Evaluation of Tenofovir on Lipid Parameters in Adult Patients With Chronic Hepatitis B Infection

Abstract

Introduction: The purpose of this study was to evaluate the effects of tenofovir (Viread®) on the blood levels of cholesterol and other lipids parameters in adult patients with chronic hepatitis B infection. In the setting of HIV therapy, a number of clinical trials using Viread® (in combination with other antiretrovirals) have demonstrated a significant lowering of total cholesterol, LDL, and non-HDL cholesterol serum concentrations. We wanted to assess if Viread® monotherapy had the ability to improve a patient’s lipid profile in the context of hepatitis B treatment. Methods: A total of 39 hepatitis e-antigen positive (n=11) and negative (n=28) patients were included for analysis. Fasting lipids (total cholesterol, HDL, LDL, VLDL, and triglycerides) were collected at baseline, and every 8 weeks thereafter in the intervention (n=19) and control (n=20) arms for 16 weeks. Participants in the intervention arm meet threshold criteria for hepatitis B therapy by current guidelines, whereas those in the control arm did not (either immune tolerant or chronic carriers). No patient was placed on a cholesterol-modifying medication at baseline or throughout the duration of trial. Results: The intervention and control groups were well balanced on all baseline characteristics except for HBV-DNA (the treatment arm had a mean 2-log increase in viral load). There were no significant differences noted for any of the 5 outcome variables under investigation from baseline to 2 months (TC p=.78, HDL p=.68, LDL p=.36, VLDL p=.80, trig p=.56), baseline to 4 months (TC p=.29, HDL p=.09, LDL p=.16, VLDL p=.60, trig p=.77), and 2 months to 4 months (TC p=.26, HDL p=.21, LDL p=.33, VLDL p=.37, trig p=.42) between the treatment and control groups. Conclusion: Over a 4-month period, Viread® monotherapy for hepatitis B treatment did not significantly improve/impact any of the lipid variables examined when compared to those not on hepatitis B therapy. With this being said, it should be noted that numerical improvements were seen in the intervention group (most pronounced from baseline to 4 months) in both TC (decrease of 21 mg/dL) and LDL (decrease of 20 mg/dL) serum measurements. Disclosure - Dr. DeMicco- Grant/Research Support: Gilead Sciences, Novartis, Roche, GSK, BMS, Pfizer, Takeda, Abbvie, Amgen, Ironwood,Salix, Idenix, Salix, Ardelyx, Stockholder/Ownership Interest: Synergy. Anthanett Solis- None. Dr. Collins- Employee: Gilead. This research was supported by an industry grant from Gilead Sciences.