Gilead Sciences Inc's Truvada pills are deemed 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.
According to the Food and Drug Administration Truvada - a combination of Gilead's HIV drugs Emtriva (also known as emtricitabine see above structure), and Viread (or tenofovir see below left structure), which is already being used by patients with the human immunodeficiency virus, is well (left structure is that of Tenofovir disoproxil fumarate) tolerated overall by uninfected people and may prevent infection in high-risk individuals when used in combination with other strategies. The FDA 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.
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.” (right structure is Emtricitabine).
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 have warned 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.
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