Monitoring Viral Suppression When Switching from Fixed Dose Combination Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate (Atripla) to Fixed Dose Combination Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate (Stribild) in Virologically Suppressed Adults with HIV

Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection.

OBJECTIVE To assess the safety and efficacy of two, single-tablet regimens for the initial treatment of HIV infection. DESIGN Phase 2, randomized, double-blind, double-dummy, multicenter, active-controlled study. METHODS Antiretroviral treatment-naive adults with a screening HIV-1 RNA at least 5000 copies/ml and a CD4 cell count more than 50 cells/μl were randomized 2: 1 to receive fixed-do...

AusPAR Attachment 2: Extract from the Clinical Evaluation Report for Tenofovir disoproxil fumarate/Emtricitabine/Elvitegravir/Cobicistat

Evaluation of tolerability with the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for post-HIV exposure prophylaxis

BACKGROUND The preferred regimen for HIV post-exposure prophylaxis (PEP) is based mainly on safety and tolerability because it is given to immunocompetent people without HIV infection for a limited time (28 days). The frequency of adverse events (AEs) may be > 60%. Although AEs are generally not severe, they can lead to lack of adherence and failure to complete the regimen. We evaluated the co-...

The Antiretroviral Pregnancy Registry Interim Report.

ABACAVIR+LAMIVUDINE+ZIDOVUDINE (TRIZIVIR, TZV) ABACAVIR+DOLUTEGRAVIR+LAMIVUDINE (TRIUMEQ, TRI) ADEFOVIR DIPIVOXIL (HEPSERA, ADV) AMPRENAVIR (AGENERASE, APV) (AGENERASE NO LONGER MANUFACTURED AS OF 2007) ATAZANAVIR (REYATAZ, ATV) ATAZANAVIR+COBICISTAT (EVOTAZ, EVO) COBICISTAT (TYBOST, COBI) DARUNAVIR (PREZISTA, DRV) DARUNAVIR+COBICISTAT (PREZCOBIXTM, REZOLSTATM, PCX) DELAVIRDINE MESYLATE (RESCRI...

Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial.

BACKGROUND The HIV integrase strand transfer inhibitor elvitegravir (EVG) has been co-formulated with the CYP3A4 inhibitor cobicistat (COBI), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) into a once-daily, single tablet. We compared EVG/COBI/FTC/TDF with a ritonavir-boosted (RTV) protease inhibitor regimen of atazanavir (ATV)/RTV+FTC/TDF as initial therapy for HIV-1 infection. ...