FDA OKs 1st Pill to Help Prevent HIV

A bottle of antiretroviral drug Truvada is displayed at Jack's Pharmacy on Nov. 23, 2010 in San Anselmo, California. (Justin Sullivan/Getty Images)

The Food and Drug Adminstration today announced the approval of the first drug for use in people who are not infected with the human immunodeficiency virus (HIV), to prevent its transmission, which some are calling a landmark in the fight against AIDS.

The drug, Truvada, is actually a combination of two medicines and is manufactured by Gilead Sciences, Inc. of Foster City, Calif. While Truvada has been approved since 2004 as a treatment for those already infected with the HIV virus, this is the first time any drug has been approved for pre-exposure prophylaxis, or PrEP.

The study that led to the drug's approval found the risk of transmission among men who have sex with men decreased more than 40 percent. Furthermore, it showed a decrease of more than 70 percent in risk of transmission among heterosexual couples in which one partner was infected with HIV but the other was not.

"Truvada should not be used alone for preventing infections," cautioned Dr. Debra Birnkrant, director of the Division of Antiviral Products at the FDA's Center for Drug Evaluation and Research. "However, when used in combination with other prevention methods, such as safer sex practices, counseling, and regular testing to determine infection status, Truvada is effective in reducing the risk of transmission."

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FDA approves first pill to help prevent HIV

The Food and Drug Administration on Monday approved the first drug shown to reduce the risk of HIV infection, the latest milestone in the 30-year battle against the virus that causes AIDS.

The agency approved Gilead Sciences' pill Truvada as a preventive measure for healthy people who are at high risk of acquiring HIV through sexual activity, such as those who have HIV-infected partners. The decision comes less than two weeks after the agency approved another landmark product: the first over-the-counter HIV test that Americans can use in the privacy of their homes.

The two developments are seen as the biggest steps in years toward curbing the spread of HIV in the U.S., which has held steady at about 50,000 new infections per year for the last 15 years. An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. And it's estimated that one-fifth, or about 240,000 people, are unaware that they are infected.

"I think the combination of self-testing and a medicine that you can take at home to prevent infection could mean a whole new approach to HIV prevention that is a bit more realistic," said Dr. Demetre Daskalakis of New York University's Langone Medical Center, who served on the FDA panel that recommended approving Truvada. While a positive step forward, Daskalakis added that Truvada would likely be unavailable for many people without health insurance, who often face the greatest risk of acquiring HIV.

Researchers had long sought to create a pill that could help stem the epidemic. Public health advocates said Monday that Truvada represents a major breakthrough, both as a medical therapy and as a means of expanding other preventive measures. Patients who get a prescription for Truvada will be expected to take part in a comprehensive HIV prevention plan, which experts say will enhance the drug's impact.

"It really marks a new era in HIV prevention because in adding Truvada as a prevention strategy, what comes with it is expanded access to HIV testing, condoms and preventive counseling and support," said James Loduca, vice president of the San Francisco AIDS Foundation.

But HIV experts have raised concerns that patients might not use the drug correctly. Dr. Tom Giordano of Baylor College of Medicine said Monday the drug must be taken every day to be effective, and would be most effective for a relatively small group of people.

"It's been most effective in people who are at very high risk and are able to take the drug on a regular basis," said Giordano, who served on the FDA panel that recommended approving the drug. "When you really boil it down that's going to be a relatively focused population, but it's an important population to treat."

The drug's label carries a warning that 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, making their disease more difficult to treat. The label also warns of side effects, including kidney and liver problems.

Gilead Sciences Inc. has marketed Truvada since 2004 as a treatment for people who are already infected with the virus. The once-a-day pill is a combination of two older HIV drugs, Emtriva and Viread.

Starting in 2010, studies showed that the drug could prevent people from contracting HIV when used as a precautionary measure. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year, another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.

Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval will allow Gilead Sciences to formally market the drug for that use, which could dramatically increase prescriptions.

Truvada's groundbreaking preventive ability has exposed disagreements about managing the disease among those in the HIV community. Groups including the AIDS Healthcare Foundation asked the FDA to reject the new indication, saying it could give patients a false sense of security and reduce the use of condoms, the most reliable preventive measure against HIV.

But FDA scientists said Monday said there was no indication from clinical trials that Truvada users were more likely to engage in risky sexual behavior.

"What we found was that condom use increased over time and sexually transmitted infections either remained at baseline levels or decreased," said Dr. Debra Birnkrant, FDA's director of antiviral products. "So in essence, we don't have any strong evidence that condoms were not used or there was a decrease in condom use."

Gilead Sciences said Monday that it would keep the pill at its current price, nearly $14,000 per year. Even at that price, HIV physicians said the drug could be cost effective if it prevents people from contracting the virus.

"It is expensive, but on the other hand it's far cheaper than a lifetime of HIV treatment," said Dr. Joel Gallant of Johns Hopkins University School of Medicine. "So if there are people who will not use condoms but are willing to use this, then for those people it's cost effective."

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

The decision by the FDA on Truvada follows its approval of the OraQuick test earlier this month. The test, which detects the presence of HIV in saliva collected using a mouth swab and returns a result within 40 minutes, is aimed at people who might not otherwise be tested. The FDA has said the test is not 100 percent accurate.

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FDA Approves Truvada as First HIV Prevention Drug

in addition, patients must also practice safe sex, go through risk reduction counseling and undergo regular HIV testing.

Because of the stringent guidelines the FDA is strengthening the box warnings that patients must be confirmed that they’re HIV negative and must be tested for the virus every three months while they’re on the medication.

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Gilead wins first approval of drug to prevent HIV

Reuters – 21 hrs ago (Reuters) - Health regulators for the first time approved using an HIV drug to prevent infection in people who are at high risk of contracting the virus that causes AIDS.

Gilead Sciences Inc's Truvada was approved for people who are not yet infected but may engage in sexual activity with HIV-infected partners, a concept known as pre-exposure prophylaxis (PrEP).

Truvada, which combines two anti-HIV drugs in one pill, is already approved in combination with other antiretroviral agents to treat patients 12 years of age and older who are infected with the virus.

Under the new Food and Drug Administration approval Truvada taken daily, is to be used along with safer sex practices, risk reduction counseling and regular HIV testing to reduce the risk of sexually acquired HIV infection in adults deemed to be at high risk.

"Today's approval marks an important milestone in our fight against HIV," FDA Commissioner Margaret Hamburg said in a statement.

Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, Hamburg said. "New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."

A landmark study published in 2010 found that giving a daily dose of Truvada to men who have sex with other men could reduce HIV infection rates by 44 percent.

The use of combination therapies for people already infected with HIV has turned the virus that was once a sure death sentence into a condition people can live with for many years.

Meanwhile, researchers have been working for decades to come up with a vaccine that would prevent the virus from infecting people only to be disappointed time and again. A 2009 clinical trial in Thailand was the first to show it was possible to prevent HIV infection in humans, and more powerful vaccines using HIV-fighting antibodies are being studied amid renewed optimism that a vaccine may be within reach.

Debra Birnkrant, director of the Division of Antiviral Products at the FDA, said the federal government has a goal of a 25 percent decrease in HIV infections in the United States by 2015, and added that responsible use of Truvada for prevention could help achieve it.

In a conference call with reporters, Birnkrant was asked if the drug might give people a false sense of security that could tempt them to stop using condoms or otherwise engage in unsafe sex.

"We are concerned about risk-taking behavior, however, the (clinical) trials did not bear that out," she said. In one U.S. trial involving 400 men who have sex with other men, she said there was not an increase in unsafe sex.

"The hope is the right messages will get out and Truvada will be used properly," she said.

As part of the approval, the FDA is strengthening the warning label on the drug to make sure physicians screen individuals to ensure they are not infected with the HIV virus before prescribing the medication as a preventive measure, and at least every three months during use.

The approval comes with a risk mitigation program that includes training and education to assist prescribers in counseling people considering Truvada as a prophylaxis.

As a condition for approval, Gilead is required to collect samples from individuals who acquire HIV while taking Truvada and to evaluate them for potential resistance to the drug. It is also required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada as prophylactic.

Gilead's shares closed up 1.5 percent at $51.94 on Nasdaq.

(Reporting by Toni Clarke in Boston and Ransdell Pierson and Bill Berkrot in New York; Editing by Maureen Bavdek, Bernard Orr)

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FDA Approves 1st Pill to Help Prevent HIV Infection

HealthDay – 16 hrs ago MONDAY, July 16 (HealthDay News) -- For the first time, the U.S. Food and Drug Administration has approved the use of a pill to help prevent HIV infection in uninfected, high-risk people.

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US approves first-ever pill for HIV prevention

US approves first-ever pill for …

The first-ever daily pill to help prevent HIV infection was approved Monday by US regulators for use by healthy adults who are at risk for getting the virus that causes AIDS.

Truvada, made by Gilead Sciences in California, has been on the market since 2004 and was approved by the Food and Drug Administration for a new use as a tool to help ward off HIV, in combination with safe sex and regular testing.

The pill as pre-exposure prophylaxis (PrEP) has been hailed by some AIDS experts as a potent new tool against human immunodeficiency virus, while other health care providers are concerned it could encourage risky sex behavior.

In addition, the regimen is estimated to cost around $14,000 per year, making it out of reach of many.

"Truvada alone should not be used to prevent HIV infection," said Debra Birnkrant, director of the division of antiviral products at the FDA.

"Truvada as PrEP represents another effective, evidence-based approach that can be added to other prevention methods to help reduce the spread of HIV."

The FDA said Truvada should be used as "part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing."

Truvada was previously approved as a treatment for people infected with HIV to be used in combination with other antiretroviral drugs.

The decision by the FDA followed the advice of an independent panel in May that supported Truvada for prevention in uninfected people, after clinical trials showed it could lower the risk of HIV in gay men and heterosexual couples.

One study of men who were sexually active with other men but were not infected with the virus that causes AIDS found 44 percent fewer infections in those taking Truvada versus a placebo.

Those in the study who took the drug regularly had almost 73 percent fewer infections.

A second study on heterosexual couples in which one partner was infected with HIV and the other was not showed that Truvada reduced the risk of becoming infected by 75 percent compared with a placebo.

Common side effects were the same as experienced by people with HIV who were taking Truvada, and included diarrhea, nausea, abdominal pain, headache, and weight loss.

However, the adherence rate -- meaning how often people in the study actually took the drug daily -- was low in the study of men who have sex with men, at just 30 percent, Birnkrant said.

In the study of heterosexual partners, adherence was much higher, at between 80 and 90 percent.

Therefore, the drug label must include special instructions for health care providers on how to counsel potential users of the drug.

The drugmaker must also include a warning that Truvada for PrEP "must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use."

As to concerns about whether the pill might boost risky sex practices and lead people to abandon condoms as a first line of protection, Birnkrant said the studies have not shown that so far.

"We don't really have any strong evidence to show that condoms were not used or that there was a decrease in condom use when Truvada was used," she told reporters.

The goal of the approval is to eventually cut back on the rate of new infections in the United States, which have stayed steady in recent years at about 50,000 annually, she said.

A key goal of the US strategy against HIV/AIDS, set forth in 2010, is to decrease the number of new infections by 25 percent by 2015.

"The hope is that over time it will decrease the rate of new infections or incidence in the United States," Birnkrant said.

The FDA approval drew the support of amfaR, The Foundation for AIDS Research.

"We know that Truvada, when taken as directed, works. Now we need to figure out how to properly use it to change the course of the epidemic," said a statement by amfaR chief executive Kevin Robert Frost.

However, the AIDS Healthcare Foundation described the move as "reckless," largely because the FDA recommends but does not explicitly require a negative HIV test prior to use.

"The FDA's move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people," said AHF president Michael Weinstein.

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Delta Needle-Stick Victim Faces Sleepless Nights

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Oh for crying out loud, stop with the drama queen hysterics of having sleepless nights and having to take HIV medications. What a bunch of overkill intended only to pad a lawsuit. These were sewing needles, not injectibles – you can’t get HIV (or hepatitis either as they claim he is worried about) from sewing needles. While he should be entitled to some compensation for the incident, the amount of overacting this guy is doing is worthy of an Oscar.

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UNAIDS welcomes US approval of drug to stop HIV

"The UN agency tasked with fighting AIDS welcomed the decision by the United States to allow the use of Truvada, an HIV prevention pill for the first time. (AFP Photo/Justin Sullivan)" title

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First Drug Approved to Lower Risk of Acquiring HIV

HealthDay – 2 hrs 2 mins ago TUESDAY, July 17 (HealthDay News) -- Truvada (emtricitabine/tenofovir disoproxil fumarate) is the first drug to be approved by the U.S. Food and Drug Administration to reduce the risk of contracting HIV among adults at higher risk of acquiring the AIDS-causing virus.

In a statement, the agency said Truvada was meant to be taken daily to reduce the chances of becoming HIV-infected among adults exposed to the virus. The agency previously approved Truvada in combination with other anti-viral drugs to treat HIV-infected people 12 years and older.

The FDA said it would strengthen the drug's label to warn that people who take the drug as a preventive should confirm they are not already HIV infected.

Truvada's safety and effectiveness were clinically evaluated among 2,499 HIV-negative gay men and transgender women "with evidence of high risk behavior for HIV infection," the agency said. Results showed the drug reduced HIV infection by 42 percent, compared with those who took a placebo.

A second study involved 4,758 heterosexual couples where one partner was infected, while the other was not. Truvada reduced the risk of transmitting infection by 75 percent, compared to those who took a placebo, the FDA said.

The most common side effects reported were diarrhea, nausea, abdominal pain, headache and weight loss. Most serious but less common adverse reactions included kidney or bone toxicity.

Drugmaker Gilead Sciences, based in Foster City, Calif., is required to conduct follow-up studies to evaluate long-term HIV resistance, and the drug's effects among pregnant women, the FDA said.

More information

To learn more about this disease, visit AIDS.gov.

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Colo. Dental Patients Advised to Get HIV Testing

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U.S. busts $108 million black market in Medicaid drugs

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Leaky bladder affects young women too

Reuters – 2 hrs 20 mins ago NEW YORK (Reuters Health) - Bladder control problems may be seen as a problem of older people, but a good percentage of college-age women have symptoms too, a study published Monday suggests.

In a survey of 1,000 young Australian women, researchers found that 13 percent said they'd had urinary incontinence in the past month. That meant problems like leaking urine when they exercised, or often having to rush to the bathroom to avert an accident.

"The traditional belief has been that incontinence really occurs as a consequence of pregnancy and aging," senior researcher Susan R. Davis, of Monash University in Melbourne, said in an email.

"What prompted us to undertake this study was the fact that nobody had actually looked at incontinence in younger women who had never been pregnant," said Davis, whose work was supported by Australian state and federal funds.

The study "contributes significantly to current knowledge about urinary incontinence in young women," said Mary K. Townsend, an epidemiologist at Brigham and Women's Hospital and Harvard Medical School in Boston.

Townsend, who was not involved in the research, has studied the prevalence of urinary incontinence and possible risk factors for it.

"Overall, a key message from this study is that urinary incontinence is a significant problem for women of all ages," Townsend said in an email.

But, she noted, the 13 percent figure could be either an underestimate or overestimate.

That's because the study participants, who were about 22 years old on average, were recruited from college campuses and health clinics. So they may not be representative of all young women.

"It will be important for future studies to confirm these results in a larger, population-based sample of young women," Townsend said.

LINK TO BIRTH CONTROL USE

The study, which appears in the Annals of Internal Medicine, also tried to weed out the possible risk factors for urinary incontinence in young, never-pregnant women.

It turned out that women were sexually active and not using birth control pills had the highest risk: about 22 percent had urinary problems in the past month.

That compared with rates of around 10 percent among women who had either never had sex or were sexually active and on the Pill.

The link to sexual activity might be related to urinary tract infections, Townsend speculated. Sexually active women have a higher rate of UTI, and those infections can trigger incontinence.

But the reasons for the birth control finding are not clear.

Townsend said past studies have come to conflicting conclusions on whether birth control pills are related to higher or lower risks of urinary incontinence -- or whether there's a relationship at all.

She and Davis both said more research is needed to see whether birth control pills, themselves, have any effect on bladder control problems.

There was no strong evidence that overweight young women had an increased risk of incontinence. And that's in contrast to what's been seen among older women.

But Davis said that may be because of numbers: only 15 percent of the study participants were overweight. And as a group, they were fairly healthy and physically active.

"This leaves open the possibility that the rate of incontinence we observed may in fact be an underestimate of the rate in a less healthy group of young women," Davis said.

Both she and Townsend said that young women who find their urinary symptoms troublesome should seek help. In this study, women with symptoms scored lower on a measure of mood and psychological well-being.

"I think the most important take-home message is that if young women experience urinary incontinence they should not feel embarrassed to seek help," Davis said.

There are different options for combating the symptoms, she noted.

Sometimes all you need are lifestyle changes -- like cutting back on caffeine and alcohol, and limiting how much fluid you drink at night.

Another option is "bladder training," which involves tactics like going to the bathroom at fixed times, even if you don't feel like you need to go. That often includes Kegel exercises to strengthen the pelvic muscles that control urination.

Depending on the type of incontinence, medications -- like oxybutynin (Ditropan), solifenacin (Vesicare), tolterodine (Detrol) -- may also help. But research shows that they work for only a minority of women, and they can have side effects like dry mouth, constipation and blurred vision.

SOURCE: http://bit.ly/PdxBlf Annals of Internal Medicine, July 17, 2012.

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