The AMERICAN ACADEMY of HIV MEDICINE PATIENT CARE, PRACTICE MANAGEMENT & PROFESSIONAL DEVELOPMENT INFORMATION for HIV CARE PROVIDERS
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چکیده
28 32 24 10 Viral Load Diagnostics Superbugs Immunotherapy Occupational Exposure HIV Clinical update STRIBILD is indicated as a complete single-tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve. 1 • STRIBILD achieves strong effi cacy with an overall rapid reduction in viral load 3,4 – Noninferior effi cacy at week 48 • 90% of subjects taking STRIBILD reached undetectable viral loads compared to 87% of subjects taking ATV + RTV + FTC/TDF • 88% of subjects taking STRIBILD reached undetectable viral loads compared to 84% of subjects taking EFV/FTC/TDF • Convenient single-tablet regimen dosing – 1 tablet taken once daily with food – Do not initiate in patients with eGFR <70 mL/min; discontinue in patients with eGFR <50 mL/min; not recommended in patients with severe hepatic impairment • Safety and tolerability profi le through 48 weeks – The most common adverse drug reactions (all severity grades) reported in ≥5% of subjects were nausea (16%), diarrhea (12%), abnormal dreams (9%), headache (7%), and fatigue (5%) – 3.7% of subjects taking STRIBILD discontinued therapy due to adverse events compared to 5.1% of subjects taking either ATV + RTV + FTC/TDF or EFV/FTC/TDF Study designs: STRIBILD was assessed in 2 randomized, double-blind, active-controlled, phase 3, noninferiority clinical trials in treatment-naïve, HIV-1–infected subjects with baseline estimated creatinine clearance >70 mL/min. Study 103 compared STRIBILD (n = 353) to ATV + RTV + FTC/TDF (n = 355); Study 102 compared STRIBILD (n = 348) to a single-tablet regimen consisting of EFV/FTC/TDF (n = 352). The primary endpoint of both studies was the proportion of subjects with viral suppression (<50 copies/mL) at week 48 according to FDA snapshot analysis. Baseline characteristics: Viral load: In Studies 103 and 102, respectively, 41% and 33% of subjects had baseline viral loads >100,000 copies/mL.
منابع مشابه
The AmericAn AcAdemy of HiV medicine PatiEnt CaRE, PRaCtiCE ManagEMEnt & PRofEssional DEvEloPMEnt infoRMation for Hiv CaRE PRoviDERs
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