US experts urge approval of first AIDS prevention pill

US health advisers urged regulators to approve Truvada, made by Gilead Sciences, as the first preventive pill against HIV/AIDS instead of just a treatment for infected people.

The favorable vote came after clinical trials showed Truvada could lower the risk of HIV in gay men by 44 to 73 percent, and was hailed by some AIDS advocates as a potent new tool against human immunodeficiency virus.

However, many concerns were raised during a marathon 11-hour panel meeting in which about three dozen health care providers warned that the pill could boost risky behaviors and possibly lead to a drug-resistant strain of HIV.

The Food and Drug Administration is not bound by the recommendations of its expert panel, but usually follows the advice. A final decision by the FDA is expected by June 15.

Mitchell Warren, executive director of HIV prevention group AVAC, said after the vote that pre-exposure prophylaxis (PrEP), or the method of taking a drug ahead of potential exposure to HIV, "while not a panacea, will be an essential additional part to the world's success in ending AIDS."

"For the millions of men and women who remain at risk for HIV worldwide, each new HIV prevention option offers additional hope," he added.

The drug, made by the California-based Gilead Sciences, is currently available as a treatment for people with HIV in combination with other anti-retroviral drugs, and received FDA approval in 2004.

The panel's nod came in response to the pharmaceutical company's request for a supplemental new drug application to market it for prevention purposes.

The Antiviral Drugs Advisory Committee voted for the drug as a preventive measure for three groups: 19-3 in favor for men who have sex with men, 19-2 with one abstention for couples in which a partner is HIV positive and 12-8 with two abstentions for other at-risk groups.

Gay men account for more than half of the 56,000 new HIV cases in the United States each year, according to the Centers for Disease Control and Prevention (CDC).

But critics noted that the pill is costly -- up to $14,000 per year -- and could offer a false sense of protection, leading to a spike in unsafe sex and a new surge in AIDS cases.

"We need to slow down. I care too much about my community not to speak my concerns," said Joey Terrill, advocacy manager at the AIDS Healthcare Foundation, which campaigned against the drug's approval for PrEP.

There also remains some controversy about who would benefit from the treatment, as trials in women have shown feeble results, possibly due to poor adherence to the regimen.

"I am concerned about the potential for development of resistance," said Roxanne Cox-Iyamu, a doctor who spoke at the panel's meeting.

"I am concerned as a black woman that we don't have enough data that this actually works in women."

Nurse Karen Haughey said Truvada will not work because "it is not in our nature to always do as human beings what we are told 100 percent of the time."

She also said Truvada's main side effects -- diarrhea and risk of kidney failure -- were a major deterrent.

The main set of data considered came from the iPrEx HIV Prevention Study, carried out from July 2007 to December 2009 in six countries -- Brazil, Ecuador, Peru, South Africa, Thailand and the United States.

The study was conducted among 2,499 men who were sexually active with other men but were not infected with the virus that causes AIDS.

Participants were selected at random to take a daily dose of Truvada -- a combination of 200 milligrams of emtricitabine and 300 milligrams of tenofovir disoproxil fumarate -- or a placebo.

Those in the study who took the drug regularly had almost 73 percent fewer infections. Across the entire study, including those who had not been as diligent in taking Truvada, there were 44 percent fewer infections than in those who took a placebo.

After publication in 2010 in the New England Journal of Medicine, some experts hailed the results as game-changing and the first demonstration that an already-approved oral drug could decrease the likelihood of HIV infections.

Joseph McGowan, medical director of the Center for AIDS Research and Treatment at North Shore University Hospital in New York, said the CDC was expected to soon issue guidance for health professionals who may prescribe the drug.

"I don't see it as something that would be useful to the general public but to certain people who are particularly high risk, there may be some benefit," he said.

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Advocates: HIV prevention pill could save lives

CHICAGO (AP) — A pill to prevent HIV infection is already being given to some healthy people, but without government approval, it remains out of reach and too costly for many who need it.

Doctors, patients and advocates say that would change if the Food and Drug Administration takes a landmark step and allows the pill, Truvada, to be marketed for prevention. The drug has been used for some time as a treatment for those already infected with the AIDS virus.

"This is a pretty radical step, but I think it's a necessary step," said Dr. Lisa Sterman of San Francisco, who prescribes the drug for already infected patients and those who are healthy but at risk of getting the virus from their partners or through risky sex.

"We've come as far as we can with condom use and safe sex strategies," Sterman said.

A panel of advisers to the Food and Drug Administration late Thursday endorsed using Truvada as a preventive.

In the 30-year battle against AIDS, "it's the first time we have talked about a medication for prevention of HIV," Sterman said.

Doctors are allowed to prescribe Truvada "off-label" for prevention, but FDA approval would formally allow the pill's maker Gilead Sciences to market it for that use. It would probably lead many more insurance companies to pay for the costly drug. The FDA usually follows advisers' recommendations and a decision is expected by June 15.

The panel's action "is a huge step forward," said Nick Literski, a federal worker in Seattle who has been taking Truvada for HIV prevention for more than a year. His partner has the AIDS virus. Literski's insurance covers his preventive treatment. The pill's annual cost ranges from just under $11,000 up to $14,000.

Using the drug for prevention "is really allowing people to make educated choices about their health," Literski said.

An estimated 1.2 million Americans have HIV and many more worldwide. AIDS can develop unless the virus is treated with antiviral drugs. The success of such medicines has helped make the disease more manageable and allows patients to live much longer than when the epidemic began 30 years ago.

About 50,000 new HIV infections are diagnosed in the U.S. each year — a number that has held steady for about 15 years.

"We're going to have to take some radical steps in order to stop this epidemic," Sterman said.

Truvada is marketed by Gilead Sciences Inc. of Foster City, Calif. Studies have shown daily use is highly effective at preventing HIV infections.

Some Truvada prevention studies took place in Africa, and the drug is available as an HIV treatment there and in poor nations elsewhere, but Gilead is seeking approval for using it for prevention in the United States only, a company spokeswoman said.

A September editorial in the medical journal Lancet raised concerns about using HIV treatments for prevention when many HIV infected people globally lack access to effective treatments.

James Loduca, a spokesman for the San Francisco AIDS Foundation, praised the advisory panel's action.

"With this recommendation, we're nearing a watershed moment in our fight against HIV," Loduca said. "We know this isn't a magic bullet, and it's not going to be the right prevention strategy for everyone, but it could save thousands of lives in the United States and potentially millions around the world."

Not everyone in the HIV community is so gung-ho about using Truvada for prevention.

Michael Weinstein, president of the AIDS Healthcare Foundation, is among the most vocal opponents. His Los Angeles-based group bills itself as the nation's largest provider of medical care for HIV and AIDS, and Weinstein's main concern is that patients won't take the drug as directed — a pill a day plus the use of condoms. Misuse could create drug-resistant HIV strains, and lead to more infections.

The FDA panelists acknowledged that concern, and said people should be tested to make sure they don't have HIV before starting Truvada. Patients who already have the virus and begin taking Truvada could develop a resistance to the drug, making their disease even more difficult to treat.

Justin Terry-Smith, a Washington-area writer with HIV, has different concerns. He took Truvada for four years to suppress his infection. He said he has friends with the AIDS virus in other cities who can't find the drug, and he worries that making it widely available for prevention could result in shortages and pose problems for patients who need it for treatment.

"There has to much more production of this drug for this to actually go forward," he said.

His doctor recently put him on another drug regimen — switching medicines is a common tactic in HIV treatment. But unlike his other HIV medicines, Truvada had no side effects, and he said it needs to remain available for already infected patients.

Sterman said approval of Truvada for prevention would be unlikely to lead to shortages because the drug would be recommended only for people at high risk for getting the virus.

"I don't think demand for it is going to be that high," she said.

Truvada's costs are another concern. But supporters of the drug note that the lifetime cost of treating one person diagnosed with the AIDS virus has been estimated at more than $600,000.

"It's much more cost-effective to prevent a new infection than it is to treat someone for their lifetime," Loduca said. "Of course the ultimate goal is a vaccine and a cure but we're many years away from that."

Jim Pickett, director of prevention advocacy and gay men's health at the AIDS Foundation of Chicago, has had the AIDS virus since 1995. He says his medical costs, mostly covered by health insurance, have continually increased since then; his HIV medicines alone cost $30,000 a year.

He took Truvada for a while for HIV treatment and had no complications. Side effects from long-term use are unclear, but some of the more serious complications linked with Truvada include kidney and liver problems.

The potential for those problems shouldn't be dismissed, but it's not a reason to reject using the drug for prevention, said Pickett, whose group is not affiliated with the San Francisco foundation.

For some people, the risk of kidney problems "10 years down the line may be less than the risk for acquiring HIV, which is significantly more problematic and can be fatal," Pickett said.

"We need options for people. This is one option. It wouldn't be an option for everybody. It's not meant for everybody," Pickett said.

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AP Health Writer Matthew Perrone contributed to this story from Washington.

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Online:

FDA: http://www.fda.gov

AIDS: http://www.aids.gov

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AP Medical Writer Lindsey Tanner can be reached at http://www.twitter.com/LindseyTanner

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AIDS fight enters new phase with prevention pill

CHICAGO (AP) — Condoms and other safe-sex practices have accomplished only so much. Now the 30-year battle against AIDS is on the verge of a radical new phase, with the government expected to endorse a once-a-day pill to prevent infection with the virus.

Some doctors are already giving patients the drug, Truvada, to ward off infection. But Food and Drug Administration approval would expand that practice and could make the highly expensive medicine more affordable. Truvada costs around $11,000 to $14,000 a year.

Approval seems likely after an FDA advisory panel Thursday endorsed the use of Truvada for prevention.

In the generation-long fight against AIDS, "it's the first time we have talked about a medication for prevention of HIV," said Dr. Lisa Sterman of Francisco, who treats HIV-positive patients.

"With this recommendation, we're nearing a watershed moment in our fight against HIV," said James Loduca, a spokesman for the San Francisco AIDS Foundation. "We know this isn't a magic bullet, and it's not going to be the right prevention strategy for everyone, but it could save thousands of lives in the United States and potentially millions around the world."

Truvada has been FDA-approved since 2004 for treating people infected with the AIDS virus. Once a drug is on the market, doctors are free to prescribe it for off-label, or unapproved, uses, and that's what some have been doing in giving Truvada to patients who are healthy but in danger of getting the virus from their partners or through risky sex.

Official FDA backing of the practice would allow Truvada's maker, Gilead Sciences Inc. of Foster City, Calif., to market it for prevention. Approval would also probably lead many more insurance companies to pay for the drug. And by widening the market for Truvada, it could prompt Gilead to lower the price.

An FDA decision is expected by June 15.

The FDA is also considering approving the first over-the-counter HIV test for use at home. Experts said it could help slow the spread of HIV.

An estimated 1.2 million Americans and millions more around the world have HIV. Unless the virus is treated with antiviral drugs, it can turn into full-blown AIDS. Antivirals have made the disease more manageable and allowed patients to live much longer than when the epidemic began in the early 1980s.

Nevertheless, about 50,000 new infections are diagnosed in the U.S. each year, a number that has held steady for about 15 years.

Truvada represents "a pretty radical step, but I think it's a necessary step," said Sterman, who prescribes it to infected patients and those who are healthy but at risk. "We've come as far as we can with condom use and safe-sex strategies."

The drug would be recommended for people at high risk of getting the virus, such as gay men with multiple sex partners, prostitutes and people whose partners are infected.

In one U.S. government study of more than 1,200 men and women in Botswana, Truvada lowered the HIV infection risk by about 78 percent. Another larger study in Africa found a slightly lower rate of effectiveness, but researchers say that if used as directed, the pill can be 90 percent effective or higher.

It is available as an HIV treatment in Africa and other poor regions, but Gilead is seeking approval for prevention in the U.S. only, a company spokeswoman said. Some experts have expressed concern that the use of Truvada for prevention could cause shortages in poor countries that desperately need the drug to treat infected people.

Not everyone in the HIV community is gung-ho about the drug.

Michael Weinstein, president of the AIDS Healthcare Foundation, a Los Angeles-based group that calls itself the nation's largest provider of medical care for HIV, said his main concern is that patients won't take the drug as directed — once a day, while also using condoms. Misuse could create drug-resistant HIV strains and lead to more infections.

The FDA panelists acknowledged that concern and said people should be tested to make sure they don't have HIV before starting Truvada. Patients who already have the virus could develop resistance to the drug.

As for the drug's high cost, generic Truvada for HIV treatment is available in poor countries for as little as $9 per month, a Gilead spokeswoman said. But generic versions are not available in the United States and won't be until after Truvada's U.S. patent expires in 2021. Sterman said she hopes FDA approval leads Gilead to lower the price.

The lifetime cost of treating one person diagnosed with the AIDS virus has been estimated at more than $600,000.

"It's much more cost-effective to prevent a new infection than it is to treat someone for their lifetime," Loduca said. "Of course, the ultimate goal is a vaccine and a cure, but we're many years away from that."

Some of the more serious complications linked to Truvada include kidney and liver problems. But for some people, the risk of kidney problems "10 years down the line may be less than the risk for acquiring HIV, which is significantly more problematic and can be fatal," said Jim Pickett, director of prevention advocacy at the AIDS Foundation of Chicago.

Nick Literski, a government employee in Seattle, has been taking Truvada for HIV prevention for more than a year because his partner is infected. He said the drug has helped prevent the breakup of relationships like his.

"Many HIV-positive men end up ending their relationships with HIV-negative men out of fear of infecting their partner," Literski said.

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AP Health Writer Matthew Perrone contributed to this story from Washington.

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Online:

FDA: http://www.fda.gov

AIDS: http://www.aids.gov

___

AP Medical Writer Lindsey Tanner can be reached at http://www.twitter.com/LindseyTanner

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