STRIBILD resistance profile through 96 weeks1-6
Analysis of resistance was performed in subjects with virologic failure or HIV-1 RNA concentration >400 copies/mL at study discontinuation:
- In Study 103, 19/353 (5%) subjects in the STRIBILD group and 16/355 (5%) in the ATV + RTV + FTC/TDF group were analyzed for the presence of resistance. Resistance was detected in 6/19 (32%) subjects taking STRIBILD and 0/16 (0%) taking ATV +RTV + FTC/TDF1-3,6
- In Study 102, 17/348 (5%) subjects in the STRIBILD group and 23/352 (7%) in the EFV/FTC/TDF group were analyzed for the presence of resistance. Resistance was detected in 10/17 (59%) subjects taking STRIBILD and 10/23 (43%) taking EFV/FTC/TDF4-6
Most common drug resistance mutations by treatment arm (n)
- In combined clinical studies, some subjects failed with multiple mutations1
- In combined clinical studies, one or more resistance mutations to EVG, FTC, and/or TDF was detected in 16/30 (53%) subjects treated with STRIBILD who received at least 8 weeks of treatment, had HIV-RNA >400 copies/mL at week 96, or discontinuation, and had evaluable resistance data
- In a pooled analysis from both studies, all subjects with evaluable data for RT and IN and who developed EVG resistance (n=13) also showed susceptibility to FTC (due to the development of the M184V/I substitution)
- EVG-resistant viruses showed varying degrees of cross-resistance in cell culture to raltegravir
- STRIBILD-resistant isolates remained susceptible to all NNRTIs and protease inhibitors
Resistance data through 144 weeks
- From weeks 96 to 144 of Study 103, 2 additional subjects developed resistance to components of STRIBILD, 1 with both INSTI and NRTI resistance, and the other with NRTI resistance (no IN genotype data available). Two subjects in the ATV + RTV + FTC/TDF arm also developed NRTI resistance between weeks 96 and 1447
- In Study 102, no subjects taking STRIBILD developed resistance between weeks 96 and 144; 4 additional subjects in the EFV/FTC/TDF arm developed either NNRTI resistance only or both NNRTI and NRTI resistance between weeks 96 and 1448
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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