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.
Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., announced today that the U.S. Food and Drug Administration (FDA) has approved a revision to the dosing recommendation to include once-daily dosing of PREZISTA® (darunavir) tablets in combination with ritonavir for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients with no darunavir resistance-associated mutations (DRV RAMs).
Millennium: The Takeda Oncology Company today reported results from a randomized, international Phase III clinical trial comparing subcutaneous and intravenous administration of VELCADE (bortezomib) in patients with relapsed multiple myeloma. These data were presented at the 52nd annual meeting of the American Society of Hematology, held December 4-7 in Orlando, Florida.
Merck today reported initial results from the Phase III study investigating the efficacy and safety of a treatment regimen including ISENTRESS® (raltegravir) Tablets once daily in treatment-naïve adult patients infected with HIV-1. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults.
Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.
The same powerful drugs that have extended the lives of countless people with HIV come with a price - insulin resistance that can lead to diabetes and cardiovascular disease.
In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)
Results from a European Observational Study, which included 1,294 antiretroviral (ARV)-experienced patients presented today at the Tenth International Congress on Drug Therapy in HIV Infection (HIV10), demonstrated a low rate of discontinuation and sustained virologic suppression with REYATAZ- (atazanavir)/ritonavir-based regimens over a follow-up period of up to five years.
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.
After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
The U.S. Food and Drug Administration today announced that new safety information has been added to the label for the HIV antiviral drug Invirase (saquinavir), describing potentially life-threatening side effects on the heart when used with Norvir (ritonavir), another HIV antiviral medication.
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.
Findings from a study, which appear in the Oct. 14, 2010 New England Journal of Medicine, helped influence the World Health Organization (WHO) to change its guidelines this year for the treatment of HIV-infected women who receive a single dose of the antiretroviral drug nevirapine to prevent HIV transmission to their babies.
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced the launch of My SPRYCEL (dasatinib) Support, a useful resource to assist adult patients with chronic myeloid leukemia (CML) who are taking SPRYCEL.
Tobira Therapeutics Inc., a biopharmaceutical company focused on developing and commercializing innovative antiviral compounds to treat HIV disease, today announced the completion of a $31 million Series B financing. New investor Novo A/S is leading the round, joined by original investors, Domain Associates, L.L.C., Frazier Healthcare Ventures, Montreux Equity Partners and Canaan Partners.
Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.
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).
Nevirapine is widely used to help prevent mother-to-child transmission of the HIV virus. In cases where the infants are nonetheless infected with HIV virus at birth, the standard treatment is to use protease inhibitors (PI) to reduce the amount of virus in their bloodstream. A new study involving 195 infants in South Africa found that children who were treated with PI and then switched to nevirapine were more likely to maintain virus below the detection threshold of the test than infants who continued to receive PI.
HIV infected children in South Africa who were exposed to the drug nevirapine at birth (used to help prevent mother to child HIV transmission) and then received a protease inhibitor (PI) for viral suppression achieved lower rates of viremia (virus in the blood stream) if they were switched to nevirapine, compared to children who continued on the PI-based regimen, according to a study in the September 8 issue of JAMA.
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.
There are a handful of drugs effective in treating HIV/AIDS. However new research shows that some of these drugs can increase the risk of heart attacks. The results come from a Garvan Institute of Medical Research study involving 20 people, 10 taking the drug Ritonavir and 10 others the drug Raltegravir for one month.
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