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. 2019 Nov 11;7(1):ofz472.
doi: 10.1093/ofid/ofz472. eCollection 2020 Jan.

Atherosclerotic Cardiovascular Disease Risk Profile of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate

Gregory D Huhn  1 , David J Shamblaw  2 , Jean-Guy Baril  3 , Priscilla Y Hsue  4 , Brittany L Mills  5 , Thai Nguyen-Cleary  5 , Scott McCallister  5 , Moupali Das  5
Affiliations

Atherosclerotic Cardiovascular Disease Risk Profile of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate

Gregory D Huhn et al. Open Forum Infect Dis. .

Abstract

Background: In human immunodeficiency virus (HIV) treatment, tenofovir alafenamide (TAF) is associated with greater increases in all fasting cholesterol subgroups compared with tenofovir disoproxil fumarate (TDF). Because lipid abnormalities may contribute to cardiovascular morbidity and mortality, cardiovascular risk assessment is integral to routine HIV care. This post hoc study evaluates the impact of lipid changes on predicted atherosclerotic cardiovascular disease (ASCVD) risk and statin eligibility in treatment-naive adults living with HIV treated with TAF or TDF.

Methods: Participants (N = 1744) were randomized (1:1) to initiate TAF or TDF, each coformulated with elvitegravir/cobicistat/emtricitabine (studies GS-US-292-0104 and GS-US-292-0111). Eligibility for statin therapy and estimated 10-year ASCVD risk among adults aged 40-79 years treated with TAF or TDF for 96 weeks (W96) were analyzed based on American College of Cardiology/American Heart Association Pooled Cohort Equations. Categorical shifts in 10-year ASCVD risk from <7.5% to ≥7.5% by W96 on TAF versus TDF were calculated.

Results: Participants initiating TAF versus TDF in the overall study population showed small but significant increases in median fasting lipid parameters at W96, including total cholesterol (191 vs 177 mg/dL; P < .001), low-density lipoprotein ([LDL] 119 vs 112 mg/dL; P < .001), and high-density lipoprotein ([HDL] 51 vs 48 mg/dL; P < .001), respectively. At baseline, 18% and 23% on TAF versus TDF had a 10-year ASCVD risk score ≥7.5%, with mean risk scores low overall for TAF versus TDF at baseline (4.9% vs 5.4%; P = .35) and W96 (6.1% vs 6.2%; P = .04). Increases in ASCVD risk from baseline to W96 were driven by both increasing age and changes in total cholesterol (TC) and HDL cholesterol. At W96, TC/HDL ratios (median) were 3.7 for both groups (P = .69). There was no difference between shifts in categorical risk for TAF versus TDF (9% vs 5%; P = .19). Eligibility for high-intensity statin therapy were similar for TAF versus TDF groups (19% vs 21%; P = .47).

Conclusions: Lipid changes with TAF as part of coformulated regimens do not substantively affect CVD risk profiles compared with TDF.

Keywords: HIV; atherosclerosis; cardiovascular disease; tenofovir alafenamide; tenofovir disoproxil fumarate.

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Figures

Figure 1.
Figure 1.
American College of Cardiology/American Heart Association (ACC/AHA) 2013 Pooled Cohort Risk Equations. BP, blood pressure; HDL, high-density lipoprotein; SBP, systolic BP.
Figure 2.
Figure 2.
Fasting lipids at baseline and Week 96 results. C, cobicistat; E, elvitegravir; F, emtricitabine; HDL, high-density lipoprotein; LDL, low-density lipoprotein; TAF, tenofovir alafenamide; TC, total cholesterol; TDF, tenofovir disoproxil fumarate.
Figure 3.
Figure 3.
Cardiovascular disease risk by high-density lipoprotein (HDL) category at baseline (BL) and Week 96 (W96) results. C, cobicistat; E, elvitegravir; F, emtricitabine; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
Figure 4.
Figure 4.
Proportion eligible for high-intensity statin. ASCVD, atherosclerotic cardiovascular disease; C, cobicistat; CVD, cardiovascular disease; E, elvitegravir; F, emtricitabine; LDL, low-density lipoprotein; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
Figure 5.
Figure 5.
Mean estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk score. C, cobicistat; E, elvitegravir; F, emtricitabine; HDL, high-density lipoprotein; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
Figure 6.
Figure 6.
Cardiovascular adverse events (AEs) results. C, cobicistat; E, elvitegravir; F, emtricitabine; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
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