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Issue No. 43 | October 15, 2010

News and Features

NIH Studies Influence Revision of WHO Guidelines for Treating HIV-Infected Women and Infants

“Two studies appearing in the October 14, 2010 New England Journal of Medicine and funded by the National Institutes of Health helped influence the World Health Organization (WHO) to change its guidelines this year for the treatment of HIV infection in certain women and children. The recently updated guidelines affect HIV-infected women who receive a single dose of the antiretroviral drug nevirapine to prevent HIV transmission to their babies, and infants who receive a single dose of nevirapine to prevent acquiring the virus from their HIV-infected mothers but nevertheless become infected. The studies demonstrated that in both cases, the single dose of nevirapine used to prevent mother-to-child transmission of HIV can hamper the drug’s effectiveness if it is also used later as part of a regimen to treat these same individuals.

“An interim review of the first study, known as OCTANE or ACTG 5208, found that exposing HIV-infected women to a single dose of nevirapine to prevent mother-to-child HIV transmission without subsequently administering a short course of other antiretroviral drugs may lead these women to develop nevirapine-resistant HIV. …

“An interim review of the second study, known as P1060, found that HIV-infected infants who received single-dose nevirapine but nevertheless acquired HIV from their infected mothers control the virus better if their HIV treatment regimen includes the antiretroviral drug ritonavir-boosted lopinavir rather than the more commonly used nevirapine."

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Join AIDSinfo in Observing National Latino AIDS Awareness Day

October 15 is National Latino AIDS Awareness Day (NLAAD), a day that serves to increase awareness of HIV/AIDS in the Hispanic/Latino community. According to the 2008 surveillance data from the Centers for Disease Control and Prevention (CDC), the Hispanic/Latino community continues to be disproportionately affected by HIV infection, as the number of Hispanics/Latinos who receive a diagnosis of HIV infection has been increasing over the past several years. The U.S. Department of Health and Human Services (HHS) is committed to addressing this disparity in the Hispanic/Latino community.

AIDSinfo has developed a specialty page for this awareness day with information and resources about HIV/AIDS and the Hispanic/Latino community.

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FDA to Hold Public Meeting on the Biologics Price Competition and Innovation Act

“The U.S. Food and Drug Administration has scheduled a two-day public hearing on Nov. 2 - 3, 2010, on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009. The hearing will be held from 8:30 a.m. to 4:30 p.m. at the FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31, room 1503, in Silver Spring, Md.

“The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to, or interchangeable with, an FDA-licensed biological product.

“The purpose of the hearing is to receive input on the act’s implementation from the public, health care professionals, health care institutions, manufacturers of biomedical products, industry and professional associations, patients and patient associations, third party payers, and current and prospective biological license application and new drug application holders.”

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