In an advisory it is expected to issue Thursday, the agency says that patients with a particular variation in an immune system gene should not be given the drug abacavir because they are at a far higher risk of a severe allergic reaction to the drug.

Abacavir, developed by GlaxoSmithKline, is sold under the name Ziagen. It is also a component of two combination pills — Trizivir and Epzicom.

The recommendation for the test is part of a movement toward so-called personalized medicine, in which genetic or other tests are used to determine which drugs are best for a patient and which should be avoided.

The labels of several other drugs, like the blood thinner warfarin and the cancer drug irinotecan, also recommend tests aimed at avoiding side effects or helping to adjust the dose.

F.D.A. officials said they believed that the genetic test, which is already available from some laboratories, would be quickly adopted for screening patients before prescribing abacavir. In part that is because the test recommendation will be included in a black box warning, the strongest kind, on the drug’s label.

A small percentage of abacavir users suffer so-called hypersensitivity reactions, either when they start the drug or when they resume using it after some interval. Symptoms can include fever, rash, nausea and breathing difficulties.

The association between the variant in the immune system gene and risk of the reactions was first reported several years ago. But F.D.A. officials said a randomized clinical trial had since definitively proved the value of the genetic prescreening.

The study, published in The New England Journal of Medicine in February, found that prescreening reduced the incidence of suspected hypersensitivity reactions to 3.4 percent, from 7.8 percent. Based on that data it was estimated that 61 percent of people with the genetic variant — called HLA-B*5701 — would suffer a hypersensitivity reaction, in contrast to only 4 percent without the variant, according to new information on the drug’s label.

Drug companies often are reluctant to back tests that exclude patients from getting their drug. But GlaxoSmithKline sponsored and helped conduct the study published in February.

Because only about 5 percent of people have the genetic variant, excluding them from using abacavir does not shrink the market much. But it may reassure doctors that they can safely prescribe the drug for a vast majority of patients who do not have the variant.

The label for abacavir is also being changed to mention a study that found a correlation between taking the drug and elevated incidence of heart attacks. But the label also mentions that Glaxo then did its own review, pooling the results of numerous clinical trials, and found no elevated risk of heart attack.

The new label says that “in totality” the data are “inconclusive” on whether there is an elevated risk of heart attack, but that doctors should be cautious nonetheless.

Source: New York Times

Sub-Saharan Africa shares just ten percent of the world population, yet the region is home to 70 percent of all people living with HIV disease. In the United States, African Americans make up 12 percent of the nation’s population, but African Americans account for half newly diagnosed HIV infections.

According to Phill Wilson of the Black AIDS Institute in Los Angeles, previous studies on sexual behavior of gay men indicated that “gay black men did not engage in riskier behavior than gay white men,” but nonetheless had higher rates of infection.

Based on research led by Dr. Sunil Ahuja, a professor of infectious diseases at the University of Texas Health Science Center at San Antonio, an estimated 11 percent of 25 million HIV infections in Sub Saharan Africa — roughly 2.7 million cases — are caused by the gene variant.

Their findings center around a protein found on the surface of red blood cells known as the “Duffy antigen.” This Duffy antigen can be used by certain species of malaria parasites to enter red blood cells, but nearly all Africans carry a gene that disables the antigen and thus, protecting them from malaria. The trait is somewhat less common in African Americans due to mixture of African and European blood lines.

It was previously established that the Duffy protein also absorbs HIV particles like a sponge, effectively limiting the virus from invading white blood cells and hampering HIV infection. People with disabled Duffy proteins were believed to be more vulnerable to infection.

Ahuja’s team investigated this possibility by examining the blood of American military personnel, whose blood had been collected and stored for years. Comparing 814 African American soldiers who were HIV negative against 470 who had HIV, they found a 40 percent higher risk of HIV among those whose genes suppressed the Duffy protein.

In the course of their study, researchers also made a second remarkable finding: the African gene also appears to prolong survival. The Duffy protein also plays a natural role in ramping up the immune system in response to infections, promoting inflammation and pumping out white blood cells. This very defense mechanism is a boon for HIV however, speeding the progression to AIDS. Those who carry the disabled Duffy protein are more likely to get infected in the first place, but last longer without treatment.

Many scientists in the field, however, caution against accepting the findings as fact so soon. Cheryl Winkler of the Laboratory of Genomic Diversity at the National Cancer Institute, in Frederick, Md., points out that the differences in infection rates Anuja’s team found were “statistically significant, but barely so.” She says that “they don’t have enough evidence” and more study and replication of the finding are required before coming to firm conclusions.

Nonetheless, scienctists are intrigued. Dr. Warner Greene, a professor at UCSF and director of the Gladstone Institute of Virology in San Francisco, said the study opens new areas for research into the complex relationship between blood cells and chemical signals that guide the immune system. Dr. Jay Levy, another UCSF virologist who once helped isolate HIV as the cause of AIDS, notes that Anuja’s findings “poses a nice challenge to researchers trying to understand who HIV causes disease.”

Source: San Francisco Chronicle

Medical records show that, before 1996 - when combinations of antiviral drugs became available - the death rates for HIV-infected patients were 41 times that of people of comparable age in 10 European nations and Australia.

Death rates fell dramatically by 1997, to 31 times the norm, and continued dropping until they reach six times the norm by 2006.

That’s still a substantial increase in risk of death from HIV, but it takes into account patients who were diagnosed long ago and have been switching from one drug regimen to the next to stay alive. It also includes those who contracted the virus through sharing of needles, and who live with a variety of health risks related to their drug use.

The picture is brighter for those who were infected more recently and have been treated with the latest generation of drugs.

Among a sub-group of HIV-positives - those diagnosed with a sexually transmitted infection since 1999 and treated with the latest AIDS drug cocktails - the analysis found virtually no difference in death rates between them and uninfected people of similar age.

By 2006, excess mortality - deaths attributed to AIDS - had fallen 94 percent compared to pre-1996 levels, said the study authors, led by Kholoud Porter of the Medical Research Council Clinical Trials Unit in London. Their work, which analyzed the records of more than 16,000 patients, was published Tuesday in the Journal of the American Medical Association.

“We found that the gap in mortality rates between HIV-infected individuals in our study and the general population narrowed in every calendar period from 1996 onward,” Porter and colleagues wrote.

The researchers tempered their upbeat findings with a warning that the study still found an increased risk of death for HIV-infected people of all ages based on the amount of time they have been living with the virus.

They wrote that excess probability of death becomes “apparent only later in the course of infection.” The analysis showed, for example, that the increased risk of death for someone aged 15 to 24 years of age at the time of infection was 4.8 percent over a 10-year period.

Source: San Francisco Chronicle

Which group do you fall into?

“Basic HIV vaccine research must remain one of the many prevention strategies being pursued at a national level,” writes Rebecca Haag, executive director of advocacy group AIDS Action, in a press release. “We will continue to advocate for HIV vaccine research here in Washington, DC, and raise awareness of and support for HIV vaccine research across the country.”

The 11th annual awareness day, sponsored by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, came on the heels of dissension in the AIDS community surrounding the value of vaccine research.

This past March, the AIDS Healthcare Foundation (AHF) called for more funding to be spent on strategies that have been proven effective, such as prevention, routine testing and treatment—instead of vaccine research. According to the AHF, the failures of recent vaccine trials—including a Merck trial that may have increased participants’ risk of contracting HIV—served as evidence of a rationale for shifting funding away from vaccine trials.

However, many vaccine supporters have spoken out against this argument, pointing to the importance of spending time and money on vaccine research.

“The failure of one vaccine candidate does not signify the failure of all HIV vaccine research. This setback, as have others, may be a stepping-stone to future success,” says Haag in her statement.

Other groups, including the National Association of People with AIDS (NAPWA) and the National Minority AIDS Council (NMAC), released similar statements asking people not to give up on the idea that an effective HIV vaccine can be developed.

“An accessible preventive vaccine against AIDS could have a profound impact both on our efforts to prevent further spread as well as stigma associated with the disease and those living with it,” says NAPWA President and CEO, Frank J. Oldham Jr. in a statement.

NMAC is holding an HIV Vaccine Awareness poster contest, which invites artists to create posters encouraging people to join the fight against AIDS and learn more about HIV vaccines. Entries are due by June 30, 2008. (Click here to learn more.)

“Vaccines [have] often taken many years to develop, and must be tested in multiple trials with a diverse range of people to ensure that they work for the entire population,” said Paul A. Kawata, NMAC’s executive director, in a National HIV Vaccine Awareness Day statement. “If we want make this much-needed HIV prevention tool a reality faster, we all need to work together to raise awareness around, and participate in, vaccine research.”

According to this report, AIDS is the leading cause of death of working-age people and loss of working days in Asia. In Asia, including Vietnam, HIV preventive services are accessible to one-third of prostitutes, 1/50 of drug addicts, 1/20 of men who have sexual relations with men and 1/10 of pregnant women.

Vietnam has exerted efforts to prevent HIV/AIDS but the country is rated among nations that have the highest rates of HIV carriers in the world, with over 133,000 people living with HIV, including 27,000 AIDS cases. HIV/AIDS is reported in all 64 provinces and cities and over 96% of districts. People between the ages of 20 and 39 account for over 78% of the total infected.

Dr. Rao said Vietnam should further harmonise articles of its Law on HIV/AIDS Prevention to protect high-risk groups in society and take measures to ensure the lives of HIV carriers.

There are nearly 5 million people living with HIV in Asia and the Pacific, including 440,000 newly infected and around 300,000 that died of AIDS in 2007.

Source: VietnamNet

The analysis of a federal survey of more than 2,200 males and females ages 15 to 19, released Monday, found that more than half reported having had oral sex. But those who described themselves as virgins were far less likely to say they had tried it than those who had had intercourse.

“There’s a popular perception that teens are engaging in serial oral sex as a strategy to avoid vaginal intercourse,” said Rachel Jones of the Guttmacher Institute, a research organization in New York, who helped conduct the study. “Our research suggests that’s a misperception.”

Instead, the study found that teens tend to become sexually active in many ways at about the same time. For example, although only 1 in 4 teen virgins had engaged in oral sex, within six months after their first intercourse more than 4 out of 5 adolescents reported having oral sex.

“That suggests that oral and vaginal sex are closely linked,” said Jones, whose findings will be published in the July issue of the Journal of Adolescent Health. “Most teens don’t have oral sex until they have had vaginal sex.”

Proponents of sex education programs that focus on abstinence said the findings debunked the criticism that the approach was inadvertently prompting more teens to have oral sex, which still carries the risk of sexually transmitted disease, in order to preserve their virginity.

If anything, the findings support the need to encourage more teens to delay sexual activity of all kinds, said Valerie Huber, executive director of the National Abstinence Education Association.

“This report reveals that teen sex - even with a condom - presents significant risk for future sexual experimentation and so underscores the need for redoubled emphasis on abstinence education for teens,” she said. “Only abstinence education adequately addresses this problem.”

But critics of abstinence programs said the findings reinforced the need for comprehensive sex education, because teens engage in a wide variety of sexual activities, all of which carry risks for the spread of sexually transmitted diseases.

“More than half of our teens are having sex - vaginal and oral,” said James Wagoner, president of the group Advocates for Youth. “We can’t afford the luxury of denial. Abstinence-only programs are the embodiment of denial. They have been proven not to work, and it’s time to invest in real sex education, including condoms.”

Others praised the research for providing much-needed data in the often highly polarized debate over teenage sexuality.

“We have these images of oral sex parties, but it’s not based on evidence. It’s not based on research,” said Claire Brindis, a professor of pediatrics and health policy at UC San Francisco. “A study like this allows us to begin to dissect what actually is going on.”

The new study analyzed data collected from a nationally representative sample of 1,150 females and 1,121 males ages 15 to 19 who were questioned in detail in 2002 as part of the federal government’s National Survey of Family Growth.

A majority of the teens - 55 percent - said they had engaged in oral sex, which was slightly more than the 50 percent who said they had had vaginal sex. But oral sex was much more common among those who already had had intercourse: 87 percent of those who reported on a computerized survey that they had had vaginal sex said they had engaged in oral sex as well, compared with 23 percent who described themselves as virgins.

When the researchers examined the number of partners the teens reported, they found that among those who reported engaging in oral sex, 67 percent had only one partner, “another piece of evidence that there’s not a lot of teens engaging in serial oral sex,” Jones said.

Source: San Francisco Chronicle

Hot or Not, a Web site where people submit photographs of themselves so that strangers can rate how attractive they are on a scale of 1 to 10, has spawned many imitators (plus a fair number of critics who view it as a sign of the end of civilization as we know it).

One new spinoff, Pos or Not, has a serious purpose (tasteful or not). The site, www.posornot.com, introduced in late April, is an H.I.V. education effort disguised as a game. It shows photographs and brief biographies of men and women ages 21 to 30, and asks visitors to decide whether each is H.I.V. positive or negative. The message is that you can’t judge someone’s virus status by looks, occupation or taste in music.

The site is sponsored by MTV’s college network and the Kaiser Family Foundation, a nonprofit group that focuses on health policy. “We feel it’s another kind of activist tool to get out the word about H.I.V. protection,” said Stephen K. Friedman, the general manager of mtvU, the college and university offshoot of Viacom’s MTV network.

The first trial by mtvU of what Mr. Friedman calls “games for change” was Darfur Is Dying, an online simulation of a refugee camp that has logged more than 1.5 million plays since 2006. Other companies have sponsored games about the Israeli-Palestinian conflict, the immigration debate and the world’s water resources.

The network wants the word about its H.I.V. site and its message to be spread like a popular YouTube video. It enlisted celebrities like Wyclef Jean, a musician, and Rosario Dawson, an actress, to make promotions for the game, which are playing across MTV’s networks.

The game — if it can really be called that — was played about 5.1 million times by 400,000 people in its first three weeks, according to mtvU. Entertainment Weekly’s Web site suggested it might be the “most depressing use” of an Internet trend ever, but suggested that any H.I.V. outreach effort could be beneficial.

Mr. Friedman said that in a media-saturated climate, maybe young people have to be shocked into paying attention. “Looking at the statistics that one in four people who are H.I.V. positive in the U.S. don’t know it, it’s pretty staggering,” he said. “We hope that something like this will get under their skin.”

“If it makes some people uncomfortable,” he added, “that’s not necessarily a bad thing.”

Dating has been a touchy subject for me ever I tested HIV+ half a year ago.

It was difficult enough meeting people before my diagnosis, and after I found out, I thought it would be next to impossible to find someone who would give me any attention. A lot of this stems from my own ambivalence towards people who were HIV-positive. Despite living in an urban environment and interning with a wellness clinic, I haven’t met anyone who was open about their HIV serostatus — that is, until a year ago. Would I have dated someone who was positive? Perhaps. Would I have contemplated entering into a serious relationship with said person? I am not quite so sure. I never really did pay serious attention to whether or not I would date someone who was positive, simply out of the fact that I didn’t know anyone who was. But now, at this point in my life, I have engaged in on and off introspection and came to a guilty conclusion that I would not engage in anything serious with a person who was poz.

But all of that has changed.

So I met this one boy — who shall remain unnamed — spring of 2007. I disclosed my status to him early fall of last year and he took it in good stride. He didn’t seem to treat my any differently and, in fact, I dare say it brought us closer together. But that doesn’t mean that all of my anxieties and doubt were washed away. On the contrary, meeting someone who accepted my serostatus made me acutely aware that dating would be forever different. Coming out of the closet is one thing, but disclosing your HIV status is a different beast altogether. Media and society is slowly warming up to homosexuality but HIV, on the other hand, is still taboo and is not widely discussed within the gay community, much less within communities of color. I feel normal when I am around him. We joke around, study and go out together. We watch movies and take naps. But there are still times that I am reminded that I am different, that I have this demon within me waiting and lurking. I was initially scared to become intimate with him, fearing some sort of rejection or judgment. I assumed that he wouldn’t want to do anything risky, given our different serostatuses.

So I tried keeping him at a distance, maintaining an emotional disconnect, just waiting for the inevitable moment that he would just move on. It is hard enough to believe that someone would be interested in me, but I was imagining that being HIV-positive would make it all the more difficult. So I kept up the charade for as long as I could. I wouldn’t call nor text him back. I wouldn’t respond to his messages nor emails. I feigned indifference. But he unexpectedly called me out on it. He asked my why I was actively pushing him away. I just told him I found it difficult to believe anyone would have a serious interest in me. I told my therapist and close friends of how I was feeling and what I should do. They all gave me the same advice. If he weren’t serious about his feelings, would he have been so persistent in trying to talk to me? That put a lot of things into perspective.

Soon after I tested poz, I tried going online to find other people for support. I started off with the usual sites such as poz.com or aidsmeds.com, but as the search went on, I become increasingly disillusioned. The majority of people I found were overwhelmingly white and much older than I am. I suppose I was naively idealistic in that I assumed I would have found someone like me right off the bat. Much like within any community, there needs to be more than a tenuous self-identification such as being gay and in this case, being HIV-positive. I could surely talk about my experiences on testing positive — and I did — but if I am to truly discern this monumental change, I have to do it under other axes. My experiences are focused around being a person of color, first and foremost. My struggle with depression, the loss of my father and being the first one in my family to go to college are also other factors.

There must be other young adults around my age that have tested HIV-positive, seeing that over half of new infections are under the age of 25. Perhaps, I thought, maybe they are in the same position I am, afraid to disclose their status out of fear of rejection and discrimination. But this also raises a scary scenario, what if these individuals are unaware of their status? I have heard statistics and anecdotal evidence that young adults don’t get tested as often as they should be. I have a few friends in the Los Angeles are who admitted that they haven’t gotten tested in months, if not years. I asked them why and they said that they didn’t know anyone who was poz and they assumed that they were safe. Popular conceptions paint HIV as a gay white male disease, or something that only afflicts I.V. drug users. But HIV does not discriminate, it crosses all social lines and divisions — I know first hand.

I suppose I lucked out, seeing that the boy was progressive and that we shared many interests. I was slowly overcoming my overwhelming insecurities and tried to put myself out there. But old habits die hard. I keep oscillating between trust and distrust. I want to open up to him but I want to protect myself at the same time. How can anyone love me if I don’t love myself? I feel I am now at a crossroads. He will be coming back from his trip the day before school starts and I am already planning on just ignoring him. I just hate the sway he has over me. I hate how I find myself thinking about him. I hate how I am reminded of him just walking through campus. I sometimes wish I had never met him, so to save myself from all this doubt. It is pretty pathetic.

But I think to myself: Is all this really worth it? Can I still push people away forever? My therapist outright tells me to grow up and accept responsibility. I need to take responsibility for my actions. I need to control my emotions and my perspectives on the world. I need to remain rational and logical.

My confidantes are right. Would he continue to put all this effort into hanging out with me if he weren’t serious? Would he have asked to see me the night before he flew out? I cannot play these cat and mouse games. I cannot continue to test my friends, family and loved ones. Testing HIV-positive reminds me of my mortality — there isn’t a second to waste. I need to start putting more effort into this. If it works, it works; if it doesn’t, I will eventually move on. If only I would just let myself live.

The meeting at a convention center in Havana’s Vedado district may have been the largest gathering of openly gay activists ever on the communist-run island. President Raul Castro’s daughter Mariela, who has promoted the rights of sexual minorities, presided.

“This is a very important moment for us, the men and women of Cuba, because for the first time we can gather in this way and speak profoundly and with scientific basis about these topics,” said Castro, director of Cuba’s Center for Sexual Education.

Mariela Castro joined government leaders and hundreds of activists at the one-day conference for the International Day Against Homophobia that featured shows, lectures, panel discussions and book presentations. A station also offered blood-tests for sexually transmitted diseases.

Cuban state television gave prime-time play Friday to the U.S. film “Brokeback Mountain,” which tells the story of two cowboys who conceal their homosexual affair.

Prejudice against homosexuals remains deeply rooted in Cuban society, but the government has steadily moved away from the Puritanism of the 1960s and 1970s, when homosexuals hid their sexuality for fear of being ridiculed, fired from work or even imprisoned.

Now Cuba’s parliament is studying proposals to legalize same-sex unions and give gay couples the benefits that people in traditional marriages enjoy.

Parliament head Ricardo Alarcon said the government needs to do more to promote gay rights, but said many Cubans still need to be convinced.

Things “are advancing, but must continue advancing, and I think we should do that in a coherent, appropriate and precise way because these are topics that have been taboo and continue to be for many,” Alarcon told reporters.

Some at the conference spoke of streaming out into the streets for a spontaneous gay-pride parade, but others urged caution.

The gay rights movement should be careful not to “flood” Cuban society with a message that many are not ready to hear, physician and gay activist Alberto Roque cautioned.

And Mariela Castro said gay activists should opt for more subtle ways to chip away at deep-seated homophobic attitudes.

Defending equal rights for Cubans, of all sexual orientations, is a key principal of the Cuban revolution led by her uncle Fidel Castro, who overthrew dictator Fulgencio Batista in 1959, she said.

“The freedom of sexual choice and gender identity (are) exercises in equality and social justice,” she said.