Changing trends in lipid profile and biomarkers of renal function and bone metabolism before and after switching from tenofovir disoproxil fumarate to tenofovir alafenamide: a prospective observational study

Mahoko Ikeda, Yoshitaka Wakabayashi, Koh Okamoto, Shintaro Yanagimoto, Shu Okugawa, Kyoji Moriya, Mahoko Ikeda, Yoshitaka Wakabayashi, Koh Okamoto, Shintaro Yanagimoto, Shu Okugawa, Kyoji Moriya

Abstract

Background: Antiretrovirals, including tenofovir, can suppress human immunodeficiency virus (HIV) infection but cannot completely eradicate it. Patients with HIV infection are administered antiretroviral drugs over a long term; thus, managing consequent adverse drug reactions, such as renal dysfunction and bone mineral loss, is important. Currently, highly sensitive biomarkers that can detect adverse drug reactions early have not been well studied.

Methods: This single-center, prospective, observational study explored changes in the biomarkers of renal function, bone metabolism, and lipid profile before and after switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) in patients with HIV infection.

Results: All 31 enrolled patients had been treated with antiretrovirals for more than 5 years. The rate of proteinuria decreased significantly after starting TAF-containing antiretroviral regimen. The urinary liver-type fatty acid binding protein (L-FABP)/creatinine ratio was significantly decreased at 3 and 6 months after switching to TAF compared with that before switching to TAF (- 0.5 μg/g Cr at 3 months, and - 0.8 μg/g Cr at 6 months; p < 005 for both at 3 and 6 months). The urinary N-terminal telopeptide (NTx)/creatinine ratio decreased over the study period, and the ratios were significantly different between 3 and 6 months (- 11 nmol/mmol Cr at 3 months, - 15.2 nmol/mmol Cr at 6 months; p = 0.0069 at 3 months, p < 0.0001 at 6 months). Low density lipoprotein-cholesterol level significantly increased at 3 (+ 26 mg/dL) and 6 months (+ 13 mg/dL) compared with that at the baseline (p < 0.0001).

Conclusions: Switching from TDF to TAF decreased the levels of renal and bone biomarkers, such as urinary L-FABP and NTx, but increased low density lipoprotein-cholesterol levels. Future studies should evaluate if these biomarkers, such as urinary L-FABP and NTx, truly detect serious adverse drug reactions early.

Keywords: Antiretrovirals; Biomarkers; HIV-infection; Tenofovir alafenamide; Tenofovir disoproxil fumarate.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Rate of change in biomarkers before and after switching from tenofovir disoproxil to tenofovir alafenamide. Vertical axis represents the rate of change (%) of each biomarker compared to the baseline (before switching antiretrovirals). a Rate of change in urine-liver-type fatty acid binding protein/creatinine (L-FABP/Cr) levels. b Rate of change in low-density lipoprotein cholesterol (LDL-C) levels. c Rate of change in urine-N-terminal telopeptide/creatinine (U-NTx/Cr) levels. d Rate of change in bone-specific alkaline phosphatase (BAP) levels. e Percentage of detection of proteinuria

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