FDA staff: Gilead's Truvada may help reduce HIV risk

WASHINGTON Tue May 8, 2012 12:39pm EDT

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WASHINGTON (Reuters) - Gilead Sciences Inc's Truvada tablets appear safe and effective for reducing the risk of HIV infection, U.S. regulators said on Tuesday. But they recommended a cautious approach for using the drug in efforts to prevent the virus that causes AIDS.

Food and Drug Administration staff said Truvada, which is already being used by patients with the human immunodeficiency virus, is well tolerated overall by uninfected people and may prevent infection in high-risk individuals when used in combination with other strategies.

FDA staff also acknowledged a strong correlation between the drug's efficacy at reducing HIV infection and the willingness of those taking it to adhere to the treatment.

Their 47-page review document said preventive use of the drug -- a combination of Gilead's HIV drugs Emtriva, also known as emtricitabine, and Viread, or tenofovir -- should be weighed carefully against an individual's risk for infection, readiness to adhere to the treatment and potential for kidney problems.

"The individual at risk may be spared infection with a serious and life-threatening illness that requires lifelong treatment," the report said.

Truvada represents a potential milestone in the evolution of the worldwide AIDS epidemic by offering a tablet capable of preventing infection. An estimated 1.2 million Americans have HIV, according to the Centers for Disease Control and Prevention.

An outside panel of experts is scheduled to examine the FDA review documents on Thursday and make recommendations that U.S. health regulators will consider in deciding whether the drug should be used as a preventive treatment.

Some experts warn that the drug is only partly effective against HIV and that using it to prevent infection could cause protection from the virus to falter if patients fail to adhere to treatment.

Shares in Gilead Sciences were off 1.5 percent at $49.17 after the FDA released the review document.


UBS analyst Matthew Rodin told investors that the review should have only limited impact on the company because Truvada, which has FDA approval to treat people infected with HIV, is already being used off-label as a prophylactic.

He said a Friday advisory committee meeting on Gilead Sciences' Quad HIV pill for controlling the HIV virus could have bigger implications for the company. Quad is seen as key to Gilead's continued dominance of the market for HIV drugs.

Meanwhile, FDA staff acknowledged that resistance is likely to occur among people who become infected while taking the drug. "The frequency of resistance might be minimized by limiting the duration of drug exposure after infection occurs," the review document said.

The Boston-based Fenway Health Institute, which advocates for the lesbian, gay, bisexual and transgender communities, issued a statement calling on the FDA to approve the drug as a means of reducing the risk of HIV infection.

"If the FDA approves the additional indication of the use of tenofovir-emtricitabine ... health programs and individuals will have improved choices," the group said.

In a 2010 landmark study in the New England Journal of Medicine, researchers found that giving a daily dose of Truvada to men who have sex with men can reduce HIV infection rates 44 percent.

But other research shows that Truvada's high price makes it too costly to provide it to all homosexual and bisexual men, who account for more than half of the estimated 56,000 new infections annually in the United States.

A team of researchers at Stanford University had estimated that giving a daily preventive dose of the drug to all U.S. men who have sex with men would cost $495 billion over 20 years in terms of the cost of drugs and healthcare visits.

The strategy would be far more effective if it targeted men who are at high risk of developing HIV because they have five or more sexual partners a year, they said.

If just 20 percent of these high-risk individuals took the drug, the research team found, it could prevent 41,000 new infections over a period of 20 years at a cost of about $16.6 billion.

(Reporting By David Morgan, editing by Dave Zimmerman, Maureen Bavdek and Gunna Dickson)

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Comments (1)
umojaresearch wrote:
How the FDA favors any drug for HIV Prevention is interesting, most of these drugs are known to have a number of severe reactions to the human body and many of these severe reactions can be more deadly than the problem the drug is trying to remedy.

Suggesting Truvada has anything to do with the prevention of AIDS/HIV is simply not true. Where is the scientific proof to support this drug can in fact help people without harming them. Of course there is none.

If we look at the Facts about Truvada we find there are too many side effects to believe this drug is anything beneficial, or out of the ordinary, working in the best interest of those taking it. The list of adverse reactions is so disturbing it becomes unbelievable that the FDA or anyone else could recommend this drug for human consumption.

Some of the symptoms are:

Severe allergic reactions may include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; bone pain; chest pain; fever; mental or mood changes (eg, depression); muscle pain or weakness; numbness, burning, pain, or tingling in the hands or feet; severe or persistent dizziness; severe or persistent nausea or vomiting; shortness of breath; stomach pain; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite). Any drug which harms the Kidney and Liver, should be considered dangerous.

This drug is really no different than the other supposed AIDS/HIV cures, which actually mimic the AIDS/HIV by destroying the immune systems T-Cells, which creates more opportunities for opportunistic disease not kept in check by the T-Cells.

Like many of the other AIDS/HIV Drugs, this drug is trying to control the replication of this animal retro-virus by blocking the Reverse Transcriptase Enzyme needed for the AIDS/HIV Virus to replicate. In other words, in order for AIDS/HIV to grow, it needs the reverse transcriptase enzyme to reproduce. So scientiests are trying to produce a synthetic drug, which cost you about $1,425.00 a month, to stop the replication of this man-made disease.

What should be important to the AIDS/HIV Activists and victims is that nature provided the olive leaf extract, which has been used for thousands of years to control every type of reverse transcriptase, virus, bacteria and fungus with its own antioxidant which is very effective against most diseases and its own natural antibiotic effective against a host of diseases and illnesses. The problem for scientists and drug companies is they cannot patent nature, so they will never let you know that Proper Diet and Herbs can remedy many health problems.

It should also be noted that the idea of using a Condom cannot prevent AIDS/HIV, because when a person has AIDS/HIV the virus is in all body fluids. So Safe Sex and Condoms is just another lie. The danger of sex without a condom has do do with the fact that AIDS/HIV is DNA specific and having sex with multiple partners means you may contract different variations of the disease.


1.Olive Leaf Extract (Nature’s Antibiotic) Dr. Morton Walker
2.This Is A Bio-Attack Alert March 28, 1986, Attorney Theodore Strecker, Dr. Robert Strecker
3.DVD, AIDS Inc., Gary Null, PhD
4.DVD, The Strecker Memorandum, Dr. Robert Strecker
5.Some Call It AIDS I Call It Murder, Dr. Eva Sneed
6.AIDS and The Doctors Of Death, Dr. Alan Cantwell Jr.
7.The Strecker Group, AIDS Reference List

May 08, 2012 8:03pm EDT  --  Report as abuse
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