Emtricitabine, also known as Emtriva or FTC, is a type of medicine called a nucleoside reverse transcriptase inhibitor (NRTI). NRTIs block reverse transcriptase, a protein that HIV needs to make more copies of itself. Emtricitabine in capsule form was approved by the FDA on July 2, 2003, for use with other antiretroviral agents in the treatment of HIV infection in adults. Emtricitabine oral solution was approved by the FDA on September 28, 2005, and is now approved for use with other anti-HIV drugs in the treatment of HIV-1 infection in patients older than 3 months of age. This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.
Gilead Sciences, Inc. today announced that a Phase 2 clinical trial evaluating tenofovir alafenamide fumarate, an investigational novel prodrug of tenofovir for the treatment of HIV-1 infection, met its primary objective.
Several large clinical trials have demonstrated that a daily oral dose of one or two antiretroviral drugs used to treat HIV infection can prevent infection in an approach known as pre-exposure prophylaxis, or PrEP.
The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.
Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.
Gilead Sciences Inc. announced Thursday that it plans to partner with Mylan Inc., Ranbaxy Laboratories Ltd. and Strides Arcolab Ltd. "to promote access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine in developing countries," the Wall Street Journal reports.
Mylan Inc. today announced the establishment of a new agreement between its subsidiary Mylan Laboratories Limited and Gilead Sciences Inc. Under this agreement, Mylan has licensed the rights to produce and market generic versions of Gilead HIV/AIDS therapies containing Emtricitabine, including single and fixed-dose combinations.
Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2012.
A large clinical trial testing the long-term safety and effectiveness of a new approach for preventing HIV in women - a vaginal ring used once a month - is now underway in Africa, researchers announced today at the XIX International AIDS Conference (AIDS 2012).
Included in the 2012 International Antiviral Society-USA panel recommendations for human immunodeficiency virus (HIV) patient care is that all adult patients, regardless of CD4 cell count, should be offered antiretroviral therapy (ART), according to an article in the July 25 issue of JAMA, a theme issue on HIV/AIDS.
Scientists are launching the first clinical trial to test whether drug regimens containing maraviroc, a medication currently approved to treat HIV infection, are also safe and tolerable when taken once daily by HIV-uninfected individuals at increased risk for acquiring HIV infection. The eventual goal is to see if the drug regimens can reduce the risk of infection.
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.
Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truto reduce the risk of sexually-acquired HIV infection in adults at high risk.
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
A single tablet containing four antiviral agents may be an effective initial once-daily therapy for adults infected with HIV, shows phase III clinical research.
Shionogi-ViiV Healthcare LLC today announced that initial results have been received from the Phase III SINGLE (ING114467) study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1.
People at high risk of HIV infection can reduce their risk of acquiring the disease by taking antiretroviral drugs, according to Cochrane researchers. In an update of a systematic review first published in 2009, the researchers found that uninfected people in relationships with HIV-infected partners, men who have sex with men and those in other high risk groups are at a lower risk of becoming infected with the virus if they regularly take drugs that are normally prescribed to treat people with HIV.
A new once-daily pill combining three antiretrovirals and a booster molecule is a safe and effective alternative to two widely used drug regimens for newly diagnosed HIV-positive adults who have had no previous treatment. The findings of two large international randomised trials published in this week’s Lancet also indicate that the new “Quad” pill is faster acting, doesn’t have the neuropsychiatric side effects associated with other combinations, and could improve compliance with treatment.
Gilead Sciences, Inc. announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing.
Gilead Sciences, Inc. announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults.
Gilead Sciences, Inc. announced today that its Marketing Authorisation Application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients, has been validated by the European Medicines Agency (EMA).
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