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.
Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.
InterMune, Inc. today announced that the on-going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin) in HCV treatment-naive patients has been modified.
Concert Pharmaceuticals, Inc. announced today that it has initiated a Phase 1b clinical study with CTP-518, its investigational oral HIV protease inhibitor for the treatment of HIV infection. In connection with the start of this multiple ascending dose arm of the Phase 1 study, Concert will receive a $12 million milestone payment under the company’s strategic alliance with GlaxoSmithKline.
Schering-Plough Corporation reported that interim results from an ongoing Phase IIa study of narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1.
Merck Frosst Canada Ltd. is pleased to announce that (Pr)ISENTRESS(R) (raltegravir) is now indicated for use in treatment-naïve HIV-1 infected adults in combination with other antiretroviral agents.
AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.
A $6 million, five-year federal grant to The Children's Hospital of Philadelphia Research Institute will enable researchers to investigate a novel approach in treating HIV infection---a unique class of drugs focused on developing therapies for psychological and neurological effects in AIDS.
Merck Sharp & Dohme Limited (MSD) announced today that ISENTRESS® (raltegravir) has been granted an expanded licence from the European Union Commission (Commission) for use in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in adult patients, including adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as treatment-experienced adult patients.
Schering-Plough Corporation today reported long-term data with vicriviroc, its investigational CCR5 receptor antagonist, from an ongoing, open-label extension of the Phase II VICTOR-E1 study in treatment-experienced HIV-infected patients.
ISENTRESS , an integrase inhibitor from Merck & Co., Inc., was studied in comparison to efavirenz in maintaining viral load suppression to undetectable levels (less than 50 copies/mL) and at improving CD4 cell counts in previously untreated (treatment-naïve) HIV-1-infected patients through 96 weeks in a Phase III study called STARTMRK.
Roche (SIX: ROG.VX; RO.S, OTCQX: RHHBY) and InterMune, Inc. (Nasdaq: ITMN) today announced that the first patient has been dosed in a Phase 2b study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with PEGASYS(R) (pegylated interferon alfa-2a) and COPEGUS(R) (ribavirin). The study, to be conducted at 45 sites globally, will further define the safety and efficacy profile of RG7227/ ITMN-191, for a treatment duration of up to 24 weeks. Approximately 300 treatment-naive patients chronically infected with HCV genotype 1 - the most difficult to treat form of the virus - will participate.
Former President Bill Clinton on Thursday announced deals with drugmakers Matrix Laboratories and Pfizer to lower the cost of medications to treat patients with drug-resistant forms of HIV/AIDS in the developing world, Reuters reports (Honan, 8/6).
President Bill Clinton announced two important and complementary agreements today to enable better, more affordable treatments for patients on second-line antiretroviral (ARV) therapy for HIV/AIDS in the developing world.
Schering-Plough Corporation has announced that it has extended to stage two an ongoing Phase II clinical study with vicriviroc, its investigational CCR5 antagonist, for use in first-line therapy of adult treatment-naive HIV-infected patients with R5-type virus only. In this study, vicriviroc is being evaluated in a novel nucleoside-sparing regimen that is designed to provide additional options for treatment-naive patients in a once daily regimen, while preserving other drug classes for subsequent lines of treatment.
HIV-positive patients who don't seek medical attention until they have a serious AIDS-related condition can reduce their risk of death or other complications by half if they get antiretroviral treatment early on, according to a new multicenter trial led by researchers at the Stanford University School of Medicine.
A clinical study, led by researchers from University College Dublin, Ireland, and Stanford University, California, USA, with international collaborators, demonstrates that mortality rates of HIV patients can be almost halved when early antiretroviral (ARV) therapy is added to the treatment of AIDS-related opportunistic infections (OIs) such as pneumonia, meningitis or other serious bacterial infections.
Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received the first and only World Health Organization (WHO) approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.
As World AIDS Day 2008 approaches, a coalition of hundreds of HIV/AIDS medical care providers and advocates, representing dozens of organizations, today sent a letter to Dr. Margaret Chan, Director General of the World Health Organization (WHO), urging an end to harmful single-dose HIV/AIDS treatment as a recommended treatment for expectant mothers and infants worldwide.
Testing very young babies for HIV and giving antiretroviral therapy (ART) immediately to those found infected with the virus dramatically prevents illness and death, according to a report in the New England Journal of Medicine.
New data from the JUPITER study demonstrated that Crestor (rosuvastatin calcium) 20 mg significantly reduced major cardiovascular (CV) events (defined in this study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by a dramatic 44% compared to placebo (p<0.001) among men and women with elevated hsCRP but low to normal cholesterol levels.
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