TY - JOUR
T1 - A randomized, double-blind comparison of coformulated elvitegravir/ cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection
T2 - Analysis of week 96 results
AU - Rockstroh, Jürgen K.
AU - Dejesus, Edwin
AU - Henry, Keith
AU - Molina, Jean Michel
AU - Gathe, Joseph
AU - Ramanathan, Srinivasan
AU - Wei, Xuelian
AU - Plummer, Andrew
AU - Abram, Michael
AU - Cheng, Andrew K.
AU - Fordyce, Marshall W.
AU - Szwarcberg, Javier
PY - 2013/4/15
Y1 - 2013/4/15
N2 - This ongoing, randomized, double-blind, active-controlled phase 3 international trial demonstrated the noninferior efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/ FTC/TDF) compared with atazanavir boosted by ritonavir (ATV/ RTV) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) at 48 weeks. Here, we report the week 96 results. Of 708 treated subjects, virological success (Food and Drug Administration snapshot) was maintained at week 96 with EVG/COBI/FTC/TDF and ATV/ RTV + FTC/TDF (83% vs 82%, difference 1.1%, 95% confidence interval 24.5% to 6.7%). Study drug discontinuations due to adverse events were low (4% vs 6%). Median increases from baseline in serum Cr (mg/dL) in EVG/COBI/FTC/TDF vs ATV/RTV + FTC/TDF at week 96 (0.12 vs 0.08) were similar to those at week 48 (0.12 vs 0.08). EVG/ COBI/FTC/TDF showed similar mean decreases (%) in bone mineral density from baseline vs ATV/RTV + FTC/TDF (hip: 23.16 vs 24.19, P = 0.069; spine: 21.96 vs 23.54, P = 0.049). Overall, week 96 results support durable efficacy and safety of EVG/COBI/FTC/TDF in HIV-1- infected patients.
AB - This ongoing, randomized, double-blind, active-controlled phase 3 international trial demonstrated the noninferior efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/ FTC/TDF) compared with atazanavir boosted by ritonavir (ATV/ RTV) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) at 48 weeks. Here, we report the week 96 results. Of 708 treated subjects, virological success (Food and Drug Administration snapshot) was maintained at week 96 with EVG/COBI/FTC/TDF and ATV/ RTV + FTC/TDF (83% vs 82%, difference 1.1%, 95% confidence interval 24.5% to 6.7%). Study drug discontinuations due to adverse events were low (4% vs 6%). Median increases from baseline in serum Cr (mg/dL) in EVG/COBI/FTC/TDF vs ATV/RTV + FTC/TDF at week 96 (0.12 vs 0.08) were similar to those at week 48 (0.12 vs 0.08). EVG/ COBI/FTC/TDF showed similar mean decreases (%) in bone mineral density from baseline vs ATV/RTV + FTC/TDF (hip: 23.16 vs 24.19, P = 0.069; spine: 21.96 vs 23.54, P = 0.049). Overall, week 96 results support durable efficacy and safety of EVG/COBI/FTC/TDF in HIV-1- infected patients.
KW - Antiretroviral therapy
KW - Cobicistat
KW - Efavirenz
KW - Elvitegravir
KW - Emtricitabine
KW - HIV
KW - Tenofovir
KW - Treatment-naive
UR - http://www.scopus.com/inward/record.url?scp=84876409173&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84876409173&partnerID=8YFLogxK
U2 - 10.1097/QAI.0b013e318286415c
DO - 10.1097/QAI.0b013e318286415c
M3 - Article
C2 - 23337366
AN - SCOPUS:84876409173
SN - 1525-4135
VL - 62
SP - 483
EP - 486
JO - Journal of Acquired Immune Deficiency Syndromes
JF - Journal of Acquired Immune Deficiency Syndromes
IS - 5
ER -
