Lactic Acidosis/Severe Hepatomegaly with Steatosis & 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 GENVOYA [see Warnings and Precautions (5.1)] or STRIBILD [see Warnings and Precautions (5.1)].

• GENVOYA  and STRIBILD are not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of GENVOYA and STRIBILD 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 and/or 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 GENVOYA. If appropriate, initiation of anti-hepatitis B therapy may be warranted GENVOYA [see Warnings and Precautions (5.2)] or STRIBILD [see Warnings and Precautions (5.2)].