STRIBILD demonstrated sustained and noninferior efficacy at week 144 in adults with no ARV treatment history1-3
The primary endpoint of both noninferiority trials was the percentage of treatment-naive subjects with an HIV-1 viral load <50 copies/mL at week 48 using FDA snapshot analysis.1 The charts below show the primary endpoint data (snapshot analysis) and the intent-to-treat (ITT), missing = failure (M=F) analysis.
Study 103: Virologic success (HIV-1 RNA <50 copies/mL) at week 1441,4,5
Study 102: Virologic success (HIV-1 RNA <50 copies/mL) at week 1441,6,7
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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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