News (Updated August 20, 2006)

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'Elite' HIV patients mystify, intrigue doctors

TORONTO (Reuters) - As many as one in 300 HIV patients never get sick and never suffer damage to their immune systems and AIDS experts said on Wednesday they want to know why.

Most have gone unnoticed by the top researchers, because they are well, do not need treatment and do not want attention, said Dr. Bruce Walker of Harvard Medical School.

But Walker and colleagues want to study these so-called "elite" patients in the hope that their cases can help in the search for a vaccine or treatments.

"What in the heck is going on in people that successfully control this virus?" Walker asked a news conference held at the 16th International Conference on AIDS.

"If we can figure out how people are doing that, we can try to replicate it."

So far Walker and colleagues have not been able to find out why certain people can live for 15 years and longer with the virus and never get ill. The AIDS virus usually kills patients within two years if they are not treated.

Some even appear to have weak immune responses, he noted. "Is it just that these people got infected with a wimpy virus? The answer to that is no," Walker said.

"Some of the people know who infected them," he added, and in those cases, the person who infected the "elite" patients always went on to become ill.

A few years into the AIDS epidemic, researchers identified people who were called "long-term non-progressors." These were patients infected with HIV who did not become ill.

Many have become ill as the years have gone by, and required treatment.

Walker said a few of the long-term non-progressors were now classified as "elite" patients. But the difference is that the "elite" status is clearly defined by how much virus they have circulating in their blood.

Loreen Willenberg, of Diamond Springs, California, is a newly designated "elite." Now 52 and healthy, she said she became infected in 1992.

BAD DREAM

"I dreamed that I was HIV positive," Willenberg told the news conference.

"I was really going through a very bad flu." She sought testing, and after getting an inconclusive result was later declared HIV positive.

HIV patients are not immediately put onto drugs that can keep them healthy, but wait until the virus reaches a certain level in the blood or until the virus kills a certain number of immune system cells called CD4 T-cells.

Willenberg, a landscape designer, never got to that point.

"I am in perfect health. I think I have had maybe only one cold in the past 14 years," she said.

Walker has tracked down 200 elite patients and has now joined up with other prominent AIDS researchers to find at least 1,000 "elites" in North America and as many as possible globally.

Based on research done so far, Walker estimates there are 2,000 of them in the United States.

His team wants to take blood and DNA samples to see what might be different about them. Confidentiality is promised.

The recently published map of the human genome will make this possible.

They will compare key genetic sequences of the "elite" patients to genetic readouts from healthy people and from other HIV patients. Maybe a few genetic variations can explain what is happening, Walker hopes.

 

FDA tells body part collection firm to close

Fri Aug 18, 2006 06:21 PM ET

WASHINGTON (Reuters) - U.S. health officials ordered a human tissue collection company to shut down on Friday, saying lapses in screening and record keeping put recipients of the donated body parts at risk of infection.

Donor Referral Services of Raleigh, North Carolina, and its owner, Philip Guyett, must immediately stop recovery and shipment of cells and tissues from human donors, the Food and Drug Administration said in a letter to the company.

FDA inspectors found the company did not follow procedures meant to make sure body parts from cadavers are free from infectious diseases such as HIV or hepatitis. In part, the company failed to review relevant medical records to check for risk factors for infectious disease, the FDA said.

The problems were "so serious and widespread that FDA finds there are reasonable grounds to believe that they present a danger to public health," the letter said.

Guyett did not immediately respond to a request for comment.

The FDA said it had not received any reports of harm related to tissue from the company.

Tissue collection companies process a variety of human material from deceased donors, such as bone, ligaments, skin and tendons, that can be transplanted into patients.

 

Rapid tests mean more learn HIV status

Fri Aug 18, 2006 03:25 PM ET

By Terri Coles

TORONTO (Reuters Health) - Rapid HIV tests lead to more people getting tested and receiving their results, according to a study by the US Department of Veterans Affairs presented at the 16th International AIDS Conference.

Both traditional testing and newer rapid tests were likely to result in higher screening rates for HIV, according to the study. But patients who received rapid testing were much more likely to learn their results.

HIV testing is cost-effective, but testing rates for at-risk populations in the U.S. are low. "Even people who are in care and are seeing their doctor on a regular basis, and are identified as being at risk for HIV infection, are not being tested at nearly the rate that they should be," said Dr. Henry Anaya, who presented the study.

Testing is important because people tend to reduce their risk behaviors when they know their HIV status, Anaya said.

Patients waiting for an appointment at VA primary/urgent care clinics in Los Angeles were randomly split into three testing groups. The patients were all between 18 and 65 years of age and were unaware of their HIV status. None had been tested in the past year.

The first group of patients was prompted to ask their doctor for an HIV test during their appointment; the second group was referred to a nurse for traditional HIV testing; and the third group was also referred to a nurse but these patients received the rapid HIV test.

Traditional HIV testing involves two appointments -- one for testing, and another some days later, to receive the results and counseling. Rapid tests involve an oral swab or a finger stick and results can be available in as little as 20 minutes.

Forty-one percent of the patients told to ask their physician for a test actually did, and 41 percent of those tested received their results. Double the patients who were referred to a nurse for testing actually did take the HIV test. Eighty-four percent of those referred for traditional testing received it, as did 93 percent of those in the rapid test group.

But many more patients in the rapid test group actually received their results -- 90 percent compared to 52 percent for those who had to return to get their results and counseling.

"The magnitude and direction of these results surprised even us," Anaya said.

The results show that referring patients for testing is effective in both cases, but rapid testing resulted in nearly double the patients ultimately learning their HIV status.

The testing project is currently being used in an outreach effort directed at homeless veterans with the Los Angeles County, and the hope is for it to be expanded nationally across the Department of Veterans Affairs, Anaya said.

 

Drug abuse seen driving new HIV epidemics

Wed Aug 16, 2006 08:52 AM ET

By Terri Coles

TORONTO (Reuters Health) - Many populations worldwide have seen a decrease in HIV prevalence, but in several countries drug use is fueling new HIV epidemics. Prevention has become a key focus of the 16th International AIDS Conference in Toronto, highlighting the importance of targeting and engaging drug users in the fight against HIV and AIDS.

Users of illegal injection drugs are at a disproportionally higher risk of becoming infected with HIV, and their health is poorer when they are HIV-positive. But non-injection drugs are also of concern in the fight against HIV and AIDS.

"Meth is the major driver of the HIV epidemic in the United States," said Dr. Steffanie Strathdee of the University of California, San Diego at a conference presentation on Monday.

Dr. Strathdee's research focused on heterosexual methamphetamine (or meth) users, but there has been concern about meth use in the gay community possibly leading to risky sexual behavior.

"One of the recreational purposes of the use of meth is increased sexual stimulation," said Amy Drake of the Centers for Disease Control and Prevention on Tuesday. Therefore, Drake said, "Meth use among men who have sex with men is of concern for HIV prevention."

The CDC surveyed homosexuals, bisexuals and other men who have sex with men (MSMs) in 15 American cities about their sexual activities and drug use. They found that meth use was more common in men infected with HIV. Also, regardless of HIV status, MSM meth users were more likely to report engaging in high-risk unprotected anal sex. "It is clear from our data and other data that meth use among men who have sex with men presents a challenge," Drake said.

But drug users are often left out of the fight against HIV/AIDS because of discrimination against illegal drugs and those who use them. During the conference's opening ceremony on Sunday, Bill and Melinda Gates called attention to the stigma that prevents drug users from gaining access to testing, treatment and prevention supplies like condoms and clean needles.

As well, misconceptions can contribute to the stigma, even among the users themselves. There's a widespread impression that using meth causes irrational and risky behavior, said Sandra L. Bullock of the University of Waterloo in Waterloo, Ontario.

"It can lead to a self-fulfilling prophecy," Bullock said during a presentation on Tuesday. "If we're telling people that using this is going to cause you to do things you're not going to otherwise do, it can be a built-in excuse."

Facilities like safe injection sites are key to preventing HIV infection in drug users and controlling the epidemic, said Dr. Alex Wodak, former president of the International Harm Reduction Association, at a conference session on Tuesday.

Harm reduction is effective, safe and cost-effective, and it's necessary to push for its use even if it appears to some to be promoting illegal drug use, said Dr. Wodak, now director of the Alcohol and Drug Service at St. Vincent's hospital in Australia.

Behavioral intervention can reduce risk behavior even if it doesn't target drug use directly, said Dr. Strathdee. "Heterosexual active meth users can reduce their high risk sexual behavior even though they're still engaging in active meth use."

In the face of "monstrous" stigma, there is a need for a comprehensive, whole-person approach that engages drug users where they are at the time of intervention, not where we wish they were, said Walter Cavalieri, director of The Canadian Harm Reduction Network.

"Harm reduction is not just needle exchanges, not just safe injection facilities," said Cavalieri. "Needle exchange has done wonderful work, but more than anything it's a bridge to more work."

Day-to-day support and physical and mental health also need to be considered, he said, along with a wider look at the effectiveness of current restrictions on illegal drugs and drug paraphernalia and how they affect use and stigma. "You cannot look at harm reduction without looking at how we deal with regulation of drugs."

 

Future seen promising for AIDS vaccine

Wed Aug 16, 2006 05:04 AM ET

By Maggie Fox, Health and Science Correspondent

TORONTO (Reuters) - There is no vaccine against AIDS and none of the dozens of vaccines being tested is likely to completely protect people from the deadly virus, but the future looks bright for AIDS vaccine development, researchers said on Tuesday.

Scientists will learn from the vaccines now being tested, and the developing world, hardest hit by HIV, is starting to produce its own vaccine effort, said Dr. Seth Berkley, head of the nonprofit International AIDS Vaccine Initiative.

"An AIDS vaccine is the only tool that can end the pandemic," Berkley told a news conference to launch a biennial report on vaccines at the 16th International AIDS Conference in Toronto.

"All evidence suggests that a vaccine is possible. There is progress being made. It's slow but it's steady," he added.

"To me, we are about to enter a renaissance in AIDS vaccine research."

Yet Berkley said only two AIDS vaccine candidates are in advanced human trials -- one made by Merck and Co. and another by Sanofi-Aventis SA.

"The next major milestone for the field is likely to be the Merck result, which is a test for cellular immunity," Berkley said.

Berkley and others do not expect the Merck vaccine will protect against disease in the way, for instance, a measles vaccine does.

The AIDS virus infects more than 39 million people globally, more than 60 percent of them in sub-Saharan Africa. It kills more than 4 million people every year and has killed 25 million people since it was identified in the 1980s.

It is difficult to vaccinate against because the virus infects the very immune system cells that are usually stimulated by a vaccine.

"This is probably the toughest adversary that has ever been out there for vaccine development," Berkley said.

Most vaccine stimulate antibodies, immune system proteins that mark enemy invaders for destruction. Vaccine researchers believe that a good AIDS vaccine will have to stimulate both antibodies and so-called cellular immunity, which is the job of T-cells, dendritic cells and other immune cells.

Berkley hopes results of how well the Merck vaccine works will be available in 2008. If it reduces infection rates by even a little, scientists can study the volunteers and see just what successful aspects could be used as clues for further research.

If it does not work at all, whole new approaches will have to be pursued.

Even a partially effective vaccine could be useful, said Stephen Lewis, the United Nations delegate to Africa for AIDS.

"I think it's fair to say ... even a modestly effective vaccine could cut the number of new infections by one-third over a decade, saving tens of millions of lives," Lewis told the news conference.

One obstacle to testing vaccines is a lack of volunteers and facilities to do the clinical trials, the tests in people that show whether a vaccine or drugs works.

"We have dramatically improved the ability to do clinical trials," Berkley said. Ten years ago such trials were only done in industrialized countries, but now they are being run in two dozen developing countries, he said.

And funding for trials has doubled over the past five years, he said.

 

New weapons eyed in AIDS battle

Tue Aug 15, 2006 10:53 PM BST

By Maggie Fox, Health and Science Correspondent

TORONTO (Reuters) - Many new tools could join condoms and counselling programs in preventing AIDS, but not enough is being done to prove they work and then get them to the people who need them most, experts told the International Conference on AIDS on Tuesday.

Although circumcision, antiviral creams or gels and diaphragms can all help combat the spread of the deadly disease, the ultimate goal of a vaccine is still far away.

"An AIDS vaccine is the only tool that can end the pandemic," said Dr. Seth Berkley of the International AIDS Vaccine Initiative.

"All evidence suggests that a vaccine is possible. There is progress being made. It's slow but it's steady."

In the meantime, every prevention method possible needs to be used, according to the report by the Global HIV Prevention Working Group, whose members work at the World Health Organisation, the Bill and Melinda Gates Foundation, the European Commission, the World Bank and elsewhere.

"Only one in five people have access to the things we have available today. While we continue to look for new approaches, there is a lot more that we can do today," said Dr. Helene Gayle of the aid group CARE and an organiser of the AIDS conference. That includes condoms and counselling.

One obstacle: a lack of health-care workers to test and treat HIV patients, and to counsel people on ways to protect themselves.

Trained workers are hired away by richer nations desperate for their skills while many in the most affected countries themselves succumb to AIDS, according to a WHO report.

While good progress has been made getting treatment to adults with HIV -- 1.3 million people in developing countries -- Medecins Sans Frontieres said only 5 percent of the 660,000 young children in urgent need of treatment were receiving it.

The United Nations AIDS agency UNAIDS estimates that $11.4 billion will be needed annually for HIV prevention by 2008, more than twice what is now spent.

The AIDS virus infects more than 39 million people globally, more than 60 percent of them in sub-Saharan Africa. It kills more than 4 million people every year.

LITTLE PLANNING

"Despite the fact that some new HIV prevention methods could be shown to be effective in the near future, virtually no planning or resources have been dedicated to ensuring future access to new prevention approaches," says the report from the Global HIV working group.

They include:

-- Circumcision: A study in South Africa showed circumcised men were 60 percent less likely than uncircumcised men to become infected with HIV from female partners. The foreskin of the penis contains many of the cells HIV can easily infect.

-- Cervical barriers: Diaphragms and similar birth control methods might block the virus from reaching the cervix, which in women is the area most susceptible to the virus.

-- Pre-exposure prophylaxis. Research in animals suggests taking one or two HIV drugs a day could protect people at high risk of infection.

-- Herpes suppression: The herpes virus, which infects up to 70 percent of people in some areas, creates lesions that make HIV easier to acquire and transmit, but can be suppressed with several antiviral drugs.

-- Microbicides: A gel or cream, perhaps containing an HIV drug, could be applied to the vagina or rectum to reduce HIV transmission.

Former U.S. President Bill Clinton told the meeting much progress had been made in beating down the price of HIV treatments and getting them to the people who need them most.

Four years ago, Clinton said, a course of treatment with generic versions of first-line HIV drugs cost $400 a year. "We were able to lower this price to just $140 a person a year," Clinton said.

And leaders who had refused to recognise the extent of the AIDS problem have signed on to fight it, he added. "China, once in a state of denial, deserves all of our respect for turning on a dime and recognising the problem," Clinton said.

He also praised Pakistan. "They deserve a big pat on the back for saying Islam does not require denial in dealing with AIDS," he said.

 

New guidelines help sort out HIV drug maze

TORONTO (Reuters) - Simpler drug combinations can control the AIDS virus well, researchers said on Sunday in several reports that will help in trying to mix and match nearly two dozen different HIV drugs in lifesaving cocktails.

The reports published in the Journal of the American Medical Association, and presented to the International AIDS Conference in Toronto, show that simplified drug regimens can be safe and effective, and safely relieve side-effects in some patients.

The HIV drugs, called antiretroviral drugs, are usually combined into three-drug cocktails called highly active antiretroviral therapy or HAART. They once had to be carefully planned out, with patients forced to take several different pills at various times of day.

Now combined pills make that easier - with one once-a-day pill on the market. And some patients might safely skip some of the more toxic drugs, the studies suggest.

"We now have 22 antiretroviral agents in five classes that are FDA (U.S. Food and Drug Administration) approved," Dr. Scott Hammer of Columbia University in New York told a news conference.

Some are clearly meant for patients who have few options because the virus in their bodies has evolved to resist most drugs. These include many of the newer drugs.

But there is clear evidence that some of the mainstay drugs can keep the virus suppressed, which in turn keeps the immune system, and patients, healthy.

"Despite the optimism, we are still faced with lots of drug toxicity issues," Hammer said. And if people take one drug, the virus can develop something called cross-resistance to other drugs.

Guidelines issued on Sunday by the non-profit International AIDS Society-USA are aimed at sorting through the choices, and mesh with World Health Organization guidelines.

WHEN TO START AND WHAT TO START WITH

Both groups say a new HIV patient should start taking the drugs as soon as the immune system cells that are destroyed by the virus reach a certain level.

And they should start on a three-drug combination of the oldest class of HIV drugs, called nucleoside or nucleotide reverse transcriptase inhibitors, along with either a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor.

Because protease inhibitors are expensive, WHO recommends waiting until they are needed.

The first once-a-day pill to hit the market, Atripla, meets these guidelines. A cooperative venture by Gilead Sciences Inc., which makes the NRTIs Emtriva and Viread, with Bristol-Myers Squibb, which makes the NNRTI Sustiva, the pill contains one of the recommended three-drug regimens.

There are also generic drugs made in Thailand, Brazil and elsewhere, as well as two-and three-drug combinations that can be taken twice a day with other drugs.

Other research suggests it may be safe to leave out some of the drugs.

Susan Swindells of the University of Nebraska Medical Center Omaha and colleagues tested the use of atazanavir, a protease inhibitor sold under the name Reyataz by Bristol-Myers Squibb, combined with a small dose of another protease inhibitor called ritonavir - known as "boosting."

They tested it on 34 patients who had been taking a three-dose combination and found the once-a-day, two-dose regimen kept them just as healthy.

"I don't think it is ready for the general public," commented Hammer, who also worked on the study.

A third study tested whether adding a fourth drug to the mix would help new HIV patients get the virus under control more quickly, but found it did not help any, and cost more.

 

Multiple partnerships fueling AIDS epidemic

Tue Aug 15, 2006 09:23 AM ET

By Terri Coles

TORONTO (Reuters Health) - In Swaziland they are called "lishendes" -- multiple concurrent sexual partners -- and they are the driving factor behind the HIV epidemic in southern Africa, said researchers on Monday at the 16th International AIDS Conference in Toronto.

Instead of casual sexual encounters with multiple partners, established partnerships outside of marriage are fueling a generalized epidemic in southern African countries. These partnerships often involve inconsistent condom use and occur in the context of low rates of male circumcision.

At the conference in a presentation titled "Prevention Works: What's The Evidence," researchers put forward evidence for various HIV prevention programs aimed at increasing education, reducing stigma and changing behavior.

"In southern Africa and a country like Swaziland we're talking about a very generalized epidemic," said Dr. Daniel Halperin of the US Agency for International Development's Southern Africa HIV-AIDS Program in Mbabane, Swaziland.

Halperin described the HIV infection rate in Swaziland as "astonishingly high." The prevalence rate for the general adult population was 33.4 percent in 2005. Multiple concurrent sexual partnerships are a main driver of the generalized epidemic in Swaziland, Dr. Halperin said. These partnerships are not casual sexual encounters or polygamy, but are instead longer-term relationships outside of marriage.

"Data worldwide consistently shows that people with a higher number of partners have a higher prevalence of HIV," Halperin said. Partner reduction can be one important element of HIV prevention, but it's not the only factor to consider.

Men in countries like Thailand and the United States report more lifetime sexual partners than men in some African countries, but have a lower prevalence rate of HIV infection. The problem is not that Africans have more sexual partners, Halperin said, but that concurrent partnerships lead to villages becoming linked up in sexual networks, aiding the spread of the virus. Having two or three regular sexual partners leads to an increase in the risk of HIV infection.

A large majority of those who responded to a baseline survey of 2000 adults in 12 randomly selected communities -- done before the start of a sexual behavior communication campaign in Swaziland -- agreed that lishendes were common or very common in their communities.

During the study, many respondents said that multiple partnerships were harmful to the fight against HIV/AIDS. Females in particular felt that choosing to have only one sexual partner at a time was important for prevention and the fight against HIV/AIDS in Swaziland.

A government-led campaign was launched in June 2005, and a follow-up survey of 2000 adults was conducted in the same 12 communities a year later, along with three rounds of focus group discussions with men and women in each of the communities.

The campaign focused on a message of abstinence and monogamy. Advertisements aimed at young people promoted waiting to have sex, while those for adults presented messages like "I choose to have only one sex partner" and "I'm circumcised, proud of it...and I'm still faithful to my partner."

Another group of advertisements had fear-based messages highlighting the risks of multiple partnerships, with messages like "Why kill your family?"

The advertisements were controversial in their approach, going against a belief by some NGOs and activist groups that fear-based messages are not effective, Halperin said.

"Many of people in the (focus) group said 'You should show people dying of AIDS, you should scare people'," Halperin said. "We're seeing a bit of a disconnect between what people in the community say and what we, as experts, believe is the right way to do AIDS prevention."

The controversial advertisements were widely discussed in Swaziland, where they were subject to heavy public and media attention. In their surveys after the fact, researchers found that more than 80 percent of respondents were aware of the campaign. Anecdotally, he said that the advertisements were widely discussed in the general population.

 

AIDS focus shifts to prevention

Tue Aug 15, 2006 09:57 AM ET

By Maggie Fox, Health and Science Correspondent

TORONTO (Reuters) - Researchers, activists and major funders have agreed to a shift in the fight against AIDS to focus on prevention and especially helping women protect themselves.

With big pharmaceutical companies making their HIV drugs available cheaply to developing nations and with generic drugs available, speakers at the 16th International Conference on AIDS agreed the focus should move to preventing new infections.

"Prevention of HIV had slipped off the agenda and now is being pushed by unexpected quarters," Dr. Peter Piot, head of the United Nations AIDS agency UNAIDS, said in an interview.

That includes activists who had previously focussed on getting lifesaving drugs to infected people, he said.

Opening the conference in Toronto on Sunday, Microsoft founder Bill Gates, who has donated hundreds of millions of dollars to AIDS programs, said he would be seeking good prevention programs that focussed on women.

These will include the development of microbicides -- gels or creams that can prevent sexual transmission of the fatal and incurable virus.

Just over half, or 17.3 million, of the 34 million adults infected with the AIDS virus are women, according to the World Health Organisation.

With more than 4 million new infections a year and 2.8 million deaths, the need for prevention is clear. But some political and religious leaders are standing in the way of effective programs, several experts said.

"The problem with prevention for many is that you cannot avoid dealing with sex and drugs," Piot said.

Barbara Lee, a California Democrat in the U.S. House of Representatives, said the administration of President George W. Bush may have to be forced into changing its policies that stress abstinence as the best prevention method.

GOING WITH WHAT WORKS

"What we see is a very ideologically driven administration, both domestically and internationally, trying to put their moral values ... on communities and countries," Lee told a news conference.

She is sponsoring legislation that would eliminate U.S. requirements that 33 percent of all funds spent on prevention go to promoting abstinence-only-until-marriage approaches.

"We know that abstinence only before marriage doesn't work," said Stephen Lewis, the U.N. ambassador to Africa for

AIDS.

The White House defended its policies. "Very little of what PEPFAR is doing in prevention in any focus country is in abstinence only," said Warren Buckingham country coordinator for the (U.S.) President's Emergency Plan for AIDS Relief in Kenya. "We all long for the day when there is an effective microbicide, but we are not there yet."

Until then counseling programs to help women speak up for themselves and to encourage men to respect women more might be more useful, Buckingham said.

Medecins sans Frontieres said the high price of newer medicines is driving up the cost of treatment for AIDS. As patients use first-line drugs, the virus in their bodies evolves resistance and they must move to new regimens, the group said in a report issued at the conference.

"In Nigeria 8 percent of patients on treatment for 18 months need second-line, which costs over seven times more than first line ($200 versus $1,473 a year)," said the group, also known as Doctors Without Borders.

 

Pricing, lack of tools hamper child AIDS treatment

Tue Aug 15, 2006 04:14 PM ET

By Cameron French

TORONTO (Reuters) - Doctors trying to treat HIV-infected newborns in sub-Saharan Africa are being held back by over-priced treatments, an absence of diagnostic tools, and a general lack of focus from policymakers and international organizations, Medecins Sans Frontieres said on Tuesday.

Most of the 2.3 million children infected with the virus live in southern Africa but the pharmaceutical industry is based largely in richer western countries, where many fewer children are infected, the group said in a report released at the 16th International AIDS conference in Toronto.

The group, also known as Doctors Without Borders, said that only five percent of the 660,000 young children in urgent need of treatment were actually receiving it. Unfortunately, they added, the treatment was hard to come by, and what was available was over priced.

"We want to do more. We know what we're doing is not enough, because our hands are tied," Moses Masaquoi, an MSF doctor working in Malawi, told a news conference.

Masaquoi said a lack of pediatric formulations of HIV drugs meant that doctors were forced to split adult tablets that were not meant to be taken in parts, while the small amount of child-designed treatment that was available is difficult to store and administer as it needed refrigeration, which could be tough in hot, poorer countries.

Pricing discrepancies also hamper their efforts, as the few companies that produce child dosages price them higher than adult dosages, even though they carry about one-fifth of the active ingredient of the adult dosages.

"Prices of pediatric formulas are not justified," Fernando Pascual, a pharmacist with MSF, told the news conference.

CLINTON OPTIMISTIC

The group is calling on policymakers and groups such as the World Health Organization and UNICEF to give clear guidance to drug manufacturers to produce child-specific formulations, and says national governments need to take the issue more seriously.

Former U.S. President Bill Clinton lamented the fact that pediatric treatment has lagged behind other treatment, but he sounded an optimistic note, predicting funding could jump ahead over the next two years.

"I understand why governments didn't spend money on pediatric medicine in the beginning. It's expensive. (But) now we've got the price down to $200 (per child per year)," he said in a separate news conference.

"I am committed to working with others who are coming up with the funds for this to do whatever is necessary to get the pediatric medicine to children who need it."

Nine out of 10 newly infected children acquire the virus through mother-to-child transmission, but diagnostic tests generally used for adults are not always accurate for infants.

Compounding the problem is the fact that most pregnant mothers do not have access to prenatal care, MSF said.

This has frustrated doctors who have seen noticeable results when children have received treatment.

MSF studies show that of children that did receive early treatment, 80 percent were alive after 2 years, while half of children who acquired the virus through mother-to-child transmission died before the age of two.

 

Cannabis pitched as pain killer at AIDS conference

By Cameron FrenchMon Aug 14, 6:44 PM ET

The light scent of marijuana wafted among exhibits at the 16th International AIDS Conference in Toronto on Monday, as activists took advantage of Canada's comparatively pot-friendly policies to make a pitch for the drug as a pain-killer.

"This is the first time that an exhibit of this kind has been at the AIDS conference," said Hilary Black, spokeswoman for the Medical Marijuana Information Resource Center which along with the Canadian AIDS Society sponsored the display.

"It's possible that it may be the only time, until we see a global shift around the policies governing this plant."

Researchers say marijuana can ease some types of severe and chronic pain as well as symptoms like nausea better and with fewer side effects than many prescription remedies.

While marijuana use is not generally legal in Canada, the federal government runs a medical marijuana program, although only about a quarter of medical marijuana users infected with HIV get their cannabis through legal sources, Black said.

In the United States, the use of medical marijuana has long been contested on the state and federal level. Last June, the U.S. House of Representatives rejected a bill that would have allowed the medical use of the herb. But efforts are under way in several other states to legalize marijuana use.

The Canadian resource center is backed by Cannasat Therapeutics Inc., a Toronto-based research company trying to develop cannabis-based medicine that would eventually be available by prescription.

The group has been passing out information on legal access and tips on the use of cannabis as a medicine and dealing with reaction from participants who have come from around the world for the week-long conference.

"We had some people here from Uganda. One doctor said its like crack cocaine, it's bad, it trouble," said Sara Lee Irwin, a spokeswoman for the center and medical marijuana user, as she cut open a foil 250 gram (8.8 ounce) bag of government-issued cannabis.

"The next guy said, 'It's not like crack, it's everywhere, why aren't we using it?'," she said.


New regimen slashes mother-to-baby HIV risk

by Isabel ParenthoenThu Aug 17, 7:47 PM ET

The risk of an HIV-infected mother handing on the AIDS virus to her baby can be reduced to less than six percent under an innovative regimen that combines drugs and bottle feeding, French researchers said at the global AIDS conference.

Two million of the nearly 39 million people infected with the human immunodeficiency virus (HIV) are children in sub-Saharan Africa, the vast majority of whom became infected in the womb or through breast feeding.

Without access to antiretroviral drugs, there is a 20-45 percent chance that an HIV-infected mother will pass infection on to her child.

Doctors with the French National Agency for Research on AIDS (ANRS) found that this risk can be hugely reduced by combining drug treatment at the end of pregnancy and during the child's delivery with alternatives to long-term breast-feeding.

The study, conducted from 2001 to 2005 in Abidjan, Ivory Coast, included 808 infected women with HIV, who gave birth to 711 babies.

The prenatal drug cocktail comprised either zidovudine (AZT) during the last four weeks of pregnancy and a single dose of nevirapine at the moment of labour or a double therapy of AZT and lamivudine (also called 3TC) during the last eight weeks of labour combined with a single dose of nevirapine during labour.

In addition, each baby received a dose of nevirapine two days after birth, and AZT for one week.

As for breast-feeding, the mothers either started bottle feeding at birth, or exclusively nursed their babies, although the breast-feeding lasted only four months.

The best combination was AZT and 3TC and bottle feeding. Only 5.6 percent of the 126 babies born under this regimen had HIV.

The least successful was AZT and nevirapine followed by the short-term breast-feeding, with a transmission rate of 15.9 percent among 169 babies.

The researchers expressed delight at this result, noting that it was the latest success in fine tuning medications and maternal practices to tackle the curse of mother-to-child HIV transmission.

"This is the first demonstration in Africa of the benefit of managing HIV-infected pregnant women with a combination of antiretroviral treatment and alternatives to prolonged maternal feeding," said ANRS' Valeriane Leroy.

She stressed, though, that if poor, infected mothers were encouraged to bottle-feed their babies for such long periods, they had to have access to clean water, and also, if possible, the material to do so.

Fewer than six percent of pregnant women in sub-Saharan Africa are offered services to prevent handing on HIV to their baby, according to UNAIDS figures for 2005.

 

Stopping HIV: Could circumcision be the kindest cut of all?

by Richard InghamThu Aug 17, 6:53 PM ET

Circumcision could be a highly effective way of braking the AIDS pandemic, experts said, cautioning though that before surgeons everywhere reached for their scalpels, major questions had to be answered.

Interest in circumcision surged among AIDS researchers last year after a French-funded trial, conducted in South Africa, found that men who had had their foreskin removed were around 60 percent less likely to be infected by HIV than uncircumcised counterparts.

Two similar trials, one in Uganda and the other in Kenya, are currently underway, the 16th International AIDS Conference heard. The trials are due to end in June and September 2007 respectively.

If their data confirm the astonishing outcome of the South African trial, the world's top agencies fighting AIDS will move to recommend male circumcision as one of a panoply of methods to prevent HIV infection, they said.

The UN's World Health Organisation (WHO) is already drafting technical recommendations, which could be implemented if circumcision gets the green light.

Advocating circumcision "seems a pretty dramatic thing to suggest, or at least a few years ago it seemed so," said Kevin De Cock, director of the WHO's HIV/AIDS Department, admitting that the South African trial had had a resounding impact.

But he also sounded a loud warning, pointing out that circumcision may reduce the risk but was only a partial protection.

So it was essential that circumcised men do not become complacent and start to practise unsafe sex in the belief that they could not contract the human immunodeficiency virus (HIV).

"It is not a silver bullet," stressed Catherine Hankins, senior advisor to the specialist UN agency UNAIDS.

Hankins also said agencies, governments and doctors had to tread carefully in advising circumcision. In some cultures, circumcision was considered a rite of passage to adulthood and a symbol of manhood; in others, it was considered an emasculation.

"In some cultures if you're not circumcised, you are not a man, and in other cultures if you are circumcised, you are not a man. I think it goes very to the heart of masculinity and what that means in the cultures."

There are even some anti-circumcision organisations, which are lobbying fiercely against what they call "male genital mutilation," said De Cock.

Scientists started to take a close interest in the circumcision question in the late 1980s, when they realized that in East and West Africa, where the rate of circumcision is high, the rate of HIV infection was low -- whereas in southern Africa, HIV rates were very high but the rate of circumcision was very low: less than 20 percent of men.

The theory behind circumcision's protective effect is that the foreskin has a very thin epithelium, or lining, and easily suffers minor abrasions during intercourse.

These microscopic cuts make it easier for the AIDS virus to enter into the man's bloodstream.

Another mooted reason is that the foreskin is rich in so-called Langerhans cells whose surface configuration makes it easy for HIV to latch on to them.

If circumcision joins condoms in the meagre arsenal of weapons to prevent HIV, it could have a mighty effect, according to a study presented at the conference.

Taking into account information on HIV infection rates and the prevalence of male circumcision across Africa, it calculated that if all men were circumcised over the next 10 years, some two million new African infections and around 300,000 deaths could be avoided.

After 20 years, the number of lives saved would be somewhere in the range 1.6-5.8 million, it estimated.

Bernar Auvert of the France's National Agency for Research on AIDS, who led the South African trial, said circumcision was a low-cost option: the operation would cost only between 50 and 60 dollars -- less than two months' of the cost of antiretroviral treatment for people who get infected with HIV.

But he stressed that circumcision was also a relatively complex operation, lasting around 30 minutes, that had to be carried out under anaesthetic by a surgeon working in hygienic conditions.

If poor countries with overstretched health services were unable to cope with demand, "males will then be circumcised by traditional circumcisers, with potential complications including death and permanent genital damage," he said.

"It will be a nightmare. The effect of AMC (adult male circumcision) will be the reverse of the expected effect. It will lead to harm instead of good."

A trial funded by the Bill and Melinda Gates Foundation is underway in Uganda to assess whether male circumcision has any impact on the risk of HIV transmission to females.

 


Researchers link music tastes to HIV risks

by Michel ComteThu Aug 17, 2:47 PM ET

US boys hooked on gospel, techno and pop are more at risk of HIV infection than devotees of other musical styles, including "bling, bling" hip hop, according to a new study.

Musical tastes may offer clues to rates of HIV infection, said researchers who tried to decipher the complex behaviors and attitudes of young men in the United States, at a global AIDS conference.

The music industry often says there is no connection between music and sexual behavior, but hundreds of young men interviewed in New York this year fiercely disagreed, said lead researcher Miguel Munoz-Laboy of Columbia University.

They said images of scantily-clad women in submissive roles in hip hop music videos, for example, had a "real impact on their lives," he said.

"There is a connection. You see it in the way people dance, dress and it has an impact on their sexuality," said Munoz-Laboy.

The researchers peered into male youth culture to help develop HIV prevention programs that target this demographic they say is too often neglected by health strategists.

They looked at three New York neighborhoods and interviewed boys aged 16 to 21 about their listening tastes and attitudes toward condom use and sexual activities.

"We often blame youth for their behavior without understanding it," Munoz-Laboy said. "(But) there is a complex story about sexuality, masculinity and culture here."

"It's clear that current schemes are not working," he said.

"It's very hard to get heterosexual young men into HIV prevention programs even though we demonize them a lot for pregnancies and passing on STDs (sexually transmitted diseases) to their girlfriends."

The study did not imply listening to certain types of music causes HIV infection but simply found links between genres and risk factors.

A behavioral analysis divided participants into two musical groups: hip hop, reggae, reggaeton, rap and rhythm and blues; and rock, heavy metal, pop, techno, electronic and gospel.

"Kids would be appalled that we grouped them this way, but this is how they mapped out in the mathematical analysis," Munoz-Laboy said.

Researchers also distinguished between two styles of hip hop: the "bling, bling" hip hop that values fancy cars, money, and many girlfriends; and "real" hip hop that tells of urban youth stricken by violence, poverty and drug abuse.

They found boys who listened to hip hop music were more likely to have vaginal intercourse and had more partners, but boys from church or New York club scenes (techno, pop, electronic) took the most sexual risks.

"Boys who listened to hip hop had more sex and more partners, but it did not impact condom use," said Munoz-Laboy. "Those who are part of religious culture or the club scene used condoms inconsistently."


HIV and TB are apocalyptic duo

by Richard InghamThu Aug 17, 1:01 PM ET

Co-infection by HIV and the tuberculosis germ is a fast-growing problem in the global AIDS epidemic, with the two pathogens working in tandem to end a quarter of a million lives every year, the 16th International AIDS Conference has heard.

"More than a third of all people infected with HIV are also infected with the tuberculosis bacillus," Helene Gayle, president of the International AIDS Society, which is organising the six-day event, said Wednesday.

"Joint TB and HIV interventions can save lives and must be accelerated."

Last year, there were at least four million new cases of HIV infection and nearly nine million new TB cases, said Paul Nunn of the Stop TB Partnership. Of the more than two million people who died of AIDS, more than one in 10 was killed by TB, a rate that rises to six in 10 in southern Africa.

The problem with co-infection is that many people carry the TB bacterium but do not know it -- only one in 10 infected by the germ actually develop the disease.

But the bug can reactivate years, even decades, later if the immune system is weak, which is what happens when an individual is infected with the human immunodeficiency virus (HIV). In some cases, co-infection of this kind can lead to death within months, experts said.

They called for efforts to step up testing of TB and for the introduction of new diagnostic tools that can swiftly spot the presence of the bacillus, and for drug companies to invest more in tackling the worsening problem of tuberculosis strains that resist frontline antibiotics.

"TB prevention, diagnostic and treatment services must become core functions of all HIV services," said Kevin De Cock, head of the HIV/AIDS department at World Health Organisation (WHO).

"People living with HIV are more vulnerable to TB, even if they're on antiretroviral therapy.

"TB can be treated and cured, so most of these deaths are absolutely preventable."

A US-led organization released the first findings of a study in Brazil that spelt out ways of preventing TB in those with HIV.

It is called CREATE -- the Consortium to Respond Effectively to the AIDS-TB Epidemic -- with the lead role taken by the Johns Hopkins Center for Tuberculosis Research in the US, backed by researchers and health-policy experts from Africa, South America and Europe.

"TB preventive treatment is successful in reducing TB cases in people living with HIV and AIDS, even for those who are already taking life-saving antiretroviral drugs," the study's principal investigator, Richard Chaisson, said.

Former South African president Nelson Mandela cast the spotlight on the TB/HIV link at the 15th International AIDS Conference in Bangkok in 2004.

Since then, there have been pledges on this issue at this year's UN General Assembly Special Session on AIDS and G8 summit, and also at last year's African summit in Nigeria, which called on all African leaders to intensify action on TB.

Developing countries already have a well-known strategy for combating TB.

DOTS -- directly observed therapy short course -- requires careworkers to monitor carefully that the patient takes a short course of powerful antibiotics all the way through to the end, ensuring that all the TB germs are wiped out rather than linger in a reservoir.

But DOTS relies on patients seeking treatment themselves and targets only those with active TB, not with latent infection.

This means more needs to be done to tackle non-symptomatic cases.

One approach is to encourage testing in places where TB is known to flourish, such as prisons or migrant workers' hostels in southern Africa, but for this to be truly effective, health workers need new-generation diagnostic tools and smarter drugs to combat the mutating germ.

 

GlaxoSmithKline, Shionogi complete HIV drug study

CHICAGO, Aug 14 (Reuters) - GlaxoSmithKline and Shionogi and Co. Ltd. on Monday said they have completed the initial clinical study for an experimental HIV/AIDS drug that blocks viral replication by preventing its integration into the genetic material of human immune cells.

The drug, called 364735, belongs to a new class of anti-HIV drugs called integrase inhibitors and is being developed by a joint venture between Glaxo and Shionogi.

Results from the Phase I study of 364735, conducted in the United States to assess the drug's safety, are being submitted for presentation at a medical conference in 2007. A Phase II study is planned to start in late 2006 in HIV-infected adults.

 

Glaxo withdraws AIDS drug patent plan in Thailand, India

Thu Aug 17, 8:21 AM ET

British pharmaceutical firm GlaxoSmithKlein has dropped its controversial application to patent a key AIDS drug in Thailand and India, the company and international HIV campaigners have said.

Glaxo, which introduced the drug Combid to Thailand four years ago, told AFP that it had informed the Thai government of its intention to withdraw the patent applications for Combid in Thailand earlier this month.

"We already informed Thai officials of our decision to withdraw the application," a Glaxo spokeswoman in Bangkok said Thursday.

A letter was submitted to the Department of Intellectual Property a day after local and international AIDS campaigners and some 500 HIV patients staged a protest in front of the Glaxo office in Bangkok on August 7.

"The letter passed through its legal advisor in Thailand, it did not explain the reason why Glaxo withdrew its application," Kannikar Kijtiwatchakul of Doctors without Borders told AFP.

"But in fact, Glaxo knows it is not qualified to patent the drug which is not newly invented."

The drug combines existing medications into a single pill, making it easier for patients to comply with their treatment programs.

But according to the AIDS Access Foundation, the medication does not merit a patent because combining existing drugs does not constitute a new invention.

Thailand's Government Pharmaceutical Organization has produced and distributed its own generic version at one-fifth the price for years.

Of the 600,000 Thais with HIV, about 80,000 are receiving treatment. Some 18,000 new cases were reported last year.

Thailand's treatment program has been widely credited with slashing the number of deaths from AIDS by about 75 percent last year.

A World Bank report Wednesday called Thailand's program "a useful beacon for other developing countries" seeking to provide treatment to people with HIV.

 

Merck to Offer HIV Drug in Expanded Access Program

 

NEW YORK (AP) -- Drug maker Merck & Co. said Thursday it will offer its experimental HIV treatment to patients who want to take it but are unable to participate in a clinical trial.

Merck said it is opening its HIV integrase inhibitor MK-0518 to expanded access, a mechanism supported by regulators whereby a company can offer an experimental drug to patients with a life-threatening illness who cannot be satisfactorily treated with existing drugs.

Enrollment in the program will begin in the next few months. MK-0518 is currently in late-stage clinical development.

Separately, Merck reported that new interim 24-week data showed that MK-0518 was comparable to Bristol-Myers Squibb's Sustiva in reducing viral load, when it is combined with other HIV drugs.

In afternoon trading on the New York Stock Exchange, Merck shares fell $2.36, or 5.7 percent, to $38.82 after a federal jury in New Orleans ordered the drug maker to pay $51 million to a heart attack victim who took the painkiller Vioxx, now withdrawn from the market. Also Thursday, a New Jersey state judge overturned a November verdict favoring the company.

 

India's Strides gets US nod for HIV tab nevirapine

MUMBAI, Aug 16 (Reuters) - India's Strides Arcolab Ltd. said on Wednesday it had received tentative approval from the U.S. Food and Drug Administration for its HIV drug nevirapine in tablet forms.

Strides also said U.S.-based Gilead Sciences Inc. had agreed to license generic versions of its AIDS drugs Viread and Truvada to the Indian firm.


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