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[ by Kieryn Graham | Apr 17, 2010 12:44 pm | No Comment ]
FDA Updates Sustiva Label To Warn Of Birth Defects, Liver Toxicity, And Drug Interactions

The United States Food and Drug Administration (FDA) has approved revisions to the package insert for Sustiva (efavirenz) capsules and tablets to include new information on potential birth defects, liver toxicity, and drug interactions.

Sustiva, which is an antiretroviral drug made by Bristol-Myers Squibb, is approved by the FDA for use in combination with other antiretroviral agents in HIV-positive adults and children older than three years of age.

Sustiva is classified as a Pregnancy Category D drug, indicating there is evidence it can cause birth defects.

The new label has…

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[ by Elisabeth Pernicone | Sep 16, 2009 2:39 pm | No Comment ]
Study Shows Isentress Is As Effective As Sustiva For First-Line Treatment Of HIV

The results of a new study comparing the efficacy of Isentress (raltegravir) and Sustiva (efavirenz) were presented on Sunday at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy.

Results of the study showed that the efficacy of Isentress was similar to the efficacy of Sustiva in treatment-naïve patients. Isentress reduced HIV RNA levels in two percent more patients than Sustiva, and, on average, Isentress raised CD4 levels higher. However, the RNA levels and CD4 counts were not statistically different between the patients receiving Isentress and the patients taking…

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[ by Marianne English | Aug 20, 2009 3:25 pm | No Comment ]
Sustiva
Brand Name: Sustiva
Generic Name: efavirenz
Company: Bristol-Myers Squibb
FDA Clinical Phase: Capsule formula approved in 1998 in combination with other HIV drugs for the treatment of HIV.  Tablet formula approved in 2002

Description

Sustiva is a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) approved by the U.S. Food and Drug Administration for HIV-1-positive adults and children older than 3 years of age.  For patients beginning antiretroviral therapy for the first time, the U.S. Department of Health…

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