Ritonavir, also known as Norvir, is a type of medicine called a protease inhibitor (PI). PIs act by blocking protease, a protein that HIV needs to make more copies of itself. Ritonavir was approved by the FDA on March 1, 1996, for use with other antiretroviral agents in the treatment of HIV infection in adults and children 2 years of age or older. Ritonavir is now approved with other anti-HIV drugs in the treatment of HIV-1 infection in children in individuals over 1 month in age. Studies have shown that ritonavir works as a booster for some other PIs. Taking ritonavir makes it possible to take a lower dose of the other PIs. 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 that the U.S. Food and Drug Administration (FDA) has approved Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.
Sexual intercourse is the major mode of HIV transmission. HIV may also be transmitted through sharing of needles or contaminated blood products (although this is rare).
Today, U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President's Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.
Included in the 2012 International Antiviral Society-USA panel recommendations for human immunodeficiency virus (HIV) patient care is that all adult patients, regardless of CD4 cell count, should be offered antiretroviral therapy (ART), according to an article in the July 25 issue of JAMA, a theme issue on HIV/AIDS.
Researchers from the University of California, San Francisco (UCSF) and Makerere University in Uganda have used hair and blood samples from three-month old infants born to HIV-positive mothers to measure the uninfected babies' exposure—both in the womb and from breast-feeding—to antiretroviral medications their mothers were taking. The results, they said, are surprising.
On the eve of the XIX International AIDS Conference in Washington, DC, the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, announces a new collaboration with Indian drug manufacturer Cipla to develop and produce an improved first-line antiretroviral (ARV) combination therapy specifically adapted to meet the treatment needs of infants and toddlers living with HIV/AIDS.
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
A single tablet containing four antiviral agents may be an effective initial once-daily therapy for adults infected with HIV, shows phase III clinical research.
Janssen Research & Development, LLC (Janssen R&D) announced today the U.S. Food and Drug Administration (FDA) has assigned a priority review designation to the supplemental New Drug Applications (sNDAs) filed on May 2, 2012 for XARELTO (rivaroxaban), an oral anticoagulant, seeking new indications to treat patients with deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent recurrent DVT and PE.
A new once-daily pill combining three antiretrovirals and a booster molecule is a safe and effective alternative to two widely used drug regimens for newly diagnosed HIV-positive adults who have had no previous treatment. The findings of two large international randomised trials published in this week’s Lancet also indicate that the new “Quad” pill is faster acting, doesn’t have the neuropsychiatric side effects associated with other combinations, and could improve compliance with treatment.
Gilead Sciences, Inc. announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing.
Gilead Sciences, Inc. announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults.
Janssen Research & Development, LLC (Janssen R&D) announced today the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS).
Gilead Sciences, Inc. announced today that its Marketing Authorisation Application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients, has been validated by the European Medicines Agency (EMA).
Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of 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 treatment-naïve adults.
Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada(emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP.
Janssen Research & Development, LLC announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of XARELTO, an oral anticoagulant, to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome.
Array BioPharma Inc. today reported financial results for the third quarter of fiscal 2012.
VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STENDRA (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S.
Abbott will present clinical trial results from two different interferon-free, Phase 2 studies for the treatment of hepatitis C (HCV) at the International Liver Congress 2012 (ILC 2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain.
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