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. announced today an expansion of its global access program in an effort to provide accelerated access to Gilead medicines for the treatment of HIV/AIDS.
Last week, a group of 55 U.S. physicians sent a letter to the U.S. Food & Drug Administration (FDA), urging the agency not to approve the use of Gilead's HIV/AIDS treatment drug Truvada for use as an HIV prevention pill - also known as "pre-exposure prophylaxis" (PrEP).
Tibotec Pharmaceuticals today announced that it has entered into a license agreement with Gilead Sciences, Inc., for the development and commercialization of a new once-daily single tablet fixed-dose antiretroviral combination product containing Tibotec's protease inhibitor PREZISTA® (darunavir) and Gilead's cobicistat, an investigational pharmacoenhancing or "boosting" agent.
Tobira Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapies for HIV, announced today that it has initiated a Phase IIb clinical trial for the CCR5/CCR2 inhibitor cenicriviroc (TBR-652).
During its quarterly meeting over the weekend, The Board of Directors of the AIDS Healthcare Foundation (AHF) adopted a resolution cautioning Gilead Sciences against seeking fast track FDA-approval for the expanded use of its best selling AIDS treatment, Truvada, as a possible form of pre-exposure prophylaxis (PrEP) to prevent the transmission of HIV.
On the heels of Centers for Disease Control announcement earlier today that an ongoing study of the use of Gilead's top selling AIDS treatment, Truvada, as a possible form of pre-exposure prophylaxis for HIV prevention in women is being abruptly halted because the, "…trial could not demonstrate efficacy," the AIDS Healthcare Foundation renewed its call on Gilead Sciences to slow its fast track pursuit of its application for FDA approval of use of its AIDS drug as a possible form of HIV prevention.
One of the studies in three African countries where women were given an AIDS drug to prevent HIV infection is being stopped because the project is not working, researchers said Monday. These women on the trial were taking a daily dose of the drug Truvada or a look-alike placebo pill and had an equal chance of becoming infected. The ones taking Truvada were expected to have had a much lower infection rate.
Gilead Sciences, Inc. today announced that the Phase III clinical trial of its investigational antiretroviral agent elvitegravir, a novel oral integrase inhibitor being evaluated for the treatment of HIV-1 infection in treatment-experienced patients, met its primary objective.
The first human studies of an oral drug regimen to prevent HIV infection in high-risk individuals yielded a promising near 50% reduction in HIV incidence, but a number of issues require additional research before oral pre-exposure prophylaxis can be implemented on a large scale, according to an article in AIDS Patient Care and STDs, a peer-reviewed journal published by Mary Ann Liebert, Inc.
AIDS Healthcare Foundation today unveiled a new national advertising campaign headlined, "There Is No Magic Pill," an advocacy and awareness campaign to educate and prompt discussion among gay men and others regarding Gilead Sciences and its likely plans to seek Food and Drug Administration approval for use of its blockbuster AIDS drug Truvada as a form a 'pre-exposure prophylaxis' to prevent HIV transmission.
The 18th Conference on Retroviruses and Opportunistic Infections is being held at the Hynes Convention Center in Boston from February 27 through March 2. Day three of this major HIV/AIDS research conference included the following selected presentations from scientists supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
At the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston on Monday, researchers "suggested the potential" of a gel containing the antiretroviral drug tenofovir to reduce the risk of anal HIV transmission, TIME's "Healthland" blog reports.
In the first study to make head-to-head comparisons between tenofovir gel and oral tenofovir - two promising approaches for preventing HIV in women - researchers found that daily use of the vaginal gel achieved a more than 100-times higher concentration of active drug in vaginal tissue than did the oral tablet, while, compared to the gel, the tablet used daily was associated with a 20-times higher active drug concentration in blood.
Gilead Sciences, Inc. announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.
Shionogi-ViiV Healthcare, LLC announced today that the first patient has entered the clinical study, SINGLE (ING114467), designed to support a new fixed-dose combination (FDC) therapy for the treatment of HIV.
Tibotec Pharmaceuticals today announced that it has granted multiple non-exclusive licenses to generic manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naive HIV-1 infected adults.
Ramius V&O Acquisition LLC, affiliates of Ramius LLC (collectively, "Ramius") and affiliates of Royalty Pharma (together with Ramius and Purchaser, the "Ramius/RP Group") announced today that the Ramius/RP Group is extending its previously announced tender offer to acquire all of the outstanding shares of common stock of Cypress Bioscience, Inc., a pharmaceutical company engaged in the development of innovative drugs to treat central nervous system (CNS) disorders, until Midnight, January 5, 2011, unless the offer is otherwise extended.
Merck today reported initial results from the Phase III study investigating the efficacy and safety of a treatment regimen including ISENTRESS® (raltegravir) Tablets once daily in treatment-naïve adult patients infected with HIV-1. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults.
In a finding with the potential to fundamentally change strategies to slow the global HIV epidemic, a new study called iPrEx shows that individuals at high risk for HIV infection who took a single daily tablet containing two widely used HIV medications, emtricitabine and tenofovir (FTC/TDF), experienced an average of 43.8% fewer HIV infections than those who received a placebo pill. New England Journal of Medicine, is the first evidence that this new HIV prevention method, called pre-exposure prophylaxis or PrEP, reduces HIV infection risk in people.
The Global Campaign for Microbicides (GCM) welcomes today's news from the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Disease (NIAID) of the US National Institutes of Health (NIH) and the Gladstone Institutes of the University of California, San Francisco that daily use of oral emtricitabine (FTC) with tenofovir (TDF) in one tablet shows promise to safely and effectively help to prevent HIV infection among men who have sex with men (MSM).
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