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 new data from the open-label phase of two pivotal Phase III clinical trials (Studies 102 and 103) evaluating the four-year efficacy of Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B virus (HBV) infection.
Gilead Sciences, Inc. announced today its results of operations for the quarter ended September 30, 2010. Total revenues for the third quarter of 2010 were $1.94 billion, up 8 percent compared to total revenues of $1.80 billion for the third quarter of 2009. Net income for the third quarter of 2010 was $704.9 million, or $0.83 per diluted share, compared to net income for the third quarter of 2009 of $673.0 million, or $0.72 per diluted share.
Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).
Tibotec Pharmaceuticals today announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TMC278 (rilpivirine, as hydrochloride), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. The proposed indication would make TMC278 available for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults.
Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.
Merck today announced the Merck Company Foundation and the Bill & Melinda Gates Foundation are committing an additional $60 million to support Botswana's African Comprehensive HIV/AIDS Partnerships (ACHAP). Merck is known as MSD outside the US and Canada. A unique program developed with and led by the Government of Botswana, ACHAP is one of sub-Saharan Africa's oldest, most successful public-private partnerships.
Bristol-Myers Squibb Company and the ADAP Crisis Task Force today announced an enhanced agreement to support the efforts of AIDS Drug Assistance Programs to provide antiretroviral medicines to people living with HIV and AIDS. Building on an agreement signed in March of 2010, today's announcement marks a multi-year enhancement to assist ADAPs in meeting the challenges of increasing patient case loads and strained government funding.
Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.
New data were presented today at the 18th International AIDS Conference from the VERxVE study that show an investigational, once-daily extended-release (400 mg QD) formulation of nevirapine was non-inferior to twice-daily immediate release Viramune® (nevirapine) tablets (200 mg BID), both in combination with Truvada® (tenofovir and emtricitabine) tablets in treatment-naive HIV-1 infected patients through 48 weeks.
Johnson and Johnson’s experimental HIV drug rilpivirine or TMC278, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is being developed for use in combination therapy for treating the human immunodeficiency virus (HIV) that causes AIDS. Two clinical trials with the drug has shown that although its effectiveness was same as the existing anti-HIV drugs, its side effects were fewer. On the flip side nearly twice as many patients failed to respond to treatment with the new drug.
Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.
Today we congratulate the Centre for the AIDS Programme of Research in South Africa and the people of South Africa on the positive findings from the CAPRISA 004 microbicide study, which marks a significant milestone both for the microbicide research field and HIV prevention as a whole.
Shionogi-ViiV Healthcare LLC today announced that it will be progressing its once-daily, unboosted investigational integrase inhibitor, S/GSK1349572 ('572) into Phase III clinical trials. '572 will be the only once-daily, unboosted integrase inhibitor in Phase III clinical development.
Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2010. Total revenues for the second quarter of 2010 were $1.93 billion, up 17 percent compared to total revenues of $1.65 billion for the second quarter of 2009. Net income for the second quarter of 2010 was $712.1 million, or $0.79 per diluted share, compared to net income for the second quarter of 2009 of $571.4 million, or $0.61 per diluted share.
"This is a historic day for HIV prevention research. The CAPRISA 004 results are the first clinical evidence that a microbicide gel can help to prevent sexual transmission of HIV infection," said AVAC Executive Director Mitchell Warren, reacting to the results of the landmark microbicide trial presented today at the International AIDS Conference in Vienna.
Abbott today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada® (tenofovir and emtricitabine) in antiretroviral-naive adult patients. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study.
Melbourne-based biotech Avexa has announced the closure of its lead HIV program for apricitabine after failing to attract a licensing partner for the Phase III drug.
Gilead Sciences, Inc. today announced that the company's Board of Directors has authorized the repurchase of up to $5 billion of the company's common stock through May 2013.
Gilead Sciences, Inc. announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).
Gilead Sciences, Inc. provided an update today on the development of the fixed-dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride, 25 mg).
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