Lactic Acidosis/Severe Hepatomegaly with Steatosis and Post Treatment Acute Exacerbation of Hepatitis B
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs in combination with other antiretrovirals.
- Not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of Emtricitabine/Rilpivirine/Tenofovir have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Emtricitabine/Rilpivirine/Tenofovir.
- Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Emtricitabine/Rilpivirine/Tenofovir. If appropriate, initiation of anti-hepatitis B therapy may be warranted
Patient Counseling Information
Updated January 2018