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.
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).
While immediate postexposure treatment for suspected HIV is critical, pre-exposure preventive treatment is a newer method that may be effective for people in high-risk groups, states a review of evidence published in CMAJ (Canadian Medical Association Journal).
Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.
Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada(emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP.
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.
"In public comments submitted this week, a group of 14 leading HIV/AIDS and health organizations stated their support for Food and Drug Administration (FDA) approval of emtricitabine/tenofovir disoproxil fumarate [TDF/FTC] ... as pre-exposure prophylaxis (PrEP) to prevent HIV infection in adult men and women," a press release from AVAC: Global Advocacy for HIV Prevention states.
In public comments submitted this week, a group of 14 leading HIV/AIDS and health organizations stated their support for Food and Drug Administration (FDA) approval of emtricitabine/ tenofovir disoproxil fumarate (TDF/FTC or Truvada) as pre-exposure prophylaxis (PrEP) to prevent HIV infection in adult men and women.
A once daily pill to prevent HIV infection could significantly reduce the spread of the AIDS-causing virus. However it would only be cost-effective if limited to men at very high risk for HIV infection, according to a new study.
An HIV prevention trial that pre-dates the shift to antiretroviral (ARV)-based approaches is nonetheless helping to answer some of the most relevant and topical questions the field is facing today.
ViiV Healthcare and Shionogi & Co., Ltd. today announced that initial results have been received from the SPRING-2 (ING113086) Phase III study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1.
"Data presented from the FEM-PrEP trial by Dr. Lut Van Damme Tuesday at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle highlighted the challenge that adherence plays in successfully deploying effective Pre-Exposure Prophylaxis (PrEP) interventions," HIV Medicine Association Executive Director Andrea Weddle writes in this guest post in the Center for Global Health Policy's "Science Speaks" blog.
Using a mathematical formula that carefully measures the degree to which HIV infection of immune system cells is stalled by antiretroviral therapy, AIDS experts at Johns Hopkins have calculated precisely how well dozens of such anti-HIV drugs work, alone or in any of 857 likely combinations, in suppressing the virus. Results of the team's latest research reveal how some combinations work better than others at impeding viral replication, and keeping the disease in check.
AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS nonprofit medical provider, today expressed its disappointment and dismay at the Food and Drug Administration's (FDA) decision to grant an expedited review for Gilead Sciences' application for expanded use of its blockbuster AIDS drug, Truvada, as a means of preventing HIV infection in non-infected people.
Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults.
AIDS Healthcare Foundation (AHF) today called for a top to bottom shake-up of the management at the Food and Drug Administration as well as a Congressional investigation following the publication of a Washington Post news article (1/31/12) that reported, "…the Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients."
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