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.
Two new clinical trials are examining the safety and acceptability of antiretroviral medicines administered via injection as a means of protecting against HIV infection. The studies are being funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and conducted by the NIAID-funded HIV Prevention Trials Network (HPTN).
Janssen R&D Ireland announced today an amendment to its existing agreement with Gilead Sciences, Inc., initially established in 2011, for the development of a once daily, darunavir-based, single-tablet regimen (STR) for the treatment of people living with HIV.
Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients.
The University of Texas Medical Branch is part of a collaboration led by the Oak Crest Institute of Science that received a $20 million grant from the National Institutes of Health to develop a novel intravaginal ring capable of delivering powerful antiretroviral drugs to prevent the spread of sexually transmitted HIV in women. The total award to UTMB is approximately $2.5 million.
For HIV-infected women in good immune health, taking a three-drug regimen during pregnancy prevents mother-to-child HIV transmission more effectively than taking one drug during pregnancy, another during labor and two more after giving birth, an international clinical trial has found.
Merck Sharp & Dohme Ltd. MSD (known as Merck & Co., Inc. in the United States and Canada), today announced the presentation of results from a Phase 2b clinical trial evaluating the safety and efficacy of once daily oral doravirine, an investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), plus tenofovir/emtricitabine (TDF/FTC) compared to efavirenz plus TDF/FTC in previously untreated patients with HIV-1 infection.
A mathematical model developed by NIH grantees predicts that women must take the antiretroviral medication Truvada daily to prevent HIV infection via vaginal sex, whereas just two doses per week can protect men from HIV infection via anal sex.
The UCSF Clinician Consultation Center at San Francisco General Hospital and Trauma Center has been funded by the Centers for Disease Control and Prevention to provide a PrEPline, a telephone consultation service that gives expert guidance to healthcare providers across the nation who prescribe antiretroviral medications to HIV uninfected individuals to prevent HIV.
ViiV Healthcare announced today that the US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.
In an innovative approach to HIV prevention, an interdisciplinary group of experts has come together for the first time to lay out a framework of best practices to optimize the role of the clinician in achieving an AIDS-free generation.
Janssen R&D Ireland Ltd announced today that they have entered into a collaboration with ViiV Healthcare to develop and commercialize a new single tablet regimen containing Janssen's Non-Nucleoside Reverse Transcriptase Inhibitor rilpivirine (marketed as EDURANT®) and ViiV's Integrase Inhibitor dolutegravir(marketed as TIVICAY®) as the sole active ingredients for the maintenance treatment of people living with Human Immunodeficiency Virus (HIV).
Merck, known as MSD outside the United States and Canada, today announced that the first patient has been enrolled in the company's global Phase 3 clinical trial, ONCEMRK.
Dolutegravir has been approved since January 2014 in combination with other antiretroviral drugs for the treatment of human immunodeficiency virus (HIV) infected adults and adolescents above 12 years of age.
The German Institute for Quality and Efficiency in Health Care (IQWiG) reassessed the antiviral drug combination rilpivirine/emtricitabine/tenofovir. In early 2012, the combination was approved for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) who have not received previous antiretroviral treatment.
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved the single tablet HIV-1 regimen Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen. Complera was first approved in 2011 for patients new to therapy and is now one of the most widely-prescribed HIV regimens in the United States.
Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Vitekta (elvitegravir 85 mg and 150 mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir.
Taking an important step toward the development of a product to prevent HIV infections associated with unprotected anal sex, researchers today announced the launch of a global Phase II clinical trial of a potential rectal microbicide.
The drug combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil (elvitegravir fixed combination, trade name: Stribild) has been approved in Germany since May 2013 for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1).
The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply.
New HIV treatment guidelines by WHO recommend offering antiretroviral therapy earlier. Recent evidence indicates that earlier ART will help people with HIV to live longer, healthier lives, and substantially reduce the risk of transmitting HIV to others.