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Truvada for HIV Prevention: FDA Review Is Favorable
  By Matthew Perrone | AP
May 9, 2012

A pill that has long been used to treat HIV has moved one step closer to becoming the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS.

The Food and Drug Administration said Tuesday that Gilead Sciences' Truvada appears to be safe and effective for HIV prevention. It concluded that taking the pill daily could spare patients "infection with a serious and life-threatening illness that requires lifelong treatment."

On Thursday a panel of FDA advisers will consider the review when it votes on whether Truvada should be approved as a preventive treatment for people who are at high risk of contracting HIV through sexual intercourse. The FDA is not required to follow the advice of its panels, but it usually does.

An estimated 1.2 million Americans have HIV, which attacks the immune system and, unless treated with antiviral drugs, develops into AIDS, a fatal condition in which the body cannot fight off infections. If Truvada is approved, it would be a major breakthrough in the 30-year campaign against the AIDS epidemic. There have been no other drugs proven to prevent HIV and a vaccine is believed to be decades away.

Gilead Sciences Inc., based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe the medications as part of a drug cocktail that makes it harder for the virus to reproduce. Patients with low viral levels have reduced symptoms and are far less likely to develop AIDS.

Researchers first reported that Truvada could prevent people from contracting HIV in 2010. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 44 percent, when accompanied by condoms and counseling. 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 already on the market to manage HIV, some doctors already prescribe it as a preventive measure. But FDA approval would allow the drugmaker Gilead Sciences to formally market its drug for that use.

FDA reviewers on Tuesday said that patients must be diligent about taking the pill every day if using it as a preventative measure. Adherence to the medication was less than perfect in clinical trials, and reviewers said that patients in the real world may forget to take their medication even more than those in clinical studies.

Some patient advocacy groups say the drug is an important new option to prevent HIV, alongside condoms, counseling and other measures. Last month, advocacy group AIDS United and more than a dozen other groups sent a letter to the FDA, urging approval of Truvada.

"If we're going to reduce the more than 50,000 new HIV infections in this country each year, we need to increase the available options for people," said Ronald Johnson, AIDS United's vice president.

But support for FDA approval is not unanimous.

Although the FDA is legally barred from considering cost when reviewing drugs, health care providers have raised concerns about Truvada's price tag: $900 a month, or just under $11,000 per year. Medicare and Medicaid, the nation's largest health insurance plans, generally cover drugs approved by the FDA, and analysts expect most large health insurers to follow suit.

Additionally, some researchers say the prevention pill is not the chemical equivalent of condoms, which they say remain the best weapon against AIDS. They also worry about Truvada's mixed success rate in preventing infection among women: Last year, a study in women was stopped early after researchers found that women taking the drug were more likely to become infected than those taking placebo.

Researchers speculated that women may require a higher dose of the drug to prevent infection. They also said the disappointing results may have resulted from women not taking the pills consistently.

"We know that if the person doesn't take the medication every day they will not be protected," said Dr. Rodney Wright, director of HIV programs at Montefiore Medical Center in New York and chairman of the AIDS Health Foundation. "So the concern is that there may not be adequate adherence to provide protection in the general population."


Gilead's Truvada Pill Is Safe for HIV Prevention, FDA Says

Ryan Flinn and Shannon Pettypiece, Bloomberg News

Tuesday, May 8, 2012

May 8 (Bloomberg) -- Gilead Sciences Inc.'s pill Truvada was safe and effective when used to protect uninfected people from getting HIV, U.S. regulators said in a report indicating the main concerns are when and how it should be used.

Truvada was "well tolerated" and its ability to reduce the risk of infection was backed by two studies, the Food and Drug Administration staff said in a report today. Gilead, based in Foster City, California, is seeking to sell the drug as the first pill to keep people from becoming infected.

The FDA asked its advisers to suggest who should get Truvada; what testing would be needed for administration; and what educational material should be used for patients and doctors. The advisers will meet May 10 to discuss the drug, the subject of debates over its appropriate use and cost.

Decisions to prescribe Truvada "should carefully weigh the individual risks for acquiring HIV, their understanding of the importance of adherence to medication, and their potential for development of renal toxicity," the FDA staff said today in a report on the agency's website. Education and counseling will be "critically important."

Gilead fell less than 1 percent to $49.46 at the close of New York trading. The FDA isn't required to follow what the advisory panel suggests.

Not Expected

Investors aren't counting on expanded use of Truvada to boost sales much, said Robyn Karnauskas, an analyst with Deutsche Bank in New York. Instead, they are focused on Gilead getting new products to market before facing the loss of half of its revenue from patent expirations beginning in 2018.

"Right now, the company is in a position where they have flat sales and Truvada isn't going to fix the patent cliff problem," Karnauskas said.

Truvada sales for prevention are estimated to peak at about $150 million a year, said Tony Butler, an analyst with Barclays Capital in New York. Insurance reimbursement may be a challenge, he said.

Debate over the appropriate use of the drug has divided the AIDS community. Some AIDS advocacy groups say the drug will be a valuable tool for reducing new cases, particularly within stable partnerships where one person has AIDS and the other doesn't. Others said it may lead to more infections, lower condom use and might build resistance to the medicine.

The population at high risk for contracting the disease includes at least 140,000 individuals whose spouses or partners have the disease, as well as 275,000 gay men who had more than two partners in the past year and didn't wear condoms during sex, according to the U.S. Centers for Disease Control and Prevention, based in Atlanta.

Three Decades

"Thirty years into the epidemic we can't dismiss any new options," James Loduca, a spokesman for the San Francisco AIDS Foundation, said in an interview. "This won't end AIDS by itself, but we can't end it without this."

Loduca said condoms aren't enough to stem the tide of new infections, and using Truvada as a preventative measure would help if taken correctly.

While the number of people infected with HIV rose to 34 million worldwide in 2009, the virus that leads to AIDS, once a death sentence, can be reduced to low levels in the blood with use of combination antiviral medicines such as Truvada.

Michael Weinstein, president of the AIDS Healthcare Foundation, said approval and prescription of Truvada as a preventative may lead to less condom use and more infections, as well as increased resistance to the drug.

Really Paranoid

"Why would you take this medication if you intended to use condoms?" he said. "You've got to be really paranoid about your pants falling down to wear a belt and suspenders."

His organization sued the FDA last year after the agency rejected its Freedom of Information act request for correspondence between regulators and Gilead. Weinstein said the studies don't prove that the pill is effective enough to warrant approval. The AIDS Healthcare Foundation has lined up speakers for the public hearing later this week to oppose its preventative use, Weinstein said.

Barry Zingman, medical director at the AIDS Center at Montefiore hospital in the Bronx, one of the largest treatment centers in New York, said he hopes the drug is approved and plans to offer it to some patients.

from ABC: "It's not a panacea by any means, but there is still a tremendous fear of becoming HIV-positive, even when couples are using all the proper protection," Zingman said. "When used in carefully selected patients getting significant support and close follow-up, it can clearly make a difference in people's lives." "Getting insurers on board will make a huge difference in its use," said Zingman, adding that some doctors already prescribe Truvada "off-label" for HIV prevention, with patients picking up the tab. "There's no doubt cost is prohibitive for the vast majority of people." Zingman said there's no evidence that Truvada would promote risky behavior, but added that he understands the controversy.

"Look at needle exchange programs. They're controversial, but they've dramatically cut rates of HIV and hepatitis among intravenous drug users," he said. "Providing clean needles is an attempt to reduce the risk in people who are already at high risk. It's the same thing here."

$11,000 Cost

He said his big concern is the drug's more than $11,000 a year price tag.

"People are really interested in the concept, but there have been issue related to insurance coverage," Zingman said. "Approval would make a significant advance in insurance coverage."

Aetna Inc. spokeswoman Tammy Arnold and WellPoint Inc. spokeswoman Lori McLaughlin said their companies would consider covering the treatment as a form of prophylaxis if approved by the FDA. UnitedHealth Group Inc. declined to comment.

Medicare, the federal program for the elderly and disabled, and Medicaid, the joint state-federal plan for the poor, typically reimburse for all FDA-approved indications.

If approved, the drug would mostly be given to people at high risk for infection, like men who have sex with men, intravenous drug users and sex workers, said Ken Mayer, medical research director at the Fenway Institute, the largest AIDS treatment center in New England. It would typically be given for a limited period of time, he said.

"I think it would be a mistake for the FDA not to approve this indication," Mayer said. "If we can figure out how to use this most effectively we can really put a dent in the number of new infections."

In a study of men who have sex with men, the drug reduced the risk of infection by 42 percent, though adherence in the trail was low, the agency said. In a study of heterosexual couples where one person was infected, the risk was reduced by 75 percent.

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