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On July 24, 2007, the FDA approved revised labeling for entecavir. Consistent with a recent change in U.S. Department of Health and Human Services treatment guidelines (ACC May 7 2007), the new label recommends against using entecavir to treat hepatitis B virus infection in HIV-coinfected patients who are not also receiving potent antiretroviral therapy. Although entecavir has not been formally evaluated in such patients, data from a small case series indicate that entecavir has anti-HIV activity and can lead to NRTI resistance (ACC Jul 9 2007).