Sustiva, Efavirenz News

Blood levels of efavirenz are not associated with discontinuation of treatment with the drug as a result of neuropsychiatric problems, investigators report in the October edition of AIDS .

FDA Advisory Committee Recommends Approval of CCR5 Antagonist Maraviroc for Treatment-naive Patients An advisory committee to the U.S. Food and Drug Administration voted 10-4 last week to recommend that the first-in-class CCR5 antagonist maraviroc be approved for use in first-line antiretroviral therapy .

Main Category: HIV / AIDS Also Included In: Regulatory Affairs / Drug Approvals Article Date: 11 Oct 2009 Pfizer Inc.

Pfizer Inc. announced today that the U.S. Food and Drug Administration's Antiviral Drugs Advisory Committee voted to recommend the approval of Selzentry tablets for use in treatment-naive adult patients with CCR5-tropic HIV-1 virus as part of combination therapy.

People with HIV in the United States are likely to get a further option for use in first-line drug combinations within the next few weeks, following yesterday's decision by the US Food and Drug Administration's Antiviral Drugs Advisory Committee to recommend marketing approval for maraviroc , the CCR5 inhibitor manufactured by Pfizer.

Doses of efavirenz can be safely reduced in patients who have high blood concentrations of the drug, Dutch investigators report in the October 1st edition of the Journal of Acquired Immune Deficiency Syndromes .

Tobacco and marijuana may reduce levels of atazanavir in the body, whilst tobacco and alcohol may lower efavirenz levels in individuals who carry specific genetic variations, according to two posters presented last week at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco.

European Commission Approves Raltegravir and Once-daily Lopinavir/ritonavir for First-Line HIV Therapy The European Commission, which plays a regulatory role similar to that of the U.S. Food and Drug Administration for the countries of the European Union, this week announced expanded approvals for 2 HIV drugs for first line therapy.

The new integrase inhibitor raltegravir has been granted marketing approval for use as a first-line HIV treatment in the European Union, manufacturer Merck Sharp & Dohme announced today.

Sep 13, 2009 - ISENTRESS A , an integrase inhibitor from Merck & Co., Inc., was studied in comparison to efavirenz in maintaining viral load suppression to undetectable levels and at improving CD4 cell counts in previously untreated HIV-1-infected patients through 96 weeks in a Phase III study called STARTMRK.

I'I I'IsIYI I I©I I- I I I IYI -BW-Merck & Co., Inc. Sept. 15, 2009 08:00 UTC European Union Commission Approves Expanded Use of ISENTRESSA , from MSD, in Adult Patients with HIV-1 Infection WHITEHOUSE STATION, N.J.-- -- Merck Sharp & Dohme Limited announced today that ISENTRESSA has been granted an expanded licence from the European Union ...

The material posted on HIV and Hepatitis.com about the 49th ICAAC is not approved by the American Society for Microbiology At 96 Weeks, Raltegravir Is as Effective as Efavirenz in Suppressing HIV Viral Load and Improving Immune Function When used as part of a combination antiretroviral therapy regimen for 96 weeks, the entry inhibitor raltegravir ...

SAN FRANCISCO A drug that recently received an expanded approval from the Food and Drug Administration as a first-time treatment for HIV-1 in adults is as effective as its competitor, according to results of a recent late-stage clinical trial.

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Two research teams presented study findings at the recent 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention in Cape Town, South Africa, showing that inadequate vitamin D levels are highly prevalent among people with HIV, and individuals taking efavirenz are at particularly high risk.

Main Category: HIV / AIDS Also Included In: Regulatory Affairs / Drug Approvals ; Clinical Trials / Drug Trials Article Date: 22 Aug 2009 - 1:00 PDT Mylan Inc.

Main Category: HIV / AIDS Also Included In: Regulatory Affairs / Drug Approvals ; Clinical Trials / Drug Trials Article Date: 22 Aug 2009 - 1:00 PDT Mylan Inc.

To the Editor: We report 5-year outcomes of 910 adults with human immunodeficiency virus infection who consecutively initiated antiretroviral therapy according to guidelines of the World Health Organization from 2003 through 2004.

On August 12, 2009, the U.S. Food and Drug Administration granted tentative approval for a generic fixed-dose combination pill containing 600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir -- equivalent to the brand-name Atripla coformulation .

Gradually increasing the dose when starting efavirenz leads to fewer and less severe neuro-psychiatric side effects without compromising antiviral efficacy, according to a study published in the August 4, 2009 issue of Annals of Internal Medicine .