Browsing by Author "Koenig, Ellen"

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    Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 Trials
    (Journal of Acquired Immune Deficiency Syndromes, 1999) Orkin, Chloe; Ajana, Faiza; Kityo, Cissy; Koenig, Ellen; Natukunda, Eva; Gandhi-Patel, Bhumi; Wang, Hui; Liu, Yapei; Wei, Xuelian; White, Kirsten; Makadzange, Tariro; Pikora, Cheryl; McNicholl, Ian; Collins, Sean E.; Brainard, Diana; Chuck, Susan K.
    We characterized the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in a broad population of pediatric/adolescent/adult/elderly females living with HIV (FWH). Setting: Integrated analysis. Methods: Available data from 5 trials were integrated. Week 48 virologic suppression (HIV-1 RNA ,50 copies/mL), resistance, adverse events (AEs), and laboratory parameters were assessed. Results: Three hundred and seventy-three FWH [304 virologically suppressed; 69 antiretroviral therapy (ART)-naive] received B/F/TAF [data from comparator regimens available for 306 individuals (236 virologically suppressed and 70 ART-naive participants)]. Virologic suppression rates with B/F/TAF at week 48 were high regardless of age in participants virologically suppressed at baseline ($95%) and in ART-naive participants ($87%). Virologic suppression rates were similar in B/F/TAF and comparator regimens (both virologically suppressed and ART-naive groups). Treatment-emergent resistance was not detected in the B/F/TAF group. AEs considered related to study drugs were experienced by 9.2% (B/F/TAF) and 5.5% (comparator regimen) of virologically suppressed participants and 15.9% (B/F/TAF) and 31.4% (comparator regimen) of ART-naive participants. For virologically suppressed and ART-naive FWH combined, only 1 of the 373 B/F/TAF–treated and 2 of the 306 comparator-regimen participants discontinued because of AEs (none were bone/renal/hepatic AEs); grade 3/4 AEs were experienced by 5.1% (B/F/TAF) and 7.8% (comparator regimen); and grade 3/4 elevation of low-density lipoprotein/total cholesterol occurred in 2.7%/ 0.3% (B/F/TAF) and 5.9%/2.0% (comparator regimen). At week 48, median changes from baseline estimated glomerular filtration rate in adults were ,5 mL/min; results were similar in B/F/TAF and comparator-regimen groups. Conclusion: B/F/TAF treatment was effective and well tolerated over 48 weeks, confirming B/F/TAF as an option for a broad population of FWH.