Important Safety Information
BOXED WARNING: 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, including tenofovir disoproxil fumarate (tenofovir DF), a component of STRIBILD, in combination with other antiretrovirals.
- STRIBILD is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of STRIBILD have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir DF, components of STRIBILD. 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 STRIBILD. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
STRIBILD is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen for ≥6 months with no history of treatment failure and no known resistance to any component of STRIBILD.
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- Clumeck N, Molina JM, Henry K, et al; GS-236-0103 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014;65(3):e121-e124.
- Wohl DA, Cohen C, Gallant JE, et al; GS-US-236-0102 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF versus single-tablet regimen efavirenz/emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014;65(3):e118-e120.
- Data on file, Gilead Sciences, Inc.
- Wohl DA, Cohen C, Gallant JE, et al. Elvitegravir/cobicistat/emtricitabine/tenofovir DF (STB) has durable efficacy and differentiated long-term safety and tolerability versus efavirenz/emtricitabine/tenofovir DF (ATR) at week 144 in treatment-naive HIV patients. 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013). Denver, September 10-13, 2013. Abstract H-672a.
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Important Safety Information
- In adults with no ARV treatment history: Common adverse reactions in clinical studies (incidence ≥5%; all grades) were nausea (16%), diarrhea (12%), abnormal dreams (9%), and headache (7%).
- In virologically suppressed adults: Common adverse reactions in clinical studies (incidence ≥2%; all grades) were nausea (4%), headache (2%), and flatulence (2%); the frequency of adverse reactions (all grades) was 24% in subjects switching to STRIBILD compared to 6% of subjects who stayed on their baseline ARV regimen.