Truvada gains FDA approval as HIV preventive

Jul 18 2012

The daily pill is the first aimed at reducing the risk of contracting HIV in healthy people who are at high risk of contracting AIDS. It will have a boxed warning that it should be used only by people whose HIV-negative status is confirmed prior to prescription and at least every three months after.

NPR: Deciding On Truvada: Who Should Take New HIV Prevention Pill
There's something new to prevent HIV infections. The Food and Drug Administration on Monday approved a one-a-day pill that can drastically lower a person's risk of getting the AIDS virus. It's called Truvada -; the first HIV prevention pill (Knox, 7/17).

Bloomberg: Gilead Wins U.S. Approval For First HIV Prevention Pill
Gilead Sciences Inc. (GILD) won U.S. approval to market its HIV treatment Truvada to prevent the virus that causes AIDS in healthy people who are at high-risk of contracting the disease. The daily drug is the first aimed at reducing the risk of HIV in uninfected people as part of a strategy that includes other prevention methods such as safe sex practices, risk reduction counseling and regular HIV testing, the Food and Drug Administration said today in a statement. Truvada will carry a boxed warning to physicians and patients that the drug should only be used by those confirmed HIV-negative prior to prescribing the drug and at least every three months during use (Edney, 7/16).

San Francisco Chronicle: FDA Approves Truvada As HIV Preventive
The U.S. Food and Drug Administration on Monday approved the marketing of the first drug shown to curb the transmission of the HIV virus, a development heralded by AIDS advocates and physicians as a turning point in the battle against the decades-long epidemic. Truvada, made by Gilead Sciences in Foster City, was approved in 2004 to treat people already infected with HIV, but studies have shown the drug is also effective at reducing the risk of contracting the virus. "It's a huge milestone that could change the course of the epidemic," said Dr. Robert Grant, a UCSF professor and a researcher with the Gladstone Institute for Virology and Immunology who led one of the two studies on which the FDA approval was based (Colliver, 7/16).

KQED:  FDA Approves First Drug To Help Prevent HIV Infection
The Food and Drug Administration has approved Truvada, the first drug shown to reduce the risk of HIV infection in people who are at high risk of acquiring HIV, the virus that causes AIDS (Aliferis, 7/16).

Medscape:  FDA Approves Drug To Prevent HIV Infection
The US Food and Drug Administration (FDA) today approved tenofovir disoproxil fumarate/emtricitabine (Truvada, Gilead) to reduce the risk for HIV infection in uninfected individuals at high risk of catching the virus, possibly through sexual activity, the agency announced.  The antiretroviral agent is now the first drug approved for prophylactic use. It is currently indicated -; in combination with other antiretrovirals -; to treat HIV-infected adults and children aged 12 years and older (Lowes, 7/16).

The Associated Press: 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 (Perrone, 7/16).