AIDS Treatment as a form of Prevention

A lot of people thought Julio Montaner was a little crazy when he first suggested that the best way to eliminate the AIDS epidemic would be a massive scheme to give AIDS medicine to every infected person.

What about the huge financial cost? What about the moral issues, the human-rights issues, the overwhelming number of tests and drugs that would be required? Wouldn't it undermine years of lecturing on monogamy and abstinence? Wouldn't it promote "condom-free sex," as some critics said?

Faced with a host of objections, the Canadian scientist was a lone voice in the wilderness for the past three years, unable to win support from the global AIDS establishment.

But this year, Dr. Montaner's solitary crusade - the controversial notion of "treatment as prevention" - has suddenly become one of the hottest issues in AIDS science. And yesterday, at the International AIDS Society conference in Cape Town, his once-ridiculed idea was endorsed by experts from around the world.

Among the latest support for his proposal is a model by World Health Organization researchers that predicts a 95-per-cent reduction in new HIV cases within 10 years if his idea is adopted.

The proposed new strategy - universal voluntary testing for HIV, combined with immediate anti-retroviral drug treatment for those who have the virus, even in its earliest stages - could save more than seven million lives by 2050, the model says.

The WHO, which had resisted the treatment-as-prevention concept for years, is now organizing a special conference this November to discuss the "feasibility and acceptability" of the concept.

"Treatment as prevention is the topic of the year," Swiss scientist Bernard Hirschel told the AIDS conference yesterday.

"I think Julio deserves a lot of credit for this. Is treatment going to be the answer? We don't know, but we'd better find out."

Dr. Montaner, president of the International AIDS Society and director of the B.C. Centre for Excellence in HIV/AIDS, has been a prominent scientific researcher on AIDS since 1981, before the virus was even identified. A pioneer in the use of anti-retrovirals and other AIDS drugs, he has been campaigning for the treatment-as-prevention strategy since 2006.

Willy Rozenbaum, one of the early discoverers of the AIDS virus and now the president of France's National AIDS Council, was another scientist who lent his support to Dr. Montaner yesterday. Providing proper treatment to those who have the AIDS virus "sharply reduces the chances that they will transmit the virus," he told the conference.

Dr. Rozenbaum acknowledged that researchers must study whether the use of medical treatment as a prevention strategy would encourage "risky" behaviour by those who think that the AIDS virus has been virtually eliminated from their bodies. But medical treatment and condom use can coexist, he said.

In an interview, Dr. Rozenbaum said the notion of treatment as prevention is being resisted by many governments because they are afraid of the cost and reluctant to admit the failure of the traditional prescription of condoms and monogamy. "They've been promoting condoms as the answer for 20 years," he said.

After initial progress in reducing AIDS in the developed world, the condom strategy has failed to make further progress in recent years, he said. "I'm not happy with a plateau. We can't accept just a stabilization of the problem."

As for the short-term financial cost of a massive expansion in AIDS medicine, it would be outweighed by savings within five or 10 years as the transmission rate is swiftly reduced, he said.

The new WHO model of how this strategy could work, presented at the conference by WHO researcher Reuben Granich, says the treatment strategy would drive up costs at first, but "may provide cost savings" in the long run as it increasingly prevents new HIV cases.

Dr. Montaner conceded that some "recalcitrant" people with the AIDS virus will refuse to be tested or treated. His plan would not force them to be tested, but this would not weaken the strategy, he said.

"A person who is appropriately treated becomes dramatically less likely to transmit," he said. "The more you treat, the more you reduce the cases. ... When we first suggested this in 2006, people thought we were a little loony. But it's now fully accepted. We just need to get started."

The notion of treatment as prevention "creates a powerful new rationale" for the expanded use of anti-retrovirals and other AIDS drugs, he said. "We have transformed treatment from being merely a life-saving tool. Now it means we are protecting society, we are protecting our children."

The Harper government in Ottawa is still resisting the proposed new strategy, even as global experts are accepting it, Dr. Montaner said. When he suggested the strategy in a letter to the federal Health Minister, he received only a form letter in response. "It's been increasingly adopted around the world, but where is Canada on this?"

*****

The global AIDS battle

World health leaders are gathering in South Africa to discuss ways to fight the disease

PEOPLE WITH HIV/AIDS AROUND THE WORLD

PERCENTAGE OF WORLD TOTAL/ 2007

Latin America and the Caribbean/ 5.0%

High-income countries/ 5.4%

Eastern Europe and Central Asia/ 3.9%

Asia/ 21.4%

Africa/ 64.4%

The overwhelming majority of people with HIV/AIDS, 95%, live in the developing world.

MONEY AVAILABLE FOR GLOBAL AIDS FIGHT, IN BILLIONS $ US

'05/ $7.9

'06/ $8.8

'07/ $11.3

"08/ $13.8

THE GLOBE AND MAIL / SOURCE: UNAIDS, AVERT.ORG

Early HAART Initiation Improves Vaccine Response Among HIV-Positive Children

HIV-positive infants who begin treatment with highly active antiretroviral therapy within the first year of life can develop normal immune responses to childhood vaccines, according to a study published online Monday in the Proceedings of the National Academy of Sciences, Reuters Health reports. Vaccines function by stimulating the production of antibodies for a particular disease, but HIV causes a decline in these antibody-producing cells and therefore reduces immunity. Prior to the new study, researchers were unsure whether the timing of HAART initiation could help preserve these cells and promote normal immune responses to vaccines among children.

For the study, Paolo Rossi of the University of Tor Vergata in Rome and colleagues examined 70 children who contracted HIV through mother-to-child transmission and 50 HIV-negative control participants. Of the HIV-positive children, 13 received HAART during their first year, six received no treatment and the remaining children received therapy later in life. All of the children in the study group received the recommended vaccinations for measles and tetanus. According to the study's findings, children who received HAART during their first year maintained normal levels of antibody producing cells, while children in the other groups had lower levels of these cells.

According to Rossi, the timing of HAART initiation is a key factor in determining whether HIV-positive children will develop normal vaccine responses and how long the response will last. The authors write that their findings support early HAART initiation for the purpose of preserving normal immune responses among HIV-positive infants. However, they add that health officials might need to revise vaccine schedules for HIV-positive children who begin treatment after the first year of life (Reuters Health, 4/29).

An abstract of the study is available online.

Microbicide Containing Natural Compound Provides Protection in Monkeys Against Simian Version of HIV

An experimental microbicide containing a naturally occurring compound provides protection in monkeys against the simian version of HIV by diminishing immune responses to the virus, according to a study published Wednesday in the journal Nature, the Los Angeles Times reports. HIV typically spreads in the body by entering CD4+ T cells, which the immune system sends out to attack the virus after exposure. The compound -- called glycerol monolaurate, or GML -- works by inhibiting immune signals that dispatch the T cells to attack the infection. It is those T cells that HIV infects and uses to proliferate throughout the body (Engel, Los Angeles Times, 3/5). GML occurs naturally in the human body and already is approved for use as an antimicrobial and anti-inflammatory ingredient in cosmetics and toiletries, as well as an emulsifier in foods. In addition, each dose of GML used in the study costs less than one cent. According to the researchers, the study's findings have promising implications for the development of effective microbicides to prevent HIV (AFP/Google.com, 3/4).

For the study -- led by Ashley Haase, head of the microbiology department at the University of Minnesota Medical School, and microbiologist Patrick Schlievert -- researchers administered the GML gel vaginally to five rhesus monkeys and then repeatedly exposed them to the simian version of HIV, or SIV. After two weeks, all of the five monkeys tested negative for the virus. However, four out of five monkeys that did not receive the GML gel contracted SIV. According to the researchers, five months after the experiment, they learned that one of the monkeys treated with GML tested positive for the virus. The researchers said they are unsure how this monkey contracted SIV, but they suggested that a small amount of the virus might have spread in the body undetected or the monkey might have been exposed to SIV after the study ended (Lerner, Minneapolis Star Tribune , 3/4).

Haase said the current research is "a relatively preliminary study but worth sharing because it establishes a novel approach." The researchers added that a mathematical model suggests that even if the microbicide were 60% effective and used 20% of the time, it still could prevent about 2.3 million HIV cases over a three-year period. According to the study authors, researchers will need to conduct further animal studies to determine whether the microbicide should be administered over a longer period of time to provide long-term protection against the virus (Los Angeles Times, 3/5). Further study also will be needed to demonstrate whether GML prevents HIV transmission among humans, they added. The researchers said they plan to undertake a larger study with monkeys, followed by a study with female volunteers. In addition, the University of Minnesota has applied for patents for the new compound combining GML with a personal lubricant, which currently is not available commercially. According to Schlievert, the ultimate goal will be to develop a gel that can be used for both men and women (Minneapolis Star Tribune, 3/4).

According to the study authors, the research "represents a highly encouraging new lead in the search for an effective microbicide to prevent HIV transmission that meets the criteria of safety, affordability and efficacy" (Fox, Reuters, 3/4). Haase said that although the research "sounds counter-intuitive, halting the body's natural defense system might actually prevent transmission and rapid spread of the infection" (AFP/Google.com, 3/4). Charlene Dezzutti, laboratory network director of the Microbicides Trial Network at the University of Pittsburgh, said the research illustrates "a new approach to thinking about microbicides." She added that she believes scientists "definitely" could develop an effective microbicide before developing an HIV/AIDS vaccine. "It's just a matter of getting all the right pieces together," she said (Lauerman, Bloomberg, 3/4). Rowena Johnston, vice president of research for the Foundation for AIDS Research, said that if further studies confirm these results, "then this is really a fabulous new finding." She said that although future microbicide research could encounter setbacks, the study is "absolutely a great beginning to a research project."

According to Schlievert, women could apply the GML microbicide "an hour or so before they had sex" to protect against HIV transmission. In addition, the gel might provide protection against other sexually transmitted infections, such as chlamydia, he said (Minneapolis Star Tribune, 3/4). According to AFP/Google.com, Schlievert first identified the microbicidal properties of GML when studying the use of the compound in preventing toxic shock syndrome associated with tampons. He said research repeatedly has found that the compound is safe and has no effect on beneficial vaginal bacteria (AFP/Google.com, 3/4). Lorraine Teel, executive director of the Minnesota AIDS Project, said the gel could provide women with a way to prevent disease transmission in areas of the world where many people do not use condoms because of cultural or other pressures. The research has "absolutely enormous implications" for women worldwide, she said (Minneapolis Star Tribune, 3/4). Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, said an effective microbicide would "empower women to protect themselves in a sexual situation in which they may not have complete control" (Los Angeles Times, 3/5).

An abstract of the study is available online.

New Orleans Officials Should Ensure That 'Glitch' in Ryan White Process Will Not Create 'Problem' With 2009 Grants

"The grant process for agencies working with" HIV-positive people is "maddening," a New Orleans Times-Picayune editorial says. According to the editorial, it "took six months" for Mayor Ray Nagin's administration to "distribute $7 million in federal grant money this year," and the city's Office of Health Policy "received the money" from the Ryan White Program in March but did not "send out grant award notices to agencies until June." It adds that contracts were not "finalized until last month."

Following criticism from the City Council on the "slow-moving process," Health Policy Director Fran Lawless "promised that her office would do better with the next round of grants," the editorial says, adding, "Unfortunately, that hasn't been the case so far." According to the editorial, a "public notice published last week to launch the 2009 process included errors that forced the city to cancel the effort and push back its start." It adds, "Even the best operations can make the type of clerical errors in the failed notice. And there are points in the public notice process where things can occasionally go wrong." However, "these problems are worrisome considering the office's history of delays," the editorial says, adding that Nagin "needs to make sure the office's director and employees can efficiently accomplish this task or find some who can." Concerns from officials involved with the grant process "surely pal[e] in comparison with the anguish of more than 4,000 people with HIV/AIDS who get treatment and case management services from the entities that the grants fund," according to the editorial. It adds, "At least one of those agencies had to close during the summer because of the city's delays. That left hundreds of people without the help they need." The editorial concludes that city "officials promise that the glitch in the process won't cause a problem with the 2009 grants. They need to ensure that it doesn't" (New Orleans Times-Picayune, 12/22).

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Women More Susceptible to HIV/AIDS than Originally Thought

A new study has found that HIV appears to attack normal, healthy genital tissue in women and does not require breaks in the skin to infiltrate cells, offering new perspectives on how the virus is spread, researchers said on Tuesday, Reuters reports. Thomas Hope, a study author from Northwestern University's Feinberg School of Medicine, said that scientists have had little detailed understanding of how HIV is transmitted sexually in women and that it was "previously thought there had to be a break in [genital tissue] somehow" for women to contract the virus. He added that the study's findings show that "[n]ormal skin is vulnerable."

For the study, researchers in a partnership between Northwestern and Tulane University introduced HIV -- which carried fluorescent, light-activated tracers, a new method developed to better see how the virus worked -- to newly removed vaginal tissue taken from hysterectomy surgeries. A microscope was used to observe the virus as it penetrated the outer lining of the female genital tract -- also called the squamous epithelium -- and found that HIV was able to move quickly past the skin barrier to reach immune cells. The process also was observed in nonhuman primates, according to Reuters. In addition, the results of the study suggest that HIV focuses on areas of the genital tissue where skin cells recently had been shed, Hope said (Steenhuysen, Reuters, 12/16). Hope said the results are "an important and unexpected result -- we have a new understanding of how HIV can invade the female vaginal tract." He added, "We urgently need new prevention strategies or therapeutics to block the entry of HIV through a woman's genital skin" (BBC News, 12/17).

According to Reuters, researchers in the past have assumed that HIV sought out breaks in the skin -- like a herpes sore -- to gain access to immune system cells deeper in tissue, and some thought the normal lining of the vaginal tract could work as a barrier to transmission during sexual intercourse. Reuters reports that the study "casts doubt" on the theory that HIV transmission requires a break in the skin or that the virus gains access through the cervical canal's single layer of skin cells. The findings also "might explain why some prevention efforts" -- such as diaphragms or herpes treatment -- have "failed," Reuters reports (Reuters, 12/16).

Lisa Power from the Terrence Higgins Trust in the United Kingdom said the results are an "important finding" but "sadly, not surprising" because it has been "long known that it is easier for a man to transmit HIV sexually to a woman than for a woman to transmit it to a man." She added that the study "helps us understand why" and "will help in developing better prevention mechanisms -- but until then, it's more clear than ever that a condom is a vital part of safer sex." The British not-for-profit organization AVERT said that the study "serves to strengthen" the argument for condom use during heterosexual intercourse and "will hopefully give weight to the need for safer heterosexual sex to be advocated further by governments and practitioners worldwide" (BBC News, 12/17). According to Hope, the findings emphasize the importance of methods to prevent transmission, such as a vaccine and condom use. He said, "People need to remember that they are vulnerable. The sad part is if people just used a condom, we wouldn't have this problem" (Reuters, 12/16).

Ryan White Funding Delays

Errors in a public notice last week in New Orleans have forced city officials to delay the start of the 2009 process for distributing an expected $5 million in Ryan White Program funding for local HIV/AIDS agencies, the New Orleans Times-Picayune reports. The announcement of the delay comes after Fran Lawless -- who serves as director of Mayor Ray Nagin's Office of Health Care Policy -- in October testified before the city council's Housing and Human Needs Committee that 2008 funding distribution was delayed by six months and that service providers went without funding from March to October.

According to the Times-Picayune, City Council member Arnie Fielkow called on officials to begin the application process for 2009 earlier in the year. In an effort to meet this request, officials listed a public request for proposals in the Times-Picayune on Dec. 8, 9 and 10, which set the deadline for picking up applications as Dec. 5 -- a date that had already past. The deadline for submission also was listed incorrectly in the electronic notice sent directly to the service providers, which left many of them confused, according to the Times-Picayune. Carlos Butler -- Health Policy office manager and the contact who was listed in the public notice -- said that the request for proposals was canceled and referred questions to Lawless and a Nagin spokesperson, who did not respond to requests for comment, the Times-Picayune reports.

Several agencies that receive funding to provide assistance to more than 4,000 people living with HIV/AIDS in the city complained in October that they would be unable to operate if their funding continued to face delays as it had in 2008, according to the Times-Picayune. Doug Morgan, who administers Ryan White Program funding for the federal Health Resources and Service Administration, said, "Our hope is that some of the issues they faced in [2008] will not be repeated in [2009]." He added, "I'm unhappy to learn the initial draft of the (requests for proposal) had glitches in it. It sounds like they're close to repeating some of the timelines they had last year, and that makes me a little nervous."

A new notice appeared Tuesday in the Times-Picayune and the deadline for submitting requests was listed as Jan. 9. The notice also will appear Wednesday and Thursday in the newspaper. Dave Munroe of In This Together -- a not-for-profit agency serving 225 patients that was forced to shut down over the summer because of the delay in funding and reopened in October -- said that the agency will not apply for 2009 funding because of "continuing issues of truthfulness, transparency and professionalism" at the city level (Hammer, New Orleans Times-Picayune, 12/17).

In the event that funding runs out, and you require alternatives, please visit www.aids-drugs-online.com

Global Financial Crisis Could Adversely Effect AIDS Funding

The current global financial crisis could harm HIV/AIDS funding and increase the factors that make people vulnerable to the disease, UNAIDS Executive Director Peter Piot said on Tuesday during an event at the Center for Strategic and International Studies, CQ HealthBeat reports. According to Piot, as rising food and energy costs drive more people into poverty worldwide, the factors that drive the spread of HIV also could increase. "That must have an impact on the spread of HIV, although it's not so clear," he said, adding that it is certain that low-income countries will be more affected by and vulnerable to the financial crisis when it comes to providing HIV/AIDS treatment. For example, 100% of the cost to provide 50,000 HIV-positive people in Rwanda with antiretroviral drugs at the end of last year was paid by donors -- such as the Global Fund To Fight AIDS, Tuberculosis and Malaria and the President's Emergency Plan for AIDS Relief -- according to Piot. He added that Brazil receives no donor funding to provide similar treatment services to its HIV-positive citizens.

Countries likely will not feel the effects of the financial crisis on HIV/AIDS "in the next six or 12 months because of commitments that have been made in better times," Piot said, adding that he wonders if it will be possible to continue enrolling 700,000 to one million people in drug treatment programs over the next few years. "If not, deaths will go up again, deaths from AIDS, no doubt about it," he said, adding, "We estimate that even if (funding) continues at the same level, deaths will go up to about three million per year by 2011."

Piot also praised the Bush administration and Congress for continuing PEPFAR, which he said is an "unprecedented program that has saved millions of lives." Piot added, "It is quite rare in international development that you can count so easily, you can measure, the impact of actions, and yet this has been the case when it comes to what PEPFAR has done, and it's unprecedented in international development." In addition, Piot commended President Bush and Secretary of State Condoleezza Rice for their comments at the recent White House summit on international development about how the U.S. should not reduce aid. "I hope that the next president will follow along the same lines," Piot said.

Jennifer Kates -- vice president and director of HIV policy at the Kaiser Family Foundation -- said it is difficult to assess how the financial crisis will affect future funding levels. "How the financial crisis plays into that, we still don't know," she said.

Piot will leave his position at UNAIDS at the end of the year to head the new Institute for Global Health at Imperial College London (Vadala, CQ HealthBeat, 10/28).

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Isentress More Effective in Un-Treated Patients

Merck's antiretroviral drug Isentress suppresses levels of HIV in previously untreated patients better than the company's antiretroviral efavirenz, according to research presented Sunday at a meeting of the American Society of Microbiology and the Infectious Diseases Society of America, Reuters reports. According to Phase III clinical trial results, Isentress -- known generically as raltegravir -- reduced HIV viral loads to undetectable levels in 86% of patients compared with 82% of patients treated with efavirenz (Fox, Reuters, 10/26).

FDA in October 2007 approved raltegravir for use by HIV-positive people who have not responded to other treatments. Raltegravir works by blocking an HIV enzyme called integrase. Integrase is one of the three enzymes necessary for HIV to replicate in the body, and integrase inhibitors stop HIV from inserting its genes into uninfected DNA (Kaiser Daily HIV/AIDS Report, 10/15/07). The agency also granted Isentress accelerated approval for use among patients who showed initial signs of resistance to existing antiretrovirals. According to Merck, up to 40% of the approximately 500,000 HIV-positive people in the U.S. receiving antiretrovirals have developed resistance to the drugs. In addition, researchers at the conference said that drug-related adverse effects were significantly fewer in patients treated with Isentress (44%) than with efavirenz (77%) (AFP/Yahoo! News, 10/26).

Robin Isaacs, executive director for infectious disease clinical research at Merck, said, "There was a desperate unmet medical need for those patients who had failed other therapies" until recent years. He added that Isentress and Pfizer's Selzentry -- also approved last year -- helped address that need, along with three other new drugs: Boehringer Ingelheim's Aptivus, and Johnson & Johnson's Prezista and Intelence. According to Isaacs, patients "have all these different options now, which they didn't before, to build new successful regimens."

According to AP/Yahoo! Finance, Pfizer at the conference also presented research from a 48-week study comparing its antiretroviral Selzentry with Bristol-Myer Squibb's antiretroviral Sustiva in a total of 417 patients also receiving GlaxoSmithKline's antiretroviral combination drug Combivir. In both groups, 68% of patients had the HIV virus reduced to undetectable levels; however, 4.2% of those who got Selzentry and 14.2% taking Sustiva stopped because of side effects (Johnson, AP/Yahoo! Finance, 10/26).

FDA Approves Prezista for Use in Treatment Naive Individuals

FDA on Tuesday approved Johnson & Johnson's protease inhibitor Prezista for use by people who have never taken antiretroviral drugs in the past, the Wall Street Journal reports. FDA in 2006 approved Prezista for HIV-positive people who had developed resistance to other drugs. The agency also granted tentative approval for the drug as part of FDA's accelerated approval mechanism, which allows drugs to be sold while further studies are conducted. J&J obtained full approval for Prezista after submitting studies to FDA through this mechanism (Corbett Dooren, Wall Street Journal, 10/23).

According to J&J, patients beginning HIV treatment should take Prezista -- generically known as darunavir -- in combination with ritonavir. Ritonavir -- sold by Abbott Laboratories under the brand name Norvir -- works in combination with Prezista by slowing down the body's processing of the drug, Reuters reports (Reuters, 10/22). As a protease inhibitor, Prezista works by blocking a protein that HIV requires for replication. Treatment-naive HIV-positive people are recommended to take two 400 mg tablets of Prezista with 100 mg of ritonavir twice daily, and patients who have previously taken other HIV medications are recommended to take 600 mg of Prezista twice daily. J&J will discontinue the production of a 300 mg tablet following a decline in demand. According to the company, the wholesale price of the drug is about $740 monthly.

Glenn Mattes, president of J&J's Tibotec Therapeutics, said FDA approval of Prezista for newly diagnosed HIV-positive people "is a significant expansion of our ability to reach the entire population of patients who should be treated with a protease inhibitor." According to the AP/Boston Globe, during a study that compared Prezista with Kaletra -- a similar drug produced by Abbott -- 84% of patients treated with Prezista had HIV viral loads drop to an undetectable level, compared with 78% of patients taking Kaletra. However, this difference was not considered statistically significant (AP/Boston Globe, 10/22). Side effects of Prezista include diarrhea, headache, nausea, skin rash and, in some cases, hepatitis and liver failure (Reuters, 10/22).

Urbanization Among Native Youth Can Increase HIV Rates Amongst the Native Population

Aboriginal youth from northern parts of the Canadian province of British Columbia recently gathered for a three-day conference on HIV/AIDS in an effort to curb the spread of the disease in their communities, the CP/Prince George Citizen reports. Conference attendees, ages 15 to 22, were selected by the First Nations chiefs, councils and health directors.

Emma Palmantier, chair of the Northern B.C. Aboriginal HIV/AIDS Task Force, said that youth attending the conference are expected to take knowledge back to their communities. She added the goal of the training is to give young people basic knowledge about HIV/AIDS, in addition to lessons on sexuality and teen pregnancy, lectures, workshops and group discussions. The CP/Citizen reports that at the end of the conference, the attendees will make recommendations to the task force, chiefs and councils, which will then be used to develop community action plans.

Palmantier said that because many youth who move to urban areas like Prince George and Vancouver come from low-income families, they often turn to commercial sex work and drug trafficking as ways to survive. She said, "The governments need to come up with funds to train these youth in trades and jobs so they can live normal lives. There's a big door of opportunity for training" (Trick, CP/Prince George Citizen, 10/21).

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Gray's Anatomy helped increase awareness

Many viewers of an episode of ABC's prime-time medical drama "Grey's Anatomy" that included a story about mother-to-child HIV transmission gained awareness of the issue, according to a survey released on Tuesday by the Kaiser Family Foundation, USA Today reports.

For the study, the Foundation worked with writers of the show to embed in the episode the story of an HIV-positive pregnant woman. According to USA Today, the woman is "distraught" before being told by her physician that with proper treatment, her child has a 98% chance of being born HIV-negative. The Foundation conducted three national random surveys of regular viewers of the show one week before, one week after and six weeks after the episode. The surveys combined had 1,505 respondents.

Victoria Rideout, vice president and director of the Foundation's program for the Study of Media and Health, said the goal of the survey was to measure the "impact of the message about mother-to-child HIV transmission" (Marcus, USA Today, 9/17). One week before the show, 15% of the viewers surveyed said that they were aware of the mother-to-child HIV transmission risk. One week after the show, 61% of viewers of the episode were aware of the risk. Six weeks after the show, 45% of viewers remembered the information correctly (Childs, ABC News, 9/17). According to the survey, the increase from 15% to 61% awareness of the risk of mother-to-child HIV transmission translates to more than eight million people learning correct information on the issue from watching the episode. The survey also found that the percentage of viewers who said it was "irresponsible for a woman who knows she is HIV-positive to have a baby" dropped from 61% to 34% after the episode aired, and then increased to 47% six weeks after the show (Kaiser Family Foundation release, 9/16). Rideout said she was "astounded" by the number of viewers who "picked up on factual health info about HIV embedded in the show, and that they remembered it weeks later."

The Foundation and the University of Southern California's Annenberg Norman Lear Center also released a second study of top-10 prime time television shows, finding that six out of 10 episodes from 2004 to 2006 included at least one health-related storyline. "People are very hungry for information about health," Linda Rosenstock, dean of the University of California-Los Angeles School of Public Health, said, adding that entertainment media do "societal good" by putting accurate health information into shows. Jay Bernhardt of CDC said that embedding information accurately into TV content could "help change behaviors about health" (USA Today, 9/17).

Online The studies, and a Kaisernetwork.org webcast of a briefing discussing them, are available online.

More money needed to reduce the number of new U.S. infections

CDC officials on Tuesday at a House Government Reform and Oversight Committee hearing said they would need an additional $4.8 billion dollars over the next five years to reduce the annual number of new HIV infections in the U.S., CQ HealthBeat reports (Stanchak, CQ HealthBeat, 9/16).

According to the Los Angeles Times, the hearing came after CDC released a study last month that found that about 56,300 new HIV infections occur annually in the U.S. (Dizikes, Los Angeles Times, 9/17).

CDC Director Julie Gerberding based on the new estimates the agency would need an additional $877 million in 2009 to reduce the number of new HIV infections. According to the Times, the fiscal year 2009 budget request for HIV prevention funding is $892 million, which includes $752.6 million requested by CDC. Waxman said that he would try to work with the House Appropriations Committee to increase funding for domestic HIV prevention efforts but added that he is "not very optimistic" the Bush administration will increase funding (Los Angeles Times, 9/17).

Gerberding; Kevin Fenton, director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention; and Anthony Fauci, director of the National Institute for Allergy and Infectious Disease, told the committee that although the additional amount of money requested is high, it could reduce the HIV transmission rate by 50% over 12 years. In addition, the increased funding could help reduce the number of HIV-positive people who are unaware of their status by 50% and help reduce racial disparities.

Gerberding said that the agency would use the increased funding to expand HIV testing, research new prevention techniques and evaluate prevention programs. Fauci added that increased funding also would allow research into new areas of HIV prevention research, such as preventing coinfection with other sexually transmitted infections, providing antiretroviral drugs to HIV-negative people as a preventive measure, testing microbicides and vaccine development.

Although the $4.8 billion request is a significant amount of money, it would be more expensive not to treat HIV, Fauci said. A "professional judgment budget" (.pdf) released by the panelists noted that each HIV infection costs more than $1 million in treatment and lost productivity and that if CDC can prevent 4,800 new infections over five years, the programs established with increased funding would be "cost saving to society."

Gerberding said the request is "not just about funding, it's about needing new tools," adding, "AIDS is a social disease as well as a viral disease ... if we don't address the underpinning issues, we'll never get to where we need to be" (CQ HealthBeat, 9/16). She said that the U.S. "need[s] to do so much more than we're doing right now" to prevent new HIV infections, adding that public health workers "need to get AIDS back on the radar screen" because HIV/AIDS "is still posing a threat to college students and to young men and women across our nation's fabric."

Panelists also called for additional HIV prevention and education programs that target blacks, Hispanics and men who have sex with men. George Ayala of AIDS Project Los Angeles told committee members that only four of CDC's 49 recommended intervention programs specifically target MSM and only one targets minority MSM. He said, "Serious HIV-related health disparities, often fueled by stigma and discrimination, continue to undermine HIV prevention efforts in communities of color" (Los Angeles Times, 9/17).

Imprisonment of Physicians Who 'Pioneered' Treatment of HIV-Positive Iranians

If Iranian President Mahmoud Ahmadinejad holds a news conference during his visit to the United Nations General Assembly next week, he should be asked why two physicians who started a broad HIV/AIDS awareness campaign in Iran and "pioneered the treatment of Iranian victims of HIV/AIDS" have been imprisoned, Philadelphia Inquirer columnist Trudy Rubin writes in an opinion piece.

According to Rubin, Arash Alaei and his brother, Kamiar -- whom Rubin interviewed in spring 2007 -- started a grass-roots campaign in Iran to treat people living with HIV/AIDS and raise awareness about the epidemic. The brothers were jailed in Iran in late June and, according to Iranian news reports, have been charged with fomenting "a velvet revolution," Rubin writes, adding that the phrase is "shorthand for trying to organize civil society against the regime."

The "irony" of the charges, Rubin writes, is that the brothers were "hoping to increase scientific collaboration with U.S. medical experts in a way that avoids politics." Is "this what scares Iranian officials?" Rubin asks, adding that officials also might fear medical cooperation with the U.S. would threaten the population's fear of a U.S. attack. Ahmadinejad also might be concerned of public unrest before the country's 2009 presidential election, Rubin writes. "[N]one of this explains arresting the doctors Alaei," Rubin writes, concluding it "indicates a government that fears the best and the brightest of its own people" (Rubin, Philadelphia Inquirer, 9/17).

Rising HIV Prevalence Among MSM in Hong Kong

The senior medical director of Hong Kong's Centre for Health Protection, Raymond Ho Lei-ming, on Tuesday warned residents that HIV prevalence in the region is increasing among men who have sex with men, Hong Kong's Standard reports (Chui, The Standard, 9/17).

According to Ho, a study released last year found that HIV prevalence among MSM in Hong Kong is about 4%, up from a 1% HIV prevalence rate in previous years. Ho said prevalence among MSM in the region could top 30% by 2020 if current trends continue. According to Ho, sex parties and low condom use have been attributed to the increased number of cases. "If we don't do anything, we are looking at a worst-case scenario," Ho said (Benitez, South China Morning Post, 9/17). He called for people at risk of HIV infection to get tested and for greater condom use and other HIV prevention measures (Standard, 9/17).

Loretta Wong Wai-kwan, the CEO of AIDS Concern, a volunteer organization offering HIV/AIDS support and prevention programs in Hong Kong, said that the number of HIV/AIDS clinics in Hong Kong has remained stagnant over the past decade. She added, "How do the existing human resources or facilities cope with the increasing case load?" (South China Morning Post, 9/17).

www.aids-drugs-online.com

Rising HIV Prevalence Among MSM in Hong Kong

The senior medical director of Hong Kong's Centre for Health Protection, Raymond Ho Lei-ming, on Tuesday warned residents that HIV prevalence in the region is increasing among men who have sex with men, Hong Kong's Standard reports (Chui, The Standard, 9/17).

According to Ho, a study released last year found that HIV prevalence among MSM in Hong Kong is about 4%, up from a 1% HIV prevalence rate in previous years. Ho said prevalence among MSM in the region could top 30% by 2020 if current trends continue. According to Ho, sex parties and low condom use have been attributed to the increased number of cases. "If we don't do anything, we are looking at a worst-case scenario," Ho said (Benitez, South China Morning Post, 9/17). He called for people at risk of HIV infection to get tested and for greater condom use and other HIV prevention measures (Standard, 9/17).

Loretta Wong Wai-kwan, the CEO of AIDS Concern, a volunteer organization offering HIV/AIDS support and prevention programs in Hong Kong, said that the number of HIV/AIDS clinics in Hong Kong has remained stagnant over the past decade. She added, "How do the existing human resources or facilities cope with the increasing case load?" (South China Morning Post, 9/17).

http://www.aids-drugs-online.com

HIV Spreading in New York City at About Three Times the National Rate

HIV is spreading in New York City at about three times the national rate, with an incidence of 72 new HIV infections per 100,000 people, compared with 23 new infections per 100,000 people nationwide, according to a study released Wednesday by the New York City Department of Health and Mental Hygiene, the New York Times reports (Chan, New York Times, 8/28).

The study's findings are based on a new HIV testing method developed by CDC that can determine when an HIV infection occurred. Previous data did not distinguish recent infections from those that occurred years earlier, according to the health department. About 100,000 New York residents are living with HIV, health officials said (Honan, Reuters, 8/27). According to the study, 4,762 New York residents contracted HIV in 2006 (New York Times, 8/28). Health officials attributed the higher rate of new HIV infections in the city to large populations of blacks, men who have sex with men and other high-risk groups (AP/Google.com, 8/27). According to the health department, it is unclear whether the number of new infections that occurred in the city in 2006 had increased or decreased over previous years because the testing method is new.

According to the study, men accounted for 76% of new HIV infections while women accounted for 25%. Blacks accounted for 46% of new infections, Hispanics for 32% and whites for 21%. Whites living in the city contracted HIV at four times the national rate, Hispanics at three times the national rate, and blacks in the city contracted the virus at almost twice the national rate. The study found that 4% of new infections were among people younger than age 20, while people ages 20 to 29 accounted for 24% of new infections. People ages 30 to 39 and those ages 40 to 49 each accounted for 29% of new infections, while people older than age 50 accounted for 15%. People younger than age 30 accounted for 28% of new infections in New York City, compared with 41% nationwide.

The primary mode of HIV transmission was sex between men, which accounted for 50% of new infections. High-risk heterosexual sex accounted for 22% of new infections, and injection drug use accounted for 8%. The mode of transmission was unknown in 18% of new cases, the study found (New York Times, 8/28).

In addition, the study found that blacks living in the city contracted HIV at three times the rate of whites and that blacks accounted for almost half of new infections (Reuters, 8/27). Of new HIV infections among MSM younger than age 30, 77% occurred in black and Hispanic men. Black and Hispanic MSM ages 30 to 50 also accounted for 59% of new infections among MSM in that age group (New York Times, 8/28).

Assistant Health Commissioner Monica Sweeney said the study's findings reinforce the need to continue promoting HIV testing and prevention throughout the city (AP/Google.com, 8/27). The department in a statement added that "even a rough gauge of HIV incidence is a valuable tool for understanding -- and combating -- the spread of HIV." The department said that by using the same testing method in future years, "researchers may be able to discern increases and decreases [in HIV incidence] over time and target prevention efforts accordingly" (New York Times, 8/28).

FDA Gives Tentative Approval to New Generic AIDS Drug

The Food and Drug Administration (FDA) today announced the tentative approval of a generic AIDS drug - abacavir (a-BAK-a-veer) sulfate tablets manufactured by Aurobindo Pharma LTD. of Hyderabad, India. Abacavir sulfate tablets are the first generic version of the already approved Ziagen Tablets, an anti-HIV medication manufactured by GlaxoSmithKline. This product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief.

"FDA's action adds yet another anti-HIV product to those available for purchase under the President's Plan and demonstrates our continuing commitment to ensuring that safe, effective, and quality manufactured medications are available for purchase under the President's Plan," said Murray M. Lumpkin, M.D., Deputy Commissioner for International and Special Programs.

The President's Emergency Plan for AIDSRelief, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries. The President's plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children. It targets three specific areas related to HIV/AIDS:

Prevention of HIV transmission;
Treatment of AIDS and associated conditions;
Care, including palliative care for HIV infected-individuals, and care for orphans and vulnerable children.
Abacavir is one of the nucleoside reverse transcriptase inhibitors (NRTIs), a class of drugs that helps keep the AIDS virus from reproducing. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The agency's tentative approval of this product means that Aurobindo's product meets all of FDA's manufacturing quality and clinical safety and efficacy standards. Although existing patents and/or exclusivity prevent its marketing in the United States, the product can be marketed abroad and used under the PEPFAR plan.

More information on HIV and AIDS is available online at FDA's website:http://www.fda.gov/oashi/aids/hiv.html

Doctor's advice on Viraday - Taken from thebody.com

How long they live with Viraday? Apr 10, 2007 The patient found CD4 at 8 and viral load at 350,000 started treatment by taking medicine of "Viraday" (Cipla company). By continuing the treatment how long the patient can live? What are the cautions to be taken by the patient? Response from Dr. Pierone Viraday is a combination of Viread, Emtriva, and Sustiva, the same components which are in Atripla. This combination agent leads to an undetectable viral load and increases in CD4+ lymphocyte counts in the great majority of patients. AIDS is a chronic, manageable disease for people who have access to potent combination therapy like this. The expectation is that individuals on successful treatment for HIV infection and AIDS will have a normal or near normal lifespan. The precautions for this medication would mainly be for the Sustiva component of this medication which produces neuro-cognitive adverse events more than half of the time, but these effects tend to dissipate after the first several weeks. Viread can produce kidney problems, but not commonly, and usually in patients who already have kidney problems or are on other medications with kidney toxicity. I hope that this information helps and best of luck!

The Bronx to Test Everyone for HIV/AIDS

The New York City Department of Health and Mental Hygiene on Friday will begin a three-year effort to test every adult living in the Bronx -- which has the highest rate of HIV/AIDS-related deaths in the city -- for HIV, the New York Times reports. According to the Times, the campaign will initially work to make voluntary testing routine in emergency rooms and storefront clinics, where city officials say that state consent procedures deter physicians from offering the tests. City Health Commissioner Thomas Frieden said that routine testing "would mean if you came into the emergency room for asthma or a broken leg, we test everyone for HIV, if they're willing."

Although Manhattan has the highest incidence of HIV/AIDS cases in the city, the Bronx, which has a lower-income population, reports more deaths from the disease. Public health officials say the high mortality rate is associated with people not getting tested until it is too late to effectively treat the virus. According to city officials, 40% of the borough's 830,000 people ages 18 to 64 have undergone HIV testing in the past year, and half of the remainder, about 250,000, have never been tested. The campaign intends to first test this group at 40 designated sites, including clinics, community centers, churches and emergency rooms. Monica Sweeney, an assistant health commissioner for HIV prevention, said the city has not set aside money specifically for the program, but that it would absorb the $12 cost of each test.

The Times reports that several HIV/AIDS experts have described the effort as the most aggressive in the country. Donna Futterman -- director of Montefiore Medical Center's Adolescent AIDS Program in the Bronx, which helped New York City develop the program -- said, "What's new here is that we are implementing it on this large a level," adding, "The Bronx has 1.3 million people. It's bigger than most cities, bigger than Boston, bigger than Washington. We're talking about a significant urban population." Frieden -- who has enlisted the support of Bronx elected officials, health care providers and clergy members -- said the health department chose the Bronx because it has good relationships with clinics and hospitals there. City officials also said that Bronx residents already are more likely to be tested than adults in other boroughs.

However, Frieden said the efforts come after years of lobbying to overhaul strict state regulations -- which have changed little since HIV/AIDS was first discovered in the 1980s -- that require patients to give written permission for testing after being counseled on the process. According to Frieden, New York's consent law is one of the strictest in the country; CDC recommends that written consent and pretest counseling requirements be dropped.

Futterman said that she hopes that making HIV testing routine by including the test as part of a patient's blood work will change the mentality surrounding the test and spur state legislators to ease consent rules. "Everything in AIDS has changed except the old testing paradigm," she said, adding, "Old school was that you had to tell them everything that could happen. That starts to seem cruel. If you go for cancer diagnosis, they don't make the doctor say what you're going to do if your mammogram is positive."

According to the Times, under the new initiative, hospital administrators in the Bronx have agreed to test in emergency departments, where physicians have felt the requirement interferes with more immediate health needs, but still follow state consent laws. Futterman said she has carefully constructed a script for physicians that follows state law but condenses what is typically a 20-minute counseling and consent process into five minutes. She added that using the process has helped her increase the proportion of her patients being tested to between 20% and 25%, up from 10%.

In an attempt to make HIV testing less intimidating, the city also will issue public service announcements and information on its 311 hotline. It also is posting tear-off sheets with addresses of testing centers in places like check-cashing stores, where residents can discreetly slip them into pockets. Sweeney said, "It's not about one group doing it, it's about everybody doing it." Community organizations, universities, churches and politicians are going to have all their constituents that come to them for other services, they're going to use it as an opportunity to say, 'Get your HIV test'" (Hartocollis, New York Times, 6/26).

Drug Access | Boehringer, Gilead Freeze Antiretroviral Prices for Some U.S. Agencies

[Jun 05, 2008]

Pharmaceutical companies Boehringer Ingelheim and Gilead Sciences are freezing the prices of their antiretroviral drugs for select agencies in the U.S., the AIDS Healthcare Foundation announced on Tuesday, Bloomberg reports. Gilead will freeze the prices on its antiretrovirals Viread, Truvada and Emtriva for the U.S. Public Health Service, the Federal Supply Service and state AIDS Drug Assistance Programs, according to company spokesperson Amy Flood. The price freeze will be effective through Dec. 31, 2010, according to AHF. The wholesale acquisition cost is $552 monthly for Viread, $329 monthly for Emtriva and $840 monthly for Truvada, Flood said. She added that government purchasers generally receive partial rebates from the prices. "We share your concern regarding antiretroviral cost pressures faced by government payers, particularly during times of limited budget access and flat funding," Gregg Alton, senior vice president and general counsel at Gilead, said in a letter to AHF.

Boehringer will freeze the price of its antiretroviral Aptivus for ADAPs through May 1, 2009, according to AHF. The price freeze became effective May 1, according to a Boehringer letter to AHF. Boehringer spokesperson Judith von Gordon did not return calls for comment, Bloomberg reports.

"We urge the other drug companies to follow [Boehringer's] and Gilead's lead and to freeze price increases that create an unnecessary burden on an already overburdened public health system and keep lifesaving drugs out of reach for those who need them," AHF President Michael Weinstein said. AHF called on companies to freeze their prices because of issues government agencies have had in increasing access to antiretrovirals (Lauerman, Bloomberg, 6/3). Reponses from Abbott Laboratories, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Pfizer, Roche and Johnson & Johnson subsidiary Tibotec Therapeutics "reiterated the companies' commitment to increasing access but made no specific pledge with regard to" price freezes, according to an AHF release (AHF release, 6/3).

For access to low cost generics, please visit:
www.aids-drugs-online.com