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 the initiation of a Phase 2 clinical trial evaluating GS-7340 for the treatment of HIV-1 infection in treatment-naïve adults. GS-7340 is a novel prodrug of tenofovir, the active agent in Viread.
Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Viread in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12.
Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the Quad, a complete single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
VOICE, an HIV prevention trial that has been evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women - daily use of one of two different ARV tablets or of a vaginal gel - has stopped testing the gel.
Gilead Sciences, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing 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 adults.
A large-scale clinical trial evaluating whether daily use of an oral tablet or vaginal gel containing antiretroviral drugs can prevent HIV infection in women is being modified because an interim review found that the study cannot show that one of the study products, oral tenofovir, marketed under the trade name Viread, is effective.
VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women - daily use of one of two different ARV tablets or of a vaginal gel - will be dropping one of the oral tablets from the study.
Gilead Sciences, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorisation Application for the once-daily single-tablet regimen, Eviplera.
AIDS Healthcare Foundation (AHF) today filed a lawsuit against the Food and Drug Administration (FDA) over its denial of AHF's Freedom of Information Act (FOIA) requests regarding correspondence between the FDA and Gilead Sciences regarding its potential application to the FDA to expand the use of its AIDS drug, Truvada, for use as an HIV prevention pill for pre-exposure prophylaxis (PrEP) in uninfected individuals.
Gilead Sciences, Inc. today announced that the second pivotal Phase 3 clinical trial of its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being evaluated for HIV-1 infection in treatment-naïve patients, met its primary objective of non-inferiority at week 48 as compared to ritonavir-boosted atazanavir plus Truvada.
Today AIDS Healthcare Foundation (AHF) commented on an editorial published in the September 2011 issue of The Lancet Infectious Diseases that raises concerns about the use of the HIV treatment drug Truvada, manufactured by Gilead Sciences Inc., as an HIV prevention pill or pre-exposure prophylaxis (PrEP), agreeing with the publication's public health concerns.
Today AIDS Healthcare Foundation (AHF) decried the fact that the recent campaign by Gilead Sciences Inc. to obtain approval by the U.S. Food & Drug Administration for Truvada as PrEP (pre-exposure prophylaxis) has led to a "black market" for the drug in Florida.
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Complera, a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.
Janssen Therapeutics, Division of Janssen Products, LP, presented today 96-week findings from two pivotal Phase 3 clinical trials, known as ECHO and THRIVE, comparing the efficacy, safety and virology profile of its non-nucleoside reverse transcriptase inhibitor EDURANT tablets versus efavirenz (EFV) in antiretroviral treatment-naive, HIV-1-infected adults.
"Two new studies done in three African countries have shown for the first time that AIDS drugs taken daily can cut by more than half a person's chance of becoming infected with HIV through heterosexual intercourse," the Washington Post reports.
In a result that will fundamentally change approaches to HIV prevention in Africa, an international study has demonstrated that individuals at high risk for HIV infection who took a daily tablet containing an HIV medication - either the antiretroviral medication tenofovir or tenofovir in combination with emtricitabine - experienced significantly fewer HIV infections than those who received a placebo pill.
According two studies in Africa, taking a daily pill containing either one or two anti-HIV drugs can reduce transmission of the virus by as much as three-quarters among heterosexual couples. This is an encouraging finding that could help focus on AIDS prevention. The results were so compelling that the larger study was halted early and the drugs given to all the participants, researchers said Wednesday.
A small group of committed AIDS activists and advocates spearheaded by AIDS Healthcare Foundation (AHF) will protest the Bay Area's own Gilead Sciences over its pricing and policies on its HIV/AIDS medications.
"In the first agreement between a pharmaceutical company and the new international Medicines Patent Pool, Gilead Sciences announced Tuesday that it would license four of its AIDS and hepatitis B drugs to the pool," the New York Times reports.
Mylan Inc. today announced an expanded licensing agreement between Gilead Sciences Inc. and Mylan's Matrix Laboratories Limited.
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