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Issue No. 44 | October 22, 2010

News and Features

FDA Revises Saquinavir (Invirase) Label to Include Updated Risk Information on Abnormal Heart Rhythms

“The U.S. Food and Drug Administration is notifying the public that new risk information has been added to the label of the antiviral drug Invirase (saquinavir), describing a potential change in the electrical activity of the heart when Invirase is used with another antiviral medication, Norvir (ritonavir). Changes in the electrical activity of the heart may lead to abnormal heart rhythms.

“In February 2010, FDA announced it was reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase in combination with Norvir.

"This new risk information has been added to the Warnings and Precautions, Contraindications, and Clinical Pharmacology sections of the Invirase label.  In addition, the FDA will require that a Medication Guide be given to patients when picking up a prescription for Invirase.  The Medication Guide will include information on the risk of abnormal heart rhythms.”

More information is available:

CDC Releases Updates to HIV Surveillance Report

The Centers for Disease Control and Prevention (CDC) recently updated the “HIV Surveillance by Race/Ethnicity” and “HIV Surveillance in Women” slide sets with information from the HIV Surveillance Report: Diagnoses of HIV infection and AIDS in the United States and Dependent Areas, 2008. The slide sets provide information on HIV/AIDS diagnoses by race/ethnicity and HIV statistics in women, including breakdowns of HIV and AIDS diagnoses by state and transmission methods.

Study Suggests CD4 Count Superior to WHO HIV Stages in Identifying Pregnant and Postpartum Women Eligible for Antiretroviral Therapy

“Pregnant and recently postpartum HIV+ women received CD4+ cell count and World Health Organization (WHO) clinical staging at enrollment into the mother-to-child transmission Plus Initiative. [The researchers] compared immunologic and clinical criteria based on 2009 WHO ART treatment guidelines (WHO stage 3/4 or CD4+ cell count ≤350 cells/mm³) in identifying ART eligible women. …

“Among 6036 women (62% antepartum, 38% postpartum), 2915 (48%) were ART eligible. Only 23% had WHO stage 3 or 4 disease, whereas 94% met CD4+ cell count criterion. Among 5356 women with WHO stage 1 or 2 disease, 2235 (42%) had CD4+ ≤350 cells per cubic millimeter. Change of CD4+ cell count ART eligibility threshold from ≤200 to ≤350 cells per cubic millimeter increased the proportion of ART eligible women from 21% to 45%. …

“Use of CD4+ cell count criterion is superior to clinical staging in identifying pregnant and postpartum HIV+ women eligible for ART. Improving access to CD4+ testing is essential to identify and treat eligible women, optimizing maternal and child health outcomes.”

More information is available: