Treatment with tenofovir disoproxil fumarate for chronic hepatitis B did not correlate with a higher risk for worsening of renal function among patients with significant renal impairment in a study that compared therapy outcomes with Baraclude.
“Our results suggest that for healthier patients, TDF and [Baraclude] are comparable [chronic HBV] treatment choices regarding renal safety,” Sam Trinh, BS, from Stanford University Medical Center in California, and colleagues wrote. “However, for those with moderate renal impairment or over 60 years old, renal outcomes with TDF may be worse while improvement can be expected for patients treated with [Baraclude].”
In a retrospective study, Trinh and colleagues identified 116 patients with chronic HBV who were treated with Baraclude (entecavir, Bristol-Myers Squibb) and 116 patients who were treated with TDF for matched analysis.
In a sperate analysis, the researchers compared 32 entecavir-treated patients and 26 TDF-treated patients who had moderate renal impairment with estimated glomerular filtration rates (eGFR) less than 60 mL/min/1.73 m2.
In the overall unmatched cohort of 410 patients, patients treated with TDF had a significantly lower adjusted mean eGFR over the course of follow-up compared with patients treated with entecavir (69.4 vs. 78.8 mL/min/1.73 m2; P < .0001).
In the matched cohort, TDF did not correlate with development of moderate renal impairment during initial follow-up analysis or with mild renal impairment after excluding patients with mild renal impairments. Factors that correlated with moderate renal impairment included age (HR = 1.46; 95% CI, 1.32-1.63) and the presence of cirrhosis (HR = 1.99; 95% CI, 1.06-3.76) or hypertension (HR = 2.99; 95% CI, 1.71-5.24).
In a subanalysis of patients aged older than 60 years (n = 112), the adjusted mean eGFR for patients treated with TDF was significantly lower than those treated with entecavir (58.1 vs. 69.2 mL/min/1.73 m2; P < .0001).
Trinh and colleagues concluded that their results coincide with the 2018 AASLD HBV guidelines that suggest no preference between entecavir or TDF regarding renal safety. However, their study also suggests that TDF should be avoided in patients with moderate renal impairment and those with risk factors such as older age, cirrhosis and hypertension.
“In addition, since [chronic HBV] therapy is often decade(s)-long or life-long, further studies with longer follow-up are needed to further study the effect of antiviral therapy on renal function,” they wrote. – by Talitha Bennett
Disclosure: Trinh reports no relevant financial disclosures. Please see the full study for the other authors’ relevant financial disclosures.