Tag Archives: Food and Drug Administration

Anti-HIV drug effort in South Africa yields dramatic results

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An intensive campaign to combat HIV/AIDS with costly antiretroviral drugs in rural South Africa has increased life expectancy by more than 11 years and significantly reduced the risk of infection for healthy individuals, according to new research.

The two studies, published Thursday in the journal Science, come as wealthy Western nations are debating how best to stretch limited AIDS funding at a time of economic stress.

With an annual price tag of $500 to $900 per patient, antiretroviral therapy programs have stirred frequent debate. Critics argue that adherence to the drug regimen is low and social stigma prevents some from seeking care until they are very ill and have infected others. Cheaper remedies, such as condom distribution, male circumcision and behavior modification, deserve more attention and funding, they say.

The new economic analysis of a $10.8-million campaign in KwaZulu-Natal province concluded that the drug scale-up there had been highly cost-effective.

The program was administered by nurses in rural health clinics in an impoverished region of about 100,000 people. Treatment consisted primarily of daily doses of antiretroviral therapy, or ART, drugs, which patients take every day for their entire lives. Patients picked up their medication at a rural clinic once a month.

In 2003, the year before the drugs were available, 29% of all residents were infected with HIV and half of all deaths there were caused by AIDS. Life expectancy in the region was just over 49 years.

By 2011, life expectancy had grown to 60 1/2 years — “the most rapid life expectancy gains observed in the history of public health,” said study senior author Till Barnighausen, a global health professor at the Harvard School of Public Health.

Based on that increase in longevity, researchers determined just how many years of life were effectively “gained” among residents as a result of ART intervention. They used that figure and the total expense of the program to calculate a cost-effectiveness ratio of $1,593 per life-year saved.

The World Health Organization considers medical intervention to be “highly cost-effective” if the cost per year of life saved is less than a nation’s per capita gross domestic product. The program’s ratio was well below South Africa’s 2011 per capita GDP of about $11,000.

“It’s really a slam dunk of an intervention,” said study leader Jacob Bor, a graduate student at Harvard. “These investments are worthwhile.”

The research team noted that the study period coincided with the arrival of electric power and clean water for area residents. But those alone could not explain the dramatic increase in longevity, they said.

“While mortality due to HIV declined precipitously, mortality due to other causes flat-lined,” Bor said. “These changes were almost certainly due to ART scale-up.”

In a second study from the same region, researchers followed nearly 17,000 healthy people from 2004 to 2011 to determine HIV infection rates in areas with active ART intervention programs.

Healthy individuals in those areas were 38% less likely to contract HIV than people in areas where ART drugs were not widely available, researchers found. People in extremely rural areas also fared better than those in more closely populated areas clustered around national roads.

Overall HIV prevalence increased 6% during the seven years of the study, probably because the antiretroviral drugs allowed people with the virus to live longer, according to the report.

It’s not clear how the results of the new study would translate to areas where stable, cohabiting couples were not the norm, said lead author Frank Tanser, an epidemiologist at the University of KwaZulu-Natal.

AIDS researchers who weren’t involved in the studies said they provide strong support for maintaining programs like the President’s Emergency Plan for AIDS Relief, begun by President George W. Bush in 2003.

“These papers present truly remarkable data,” said Dr. Douglas Richman, director of the Center for AIDS Research at UC San Diego.

Original article via Gawker

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Desmond Tutu calls for end to gay stigma to help tackle HIV

Archbishop Desmond Tutu has called for homosexuality to be decriminalised to help tackle HIV.

His comments come in an analysis in The Lancet journal of why incidence of the virus continues to grow among men who have sex with men.

Dr Tutu said anti-homosexuality laws would in the future be seen as “wrong” as apartheid laws are now.

Campaigners said it was important for community leaders to speak out.

The archbishop is patron of the Desmond Tutu HIV Foundation, based in Cape Town, which provides treatment for HIV and carries out research.

Writing in The Lancet, he said: “In the future, the laws that criminalise so many forms of human love and commitment will look the way apartheid laws do to us now – so obviously wrong.

“Never let anyone make you feel inferior for being who you are. When you live the life you were meant to live, in freedom and dignity”.

Also writing in The Lancet, an international team of researchers, led by Prof Chris Beyrer of the Johns Hopkins Bloomberg School of Public Health in the US, said men who have sex with men (MSM) bore a “disproportionate burden” of HIV.

The fact HIV was first identified in gay men has “indelibly marked the global response” and “stigmatised those living with the virus”, they said.

The researchers’ paper said there was optimism among HIV specialists about the potential to use prevention, such as the drug Truvada, to reduce levels of HIV in men who have sex with men.

Earlier this week, the US Food and Drug Administration approved Truvada for preventative use in those at high risk of infection and who may engage in sexual activity with HIV-infected partners, the first time it has approved a drug to prevent HIV infection.

‘Struggle for equity’

But the international team said the picture was very different in many other countries.

“In too many settings in 2012, MSM still do not have access to the most basic of HIV services and technologies such as affordable and accessible condoms, appropriate lubricants and safe HIV testing and counselling,” they said.

“The struggle for equity in HIV services is likely to be inseparably linked to the struggle for sexual minority rights—and hence to be both a human rights struggle, and in many countries, a civil rights one.”

The paper, published on the eve of the international Aids 2012 conference, adds that by the end of 2011, only 87 countries had reported prevalence of HIV in MSM.

Data is most sparse in the Middle East and Africa, where homosexual activity is a criminal offence.

The researchers call for same-sex relations to be decriminalised in all countries, so that a true picture of the scale of HIV in men who have sex with men can be ascertained.

A spokeswoman for the UK’s Terrence Higgins Trust said: “We’ve got to have community leaders and people with influence speaking out.

“That’s why what Desmond Tutu is saying is so important.”

And she said it was right to focus efforts on men who have sex with men, in all countries.

She added: “In London, one in seven gay men has HIV.”

Original Article via BBC

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Even without a cure, the end of the AIDS pandemic is in sight

A very bold statement to make in the run up to AIDS 2012, none the less, this is the view of Dr. Anthony Fauci, director of the National Institute of Allergy and Infections Diseases (NIAID )

NIAID director Dr. Anthony Fauci addressing the United Nations General Assembly special session on HIV/AIDS on 10June 2008.

Dr. Fauci was appointed Director of NIAID in 1984. He oversees an extensive research portfolio of basic and applied research to prevent, diagnose, and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.  Dr. Fauci serves as one of the key advisors to the White House and Department of Health and Human Services on global AIDS issues, and on initiatives to bolster medical and public health preparedness against emerging infectious disease threats such as pandemic influenza.

Dr. Fauci has made many contributions to basic and clinical research on the pathogenesis and treatment of immune-mediated and infectious diseases. He has pioneered the field of human immunoregulation by making a number of basic scientific observations that serve as the basis for current understanding of the regulation of the human immune response. In addition, Dr. Fauci is widely recognized for delineating the precise mechanisms whereby immunosuppressive agents modulate the human immune response. He has developed effective therapies for formerly fatal inflammatory and immune-mediated diseases such as polyarteritis nodosa, Wegener’s granulomatosis, and lymphomatoid granulomatosis. A 1985 Stanford University Arthritis Center Survey of the American Rheumatism Association membership ranked the work of Dr. Fauci on the treatment of polyarteritis nodosa and Wegener’s granulomatosis as one of the most important advances in patient management in rheumatology over the previous 20 years.

AN END TO NEW INFECTIONS?

Three decades into the AIDS pandemic an end to new infections is in sight, according to Dr. Fauci.

“We don’t even know if a cure is possible. What we know is it is possible that we can end this pandemic even without a cure,”

Fauci told AFP in an interview ahead of the International AIDS conference 22nd -27th July in Washington DC, America.

Some 34 million people around the world are living with human immunodeficiency virus, which has killed 25 million since it first emerged in the 1980s.

The theme of this conference, which is held every two years, is “Turning the Tide Together,” and is based on experts sharing knowledge of the latest advances and how to best implement them in order to halt new cases of HIV/AIDS.

“We have good and effective treatments but we have to keep people on the treatments indefinitely in order to keep them well,” said Dr. Fauci, referring to antiretroviral drugs which have transformed a deadly disease into a manageable condition.

“When you have a very marked diminution of the number of new infections then you reach what we call and AIDS-free generation.”

Dr. Fauci said he did not expect any staggering breakthroughs to be announced at the conference, but that the gain would come though collaborating on ideas to speed progress by using the tools that practitioners have already at hand.

Otherwise, if progress continues at the present rate of reducing new infections worldwide by about 1.5 percent per year, the goal becomes too distant, he said.

Recent studies that tested antiretroviral drugs in healthy people as a way to prevent getting HIV through sex with infected partners have shown some promise, though getting people to take their medication daily had proven a challenge.

“The important thing is you have to take your medication,” Fauci said, noting that average HIV risk reduction in a study of men who have sex with men was just 44 percent.

The approach of treating healthy people with antiretrovirals is known as pre-exposure prophylaxis, and “is not for everyone,” Fauci said. “We have to selectively use it.”

The US Food and Drug Administration on Monday approved the first pill for HIV prevention, Truvada, despite concerns by some in the health care community that it could encourage drug resistance and risky sex.

Novel ways to boost testing are also good news, particularly with the recent US approval of the first at-home HIV test.

“It is so important in the quest to ending the AIDS pandemic to get as many people tested as possible. You can link them to care and get them on treatment. Anything that makes that goal easier would be an important advance.”

As far as an AIDS vaccine, Fauci said researchers have made “good progress” but “still have a long way to go.”

Experts are examining a trial done in Thailand that showed in 2009 modest efficacy of just over 30 percent, but is still considered a breakthrough and offers clues for future study into why some were helped and others were not.

Dr. Fauci also said he did not expect much concern to be raised over upcoming reports of the extent of drug resistance to antiretrovirals.

“People may think I am taking it lightly but quite frankly it is not a serious problem,” Fauci said.

He added that overall, AIDS research is “going well” even though “funding is restricted right now.”

And he expressed pride in the United States’ President’s Emergency Plan for AIDS Relief (PEPFAR), “which has really transformed how you can get people in low income countries to get on treatment care and prevention.”

The United States provides almost half the world’s funding for international HIV assistance, according to UNAIDS.

The International AIDS Conference is returning to the United States after more than two decades away due to a ban on travel and immigration by people with HIV that was lifted in 2008 and signed into law in 2009.

Fauci called those restrictive laws “unfortunate” and “embarrassing.”

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A History of HIV & AIDS – 1987

The first drug licensed to treat HIV was Zidovudine, (AZT). Dr. Robert E. Windom, assistant secretary for health at the Health and Human Services Department, emphasized that AZT, to be sold under the trade name Retrovir, is not a cure for AIDS (sic) but he said the action “means that significant medical relief will be available to thousands of those afflicted with this dreaded disease.”

Windom said that licensing of the drug, “Marks an important step but by no means a final victory in our ongoing war against AIDS.” AZT was expected to be expensive, costing each patient as much as $10,000 a year.

Final approval of AZT, first administered to AIDS patients in human studies begun in July, 1985, came in record time, the result of a decision by the Food and Drug Administration to consider AIDS drugs as a top regulatory priority. Typically, the process takes an average of 8½ years from the earliest studies to licensing, AZT smashed this timeframe and was licenced after just 2 years.

Soon after its introduction, activists establish the AIDS Coalition to Unleash Power (ACT UP) to challenge high drug prices and rally on Wall Street where “17 homosexual-rights protestors” were arrested, charged then released.

AIDS activism continues around the world to raise awareness of HIV and AIDS, and to challenge the stigma and prejudice faced by those living the disease. In the US, the AIDS memorial quilt is displayed for the first time during the National March on Washington for Lesbian and Gay Rights.

The US government closes its country’s borders to HIV-positive immigrants and visitors which eventually lead to many non-profit organisations to boycott the international AIDS conference in San Francisco in 1990. By 1992, the conference moves from Boston to Amsterdam because of America’s border controls.

An advert featuring The Grim Reaper was launched in Australia to warn people about the dangers of HIV was launched by the National Advisory Committee on AIDS (NACAIDS). The advertisement depicted the Grim Reaper in a bowling alley, bowling over various people from men and women to babies and toddlers, knocking over human ‘pins’ which represented people with HIV.  The commercial first screened on 5 April 1987 and was highly controversial; one reason is the unfortunate blow to the gay community, which had already taken the lead in AIDS awareness and safe sex practices.

The Grim Reaper became identified with gay men rather than as the Reaper which was unintentional, however viewers believed that the Reaper was people with HIV infection, rather than the Reaper harvesting the dead.

The commercial was widely criticised at the time, but it succeeded in creating widespread discussion about AIDS.

1987 also marked a UK Government Cabinet Committee devoted to combatting the epidemic. £20 million was earmarked for a publicity campaign, £5 million of which was to be spent on television commercials which could be adapted for cinema. The dilemma facing the government and advertising agency was whether to use shock tactics, as recommended by health groups or take heed of moral campaigners like Mary Whitehouse, who called for the promotion of “monogamy, not sexual precautions”. Another contentious issue was whether to overturn the Independent Broadcasting Authority’s restriction on commercials recommending condom use.

The result was a hard-hitting campaign containing apocalyptic images of icebergs, crumbling mountains and falling monoliths crashing on our screens.  The aim was to shock people into practising safer sex.

The most remembered of the five advertisements were Tombstone and Iceberg, with their iconic, nightmarish imagery, compounded by John Hurt’s chilling commentary.

The television advertisement campaign was accompanied by educational television and radio programmes on AIDS and related leaflets, bearing the ‘Don’t Die of Ignorance’, slogan were sent to every home in the country. (Click the image above for a copy).  Despite widespread apprehension, the campaign was later acknowledged that it had been successful in precipitating more open discussion about AIDS in the media.

Although cases of AIDS in the UK had remained low, due in part to high profile campaigns, it had become a global epidemic, by this time, the World Health Organisation had been notified of nearly 44,000 cases of AIDS in 91 countries including the cases first recorded in the Soviet Union.

At a time with high ignorance and constant struggle in the face of stigma and discrimination, most of the population thought you could get AIDS from touching someone or sharing equipment or facilities. This was the experience of Mike Sisco, a gay man with HIV.

Mike simply took a dip in a local swimming pool. Word spread quickly, and by the next day fear, panic and rumours – including one that claimed Mike had spit on food at a grocery store—had forced the pool to be closed and prompted a front-page banner headline in the local newspaper which also made the national news.

Mike says that when he went swimming at the pool, the lifeguard was the first person to recognise him, but soon the other bathers did as well. “They kind of ran like in those science fiction movies where Godzilla walks into the street.”

This wasn’t the first time the community had reacted negatively to seeing Mike in public. He says he returned home after contracting AIDS (sic) while living in Dallas. He says his illness quickly became known in the community through the whispers of small-town gossip.  The Opera Winfrey show examed the case in an hour long special filmed at the town hall.

Watch Mike tell Oprah his story in his own words here  and read more about it here.

At a time when panic, fear, prejudice, stigma and discrimination were wide spread, people with HIV were often rejected by friends and family, and ostracised by society, there seemed to be little hope of educating socialy. What was needed was a public figure to openly demonstrate that HIV could not be caught by sharing cups, towels or even air and that support came in the form of Princess Diana.

Diane was drawn to people she felt were not treated fairly and did not receive the support they deserved. She understood that people living with HIV were desperately in need of understanding and support and that is why HIV was a cause she supported so passionately.

She knew that her public profile meant any cause she supported would receive enormous public attention and recognition. For this reason, she chose to support causes which were not considered popular and glamorous – as she knew it was these causes she could make a major difference to.

Princess Diana worked tirelessly both in front of the cameras and behind the scenes to support people living with HIV and to change society’s attitude to HIV – whether visiting HIV positive people in hospital, opening wards, attending conferences and events or supporting fundraising initiatives.

Princess Diana’s commitment and dedication to raising the profile of HIV helped challenge the stigma of the virus. She often publically wore a red ribbon and was the first prominent public figure in the UK to be pictured holding the hand of a person with AIDS in his hospital bed. This iconic image was seen by millions all over the world and had an amazing effect in challenging attitudes towards people living with HIV and breaking down stigma and misconceptions.

In Leicester, an initial meeting brings together around 40 people with an interest in practical action to address the issues related around AIDS and HIV.  A general meeting adopts a constitution and elects a management committee which carries on the work of an initial steering group forming links with other agencies pursuing funding and seeking premises.  The organisation is called: Leicestershire AIDS Support Services.

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US Regulators Vote For Approval of PrEP by Large Majority

The US Food and Drug Administration (FDA) took a decisive step yesterday towards approving the use of combination pill Truvada(tenofovir/FTC) as a prevention method for HIV-negative people.

The FDA’s Antiviral Drugs Advisory Committee (ADAC) voted by a majority of 19 to 3 in favour of recommending Truvada as PrEP (pre-exposure prophylaxis) for men who have sex with men, and by 19 to 2 with one abstention for an approval for use by the HIV-negative partner in serodiscordant couples.

There was a close vote, however, when it came to recommending its use generally in individuals for people at risk of HIV infection: 12 to 8, with two abstentions, voted for a general recommendation for any person at risk of HIV.

The ADAC decision was taken after an all-day meeting on 10 May. This meeting discussed the findings of a written report and also heard submissions from a large number of community prevention and treatment advocates. Interest was such that the FDA extended the time for submissions from advocates and community members from one hour to two and had to organise a ballot for access to the hearings.

The written report had concluded that concerns about safety and HIV drug resistance were not sufficient to delay the introduction of PrEP. It also decided that concerns about poor adherence levels seen in some randomised controlled trials, and about whether PrEP would negatively influence behaviour to such a degree that people ended up at greater risk of HIV, were beyond the remit of the FDA.

“I don’t think it’s our charge to judge whether people will take the medicine,” panellist Dr Tom Giordano told the Los Angeles Times. “Our charge is to judge whether it works when taken.”

Considerations of cost are also explicitly ruled out of the FDA’s remit when it comes to approving a new drug or indication.

The FDA is not bound to follow the recommendations of its advisory committees and will make a final decision by 15 June. However it is very rare for it not to do so and the large majority in favour of its approval for gay men and in serodiscordant couples makes this unlikely.

PrEP has always excited controversy amongst HIV prevention advocates and people affected by HIV. Some organisations have opposed its introduction and the AIDS Healthcare Foundation, in particular, has mounted a provocative campaign against its approval. “If you love Vioxx you’ll love PrEP,” read one poster displayed on bus shelters near the White House, referring to the painkilling drug that was withdrawn in 2004 when it was linked to heart attacks.

The majority of HIV prevention advocates, however, has supported PrEP. Mitchell Warren of the AIDS Vaccine Advocacy Coalition (AVAC) commented: “Some funders and policy makers have been awaiting a signal from the FDA before launching demonstration projects or developing implementation plans.

“The time for waiting is over. We need to get on with the work of setting priorities and rolling out PrEP to people who can benefit the most.”
The controversy was if anything reinforced when the randomised controlled trials (RCTs) of PrEP that have reported in the last 18 months –iPrEX, Fem-PrEP, Partners PrEP and TDF2 – produced strikingly different results, with headline efficacy levels ranging from zero (in Fem-PrEP) to 83% (for men in Partners PrEP). Studies of drug levels found that these results could be explained by different levels of adherence in trial participants. PrEP was 92% efficacious in participants in iPrEx who had detectable levels of drug in their blood, and it is clear that adherence levels will crucially determine whether it protects the people who take it.

At present randomised controlled trials have only tested daily doses of PrEP, though a study in France, IPERGAY, is currently testing its efficacy in gay men when taken on a before-and-after-sex basis.
In contrast concerns about negative behaviour change and participants putting themselves at greater risk of HIV have not been supported by RCT findings, but it is recognised that these will only be answered by an open-label study in which people know for sure that they are taking the drug and not a placebo.

Such a study, called PROUD, has been suggested for the UK and is awaiting a decision on approval. In this study gay men attending genitoruinary medicine clinics in the UK who are at significant risk of HIV will be offered TruvadaPrEP plus a package of behavioural support and counselling, but will be randomised to receive the PrEP component either immediately or a year later.

Principal Investigator of the proposed study, Dr Sheena McCormack of the UK Medical Research Council (MRC), told Aidsmap: “It is unusual for the MRC to talk publicly about a trial before it receives approval, but in the case of PrEP it is so important that the trial involves and is supported by its target community.”

Original article by Gus Cairns at Nam

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Cuba Will Start Clinical Human Trials of a Vaccine Against HIV This Year.

The announcement was confirmed by the director of clinical research of Cuba’s genetic engineering and biotechnology centre, Dr Verena Muizo, at the International Biotech Conference-Havana 2012.

“In terms of the vaccine against the human immunodeficiency virus (HIV), it should start soon,” he said.

“We hope in the second quarter of this year, or in the third. It is a clinical study of individuals infected with the human immunodeficiency virus, but it is a phase one study, for safety, and to start to try this possible vaccine.

Dr Muizo said the vaccine, known as TERAVAC-VIH-1, would start as a small study in just a few patients.  “The clinical study that we are going to do is going to be done with a small number of patients, 30.

“These are individuals that have not reached the Aids stage but are instead in the seropositive stage without reaching the clinical Aids stage.”
A seropositive patient tests positive for HIV antibodies, but still has an immune system strong enough to fight off opportunistic infections that can cause complications with patients with full-blown Aids. (sic)

The researchers working on the HIV vaccine, though hopeful, were quick to point out that the investigation is still in the early phases and they will not know for many years whether the vaccine is effective or not.

“The vaccine is starting its clinical evaluation and we hope it works.
“But really, we need a lot more time to really be able to show its effectiveness as a product,” Dr Muizo added.

In December last year a group of Canadian scientists won approval to start testing an experimental vaccine on humans. Developed by researchers from the University of Western Ontario, it received a green light from the US Food and Drug Administration.

Original article via Sky News

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Questions on Tactics to Prevent HIV [PrEP]

PrEP is short for PreExposure Prophylaxis and may be part of comprehensive HIV prevention services in which HIV negative people who are at high risk, take antiretroviral medication daily to try to lower their chances of becoming infected with HIV if they are exposed to it.

To date, PrEP has been shown to be effective in men who have sex with men (MSM) and heterosexual men and women.

The effectiveness of biomedical approaches to prevent HIV infection was a key theme of the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011), held July 17-20, 2011, in Rome.

Among the major studies presented, Robert Grant from the Gladstone Institute of the University of California at San Francisco described final data from the iPrEx trial, which showed that pre-exposure prophylaxis (PrEP) using tenofovir/emtricitabine (Truvada) reduced new HIV infections by 42% overall, and by more than 90% among people who demonstrated good adherence.

The US Centers for Disease Control and Prevention (CDC) has recommended testing patients for HIV before they begin taking the drugs and again at two- to three-month intervals. The FDA could also require drug companies to set up a registry of patients taking the drugs and ask that patients provide proof of a negative HIV test before getting their medications refilled.

Deciding who to treat with PrEP could also be a challenge. The CDC reported on 3 August that rates of new HIV infection in the United States are stable overall, but are rising in young men who have sex with men. Yet if these men aren’t using the prevention measures already available, there’s little reason to think doctors will have an easier time convincing them to take a daily pill.

The question of who should get PrEP is more difficult in many developing nations, which cannot even afford to treat everyone currently infected with HIV. PrEP would cost hundreds of dollars per patient per year in developing countries, and many thousands of dollars in rich nations.

Even with regimens costing less than £1 per day, developing nations will be forced to choose between providing more treatment for those who already need it and potentially preventing new infections. Myron Cohen, a doctor and researcher at the University of North Carolina at Chapel Hill, points out that half of young girls in some parts of sub-Saharan Africa become infected with HIV by their mid-twenties. “That’s unacceptable, so I see that as one potential population for PrEP,” says Cohen.

Although the cost-effectiveness of PrEP increases in higher-risk populations, it will be politically dicey for financially strapped countries to justify distributing drugs to those in these groups. “Even if you thought the best use of the pills would be for sex workers, it would be very difficult to take a limited supply of pills and give them to high-risk populations at the expense of people who are dying of infection,” says Cohen.

In the past year, three landmark clinical trials have shown that a daily dose of the antiretroviral medication Truvada can protect individuals from infection with H.I.V.— a significant discovery, given the failure so far of all efforts to develop a vaccine against the virus.

Now researchers in San Francisco and Miami are planning to test this prevention strategy, called pre-exposure prophylaxis, or PrEP, in a pilot study supported by the National Institutes of Health. The researchers will soon recruit up to 500 uninfected men who have sex with men, especially those considered to be at greatest risk of infection, such as younger gay men and, in particular, African-Americans.

The men will be asked to take Truvada daily, and the researchers will monitor their compliance with the regimen, their sexual behavior and their health status. Already, though, the prospect of antiretroviral drugs’ being used for prevention as well as treatment is raising complex questions for researchers and advocates.

Will healthy uninfected people consistently take an expensive and powerful drug that can cause a range of side effects? Is it fair to provide medications to H.I.V.-negative individuals when so many of those already infected do not have access? Will those receiving the drug be more likely to engage in risky sex because they believe they are protected — even if they do not always take it as prescribed?

The issues are more than academic: According to anecdotal reports, some doctors are already prescribing the medications to some H.I.V.-negative patients, said Dr. Kenneth Mayer, a chairman of the Fenway Institute, a research and advocacy center for  gay, lesbian, bisexual and transgender health in Boston, who has been involved in research into PrEP.

“I think that’s going to increase, but it’s very incremental,” said Dr. Mayer, who believes PrEP is an important new weapon in the H.I.V. prevention arsenal. “People have a lot of questions.”

AIDS advocates have generally expressed optimism that the strategy, if applied carefully, could help reduce the approximately 50,000 new H.I.V. infections that occur annually in the United States. But one major provider of services to people with H.I.V., the AIDS Healthcare Foundation in Los Angeles, has initiated a media and ad campaign raising serious concerns.

The foundation’s president, Michael Weinstein, noted that participants in the first round of PrEP research were counseled extensively that not following the protocol could reduce any protective effect, and yet many still failed to take their pills as prescribed. Adherence to the regimen is likely to be even worse under real-world conditions, he said.

“We deal with tens of thousands of patients here who are positive, and a high percentage of them have adherence issues,” said Mr. Weinstein. “So the idea that young gay men who don’t have this disease are going to take this routinely is highly questionable.”

Mr. Weinstein is particularly concerned that the Food and Drug Administration could soon approve Truvada for use in H.I.V. prevention as well as treatment, which would undoubtedly lead to greater use of the drug. Gilead Sciences, the company that makes the drug, has said it is likely to file such an application with the F.D.A. early next year.

Once the F.D.A. approves a drug for any use, doctors can legally prescribe it “off-label” for other purposes. Drug companies, however, are allowed to promote their products only for indications specifically approved by the agency.

In one of the three earlier clinical trials, among men who have sex with men, PrEP reduced new infections by 44 percent over all. Among men who adhered closely to the prescribed daily regimen, however, protection against infection was greater than 90 percent.

Some researchers worry that sexually active individuals who only sporadically adhere to the PrEP regimen may not realize that they are still at risk for infection; at the same time, feeling “protected,” they may be less vigilant about practicing safe sex and getting regular H.I.V. testing.

And inconsistent use of medications among those who do not realize they are infected could encourage new drug-resistant forms of H.I.V., some experts fear.

Dr. Grant Colfax, director of H.I.V. prevention and research at the San Francisco Department of Public Health, said he hopes that the new research will yield important information about how best to use the emerging strategy.

“The question is, will people be able to maintain the regimen?” said Dr. Colfax, whose agency is a major partner in the study. “What are the risks and benefits outside of a randomized clinical trial? Will they want to take the pill, will there be changes in their risky behavior, will they come back to get H.I.V. testing on a quarterly basis?”

Dr. Howard Jaffe, chairman and president of the Gilead Foundation, acknowledged that adherence was a problem in earlier studies. But he said that participants in the upcoming research, unlike those in the trials, will all know that they are receiving the actual drug, not a placebo, and that the drug can prevent H.I.V. infection if taken as directed. That critical new information, he said, could help motivate them to stick to the prescribed regimen.

The three recent PrEP trials focused on different populations: heterosexual couples in East Africa in which one person was H.I.V.-positive and the other was not; sexually active young adults in Botswana; and men who have sex with men in the United States and five other countries. (A fourth trial, among African women, was stopped early because PrEP was not found to be working.)

The trial involving the East African couples reported that the infection rate was 73 percent lower in the group taking Truvada; among the group in Botswana, there was a 63-percent drop.

“Now that it’s been proven to be effective, the discussion is a much different discussion than when you’re enrolling people for a placebo-controlled trial,” Dr. Jaffe of the Gilead Foundation said.

Truvada combines two antiretroviral drugs, Viread and Emtriva, both also made by Gilead. Besides the upcoming study in the United States, results from additional research into the use of Truvada as H.I.V. prevention are expected over the next few years.

The drug currently costs thousands of dollars a year. A recent editorial in the medical journal Lancet Infectious Diseases raised ethical concerns about the new approach, noting that many people with H.I.V. do not have access to the lifesaving medications.

“How can these drugs be provided as prevention to those high-risk populations, while people with the disease in need of treatment continue to go without?” said the editorial.

In response, proponents of PrEP say that it would be unethical not to explore the new approach, given its potential to reduce infection rates, especially among vulnerable populations whose members have often found it difficult to consistently practice safe sex.

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