Lactic Acidosis and Severe Hepatomegaly: HepB Co-Infection

Lactic Acidosis and Severe Hepatomeglay

• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.

Acute Exacerbation of Hepatitis B

• Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory followup for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted (See Warnings)
• Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if this drug is used to treat chronic hepatitis B virus infection that is not being treated.

Coinfected HIV/HBV Patients

• Therapy with this drug is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). See Warnings: Co-infection with HIV