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Lactic Acidosis/Severe Hepatomegaly with Steatosis & Post Treatment Acute Exacerbation of Hepatitis B

  • 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)].

Patient Counseling Information

Package Inserts

Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate (Genvoya)

Elvitegravir/Cobicistat/Emtrictabine/Tenofovir Disoproxil Fumarate (STRIBILD)

Additional Information

Updated January 2018