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.
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.
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.
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