Inspired by the summer festival season, H&M is launching it's third Fashion Against AIDS! campaign with a collection of rock and roll summer styles, with 25% of the proceeds going to youth HIV/AIDS awareness projects.
"It is very important to make people aware of the problem with AIDS and HIV and we want to contribute in the fight against the disease by donating some of the sales from this collection,” says Ann-Sofie Johansson, H&M’s head of design, in a press release.
Described as "a mix of rock with bohemia and glamour with added ethnic touches," the girls collection consists of ready-for-summer denim hotpants, patterned leggings, embellished tunic tops, maxi-dresses, leather jackets, gladiator shoes, chunky bracelets, wide belts , and beaded necklaces.
And for guys who want to look like they're in the band, the boy's collection offers slim blazers and jackets, faded and patched denim jeans and cropped shorts, embellished waistcoats, paisley vests and the "essential rocker’s hat."
Of course if your headed out to a summer music festival, your going to need supplies for camping out. For this reason the collection offers rocker-chic tents, sleeping bags and folding chairs, along with guys and gals themed toiletry kits.
Born to rock but sticking close to home this summer? The collection offers a quartet of headphones in vibrant patterns and colors so you can rock out even if your not at a hot concert.
Hitting stores May 20th and priced from just $2.95 to $79.95, the Fashion Against Aids! collection allows you to give back at a bargain price.
Wednesday, April 14, 2010
City Endorses New Policy for Treatment of H.I.V.
Published: April 2, 2010 - By SABIN RUSSELL - NY Times
In a major shift of H.I.V. treatment policy, San Francisco public health doctors have begun to advise patients to start taking antiviral medicines as soon as they are found to be infected, rather than waiting — sometimes years — for signs that their immune systems have started to fail.
The new, controversial city guidelines, to be announced next week by the Department of Public Health, may be the most forceful anywhere in their endorsement of early treatment against H.I.V., the virus that causes AIDS.
Ever since combinations of antiviral drugs were found to slow progression of the disease in the mid-1990s, doctors and patients have wrestled with the question of when to begin a lifetime regimen of costly and sometimes toxic medicines. The answer remains in dispute, but public health leaders here are now making a case for a change.
Behind the policy switch is mounting evidence that patients who start early are more likely to live longer, and less likely to suffer a variety of ailments — including heart disease, kidney failure and cancer — that plague long-term survivors. Studies suggest that in the early years of infection, when a patient may show few signs of immune system failure, the virus is in fact causing permanent damage that becomes evident later.
For instance, in older patients who finally start taking the drugs, the effects of chronic inflammation take their toll.
“The impact on health risk is comparable to that of diabetes,” said Dr. Steven G. Deeks, a researcher at the University of California, San Francisco. “Their immune system may look like that of someone 30 years older.”
Dr. Diane V. Havlir, chief of the H.I.V./AIDS division at San Francisco General Hospital, said the new policy was already in effect for her patients. Although a decision whether or not to take the medicine rests with the patient, all those testing positive for H.I.V. will be offered combination therapy, with advice to pursue it.
“The history of H.I.V. disease has always been about change,” she said. “We pride ourselves on working quickly with new data.”
At the public hospital’s H.I.V. clinic, a 30-year-old man is mulling advice from Dr. C. Bradley Hare to start on antiviral drugs. He was infected four years ago, but his T-cell count, a measure of infection-fighting white blood cells, is 735, comparable to that of an uninfected, healthy adult. He is buff and athletic and feels good.
The man has decided to keep waiting. “Once you start the drugs, you can’t stop,” he said. “You know how they say, ‘If it ain’t broke, don’t fix it?’ ”
Dr. Hare has been following research on early treatment, and for the last several years he has asked his patients to think about it. Now, he is recommending it outright. He said most of his patients did not have serious problems with drug side effects. “A lot of times they have a sense of relief when they start the meds,” he said.
The turning point in San Francisco’s thinking may have been a study in The New England Journal of Medicine on April 1, 2009, that compared death rates among thousands of North American H.I.V. patients. Dr. Mari Kitahata, an epidemiologist at the University of Washington, and her team of researchers found that patients who put off therapy until their immune system showed signs of damage had a nearly twofold greater risk of dying — from any cause — than those who started treatment when their T-cell counts were above 500.
There is another motivation prompting the change. Reducing the level of virus in the population of infected people may reduce the spread of the disease.
“I do anticipate it will drive down the rates of new infections,” Dr. Mitchell H. Katz, San Francisco director of public health, said. “It’s a nice, secondary benefit of this new policy.”
Dr. Katz said that despite cuts in health budgets, a policy to add to the number of H.I.V. patients taking expensive drugs made economic sense. “H.I.V. medications have been continually proven to be cost effective,” he said, “and in this case, it is also the right thing to do.”
The program is being carried out without a clear picture of its cost to city and state health agencies. Antiviral drugs can cost $12,000 a year, consuming $350 million of the budget of California AIDS Drug Assistance Plan.
Dr. Michelle Roland, chief of the state’s Office of AIDS, said she and her counterparts across the country were working with the Centers for Disease Control and Prevention to estimate the added cost of early treatment.
In San Francisco, up to 2,000 people know they are H.I.V. positive, have healthy T-cell counts and are not yet on treatment, according to the city. Cost estimates are complicated by unknowns, like the number of patients choosing to participate, how close they were to needing treatment under the previous system and whether they had private insurance.
When the first combinations of AIDS drugs came out in 1996, the thinking was “hit early, and hit hard.” But as patients battled nasty side effects, like diarrhea and disfiguring shifts in body fat, therapy was deferred until T-cell counts fell as low as 200.
Today, with safer drugs, quick viral suppression is back in fashion.
“The field is moving, inexorably, to earlier and earlier therapy,” said Dr. Anthony Fauci, director of the National Institutes for Allergy and Infectious Diseases. He called San Francisco’s decision “an important step in that direction.”
But the proposal is highly controversial, even in San Francisco. “It’s just too risky,” said Dr. Jay Levy, the U.C.S.F. virologist who was among the first to identify the cause of AIDS. The new drugs may be less toxic, Dr. Levy said, but no one knows the effects of taking them for decades.
San Francisco’s decision follows a split vote in December by a 38-member federal panel on treatment guidelines. Only half of the H.I.V. experts gathered by the Department of Health and Human Services favored starting drugs in patients with healthy levels of more than 500 T-cells.
One panel member, James D. Neaton of the University of Minnesota School of Public Health, contends that a rigorous, randomized clinical trial is needed to show whether early intervention works. The risks of early treatment — giving powerful drugs to people at low risk of disease — - could outweigh the “modest predicted benefit,” Dr. Neaton wrote in an e-mail message. “That is why we do randomized trials.”
In 2009, the University of Minnesota began a study to find that proof. Results are expected in 2015.
Dr. Lisa C. Capaldini, who runs an AIDS practice in the Castro district, also has strong reservations. “H.I.V. behaves differently in different people,” she said.
Although Dr. Capaldini recognizes that today’s drugs are a vast improvement over earlier therapies, the program, she said “is not ready for prime time.”
But the changes make sense to Dr. Stephen Follansbee, director of H.I.V. Services for Kaiser Permanente in San Francisco, who oversees a program that covers 2,100 people with the virus.
“The idea of living in happy symbiosis with this virus is delusional,” Dr. Follansbee said. “If you have a fire in one part of the house, but not in the living room, you don’t wait for it to reach the living room before you call the fire department.”
In a major shift of H.I.V. treatment policy, San Francisco public health doctors have begun to advise patients to start taking antiviral medicines as soon as they are found to be infected, rather than waiting — sometimes years — for signs that their immune systems have started to fail.
The new, controversial city guidelines, to be announced next week by the Department of Public Health, may be the most forceful anywhere in their endorsement of early treatment against H.I.V., the virus that causes AIDS.
Ever since combinations of antiviral drugs were found to slow progression of the disease in the mid-1990s, doctors and patients have wrestled with the question of when to begin a lifetime regimen of costly and sometimes toxic medicines. The answer remains in dispute, but public health leaders here are now making a case for a change.
Behind the policy switch is mounting evidence that patients who start early are more likely to live longer, and less likely to suffer a variety of ailments — including heart disease, kidney failure and cancer — that plague long-term survivors. Studies suggest that in the early years of infection, when a patient may show few signs of immune system failure, the virus is in fact causing permanent damage that becomes evident later.
For instance, in older patients who finally start taking the drugs, the effects of chronic inflammation take their toll.
“The impact on health risk is comparable to that of diabetes,” said Dr. Steven G. Deeks, a researcher at the University of California, San Francisco. “Their immune system may look like that of someone 30 years older.”
Dr. Diane V. Havlir, chief of the H.I.V./AIDS division at San Francisco General Hospital, said the new policy was already in effect for her patients. Although a decision whether or not to take the medicine rests with the patient, all those testing positive for H.I.V. will be offered combination therapy, with advice to pursue it.
“The history of H.I.V. disease has always been about change,” she said. “We pride ourselves on working quickly with new data.”
At the public hospital’s H.I.V. clinic, a 30-year-old man is mulling advice from Dr. C. Bradley Hare to start on antiviral drugs. He was infected four years ago, but his T-cell count, a measure of infection-fighting white blood cells, is 735, comparable to that of an uninfected, healthy adult. He is buff and athletic and feels good.
The man has decided to keep waiting. “Once you start the drugs, you can’t stop,” he said. “You know how they say, ‘If it ain’t broke, don’t fix it?’ ”
Dr. Hare has been following research on early treatment, and for the last several years he has asked his patients to think about it. Now, he is recommending it outright. He said most of his patients did not have serious problems with drug side effects. “A lot of times they have a sense of relief when they start the meds,” he said.
The turning point in San Francisco’s thinking may have been a study in The New England Journal of Medicine on April 1, 2009, that compared death rates among thousands of North American H.I.V. patients. Dr. Mari Kitahata, an epidemiologist at the University of Washington, and her team of researchers found that patients who put off therapy until their immune system showed signs of damage had a nearly twofold greater risk of dying — from any cause — than those who started treatment when their T-cell counts were above 500.
There is another motivation prompting the change. Reducing the level of virus in the population of infected people may reduce the spread of the disease.
“I do anticipate it will drive down the rates of new infections,” Dr. Mitchell H. Katz, San Francisco director of public health, said. “It’s a nice, secondary benefit of this new policy.”
Dr. Katz said that despite cuts in health budgets, a policy to add to the number of H.I.V. patients taking expensive drugs made economic sense. “H.I.V. medications have been continually proven to be cost effective,” he said, “and in this case, it is also the right thing to do.”
The program is being carried out without a clear picture of its cost to city and state health agencies. Antiviral drugs can cost $12,000 a year, consuming $350 million of the budget of California AIDS Drug Assistance Plan.
Dr. Michelle Roland, chief of the state’s Office of AIDS, said she and her counterparts across the country were working with the Centers for Disease Control and Prevention to estimate the added cost of early treatment.
In San Francisco, up to 2,000 people know they are H.I.V. positive, have healthy T-cell counts and are not yet on treatment, according to the city. Cost estimates are complicated by unknowns, like the number of patients choosing to participate, how close they were to needing treatment under the previous system and whether they had private insurance.
When the first combinations of AIDS drugs came out in 1996, the thinking was “hit early, and hit hard.” But as patients battled nasty side effects, like diarrhea and disfiguring shifts in body fat, therapy was deferred until T-cell counts fell as low as 200.
Today, with safer drugs, quick viral suppression is back in fashion.
“The field is moving, inexorably, to earlier and earlier therapy,” said Dr. Anthony Fauci, director of the National Institutes for Allergy and Infectious Diseases. He called San Francisco’s decision “an important step in that direction.”
But the proposal is highly controversial, even in San Francisco. “It’s just too risky,” said Dr. Jay Levy, the U.C.S.F. virologist who was among the first to identify the cause of AIDS. The new drugs may be less toxic, Dr. Levy said, but no one knows the effects of taking them for decades.
San Francisco’s decision follows a split vote in December by a 38-member federal panel on treatment guidelines. Only half of the H.I.V. experts gathered by the Department of Health and Human Services favored starting drugs in patients with healthy levels of more than 500 T-cells.
One panel member, James D. Neaton of the University of Minnesota School of Public Health, contends that a rigorous, randomized clinical trial is needed to show whether early intervention works. The risks of early treatment — giving powerful drugs to people at low risk of disease — - could outweigh the “modest predicted benefit,” Dr. Neaton wrote in an e-mail message. “That is why we do randomized trials.”
In 2009, the University of Minnesota began a study to find that proof. Results are expected in 2015.
Dr. Lisa C. Capaldini, who runs an AIDS practice in the Castro district, also has strong reservations. “H.I.V. behaves differently in different people,” she said.
Although Dr. Capaldini recognizes that today’s drugs are a vast improvement over earlier therapies, the program, she said “is not ready for prime time.”
But the changes make sense to Dr. Stephen Follansbee, director of H.I.V. Services for Kaiser Permanente in San Francisco, who oversees a program that covers 2,100 people with the virus.
“The idea of living in happy symbiosis with this virus is delusional,” Dr. Follansbee said. “If you have a fire in one part of the house, but not in the living room, you don’t wait for it to reach the living room before you call the fire department.”
A version of this article appeared in print on April 4, 2010, on page A25A of the National edition.
Labels:
AIDS,
AIDS Drugs,
HIV,
HIV Drugs,
House of Numbers
Tuesday, April 13, 2010
Miami man admits guilt in $60 mln healthcare scam
* Scheme involved recruits from Cuban immigrant community
* Suspect spent nearly $3 million on luxury cars alone
MIAMI, April 13 (Reuters) - A Miami man has pleaded guilty to a Medicare fraud scheme that sought to cheat the U.S. healthcare system out of more $60 million, authorities said on Tuesday.
The U.S. Attorney's Office for the Southern District of Florida said Ihosvany Marquez confessed to overseeing a criminal operation that submitted at least $61 million in false claims to Medicare for the treatment of patients with HIV, AIDS, cancer and a variety of other ailments at eight Miami and Orlando-area health clinics.
Medicare, the federal health insurer for more than 43 million elderly and disabled Americans, paid nearly $24 million of the bogus claims.
The returns were so good that Marquez -- a former high school pitching ace who went on to have a short-lived career in minor league baseball -- spent millions of dollars on jewelry, watches, luxury cars and race horses, according to court records.
As part of his plea agreement, he admitted to laundering the healthcare fraud proceeds through a Miami-area car dealership and through two Miami check cashing stores, Pelly Box Lunch and La Bamba Check Cashing, authorities said.
He and an unidentified number of co-conspirators, all of whom were indicted separately, concealed their involvement in the scheme by recruiting nominee or "straw" owners for each healthcare clinic they operated, the U.S. Attorney's Office said.
It said the nominal owners, mostly from the closely knit Cuban immigrant community, were paid large sums of cash to sign corporate and bank records and other documents before fleeing the country to avoid arrest.
Florida, where healthcare fraud has replaced the drug trade as the crime of choice among many felons, has long been has long been known as the capital of Medicare fraud.
The cases often involve multimillion-dollar schemes featuring bogus suppliers of durable medical equipment such as wheelchairs and sham infusion therapies for the treatment of HIV and AIDS. (Reporting by Tom Brown; Editing by Cynthia Osterman)
* Suspect spent nearly $3 million on luxury cars alone
MIAMI, April 13 (Reuters) - A Miami man has pleaded guilty to a Medicare fraud scheme that sought to cheat the U.S. healthcare system out of more $60 million, authorities said on Tuesday.
The U.S. Attorney's Office for the Southern District of Florida said Ihosvany Marquez confessed to overseeing a criminal operation that submitted at least $61 million in false claims to Medicare for the treatment of patients with HIV, AIDS, cancer and a variety of other ailments at eight Miami and Orlando-area health clinics.
Medicare, the federal health insurer for more than 43 million elderly and disabled Americans, paid nearly $24 million of the bogus claims.
The returns were so good that Marquez -- a former high school pitching ace who went on to have a short-lived career in minor league baseball -- spent millions of dollars on jewelry, watches, luxury cars and race horses, according to court records.
As part of his plea agreement, he admitted to laundering the healthcare fraud proceeds through a Miami-area car dealership and through two Miami check cashing stores, Pelly Box Lunch and La Bamba Check Cashing, authorities said.
He and an unidentified number of co-conspirators, all of whom were indicted separately, concealed their involvement in the scheme by recruiting nominee or "straw" owners for each healthcare clinic they operated, the U.S. Attorney's Office said.
It said the nominal owners, mostly from the closely knit Cuban immigrant community, were paid large sums of cash to sign corporate and bank records and other documents before fleeing the country to avoid arrest.
Florida, where healthcare fraud has replaced the drug trade as the crime of choice among many felons, has long been has long been known as the capital of Medicare fraud.
The cases often involve multimillion-dollar schemes featuring bogus suppliers of durable medical equipment such as wheelchairs and sham infusion therapies for the treatment of HIV and AIDS. (Reporting by Tom Brown; Editing by Cynthia Osterman)
Labels:
AIDS,
Health,
HIV,
House of Numbers
Lady Gaga Says She's Celibate And Fans Should Be Too 'I can't believe I'm saying this — don't have sex,' singer says.
Forget that ride on the disco stick ... at least for now. That's the message Lady Gaga is sending to her fans, telling them that they should follow her example and live a celibate lifestyle.
The 24-year-old singer who's made a career with songs that glorify carnal pleasures told London's that she is currently under a self-imposed sex ban and that others should consider a similar posture. "I can't believe I'm saying this — don't have sex. I'm single right now and I've chosen to be single because I don't have the time to get to know anybody," she said while visiting England to help promote MAC's Viva Glam campaign, which supports global HIV and AIDS projects. "So it's OK not to have sex, it's OK to get to know people. I'm celibate, celibacy's fine."
Gaga said her celibacy is something she wants to "celebrate" with her fans, extending her oft-repeated message to her "little monsters" that they should be secure in their own skin and not shy away from being different.
"It's OK to be whomever it is that you want to be," she said. "You don't have to have sex to feel good about yourself, and if you're not ready, don't do it. And if you are ready, there are free condoms given away at my concerts when you're leaving! ... I remember the cool girls when I was growing up. Everyone started to have sex. But it's not really cool anymore to have sex all the time. It's cooler to be strong and independent."
Part of the reason Gaga said she was sending the celibacy message was because of the steady rise in the rate of HIV infection among women worldwide, which has grown while the overall rate among men has continued to decline.
"The rate of infection worldwide is higher than ever for women in our particular demographic," said the singer, referring to women aged 17-24 and 38-56, the bracket of her partner in the campaign, 56-year-old '80s pop star Cyndi Lauper. "Part of the problem is that women in those groups are not getting tested. ... This is a disease that affects everyone, not just the gay community, and right now it's mostly affecting women."
Gaga realizes that her fans idolize her, as evidenced by the legion who arrive for her concerts dressed in Gaga drag and who post countless homages to her high-concept videos online. "When you're in the public eye, you're a role model whether you want to be or not. And I want to be," she said. "I'm not one of those self-obsessed artists who don't care about their fans. It's not just about the music."
The 24-year-old singer who's made a career with songs that glorify carnal pleasures told London's that she is currently under a self-imposed sex ban and that others should consider a similar posture. "I can't believe I'm saying this — don't have sex. I'm single right now and I've chosen to be single because I don't have the time to get to know anybody," she said while visiting England to help promote MAC's Viva Glam campaign, which supports global HIV and AIDS projects. "So it's OK not to have sex, it's OK to get to know people. I'm celibate, celibacy's fine." Gaga said her celibacy is something she wants to "celebrate" with her fans, extending her oft-repeated message to her "little monsters" that they should be secure in their own skin and not shy away from being different.
"It's OK to be whomever it is that you want to be," she said. "You don't have to have sex to feel good about yourself, and if you're not ready, don't do it. And if you are ready, there are free condoms given away at my concerts when you're leaving! ... I remember the cool girls when I was growing up. Everyone started to have sex. But it's not really cool anymore to have sex all the time. It's cooler to be strong and independent."
Part of the reason Gaga said she was sending the celibacy message was because of the steady rise in the rate of HIV infection among women worldwide, which has grown while the overall rate among men has continued to decline.
"The rate of infection worldwide is higher than ever for women in our particular demographic," said the singer, referring to women aged 17-24 and 38-56, the bracket of her partner in the campaign, 56-year-old '80s pop star Cyndi Lauper. "Part of the problem is that women in those groups are not getting tested. ... This is a disease that affects everyone, not just the gay community, and right now it's mostly affecting women."
Gaga realizes that her fans idolize her, as evidenced by the legion who arrive for her concerts dressed in Gaga drag and who post countless homages to her high-concept videos online. "When you're in the public eye, you're a role model whether you want to be or not. And I want to be," she said. "I'm not one of those self-obsessed artists who don't care about their fans. It's not just about the music."
Labels:
AIDS,
HIV,
House of Numbers,
Lady Gaga,
Sex
Monday, April 12, 2010
House of Numbers: The seventeenth annual Cinema Against AIDS, held during the Cannes Film Festival, is a black-tie event
Over the years, Cinema Against AIDS has become the most eagerly anticipated and best-publicized party held during the Cannes Film Festival. Cinema Against AIDS events are always marked by unforgettable moments: from Sharon Stone dancing along to an impromptu performance by Sir Elton John and Ringo Starr, to George Clooney bestowing a kiss on a lucky auction bidder. The event consistently has the most exciting and diverse guest list of any party held during the festival. It includes many of the celebrities and personalities associated with the film festival, while also attracting familiar faces from the worlds of fashion, music, business, and international society. Since 1993, Cinema Against AIDS events around the world have raised more than $50 million for lifesaving AIDS research.
SPONSORSHIP
Co-Sponsor Package—$150,000
TABLES
Grand Benefactor Package—$60,000
Benefactor Package—$40,000
TICKETS
Benefactor “Pair”—$30,000
Patron Ticket—$6,000
Supporter Ticket—$4,000*
DATE
Thursday, May 20, 2010
LOCATION
Hôtel du Cap-Eden-Roc
Cap d’Antibes, France
SPONSORSHIP
Co-Sponsor Package—$150,000
TABLES
Grand Benefactor Package—$60,000
Benefactor Package—$40,000
TICKETS
Benefactor “Pair”—$30,000
Patron Ticket—$6,000
Supporter Ticket—$4,000*
DATE
Thursday, May 20, 2010
LOCATION
Hôtel du Cap-Eden-Roc
Cap d’Antibes, France
Labels:
AIDS,
amfar,
Cannes Film Festival,
Film,
George Clooney,
HIV,
House of Numbers,
Sharron Stone
Thursday, April 8, 2010
AIDS ‘Next Big Thing’: Gilead Pill to Prevent Spread
The approach may help curb the AIDS pandemic in poor countries and bring Gilead $1 billion a year in additional U.S. sales, said Josh Schimmer, an analyst at Leerink Swann & Co. in Boston. Most investors aren’t alert to the potential benefit, he said. Researchers are compiling the first data from 10 trials involving more than 20,000 people, and initial results may be available in July.
“This could be very meaningful for Gilead,” Schimmer said in a telephone interview. “You’re potentially treating 50 patients to prevent one. Commercially that’s very attractive. I don’t hear anybody talking about this, and I think all of us should be more aware.”
If the strategy works, the pills from Foster City, California-based Gilead may promise the world a powerful tool for fighting AIDS, the deadliest infectious disease, after scientists’ failure so far to develop an effective vaccine or virus-killing gel.
Skeptics say the approach, called pre-exposure prophylaxis, or PrEP, may be too costly and impractical in sub-Saharan Africa, where 22 million people are infected with HIV -- putting millions of others at risk -- and per-capita income is $951 a year.
Side effects may also undermine the plan. While doctors regard Gilead’s drugs as relatively safe, nobody knows what the medicines do in people who are taking them for a disease they don’t have, or how eager these patients will be to put up with the diarrhea, dizziness and depression the pills may cause.
‘High Tolerance’
“People have a high tolerance for side effects if it’s saving their life,” said Mitchell Warren, executive director of the New York-based AIDS Vaccine Advocacy Coalition, a nonprofit advocacy group. “It may be harder for healthy people to accept the side effects that come with prevention.”
The trials involve giving Gilead’s Viread and Truvada, the world’s top-selling AIDS medicine, to HIV-negative people from groups most at risk of contracting the virus, such as gay men who have unsafe sex and drug users who share hypodermic needles. Results from five of the studies may be available this year, according to the researchers running them.
One trial, scheduled to report data at an AIDS conference in July, is testing Viread as a vaginal gel in women who apply it before sex. Another is measuring the preventive effect of a daily Truvada pill among 3,000 gay men in six nations.
A further three studies coordinated by the U.S. Centers for Disease Control and Prevention, based in Atlanta, are testing PrEP among gay men in the U.S., drug users in Thailand and heterosexuals in Botswana. Gilead, while donating drugs and technical advice, isn’t running the trials, the company said.
Behavior Monitored
The studies are also designed to measure whether people receiving the drugs become riskier in their behavior, in the belief they’re protected against the virus. Participants receive testing, condoms and counseling on ways to avoid infection.
If the tests are successful, PrEP distribution programs could begin in developing countries in 2012, said Bill Gates, co-founder of Microsoft Corp. and the Bill & Melinda Gates Foundation, both of Seattle. He spoke to the U.S. Senate Foreign Relations Committee about global health priorities on March 10. The Gates Foundation is sponsoring three PrEP trials.
The CDC would try to issue guidelines on the use of PrEP to health-care providers within six months of successful test results, said Jennifer Horvath, an agency spokeswoman, in an e-mail.
First Defense
“PrEP is the next big thing,” said Warren of the AIDS Vaccine Advocacy Coalition, in a telephone interview. “We have a level of biological plausibility and early data in animal studies that is stronger than anything we have seen in the other approaches.”
Gilead had revenue of $7.01 billion last year, including sales of $5.54 billion from its top three AIDS drugs -- Truvada, Atripla and Viread -- which are taken by 85 percent of HIV patients in the U.S. as a first defense against the virus.
Gilead rose 17 cents, or less than a percent, to $45.64 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The shares have increased 1 percent in 12 months. Investors aren’t sure what to make of the PrEP trials, said Jason Kantor, an analyst at RBC Capital Markets in San Francisco.
“This is not currently a focus for investors, and I have nothing in my estimates for this,” Kantor said an e-mail. “Positive data, if compelling, could be a small incremental benefit in the developed countries.”
Implications Unknown PrEP sales in the U.S. may range from “negligible” to as much as $1 billion annually, depending on the effectiveness of the drugs and how much patients and public-health agencies are willing to pay for prevention, Leerink’s Schimmer said.
Gilead itself doesn’t know what the commercial implications of PrEP might be, said Jim Rooney, the company’s director of clinical affairs.
“It’s going to depend upon the data,” Rooney said in a phone interview. “And it’s going to depend upon how the public- health officials evaluate the data and translate that into recommendations for clinical practice.”
Gilead will decide whether to seek regulatory approval of its drugs for prevention once results of the trials are known, Rooney said.
Doctors would be able to prescribe the medicines for prevention without the approval. A study published last year in the Journal of Acquired Immune Deficiency Syndromes found that among 277 gay men in Boston, one had used PrEP and 74 percent said they would use it if it were available.
Breast Milk
Drugs made by GlaxoSmithKline Plc of London and Boehringer Ingelheim GmbH of Ingelheim, Germany, are already used to prevent infected mothers from passing the virus to their babies in the womb or through breast milk. Glaxo’s Combivir is prescribed to prevent infections in men who take it after unprotected sex with an HIV-positive partner.
Those medicines show that using treatments as prevention can work, said Dawn Smith, a CDC researcher who is devising the agency’s plans to implement PrEP if the clinical trials succeed.
“I’m very hopeful that this approach will help to reduce HIV infection rates,” Smith said in a telephone interview. “But I’m enough of a scientist to be skeptical as well, and to want to see the trial results before I call myself a believer.”
Gilead’s drugs subdue HIV in infected patients by blocking an enzyme the virus needs to hijack cells in order to reproduce. Taken preemptively, the pills may prevent HIV from gaining a foothold when it first enters the body.
‘Good Reason’
A study presented at the Conference on Retroviruses & Opportunistic Infections, in Montreal last year, found Truvada cut the risk of infection almost 16-fold in monkeys. A 2007 trial of PrEP among 936 women in Africa concluded that a daily Viread pill cut the risk of infection by 65 percent, though the researchers said the trial didn’t produce enough data to prove conclusively that PrEP worked.
“From a scientific standpoint, there really is a good reason to believe that if properly done, it will work,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, based in Bethesda, Maryland, said at this year’s retroviruses conference, held in San Francisco in February.
There may be less reason to think PrEP is feasible, Fauci said.
“If we can’t get 70 percent of the people who are infected in low- and middle-income countries on therapy, how are we going to get people who aren’t even infected on therapy?” Fauci said.
If it does work, PrEP won’t come cheap. Giving Truvada to the 100,000 most at-risk gay men in the U.S. would cost more than $1 billion a year, the CDC said on its Web site. That sum covers only the cost of the pills, and doesn’t include marketing, HIV testing, and doctors’ visits.
‘Deep Down Horror’
Identifying people who are at sufficient risk of contracting HIV to receive PrEP will most likely be too difficult in Africa, where everyone who is sexually active is at risk, said Francois Venter, president of the Southern African HIV Clinicians Society, a professional group based in Johannesburg.
“Deep down I have this horror that we’ll have an effective intervention very few people are going to use,” Venter said in a telephone interview. “In America and Europe it’s probably going to be one of several interventions which are going to work. I worry that there hasn’t been enough focus on who’s going to take these drugs in my environment.”
To justify the expense of handing out drugs to people who don’t have HIV, the trials need to show that PrEP lowers the chances of infection by at least half, said Francoise Barre- Sinoussi, a French researcher who shared the 2008 Nobel Prize in medicine after helping to discover that HIV causes AIDS.
‘Little Bit Concerned’
“We will have encouraging information from those trials,” Barre-Sinoussi said in an interview in Singapore. “I’m just a little bit concerned about how to apply it at large scale.”
About 33 million people live with HIV, according to UNAIDS, the coalition of United Nations agencies formed to fight HIV. In 2008, 2.7 million people were newly infected with the virus and 2 million died from AIDS-related complications. Africa has 7 in every 10 of the world’s cases.
Assuming PrEP could prevent 50 percent of infections, it would almost cut in half the lifetime risk of catching HIV among high-risk gay men in the U.S., and almost triple the lifetime treatment costs, according to a computer simulation published in the journal Clinical Infectious Diseases in March 2009.
PrEP is “unlikely to confer sufficient benefits to justify the current costs” of Truvada in the U.S., researchers from Yale University in New Haven, Connecticut, and Harvard Medical School in Boston wrote in the study. The model assumed a drug cost of $753 a month for each patient.
Drug Costs Gilead sells a month’s supply of Viread to U.S. wholesalers for about $643. A month of Truvada costs about $930, said Cara Miller, a company spokeswoman, in an e-mail. The company charges people in poor countries about $17 a month for Viread and $26 for Truvada, she said. About 700,000 people worldwide take brand-name or generic versions of Gilead’s AIDS drugs, Miller said.
When the first AIDS drugs were approved in the U.S. in 1987, critics said they weren’t affordable in poor nations, the CDC’s Smith said. Now, about 40 percent of the patients who need them are getting the medicines, according to UNAIDS. PrEP may also prove more adoptable than its critics think, Smith said.
“If it’s highly efficacious, and if countries and UNAIDS and WHO and other public health agencies believe that it has a role to play in reducing new HIV infections, then we will find a way to make it available,” Smith said.
To contact the reporters on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net; Tom Randall in New York at trandall6@bloomberg.net
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Wednesday, April 7, 2010
CDC to Increase Funding for HIV Testing, Focusing on Disproportionately Affected Groups
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CDC Announces $31.5 Million Expansion of
Successful HIV Testing Initiative to Ensure that
More Americans Learn Their HIV Status
More than 1.4 Million Americans Tested To-Date
Through Current Initiative
Successful HIV Testing Initiative to Ensure that
More Americans Learn Their HIV Status
More than 1.4 Million Americans Tested To-Date
Through Current Initiative
The initiative, originally designed to increase testing and knowledge of HIV status primarily among African-American men and women, will now reach more U.S. jurisdictions and populations at risk. These include gay and bisexual men, as well as male and female Latinos and injection drug users. The new phase will build on the progress of the previous effort and ensure that many more Americans know their status. The HIV testing services will focus on areas across the nation where these populations are hardest hit.
The current initiative began in 2007 and will end in September 2010 when the new project begins. In the first two years of this three-year initiative, more than 10,000 HIV-infected individuals were newly diagnosed, with 75 percent linked to care. Most tests (62 percent) were conducted among African-American men and women.
Most of the current project's funds have been used to implement routine, voluntary HIV testing in health care settings, as recommended by CDC's 2006 Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings. Funds helped jurisdictions to establish the partnerships and infrastructure required to make routine HIV testing in these settings a reality. The new phase of the initiative will continue to make this a priority.
"Far too many Americans with HIV -- more than 200,000 people -- are unaware of their infection and may be unknowingly transmitting the virus to others," said Jonathan Mermin, MD, director of CDC's Division of HIV/AIDS Prevention. "The expansion of this initiative reflects CDC's continued commitment to ensure that far more Americans are tested for HIV, especially among vulnerable men and women most in need of HIV services."
Beginning today, eligible jurisdictions can apply for the funds, which will be awarded in August for the three-year initiative that begins the following month. The number of areas eligible for this cycle of funding has been increased from 25 to 30 jurisdictions. These 30 jurisdictions represent the areas with the most severe HIV epidemics among African-Americans, Latinos, injection drug users, and gay and bisexual men of all races.
For more information, please visit www.cdc.gov/hiv/topics/funding/PS10-10138/index.htm.
4/6/10
Source
Centers for Disease Control and Prevention (CDC). CDC Announces $31.5 Million Expansion of Successful HIV Testing Initiative to Ensure that More Americans Learn Their HIV Status. Press release. April 1, 2010.
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