Real-world Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Comparison With Other Regimens in People With HIV Starting Therapy With AIDS-Defining Conditions: Results From the CoRIS Cohort-The ACTUAS II Study

Abstract

Background: The comparative effectiveness and tolerability of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) has not been sufficiently evaluated in people with AIDS who initiate therapy.

Methods: The aim of the current study was to compare the effectiveness and tolerability of BIC/FTC/TAF with other first-line antiretroviral therapy (ART) regimens in treatment-naive adults from the CoRIS cohort who initiated ART with AIDS. Logistic regression models were used to estimate odds ratios (ORs) of association between initial regimen and achievement of viral suppression (VS), defined as human immunodeficiency virus RNA <50 copies/mL, and immunological recovery (IR), defined as CD4 count >200 cells/μL. Time to VS and the proportion of treatment discontinuations were also evaluated and compared, with all analyses conducted at weeks 24 and 48 after initiation of ART.

Results: We analyzed 90 individuals initiating ART with BIC/FTC/TAF and 94 with other regimens, with similar baseline characteristics. At week 24, BIC/FTC/TAF was associated with a higher proportion of VS (75.6% vs 56.5%; adjusted odds ratio [aOR], 2.78 [95% confidence interval {CI}, 1.28-6.25]) and with a lower proportion of IR (47.7% vs 61.9%; aOR, 0.49 [95% CI, .25-.99]). These differences disappeared by week 48. The proportion of treatment discontinuations was significantly lower with BIC/FTC/TAF than with other regimens (week 24: 4.4% vs 20.2%; week 48: 10% vs 36.2%). At week 48, the main reasons for discontinuations were adverse events (3.3% vs 8.5%), toxicity prevention (1.1% vs 8.5%), ART simplification (0% vs 10.6%), and treatment failure (2.2% vs 4.3%).

Conclusions: In light of our results, BIC/FTC/TAF is an effective and well-tolerated option for starting ART in people with AIDS.

Keywords: AIDS; BIC/FTC/TAF; cohort study; effectiveness and safety; naive.

Graphical Abstract

Figure 1.

Time to viral suppression during the first 48 weeks after antiretroviral therapy (ART) initiation according to initial ART regimen. Abbreviations: 3TC, lamivudine; ABC, abacavir; ART, antiretroviral therapy; BIC, bictegravir; CI, confidence interval; COBI, cobicistat; DRV, darunavir; DTG, dolutegravir; FTC, emtricitabine; IQR, interquartile range; sHR, subdistribution hazard ratio; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; VS, viral suppression.