotypical gay men.”

On their website, they claim that their goal is to “humanize gays in the media by providing alternative images for the press that represent more diversity in gay culture by showcasing leaders from around the world,” and “confront homophobia by examples and press stories about gay men that show that gay is not a stereotype and do so in a way that creates the most impact and debate.”

In the United States, gay porn is often looked upon as a poor representation of the gay community, but other countries like Argentina have less hang ups about allowing their community to be represented by someone who has participated in the industry.

For most naysayers, the problem isn’t so much that a porn star will be representing a country at the competition as it is about the validity of the competition itself.

Mr. Gay USA was awarded last week to Jonathon “JT” Taylor from San Francisco. The sexy guy has two undergraduate degrees in business and biology and is currently working on his Master of Public Health, planning to become a M.D. He seems like an amazing candidate to represent the gay community, and his amazingly hot looks couldn’t have hurt his chances of winning either. But if you really look at the field, they are all incredibly hot, with perfect shapes, great abs and fantastic smiles, so one begins to wonder: What is the competition really about?

The organizers say they are “looking for all types of guys, from gym-bunny to math geek with a passion to lead,” but the math geeks seem to have taken a much further back seat to the gym bunnies… like perhaps on a different bus.

Unfortunately, there is very little information about the new Mr. Argentina other than his toned physique adorning the new cover boy of Guapo Magazine, but even if he is a rocket scientist, would that really have been the reason he won?

The organizers insist that they are looking for the “unassuming average Joe who just may be spectacular precisely because he will inevitably say, ‘this is not my thing’,” but looking at all of the participants and finalists from the past few years, one could hardly say that any of them are average.

They are hot. Gay guys like hot guys. It’s that simple. Sure, it’s great if some brains and humor are attached to the package, but when it comes down to it, no one is going to give Woody Allen the Mr. Gay Title.

In European and Latin American countries, sex and sexuality are more accepted as a thing of beauty, which is to be admired. For them, electing a hot porn star to represent their country is more of an honor.

In the western world, expressions of sexuality are often looked down upon, even in the most liberal communities. Sexy Jeremy Taylor, aka porn star Christian Owen, was a participant in the Mr. Gay USA Competition, but didn’t even place in the final rounds.

Having a well educated man who just happens to look like a porn star is much more accepted in the United States than actually having a real porn star, but the bottom line is that the gay community reveres and honors beauty.

Undoubtedly Mr. Gay Argentina will quickly and discretely fall to the way side when he enters next years ultimate competition, which is being held in Hollywood in January. My thought is the American judges will not look so kindly on his porn background.

But at least the Argentineans were looking at the competition for exactly what it is when they made their choice for a delegate: It’s a beauty pageant. It represents the finest looking gay men in the world, and it’s great that a porn star was chosen to be part of the event.

There is nothing wrong with porn or rewarding and promoting beauty, but thinly disguising it as a means to conquer gay stereotypes seems like an injustice to the men involved.

Sometimes it’s OK to call a spade a spade, and no one will object to the eye candy that will be present at the competition. But if Mr. Gay is truly trying to break down gay stereotypes, then they may have missed the mark.

The gay community is made up of all kinds of people from the old and the ugly to the Adonis like men who grace the covers of magazines, and each of them are trying to earn acceptance in a society that still judges homosexuality as a negative trait.

There are leaders who have made an unflinching commitment to making sure that gay people are represented fairly in politics, sports, arts, entertainment and community service, and those are the true representatives of the gay community.

It’s great to break down stereotypes and to show a new face of the community to those around the world, but in order to be accepted by society as a whole, we must first learn to accept ourselves.

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The Risky Business of Bareback Porn

Posted by pozlife on March 25, 2008


Article Date: 11/01/2007

By Dylan Vox

Barebacking has been a controversial subject in the adult industry for years, but this week the argument over condom use came to a sad and inevitable forefront yet again as three UK based porn actors reported they had contracted HIV. The actors claim they were infected during the shooting of a barebacking video with a fourth actor, who says he didn’t realize he was HIV-positive until days after shooting.

Protecting porn actors from HIV has become an increasing concern in the industry over the last decade. With studios taking more precautions to prevent infection, there have been very few reported outbreaks or instances involving the spread of HIV connected to porn in recent years.

But the UK outbreak changes things. The actor tested positive days after shooting  Then his three young co-stars tested positive with a new 48-hour test screening, indicating they had likely been infected on the shoot.

One of the actors explained to Boyz Magazine it was standard practice in the European industry to perform without the use of condoms. “On all the shoots, we do everything: kiss, rim, fuck. I’m passive, but he didn’t come inside methat never happens in porn, it’s all face and mouth. It must have been from his pre-cum inside me.”

The sad report comes just days after the controversial David Awards ceremony, which honors outstanding work in the adult industry.

The David Awards are the European equivalent to the U.S. based GayVn’s, which are handed out annually to companies and models in the adult industry.

While the American version doesn’t condone or recognize companies that involve models with unsafe practices including barebacking, the David awards do not distinguish between those who promote safe sex and those who don’t… something award winning director and porn legend Chi Chi Larue took issue with.

Larue was nominated and won awards in several categories at the recent awards ceremony. An outspoken champion for safe sex practices. Larue has been instrumental in creating condom PSA’s for each of his videos.

In an interview with JC Adams, Larue explained that he was unaware that the Awards honored bareback movies and, once he was informed, he told organizers that he would make a statement about barebacking if he were to go up on stage.

“The organizer’s said, ‘No’. Just like that,” he explains. “So I handed them back my Best U.S. Director Award. I said, ‘Take it. Thanks, but I don’t want it’.”

While the straight side of the industry has had mandatory HIV testing in place for the past few years, condom use has been the primary safety measure used in the gay side of the business.

“It’s extremely safe, probably a lot more so than most people have in everyday life,” adult film star Rob Romoni explained in an e-mail interview. “We go through a lot of condoms during a scene to help prevent breaking and to keep disease risks very low.”

Many of the straight companies have gay subsidiaries and apply their testing policies across the board. HIS is the popular line of gay films created by the Hustler conglomerate, and they require all of their models to get STD tests prior to filming.

“It’s like a double safety net, to insure the safety of the models,” a HIS spokesperson explained.

In 2004, the straight side of the adult industry stopped filming for several months after model Darren James was found to have contracted HIV while filming in Brazil. Fourteen actresses who had been in films with James were also quarantined, along with 35 of their partners, in order to control any spread of the virus.

Dr. Sharon Mitchell, who helped found the Adult Industry Medical Healthcare Foundation, told Medical News Today it was very rare for STD’s like HIV to be spread in the industry given the rigorous testing procedures. AIM health care regularly tests more than 1,200 actors who are working in the adult industry, and prior to this outbreak, there had never been a reported problem, she said. 

On the gay side of the industry, most companies insist on condom use and will not work with actors who have appeared in movies involving bareback sex.

Performer Drew Case told Boyz Magazine that barebacking companies in the United States tend to work on the “don’t ask, don’t tell” policy when it comes to HIV and STD’s.

“People assume that if you are performing in barebacking films that you are positive, and are unconcerned about reinfection.”

In Europe, most companies which produce barebacking films require their models to be tested. The production company involved with this current incident had tested all of their models. According to reports, the HIV positive actor had tested false negative during routine testing, which allows for a three month window in which HIV antibodies are undetectable.

Forty-eight hour tests are not considered as reliable, but could be helpful at closing the window before filming a project. Those tests are not currently mandatory, but now film companies may be more ready to use them in order to protect the safety of their models.

Porn is a multi-billon dollar industry that has been a target of constant scrutiny. While condom porns are literally littered with warnings of condom safe practices, consumers of bareback videos understand the risks the models are taking. While many in the industry object, there continues to be a market for bareback porn and the companies are still turning in large profits.

The production company behind the video in question, which declined to go by name in the Boyz Magazine article, is reporting they are moving ahead with plans to release the video.

“Unsuspecting viewers won’t be aware that they’re actually watching the young performers being infected with HIV,” a rep from the production company said in the article.

Because the young actors signed confidentiality agreements with the studio, consumers of the tape might never know what exactly they’re watching.

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Chi Chi LaRue Takes a Stand Against Barebacking in Gay Porn

Posted by pozlife on March 25, 2008


Article Date: 02/05/2008

By Dylan Vox

Over the past few years, a frightening new trend has been developing in the gay adult industry, and now, after some controversial publicity, porn director extraordinaire Chi Chi LaRue and the company heads at Channel One Releasing are taking a stand against barebacking videos. A new website and four minute PSA featuring some of the hottest boys in the business is reiterating the message that ‘safe sex is hot sex’.

Larue has produced countless award winning films on both the straight and gay side of the industry throughout his career, and has been one of the strongest proponents for safe sex and the health of the models that he works with.

Earlier this year, his self-created studio became the largest gay adult company when it purchased both All Worlds Studio and the legendary, now defunct, Catalina line of films. The Channel One conglomerate has been vocal about the protection of the models in the industry, and after 20 years of directing and producing films, LaRue has become legendary for his success and his strong stance against unsafe sex.

In 2006, Larue turned down a huge contract with the famous Vivid Video over condom and safe sex issues.

He explains on the new safe sex promotional website, “I walked away from a lucrative contract with Vivid Video when they decided to go ‘condom optional’ so don’t ever say I don’t put my money where my mouth is!”

Earlier this year, the controversy over the increase and success of barebacking companies came to a frightening head when three UK based porn actors reported they had contracted HIV. The actors claim they were infected during the shooting of a barebacking video with a fourth actor, who says he didn’t realize he was HIV-positive until days after shooting.

Following the news, Larue along with Titan Media’s Bruce Cam and Keith Webb took a bold anti-AIDS/anti-bareback position when they refused to accept their honors at the David Awards, the European equivalent to the GAYVN’s.

Many supporters for barebacking argue that adult films are about creating fantasies and that most of the time condoms take away from the moment.

Sam Dixon of Tipo Sesso told Out Magazine, “We’re an adult industry. We’re not an educational industry.”

Larue explains that in the past, “it was pretty obvious to most that the models ‘appeared’ to be HIV+ and were having unsafe sex with what ‘appeared’ to be other HIV+ models” in barebacking films.

The trend, however, seems to have shifted, and more and more companies are relying on younger men who are willing to do riskier things for money.


“Younger gay guys who didn’t have all their friends die, who didn’t see deathly ill gay men at the grocery store, and aren’t bombarded with AIDS messages on the news daily can watch barebacking porn and it doesn’t affect their behavior,” LaRue says. 

Larue also explains that he understands that it is not just barebacking porn that is leading to the current rise of HIV/AIDS cases among young gay youth.

“I think the lack of real sex education, thanks to our current conservative regime, is a factor. Let’s not forget the rampant drug abuse in the gay community, which is definitely a factor. I also think gay men are really just tired of talking and hearing about it! But we can’t stop talking about it. I think what we are seeing is a result of too many people being way too silent!”

With the new ‘Safe Sex Is Hot Sex’ campaign, Larue hopes to put an end to all of those critics who have said that he doesn’t stand behind his messages.

“Look I understand about freedom of speech and freedom of choice more than anyone, and if people don’t want to watch the PSA, or if they don’t agree with my stance, that is their prerogative,” he told GayWired.com. “I do, however, hope that people will see that there is a safer, sexy alternative and that people can watch my movies and the films made by other condom only companies and understand that they are watching amazing hot sex that is not undermined by the use of a condom.”

Larue, who says that he has never and will never produce a barebacking film, has a strict policy of protection on all of his film sets.

“I have always promoted on my sets the same thing that I feel every gay man should practice in his personal life. Assume everyone you are having sex with is HIV+. That way you are taking a proactive approach to staying healthy and disease free.”

Since 1999, the number of new AIDS/HIV cases among the gay population has been slowly on the rise according to recent CDC reports. In 2003, approximately 63% of new cases were among men who were infected through sexual contact with other men according to the MMWR CDC report.

A majority of those new cases are among younger gay and bisexual men who have less fear about the risk of infection.

In a study presented to the CDC about unprotected sex, Dr. Kenneth Mayer, medical research director at Fenway Community Health in Boston, noted in Healthday: “We found that almost a third of the men (in the study who were reportedly HIV- positive) said that they had had unprotected anal intercourse with at least one partner of unknown serostatus, and almost a quarter had unprotected intercourse with a partner who they knew was HIV uninfected.”

Dr. Mayer talked about the importance of education to help reinstate the message that these practices are still dangerous.

Channel One’s new PSA is part of the bigger picture of education, and LaRue feels an ethical responsibility to helping educating the younger generations, as well as a sense of providing the safety for the models working in the industry.

And as Chi Chi adamantly proclaims in her service announcement, please, “Wrap it Up!”

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Gay Porn Stars Express Concern about HIV In the Industry

Posted by pozlife on March 25, 2008


Article Date: 03/04/2008

By Dylan Vox

In an anonymous survey conducted by TheSword.com last week, almost 30% of gay adult performers revealed that they were either HIV positive or were unaware of their HIV status.

While many performers believed that condom only studios were providing safety for industry workers in the area of HIV prevention, only half believed that they were receiving adequate prevention from other STD’s like syphilis, HPV and Chlamydia.

The study comes on the heels of legendary adult film director Chi Chi Larue’s new “safe sex is hot sex” campaign. The campaign, which hopes to sway porn buying audiences away from the dangers associated with unsafe sexual practices, has again called into question the issues around barebacking videos.

While many high profile companies like Channel One Releasing, Falcon and Colt require all models to use condoms during sex, very few are asking for mandatory testing for the performers.

Companies like Hustler’s HIS video, which make condom only films, are also requiring testing as an extra step in protection.

Many safe sex advocates are hoping for this practice to become more commonplace in the adult industry, but so far, companies have been unwilling to test all models because of the stigma associated with HIV.


Spenser Quest, who has detailed his trials of becoming positive in the gay adult industry on his website, commented to BGay News, “It’s a chorus that we’ve heard before more than a few times, with newly HIV positive performers fearing they’ll be blacklisted if their status is known. For those who are new to the business, or for younger performers who are relatively new to gay sex, the silence around the topic can lead to fear, shame and a lack of safety with other performers in sexual situations off set.”

Some companies have bucked this trend and are testing models and pairing them with partners of equal status. Mike Hancock of MikeHancock.com explained that he would still work with HIV positive models, but that they would have to be paired with other positive performers for everyone’s safety.

Hancock explained that he has received criticism from agents and other companies who feel like this practice violates the performers privacy, but Hancock insists that safety is his top priority.

The Sword has posted full results of the online survey, which also reveals that most performers never discuss their HIV status with screen partners before performing in a scene.

Most performers did, however, state that they would never participate in barebacking videos even if mandatory testing was put into place.

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Rapid Liver Fibrosis Occurring More Frequently Among HIV-Infected Men Newly Coinfected With Hepatitis C

Posted by pozlife on March 12, 2008


An Interview With Daniel Fierer, M.D.

By Bonnie Goldman

February 4, 2008

Daniel Fierer, M.D.

Daniel Fierer, M.D.

Listen (27 min.)

There’s nothing like hearing the results of studies directly from those who actually conducted the research. It is these women and men who are transforming HIV treatment and care. In this interview, you’ll meet one of these impressive HIV researchers and read an explanation of the study he is presenting at CROI 2008. Accompanying me on this interview is Dr. Gerald Pierone, an HIV clinician/researcher and the founder and executive director of the AIDS Research and Treatment Center of the Treasure Coast in Fort Pierce, Florida.

Daniel Fierer: I’m Daniel Fierer. I’m an infectious diseases physician at the Mt. Sinai School of Medicine in Manhattan. My presentation is describing accelerated liver fibrosis in the outbreak of acute hepatitis C in HIV-infected men,1 which had not been previously described. These were otherwise pretty healthy men who had well controlled HIV infection, many of whom were having unprotected sex with other HIV-infected men, and presented to their primary providers with classic acute hepatitis C: a new increase in liver enzymes, and new antibody to hepatitis C. They were referred, then, to me, where we performed liver biopsy early in the course after onset of their hepatitis, and nine of 11 had stage 2 out of 4 fibrosis.

That is an unprecedented finding. In other studies of acute hepatitis C in people who don’t have HIV infection, it was rare to find any fibrosis at all. In an Egyptian study of over 80 patients with acute hepatitis C, biopsied early, none had any fibrosis (all with stage 0 fibrosis). And a much smaller group in Italy of nine people who had been infected by an unfortunate contamination when they were in a clinical trial, only four had stage 1 fibrosis, the other five had no fibrosis.

Click to enlarge
For additional slides from this study, click here.
Daniel Fierer et al. CROI 2008; abstract 1050. Reprinted with permission.

And so, our findings were completely unexpected. In the recent European outbreaks of acute hepatitis C in HIV-infected men, systematic liver biopsies were not performed. I’m presenting here biopsy results from our first 11 patients: nine of them had stage 2 fibrosis; one of them had stage 1 fibrosis; and one had a different flavor of liver disease, but that is not necessarily characteristic of hepatitis C. Overall, significant fibrosis early in the course of hepatitis C infection in fairly healthy people who didn’t have any other reason to have underlying liver disease.

Gerald Pierone: So, what do you think?

Daniel Fierer: I think that underlying immunosuppression in general is a set-up for aggressive liver disease after acute hepatitis C infection. And the course of liver disease with underlying HIV infection appears to be particularly aggressive.

If you have underlying immunosuppression of some sort, schistosomiasis, for example, in Egypt causes an accelerated course of fibrosis after acute hepatitis C, four times faster than in patients without schistosomiasis. Another example is people who have had liver transplants due to hepatitis C receive immunosuppressive drugs; in some cases, biopsies show a little over stage 1 fibrosis in a year.

In contrast, our patients had stage 2 fibrosis in as little time as three weeks, up to a little over a year. People say, “Hmm… accelerated fibrosis in HIV,” and think, “Oh, we know that.” But this is actually a different disease process.

Gerald Pierone: How do you know? There are emerging reports of patients with long-term exposure to HIV medications having fibrosis based on drugs. How do you know you’re just not picking up this person, if you pulled him off the street without hep C and biopsied him, wouldn’t have stage 2 disease?

Daniel Fierer: It’s a good question, one that our reviewers have asked us as well. The short answer is that we have one patient who has never received antiretrovirals and so his fibrosis, which is indistinguishable from the eight others with stage 2 fibrosis, could not have been caused by antiretrovirals. In addition, we have one patient who had less than a year of antiretrovirals, and a number who had less than 5 years of antiretrovirals, and no “D-drugs,” which are considered the ones responsible for liver damage. So while some of our patients had antiretrovirals for 14 or 16 years, and did receive “D-drugs” as I said, most had shorter-term treatment, from less than a year, three years, five years… And those studies evaluating liver disease from antiretrovirals, they are very few and far between. We have looked in the literature for all of them that suggested fibrosis in people who took antiretrovirals. There are few reports of biopsies from only a very small number of people who had ALT elevation, and they didn’t see, from what we can tell, what would be considered to be hepatitis C–like fibrosis — although we haven’t seen those biopsies ourselves.

Gerald Pierone: Along those lines, do many of your patients have much in the way of steatohepatitis in conjunction with…?

Daniel Fierer: A really good question. There is some fat, but not of the kind usually seen with antiretrovirals or non-alcoholic steatohepatitis, it is characteristic of hepatitis C.

One of our patients might have had something related to NASH; he was the one who was infected only less than a year, and was on very few and short duration antiretrovirals. So we don’t know quite what was going on with him to explain his liver disease but it was unlikely to have been due to his antiretrovirals. Overall, I’m hoping to get a follow up liver biopsy on some of these people after treatment to see if this fibrosis has reversed at all.

But I think we can state very confidently that this is not the antiretrovirals that have caused the fibrosis that we observed.

Bonnie Goldman: I wanted to back up and talk about the infections. Because I think this is the first time in the United States where MSM has been described to have HCV transmitted to them. Because the other descriptions were in Europe. Is that correct?

Daniel Fierer: Well, I have to give credit to Annie Luetkemeyer and her colleagues at UCSF, who described a retrospective study of, as I remember, nine patients in JAIDS in 2006. And they remarked that going back to the chart and talking to the patients, that some clearly were not injection drug users, and the authors believed that there may have been sexual transmission of hepatitis C.

I am now collecting a prospective cohort, very much like the European experience, so we hope to be able to come to a more detailed understanding of the risk factors for transmission.

Bonnie Goldman: And this is in New York? Right. And could you talk about their exposures?

Daniel Fierer: Yeah, absolutely. We have a very detailed questionnaire that’s derived from Mark Danta’s from London. I asked my patients to help me modify it to be relevant to New York — for example, which Web sites they’re visiting. And our results have been fairly similar to what was reported in England, and also in Holland, who had the most detailed questionnaire studies. Most of the men in our study had unprotected anal intercourse, and also a fair number of activities that would be considered high risk for some trauma, and not many had risk factors of injection or other percutaneous exposures.

Having said that, of the 11 here who had liver biopsies — a few of them, due to, I think, a fairly mature crystal meth epidemic, have been slamming.

Bonnie Goldman: Can you describe what slamming is?

Click to enlarge
For additional slides from this study, click here.
Daniel Fierer et al. CROI 2008; abstract 1050. Reprinted with permission.

Daniel Fierer: Oh, I’m sorry. Injecting crystal meth, in particular. Some long-time crystal meth users One person was pretty sure that he had shared his works with somebody else. The others have really said they’ve been very careful to not do it but, being that high, just simply couldn’t remember it. So it’s the minority of the group, but it’s more, percentage-wise, than was reported in Europe. And I think that may represent different patterns of crystal meth use in New York compared to Europe. M patients are certainly telling me that they have seen quite a number of people who inject meth in the clubs. In addition, there are people who are going in and injecting people, as a service. So there is a fair amount of injection drug use around, anecdotally.

And I think that brings up a very significant concern, that this hepatitis C outbreak could really explode if injection drug use becomes popular in MSM, because hepatitis C is much more infectious through blood route. This could be ther route to introduce in a big way hepatitis C into this group of men in whom hepatitis C was relatively uncommon, I think, relative to other populations. Which I think is one of the reasons why sexual transmission in MSM was relatively rare in the past. But I think we may be reaching, and I hesitate to use the word “threshold” in its technical epidemiology sense, but in a more informal way: a threshold prevalence of hepatitis C at which point this outbreak may amplify significantly.

Bonnie Goldman: I see some of the exposures might have been straws. Could you talk about that, also from a prevention point of view? People don’t realize that using a straw might be dangerous.

Daniel Fierer: Epidemiologic evidence has suggested that sharing of straws is a risk factor for having hepatitis C infection. In at least one study, hepatitic C virus has been isolated from straws that have been used for snorting cocaine, but in a minority of cases. We list any possible exposures, so straws are on the list as a possibility in those who reported using them. In reality, the men in our study who shared straws had had unprotected sex with many men as well and so we don’t know that it was a straw that transmitted the virus. I think the medical community is quite skeptical in this country about hepatitis C being sexually transmitted, possibly because we haven’t had the reports in this country of outbreaks of hepatitis C until the UCSF report and ours.

Other researchers have asked me, “How do you know transmission wasn’t from injecting drugs or sharing straws? Here’s the most conservative look. This patient told me that he shared a straw a couple of times. That’s the sum total of the percutaneous exposure.

So straw sharing certainly has been considered to be a risk factor for hepatitis C infection, especially with cocaine use. And I don’t see why crystal meth would actually be different — it’s a pretty abrasive substance.

Gerald Pierone: You mentioned before that you’re going to be treating these, or you’ve treated these, patients. Any of them: did you follow them to see what percentage would actually clear the virus on their own? So my question is, perhaps could we be seeing a phenomenon where some of these patients might clear virus on their own, and also clear fibrosis on their own, as in a treated patient?

Daniel Fierer: But I think it’s a very important point about patients clearing virus on their own, that is, their own immune system clears the virus. It’s something I’m very interested in

Backing up for a second. The definition that’s in the books of what acute hepatitis C is: It was simply defined as the first six months of infection, starting from the time of infection. Well, in our patients we can’t really identify the time of infection, too many possible exposures. It is more clear in the case of a transfusiontransmitting hepatitis C. But we really can’t know that in our patients. Back to the definition of acute hepatitis C, I think the 6-month time period wasextrapolated from the hepatitis B experience after the discovery of hepatitis C.

With hepatitis B, 95% of people clear it, and they do it very quickly, within six months. Hepatitis C is totally different than that, it’s controversial how long it takes people to clear. If you look at different cohorts, they give very different answers. Some publishedthat everybody who’s going to clear clears in three months. But in an Australian cohort, for up to two years a significant number of people were still clearing.

So, based on that experience, and tempered with the consideration that underlying HIV infection may change things, I have been really individualizing the evaluation by watching patients very closely for the characteristics of acute HCV infection, which include fluctuations in viral load and LFTs.

So, back to the question: Absolutely. I give people a chance to clear, and at least 12 weeks. But sometimes up to 24 weeks from their first ALT elevation — which, technically speaking, would be longer than six months after infection because it takes a couple of months or so for the first ALT elevation. But there are patients who have wide viral load fluctuations. We want to give those people a chance. Because I think that immunologically they do much better. If they clear on their own, it’s much better. Not to mention, not having to get six months of interferon and ribavirin.

Gerald Pierone: So, did any of these 11 clear?

Daniel Fierer: I wait at least six months of an undetectable viral load to consider the patient to have cleared. We have three people who appear to have cleared by that definition. I have really just started recruiting this cohort, only about a year and a half ago, plus or minus when our first couple of patients came in. And so I haven’t had time as much as the European cohorts have had to observe them. But, yes. We have somewhere around 15 percent who spontaneously cleared right now. Others, we’ve started treatment. We have had really excellent success so far. Nobody whom we’ve initiated treatment on has failed yet, knock on wood. But we’re talking about seven or so people right now who have made it far enough to really assess to end of treatment. So, as I said: I have about 25 patients who we’ve seen. But considering the observation period and the length of treatment and then the six months afterwards to determine SVR, I don’t have long-term data on many. But we are optimistic that, despite this observation of stage 2 fibrosis, they are behaving as acute hepatitic C, and that we continue to have a very high rate of treatment success.

Gerald Pierone: Had you done any FIB-4 or FibroSures or anything to try to link to this, or no?

Daniel Fierer: I’ve looked, done a couple of the calculations.. But it is too early in the liver disease. I think most people acknowledge that stage 2, while being very significant if you have it within a month or two of your HCV infection, is not far enough advanced to see on the non-invasive tests. So it’s really silent without a biopsy.

Gerald Pierone: Why not?

Daniel Fierer: Well, I think the non-invasive tests are pretty much acknowledged to only pick up things at about stage 3 and stage 4. They are pretty good at identifying cirrhosis and stage 3 fibrosis.

Gerald Pierone: But when you look at the receiver operating curves, though, they seem to perform well.

Daniel Fierer: They perform well, but not at stage 2. They just can’t predict the earlier stages. And we’re interested in FibroScan, and are trying to obtaining a FibroScan device. We’ve been working on the funding for that. We’re interested to see that. But to get the sensitivity to detect stage 2 fibrosis, the specificity isn’t good. The Spaniards have a lot of experience with FibroScan and report that finding at this meeting, although I have not seen their actual data on that. But we’d be very interested to be able to find the fibrosis in other, non-invasive, ways.

I’m really interested in trying to understand what is driving the fibrosis. And the liver biopsy is really, unfortunately, the only way we’re going to be able to identify other contributing elements. Our pathologists have been looking very carefully for such things. This report is focused on the periportal fibrosis, but we are investigating other elements that may give us clues as to what other inflammatory processes may be going on. It would be nice to have non-invasive markers to be able to follow people over time to see how they will do, of course. But in order to really discover the pathogenesis, we do need the liver tissue.

Gerald Pierone: That would be ideal. If you do FibroSures, FibroScans, link it with your biopsy. And then, once you get a little bit of a database, then maybe you could sort things out.

Daniel Fierer: Right. And we plan to do that. But unfortunately, from fairly large experience of people with chronic hepatitis C, we don’t expect to have useful results from that. Because at least in people with chronic hepatitis C, stage 2 is really flying below the radar of these non-invasive tests. But that would be very helpful to have one that worked for us, no question.

Bonnie Goldman: I have a final question about the HCV transmission. I notice that most of the men are older. What’s your feeling about that? I don’t know if that’s duplicated in the other reports? There’s not a man in his twenties. So the average age is probably 42, or something. So that’s kind of striking. And what do you make of that?

Daniel Fierer: There are a couple of observations in there that I find distressing, as well. Some of these men in their forties have had HIV infection for some time. Some, however, were very recently HIV infected. This man whose liver biopsy is shown on the poster had only become HIV infected one year prior to his acute hepatitis C infection. Another patient had been diagnosed with HIV infection only 11 months prior.

As matter of fact, I have a number of patients who are still enrolled in an acute HIV cohort study. So not only were they newly HIV-infected, but they were involved in a clinical trial and weretherefore, very aware of risk factors.

It is particularly distressing that men in their forties who have lived through the HIV epidemic and watched their friends die…only now to become, and then hepatitis C-infected. And it’s certainly much worse for their liver, getting hepatitis C at 40.

Gerald Pierone: Do you think methamphetamine may have played a role at all in fibrosis? Early literature on methamphetamine effects on the liver?

Daniel Fierer: Methamphetamine, in large doses, can cause fulminant hepatic failure. It’s been reported a couple of times. However, many drugs cause fulminant hepatic failure. And there’s nothing reported that I have found — and I’ve really looked, including the human and animal toxicology literature — that showed that long-time lower level exposure as seen in typical recreational use can cause periportal fibrosis.

Actually, there’s a little more evidence for marijuana being a problem, interestingly enough, than methamphetamine. So that is something we’re starting to look into.

So, I don’t think the drug use is what is causing the fibrosis that we have seen. In fact, I’m going to state definitively that it’s not. The best evidence for that is that many of these men never used drugs at all. Our first few patients enrolled were all pretty big drug users. But subsequently we enrolled a number who didn’t use any drugs. And I think they’re pretty clear about their drug use and don’t minimize. They are really straightforward about their sexual risks and other things in the clinic visits and on the questionnaire. Other investigators have asked “How do you know? They’re just not telling you.” There’s a long history of docs not believing patients about sex and drug use, probably for good reason. And I think that, well, if it were one person, I could say, OK, maybe one person is telling me a story. But I’ve had enough people who, when I talk to them, have been very frank about other parts of their lives and sex lives, that I believe that they are not trying to avoid telling me that they use crystal, when they don’t use anything. So I’m pretty confident about that.

Bonnie Goldman: Thank you very much. It’s really interesting.

Daniel Fierer: You’re welcome. I hope this information gets out into the MSM community, especially to those who are having unprotected sex who don’t think they are at risk for getting hepatitis C. The patients in my study, pretty much to the man, when they first come to see me have said, “I’m not a heroin addict. How did I get this?” Everyone needs to know that hepatitis C isn’t just an infection of people who share needles. And given our finding of the nearly immediate occurrence of fibrosis, the risk of not being diagnosed and then not getting treated could be very high.

Bonnie Goldman: Many clinicians do not have it on their radar of something to test.

Daniel Fierer: That’s right. We have some very smart and aware docs in New York, but it hasn’t been on may people’s radar, unless they’ve seen a case. I’m trying to be a part of that education piece, and encourage people to at least screen ALT every three months, and hep C antibody every year. Annual hepatitic C testing is not formally recommended for MSM, and that recommendation should be changed.

In summary, hepatitis C can be transmitted sexually in MSM, although we don’t know the exact mechanisms. We therefore need to change how we think about hepatitis C transmission, and educate the MSM community and educate docs to be on the lookout for it, both with routine testing and after any sexually transmitted infection (including testing in follow up, because it may take months after infection for antibody to be made). Finally, our study shows the possibility of significant risks for missing the diagnosis, with rapid onset of significant fibrosis in HIV-infected men who develop acute hepatitis C infection. The good news is that the prospects of clearing the infection with treatment are excellent, and we hope this clearance will allow reversal of some of the liver damage already incurred. Early treatment is much more effective than treatment during the later, chronic phase of hepatitis C, so the benefits of making the diagnosis early are that much greater.

Bonnie Goldman: Thank you.

This transcript has been edited for clarity. Additional follow-up information was obtained from the interviewee after the interview concluded.

  1. Fierer D, Uriel A, Carriero D, et al, and A Branch. An emerging syndrome of rapid liver fibrosis in HIV-infected men with acute HCV infection. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections; February 3-6, 2008; Boston, Mass. Abstract 1050.
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Rapid Liver Fibrosis Occurring More Frequently Among HIV-Infected Men Newly Coinfected With Hepatitis C – The Body

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Expert Recommends "Prevention Cocktail" to Curb Epidemic of HIV Among U.S. Men Who Have Sex With Men

Posted by pozlife on March 12, 2008


February 4, 2008

Ronald Stall, M.D.

Ronald Stall, M.D.

Podcast coming soon!

This is a transcript of a press conference that took place at CROI 2008, one of the most important HIV-related medical conferences of the year. In this transcript, Ronald Stall, M.D., of the University of Pittsburgh School of Public Health, examines the reasons behind the rebounding HIV epidemic among men who have sex with men in the United States — and offers some ideas for how to stop it.1

Ronald Stall: Good afternoon. The conference asked me to do a literature review about what’s driving the AIDS epidemic among gay men, MSM, in the United States. My talk will address three primary questions. The first is: Can HIV prevention work? The second is: Is it working on the community level? And the third is: What can we do to make things better?

The first question is easily answered. Can it work? The answer is yes. There have been two important meta-analyses that show that in randomized control trials, model HIV prevention programs reduce risk among gay men in very big ways. These studies have already been published, and give large effects sizes. For example, they include a 60% increase in using condoms for anal sex.

The next question: Are these programs actually working out in the real world? To answer this question, we turn to measures of HIV incidence among Americans and men throughout the industrialized world. We conducted an analysis, a systematic review of incidence estimates for MSM in Western Europe, the United States and Australia. The field tends to use proxy measures for incidence. That’s because incidence estimates are very difficult and expensive to generate, and that may be especially the case among gay men. So you tend to see things in the literature about rising rates of unsafe sex, sexually transmitted infections, and so on.

The other problem with incidence estimates is that if you use any one estimate for a given city, it can’t be generalized to a whole country, nor can it even be generalized to that city because of sampling issues. By using all of the incidence literature across the industrialized countries, we hope to miss or avoid many of the problems that emerge with proxy measures for incidence rates, or a stand-alone measure of incidence.

Our review, using very stringent review criteria, identified 20 different studies from 1995 to 2005, the protease era in Western Europe, North America and Australia, that yielded, in turn, 65 annualized incidence rates across this period.

On the international side, the rates of HIV incidence in Australia are significantly lower, at 1.1%, than we’re seeing in North America or Europe, where those rates are about the same. The other interesting finding is that there were no increases or decreases in incidence rates among MSM in the industrialized countries from 1995 to 2000. Rates are not going up or down. The weighted mean incidence rate across all these countries is 2.5% per year.

Turning to the United States model: We looked at just the estimates for the United States. In community-based samples, which were the lowest rate of HIV incidence, compared to HIV alternative test sites or STD [sexually transmitted disease] samples, we calculated a mean incidence rate of about 2.4% per year.

The next thing we did was, we wanted to find out: What does 2.4% mean? What does 2.4%, in particular, mean over long periods of time? So we did a thought experiment, using a closed cohort of young gay men at the age of 18, none of whom were infected at 18, but calculated an incidence rate of infection of 2.4% per year as these men moved from age 20 to age 40. The model that we constructed yielded an estimate that at about age 25, about 15% of the men would be HIV positive; by age 35, about a third; and by age 40, about 41%.

The reason that we used the age of 40 as our cut-point is that AIDS was discovered a quarter of a century ago. These men would have had to have been, by definition, younger than 15 years of age. In addition, because we know that HIV incidence rates were stable from 1995 to the present, the vast majority of their sexual lives would have been in the context of this background incidence rate of about 2.4 or 2.5%.

We were kind of horrified that our model yielded prevalence estimates that high. And accordingly, we went back and looked at the largest samples published by the CDC [U.S. Centers for Disease Control and Prevention] of prevalence rates among men in the United States. The CDC just published, in 2005, a very large study of HIV prevalence rates, by age, in five American cities. What we find is that the model actually fits exactly what’s going on in terms of HIV prevalence among gay men, at least in America’s largest urban centers. This model that we are extrapolating based on the incidence rates, which culminates in an HIV prevalence rate of 40% at age 40, is not a prediction of something that may happen one day. We are describing epidemiological phenomena that are occurring all around us, and will continue to occur among young American men, if we do not find ways to lower HIV incidence rates further.

The last part of the talk focuses on how we can do a better job of HIV prevention. What I focus on are questions that gay men are asking about how to maintain sexual safety that are not being addressed by the proven programs that have yielded big effects sizes in randomized control trials. Among these are precise definitions of what is sexual safety nowadays, about maintenance of sexual safety over the long haul, about issues of community viral load.

For example, a very important analysis of African-American MSM by Greg Millett at the Centers for Disease Control showed that they actually engage in less risky behaviors than European-American gay men, and are less likely to use drugs. So if they’re less risky and less likely to use drugs, where’s all that virus coming from? Millett’s answer, in a really wonderful analysis he did, showed that the rate of unknown HIV seropositivity — [in addition to the] lack of access to antiretroviral care among African-American men who know that they are positive — is so high that there is a much higher prevalence rate of men who are viremic in the population, which we call community viral load. In the context of men whose sexual access is limited by race, and whose sexual networks have such a high community viral load, even modest levels of sexual risk-taking can result in very high transmission rates, even though the men are doing the best they can to be sexually safe. So it’s the context that matters with these guys, not their individual risk-taking behavior.

We also raised questions about the large investment that the United States has made in prevention science, but the challenge of getting this into the field so that community-based organizations can put this research to work. The amount of funding that’s going into supporting HIV prevention in the United States is actually a rather small sliver of the entire budget. Holtgrave and colleagues at Johns Hopkins have shown that the amount that we’re investing in HIV prevention only allows us to “run in place,” in terms of winning the fight for HIV/AIDS prevention in the United States.

To summarize: What I’ve been able to show in the qualitative analysis is that there are multiple levels of prevention activity that are promoting risk among gay men, but that the interventions that we’re using only operate at the level of the individual. They are not designed to operate in terms of context, [as in the case of] community viral load, or funding for getting prevention projects into the field, or policy, or treatment for comorbid conditions. Because we’re only operating at one level, as opposed to the multiple levels that are driving risk, it’s analogous to using AZT monotherapy to treat HIV infection: You can get effects sizes for short periods of time, but you cannot expect big effects for long periods of time.

I make an argument, and provide a design, for what I’m calling an “HIV prevention cocktail.” What would a prevention cocktail look like? And how would we get this into the field? Those are the main points, but basically, at the HIV incidence rates we’re already seeing in the published literature, we can expect an ongoing HIV epidemic among gay men that will yield high prevalence rates over time. The implications of this are so profound. We have got to find a smarter way to do HIV prevention in our country. Operating only at the level of the individual may not be the smartest way to go. Thank you.

Reporter #1: What are the main points of your prevention cocktail?

Ronald Stall: I would help define what sexual risk is anymore. What are the risks of negotiated safety? What are the risks of positional strategies? Gay men are finding it difficult to use condoms every single time they have sex, for decades on end. This is true of men in general. The gay community has set up a whole series of strategies to allow men to dispense with condoms in particular kinds of relationships. But we don’t have strong epidemiological data to show the long-term risks of these things.

The next point would be to continue with individual-level interventions, but to also mount interventions that would be at the level of context. For example, what would happen if we really did our best to enact strategies to diminish community viral load, particularly among African-American MSM communities? So that men who are positive are found, they are offered treatment for HIV infection, they are brought into the medical system, they are given help around maintaining sexual safety over long periods of time. So that the community viral loads in particularly vulnerable MSM communities are lowered. So that just a tiny little slip within the sexual networks of these communities does not result in HIV transmission.

Another point would be finding better ways to get proven HIV interventions into the field, so that the scientific investment that the United States has made, in terms of generating proven interventions, can actually be used by community-based organizations.

Another would be taking a good, hard look at the investment that we’re making in prevention overall, and making a decision on the policy side as to whether this investment will generate the effects sizes that we need.

The final point would be to test what happens, to see whether or not the effects sizes we get by operating at multiple levels with the prevention cocktail are larger than when we operate only at the level of the individual.

Those are among the suggestions. There are others, as well.

Reporter #2: Did you see any relationship between post-exposure prophylaxis and reduction in transmission?

Ronald Stall: We didn’t look at that.

Reporter #3: Are there any biomedical strategies that you have talked about with colleagues, or in research, that you would endorse?

Ronald Stall: The biomedical strategy that I think would make a lot of sense would be to try and do focused interventions that look at reducing community viral loads. HIV risk isn’t just about our own individual behavior. It’s about the level of HIV prevalence out in the communities in which we find our sexual partners; and the proportion of partners in those sexual networks that are viremic, and efficient transmitters. Effectively and efficiently finding HIV-positive people who are viremic and need to be brought into HIV treatment, and helping them maintain sexual safety over the long haul, would be an efficient use of our money. It’s not just biology, and it’s not just behavior; it’s interventions that would conjoin the two.

By the way, on the Australian question: One of the interesting things is that the incidence rates of infection in Australia are 1.1%. If you do the same model that I did for the United States, the results you yield are that, by age 30, about 15% of the men would be positive, and by age 40, about 20% would be positive. So under conditions that have already been obtained in Australia among MSM communities, they would yield half the expected prevalence rates we’re seeing in the United States, and one-third of what we’re seeing among African-American MSM. We can clearly do a better job. I think we need to learn from our Australian colleagues, and invent some strategies that can help replicate these successes.

Reporter #4: Information was recently published about 30 Western countries and how they score in preventable death, and the U.S. came in last. Part of the rationale for that is our health care delivery system. HIV was not one of the parameters in that study, but certainly HIV is preventable. If you can prevent HIV, you can prevent death from HIV.

I’m just wondering: In looking at other countries that do a better job in preventable death, what have they done in this same area that you’re talking about, and how can we learn from them? And does it not all boil down to the way that urgent care and acute care and health care delivery in general is set up in our country? Is there any way it can be fixed, short of total restructuring of health care delivery?

Ronald Stall: Oh, dear. Well, I’m not running for President. [Laughter]

I think that’s the question before us. How do we make it work despite our very low ranking in terms of outcomes? We’re spending that money very inefficiently. We’re spending among the highest costs of providing health care. Clearly something is wrong. And finding something to make the American health care system actually provide care to American people, help Americans stay healthy, and do so at less cost is, I think, the hundred million dollar question. If it were only a hundred million, that would be wonderful. Many people have worked on this. I don’t have fast answers.

Harold Jaffe: Maybe I could ask the last question. Do you feel that the gay community — and that’s hard to define, obviously — is as engaged in giving the same priority to prevention as it did earlier on [in the HIV epidemic]?

Ronald Stall: I think gay men are doing as well as any group of human beings could ever do, in view of the onslaught that’s happened over the past quarter of a century due to this epidemic. Men are having a hard time staying consistently safe every single time we have sex. But that’s true of all men. What we need to do is look at what’s happening around contextual issues, and areas where we can help promote health among gay men that would increase the efficacy of our prevention efforts, and increase our ability to do a better job with HIV prevention. I don’t think it’s helpful to engage in a blaming-the-victim kind of analysis. There are much smarter ways to promote health in these communities than blaming victims.

This transcript has been lightly edited for clarity.

  1. Stall R, Friedman M, Marshal M, Wisniewski S. What’s driving the US epidemic in men who have sex with men. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections; February 3-6, 2008; Boston, Mass. Abstract 53.

Expert Recommends “Prevention Cocktail” to Curb Epidemic of HIV Among U.S. Men Who Have Sex With Men – The Body

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Immune Reconstitution May Trigger Hepatic Flares in HIV/Hepatitis B Coinfected Patients Starting HAART

Posted by pozlife on March 12, 2008


An Interview With Megan Crane

By Bonnie Goldman

February 5, 2008

Megan Crane

Megan Crane

Listen (7 min.)

There’s nothing like hearing the results of studies directly from those who actually conducted the research. It is these women and men who are transforming HIV treatment and care. In this interview, you’ll meet one of these impressive HIV researchers and read an explanation of the study she is presenting at CROI 2008. Accompanying me on this interview is Dr. Gerald Pierone, an HIV clinician/researcher and the founder and executive director of the AIDS Research and Treatment Center of the Treasure Coast in Fort Pierce, Florida.

Megan Crane: My name is Megan Crane. I’m from Monash University in Melbourne, Australia. What we were actually looking at was the phenomenon of flares in HIV/HBV coinfected patients shortly after they begin the HAART treatment.1 So, what happened in our study: We had 36 patients in Thailand that were on a HAART regimen. And within 12 weeks of starting the HAART, actually 8 of the 36 patients, so about 25%, suffered an hepatic flare, which we defined as a higher-than-normal ALT, basically.

We hypothesized that this was basically an immune reconstitution syndrome. So the CD4 cells come back because of the HAART. You get a renewed response to your underlying infections, which, in this case, is the HBV. So, basically just looking at markers of immune activation in the patient plasma, and we’re looking at some markers of NK cell activation in the PBMCs [peripheral blood mononuclear cells].

What we found, basically, was that … Well, this is just summarizing the clinical data, basically. The flare cases had the ALT flare in 8 weeks, and they had higher viral loads from baseline up to week 10. From our lab data, we found in the controls — which are the ones that didn’t flare — the levels of CXCL10, which is a T-cell activation marker, and a marker of activated natural killer cells. That actually fell over the 12 weeks. And in our cases, the ones that flared, that level of CXCL10 was maintained.

Soluble CD30 is another marker of T-cell activation. That actually peaked in our flare cases at week 8, which is mirroring what happened with ALT. Levels of soluble CD26, which is produced in response to interferon gamma production, actually: we didn’t find any difference between the case and control groups, but they both actually increased over the 12-week period.

Correlations: We found that CXCL10 and soluble CD30, as well as IL-18 and MCP-1, actually correlated with high LT. In terms of our NK cells, what we were actually looking for was trying to emulate what we saw in — or what another group saw in — HBV monoinfection, where activated NK cells were important in the flares that occur, just acute flares in HBV. So they found increased levels of trial attrition, which is just an apoptosis inducing factor on the NK cells in the liver and the periphery of those patients. We didn’t find that in our coinfected patients. So I think there’s something different going on in the monoinfection and the coinfection setting.

And then, basically, this is the first study to look at immune reconstitution to these in HIV/HBV coinfected patients.

Bonnie Goldman: This has never been described before?

Megan Crane: Well, it has been, in the clinic; it’s been described. So, it’s been seen. But no one actually has looked at the immune mechanisms that are involved. So this is the first kind of feeling out, testing out, what’s going on. So we’re quite happy that we’ve found some interesting things going on with the soluble CD30.

Bonnie Goldman: What are your next steps in this?

Megan Crane: This was a pilot study, basically. We’re going to get a bigger cohort. We’ll follow on looking at these kinds of immune activation markers. We’ll expand it, look at a lot more things, because we’ll have a lot more cells. And basically we also wanted to include the seroconversion aspect of it. So these flares that occur in this IRD [immune restoration disease] setting can actually be beneficial to the patient, in that they will actually end up clearing the virus. So we’re hoping to sort of try and correlate in our own the immune events that lead to viral clearance, or the immune events that … In one case, we actually had one patient die from a very severe flare. So maybe those immune events are different in those two situations.

Gerald Pierone: Were there any clinical factors that you can look back on that would separate the patients that had a flare, versus those that did not?

Megan Crane: Yes. There is the higher baseline ALT, which is pretty well described in this, to predict a flare in the setting. And the higher HBV viral loads are also another picture — and low CD4 count. If you have a very low CD4 count to begin with, you’re going to have a greater sort of rebound in your CD4 cells, and possibly a greater immune response to your underlying infection.

Gerald Pierone: So maybe one of the messages for clinicians would be, if you have a coinfected patient with high viral load, low CD4 count, higher LFTs to begin with; be careful of that patient whenever you find an acute flare up.

Megan Crane: I’m not a clinician, but from what I know, it’s very poor sort of guidelines as to what to do with these patients and what to look out for, and how do you treat them. So there’s a little debate at the moment about whether to treat the HBV first before you start your HAART regimen, or to, like we say, just sort of almost let them have the flare, but monitor it very closely, so you don’t get a situation where someone dies. But let them have the flare, because that could lead to actually viral clearances. It could be a beneficial effect.

  1. Crane M, Oliver B, Matthews G, et al. Immunopathogenesis of hepatic flares after initiation of ART in HIV/HBV-co-infected individuals. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections; February 3-6, 2008; Boston, Mass. Abstract 1033.

Immune Reconstitution May Trigger Hepatic Flares in HIV/Hepatitis B Coinfected Patients Starting HAART – The Body

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Surprisingly, Acyclovir for HSV-2 Treatment Fails to Curtail HIV Acquisition

Posted by pozlife on March 12, 2008


A Study Summary by Connie Celum, M.D.

February 4, 2008

Connie Celum, M.D.

Connie Celum, M.D.

Listen (8 min.)

In this summary of her study, Connie Celum, M.D., of the University of Washington at Seattle, discusses surprisingly disappointing results from a study examining whether the use of acyclovir to treat herpes simplex virus type-2 infection can, in turn, help reduce a person’s risk of HIV acquisition.

Connie Celum: This was a trial of 3,277 participants who were HIV negative, and HSV-2 seropositive, who were enrolled in a trial to ask the question: If you suppress genital herpes, using the standard dose of drugs that are commonly used (acyclovir 400-mg, twice a day), could we show that we could reduce HIV acquisition?1 We had 139 people who became infected in the trial, 75 of whom were in the acyclovir arm, 64 in the placebo arm. And the difference between the two arms was not statistically significant.

I think there were a couple of surprises that came out of the study. Even though, when you look at a trial like this and you look at its so-called integrity, in terms of did it not only meet its enrollment targets; it’s really important in a study like this to also ask: Did people actually take the drug? And did we have any evidence that there was differential loss to follow by arm.

So, of the pills that were dispensed, adherence was very high: 94% of pills that were dispensed were taken. And so, at least at the present time, we can’t say that adherence is a reason why it did not work. However, we will do some additional work to look at that.

There were a couple of surprises. I think that we went into the trial expecting from past studies that you might see up to an 80% reduction in genital ulcers. We saw a 37% reduction. And there were differences by region. For example, there was like a 50% reduction among gay men in the U.S., and about 32% among women in Africa.

So I think it also is important for us to consider biologic reasons why we did not see a bigger effect. And we will be exploring those. So was the drug metabolized in the way that we expected it to, from past studies? And also, just to make sure that the viruses, the herpes viruses, were susceptible to the acyclovir. So there is more work for us to be done. We just received these results very recently.

I think the question is, many people thought this was going to be a slam-dunk. If you really look at the epidemiologic data, it was very consistent, very compelling, showing a two- to three-fold higher risk of becoming HIV infected if someone had HSV-2 antibodies. So I think the question here is just: Is it that the strategy didn’t work? That the standard dose of acyclovir, 400 b.i.d. twice daily, taken with high adherence, as best we can tell, based on pill count and self-report. Why didn’t we have an effect on HIV at all? And why did we have a lesser effect than expected on genital ulcers? So those are really important questions.

I want to just finish by reminding people that there are two sides of the coin between the interactions between herpes and HIV, and this trial focused on a wealth of epidemiologic data and some biologic plausibility data that said herpes simplex type 2, the main cause of genital herpes, increased susceptibility to becoming HIV infected. There’s also quite a substantial body of data that suggests that herpes makes people who are already HIV infected more infectious. And we have another trial ongoing, called Partners In Prevention, that is asking that question. It’s a very challenging trial in 3,400 HIV discordant couples. So we do not know the answer to that question yet, and we should within a year. I just want to make it really clear that there are two different ways in which herpes may affect HIV transmission and acquisition. This study asked about acquisition. And within a year, we’ll have data on HIV transmission, as well as whether herpes influences HIV disease progression. So stay tuned.

Reporter #1: Dr. Celum, did you do blood levels to see if they really took the medications, as opposed to took the pills?

Connie Celum: We have not. And part of the reasons for not having done that is that acyclovir has a short half-life of about four hours. And so, really, we would have a lot of imprecision in knowing much about adherence. But it would basically tell us: Did they take the last dose at the time they should have prior to this visit? Which is not, in our opinion, all that informative.

Reporter #2: Connie, do we know anything about host variability, genetic variability, in terms of both vulnerability to HSV and metabolism of acyclovir?

Connie Celum: My colleague, Anna Wald, is in the audience. And if you’re interested in this particular area of genetics and HSV-2 expression, I think there’s some data suggesting toll-like receptors are important, in terms of frequency of reactivation. But if you’re asking about, do we know sort of pharmacogenetics of acyclovir; I think that is not, to my knowledge, an area that anyone has explored. Nor has there really been enough characterization of absorption in different populations.

What we do know, just from the data from prior PK studies, is that acyclovir is not very well absorbed. Orally, it’s 15% to 20% absorption. And there is variability between persons. But in large studies of herpes suppression, even with that variability, you can achieve an 80% reduction in genital ulcers.

Reporter #3: Dr. Celum, on the study, there were different arms in Peru and Africa, and in the United States. Were your results consistent across all the arms? And how consistent were they?

Connie Celum: It’s in the abstract. I just, for time, didn’t go into it. But we looked at various aspects of homogeneity of the results, if you will, across various factors. And there really was no significant difference by gender or region, in terms of HIV acquisition. There was, as I showed in the slides, a difference in terms of incidence of genital ulcers and HSV detection, yes/no detection, as well as quantity by the different regions. So in the herpes outcomes, there were some differences by region and site.

This transcript has been lightly edited for clarity.

  1. Celum C, Wald A, Hughes J, et al, and HPTN 039. HSV-2 suppressive therapy for prevention of HIV acquisition: Results of HPTN 039. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections; February 3-6, 2008; Boston, Mass Abstract 32LB.

Surprisingly, Acyclovir for HSV-2 Treatment Fails to Curtail HIV Acquisition – The Body

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