Bone and renal safety profile at 72 weeks after switching to tenofovir alafenamide in chronic hepatitis B patients.

BACKGROUND AND AIM

Tenofovir disoproxil fumarate (TDF) has been efficacious in treating chronic hepatitis B (CHB), but long-term use is accompanied by a decline in renal function and bone mineral density (BMD). Tenofovir alefanamide (TAF) is a prodrug of tenofovir, with similar efficacy in CHB but with fewer side effects than TDF. Recent studies on patients who underwent the switch from TDF to TAF have shown improved bone and renal profiles from 24 to 48 weeks of follow-up.

METHODS

This study provides follow-up at 72 weeks in a real-world cohort of 61 Asian CHB patients who were switched from TDF to TAF. All patients had been treated with TDF for at least 12 months with hepatitis B virus DNA <21 IU/mL prior to switch.

RESULTS

Improvements in proximal tubular function, measured by urine beta-2-microglobulin to creatinine and retinol-binding protein to creatinine ratios, were sustained at 72 weeks ( < 0.01). Renal function showed decline at 72 weeks compared to baseline (GFR 90.9 96.3 mL/min, < 0.01). Improvement in hip BMD was sustained at 72 weeks (mean % change of 17.7% from baseline, < 0.01). However, spine BMD showed discordance, with initial improvement at 24 weeks (3.3% from week 0, < 0.01) but regression at 72 weeks (-0.6% from week 0, = NS). Interestingly, there was a slight increase in weight and BMI after 72 weeks ( < 0.01).

CONCLUSIONS

CHB patients who switch from long-term TDF to TAF therapy show sustained improvement in proximal tubular function and hip BMD. Weight gain was noted, and long-term studies are needed to evaluate its effect on patient outcomes.