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.
The German Institute for Quality and Efficiency in Health Care (IQWiG) reassessed the antiviral drug combination rilpivirine/emtricitabine/tenofovir. In early 2012, the combination was approved for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) who have not received previous antiretroviral treatment.
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved the single tablet HIV-1 regimen Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen. Complera was first approved in 2011 for patients new to therapy and is now one of the most widely-prescribed HIV regimens in the United States.
Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Vitekta (elvitegravir 85 mg and 150 mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir.
Taking an important step toward the development of a product to prevent HIV infections associated with unprotected anal sex, researchers today announced the launch of a global Phase II clinical trial of a potential rectal microbicide.
The drug combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil (elvitegravir fixed combination, trade name: Stribild) has been approved in Germany since May 2013 for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1).
The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply.
New HIV treatment guidelines by WHO recommend offering antiretroviral therapy earlier. Recent evidence indicates that earlier ART will help people with HIV to live longer, healthier lives, and substantially reduce the risk of transmitting HIV to others.
Emory University today announced an innovative new public-private drug development enterprise that will transition scientific discoveries more rapidly and efficiently from university laboratories into the marketplace. The new venture is expected to provide global solutions to address worldwide drug development and commercialization needs.
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a supplemental new drug application for SUSTIVA (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg.
"The Indonesian government hopes to implement one of the largest ever examples of 'compulsory licensing,' which will enable the generic manufacture of drugs still under patent," IRIN reports.
Three antiretroviral-based strategies intended to prevent HIV infection among women did not prove effective in a major clinical trial in Africa.
Gilead Sciences, Inc. announced today its results of operations for the fourth quarter and full year 2012.
Gilead Sciences, Inc. today announced the initiation of the first of two Phase 3 clinical trials (Study 104) evaluating a single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults.
Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a prescribing information update for EDURANT (rilpivirine) tablets to include 96-week pooled data from the Phase 3 ECHO and THRIVE studies, which evaluated the efficacy and safety of EDURANT for the treatment of human immunodeficiency virus type 1 (HIV-1) in antiretroviral treatment-naive adults.
Since the start of 2012, a new drug called rilpivirine has been available for adult patients infected with the human immunodeficiency virus type 1 (HIV-1). It is marketed by two different pharmaceutical companies, by one as a single agent (trade name Edurant-) and by the other as a fixed combination with other HIV drugs (trade name Eviplera-).
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.