Safety and tolerability profile through 96 weeks
The adverse reaction rates for STRIBILD are based on pooled data from 1408 subjects in Study 102 and Study 103. The table below shows the incidence of treatment-emergent adverse drug reactions (all severity grades) reported in ≥5% of subjects through 96 weeks.1
Adverse drug reactions (all severity grades)1
Studies 103 and 102 also assessed the proportion of subjects who discontinued treatment with STRIBILD vs ATV + RTV + FTC/TDF and EFV/FTC/TDF, respectively.
Low rate of discontinuation through 96 weeks1
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 are antiretroviral treatment-naive.
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