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document
A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection : analysis of week 96 results . We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate ( EVG/COBI/FTC/TDF , n = 348 ) vs efavirenz/emtricitabine/tenofovir disoproxil fumarate ( EFV/FTC/TDF , n = 352 ) . At week 48 , EVG/COBI/FTC/TDF was noninferior to EFV/FTC/TDF ( 88 % vs 84 % , difference +3.6 % , 95 % confidence interval : -1.6 % to 8.8 % ) . Virologic success ( HIV-1 RNA < 50 copies/mL ) was maintained at week 96 ( 84 % vs 82 % , difference +2.7 % , 95 % CI : -2.9 % to 8.3 % ) . Discontinuation due to adverse events was low ( 5 % vs 7 % ) . Median changes in serum creatinine ( mg/dL ) at week 96 were similar to week 48 . These results support the durable efficacy and long-term safety of EVG/COBI/FTC/TDF .
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Intervention_Pharmacological
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
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Intervention_Pharmacological
efavirenz/emtricitabine/tenofovir disoproxil fumarate
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Intervention_Pharmacological
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
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Intervention_Pharmacological
efavirenz/emtricitabine/tenofovir disoproxil fumarate
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Intervention_Pharmacological
EVG/COBI/FTC/TDF
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Intervention_Pharmacological
EFV/FTC/TDF
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Intervention_Pharmacological
EVG/COBI/FTC/TDF
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Outcome_Physical
Virologic success
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Outcome_Adverse-effects
Discontinuation due to adverse events
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Outcome_Physical
Median changes in serum creatinine
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Outcome_Other
durable efficacy
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Outcome_Other
long-term safety
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Participant_Condition
HIV-1 infection :
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Participant_Sample-size
348
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Participant_Sample-size
n = 352