FDA Issues Warning For BMS Hepatitis B Drug Entecavir

August 22, 2007 – 10:58 pm | posted in HIV / AIDS

FDA on Thursday issued a warning that Bristol-Myers Squibb’s hepatitis B drug entecavir might increase the likelihood of developing resistance to antiretroviral drugs among people coinfected with HIV, Reuters reports. The agency also added a black box warning to the drug’s label. BMS — which manufactures and sells entecavir under the brand name Baraclude — in a letter to physicians wrote that people coinfected with hepatitis B and HIV should not take entecavir unless they are taking standard antiretrovirals. According to the warning, drug resistance can develop if a person is not being treated for HIV. The warning also said that HIV testing should be offered to any person who considers taking entecavir (Reuters, 8/16). There are more than four million people worldwide living with both hepatitis B and HIV who need treatment for hepatitis B but have not started antiretrovirals (Kaiser Daily HIV/AIDS Report, 3/2).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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