Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial

Franco Maggiolo, Giuliano Rizzardini, Jean-Michel Molina, Federico Pulido, Stephane De Wit, Linos Vandekerckhove, Juan Berenguer, Michelle L D'Antoni, Christiana Blair, Susan K Chuck, David Piontkowsky, Hal Martin, Richard Haubrich, Ian R McNicholl, Joel Gallant, Franco Maggiolo, Giuliano Rizzardini, Jean-Michel Molina, Federico Pulido, Stephane De Wit, Linos Vandekerckhove, Juan Berenguer, Michelle L D'Antoni, Christiana Blair, Susan K Chuck, David Piontkowsky, Hal Martin, Richard Haubrich, Ian R McNicholl, Joel Gallant

Abstract

Introduction: We report the 48-week results of an ongoing study to assess the efficacy and safety of switching older people with HIV to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF).

Methods: This was a 96-week, phase 3b, open-label, single-arm study (GS-US-380-4449; NCT03405935). Virologically suppressed individuals aged ≥ 65 years receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or a tenofovir disoproxil fumarate-based regimen were switched to B/F/TAF. Primary endpoint was the percentage of participants with HIV-1 RNA < 50 copies/ml at week 24.

Results: Eighty-six participants (median age 69 [range 65-80] years; 87% male; 95% white) were enrolled and treated in five European countries. Rates of virologic suppression were 97.7% at week 24 and 90.7% at week 48; none had HIV-1 RNA ≥ 50 copies/ml, and 100% had virologic suppression by missing = excluded analysis at both time points. No treatment-emergent resistance was observed. There were no grade 3-4 study drug-related adverse events (AEs) or study drug-related serious AEs or deaths. Three AEs led to premature discontinuation; one (moderate abdominal discomfort) was attributed to the study drug by the investigator. At week 48, median changes from baseline in weight and estimated glomerular filtration rate were + 0.1 kg (interquartile range [IQR] - 1.0, 2.3) and - 6.0 ml/min (IQR - 10.2, 0.0), respectively. There were no clinically relevant changes from baseline to week 48 in fasting lipid parameters. Treatment satisfaction improved, and health-related quality of life was maintained from baseline through week 48. Median adherence to the study drug was 98.6% (IQR 96.0, 100).

Conclusions: Switching to B/F/TAF was effective and well tolerated through 48 weeks in virologically suppressed adults aged ≥ 65 years.

Trial registration: ClinicalTrials.gov identifier, NCT03405935.

Keywords: Age; Bictegravir; Clinical trial; Emtricitabine; HIV; Older; Safety; Tenofovir alafenamide.

Figures

Fig. 1
Fig. 1
Virologic outcomes at weeks 24 and 48 (primary efficacy endpoint: proportion of participants with HIV RNA N = 86). Annotated numbers show the number of patients
Fig. 2
Fig. 2
Change from baseline in a the estimated glomerular filtration rate calculated with Cockcroft-Gault equation (eGFRCG) and b fasting lipids and glucose at week 48 (safety analysis set). Error bars in part a represent interquartile range. Error bars in part b represent Q1 to Q3. P values calculated using the two-sided Wilcoxon signed-rank test. HDL high-density lipoprotein, LDL low-density lipoprotein, Q quartile

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