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On February 26, 2007, the FDA and Bristol-Myers Squibb (BMS) announced a revised package insert for entecavir. Current HIV treatment guidelines from the U.S. Department of Health and Human Services recommend entecavir as an option for the treatment of chronic hepatitis B virus (HBV) infection in HIV-coinfected patients who do not qualify for potent combination antiretroviral therapy. However, based on the case report summarized below, it appears that entecavir may be capable of selecting for HIV drug resistance. BMS is now advising caution with the use of entecavir in this setting.
Entecavir has not been evaluated in coinfected patients who are not receiving potent combination antiretroviral therapy. However, BMS has received one case report describing the emergence of the M184V mutation in an HIV/HBV-coinfected patient who received entecavir in the absence of such combination therapy. The patient received AZT, 3TC, and nevirapine for less than a year in 2000 and remained clinically stable after discontinuing that regimen. In early 2006, with no evidence of HIV drug resistance, he started entecavir monotherapy for treatment of his HBV infection. Six months later, the M184V mutation was detected.
Bristol-Myers Squibb. Important information regarding Baraclude® (entecavir) in patients co-infected with HIV and HBV. February 2007. (http://www.fda.gov/medwatch/safety/2007/Baraclude_DHCP_02-2007.pdf)
Comment
Entecavir was previously thought to be inactive against HIV. However, this patient is one of three coinfected patients to have experienced a 1-log reduction in HIV viral load while receiving entecavir without potent combination antiretroviral therapy. In addition, an in vitro study presented at the 14th Retrovirus Conference (Abstract 136LB) showed that entecavir could inhibit HIV and select for the M184V mutation. Pending further data, clinicians should not use entecavir to treat HBV in coinfected patients unless those patients are also on suppressive antiretroviral therapy.