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Anti-viral regimens did not increase risk for renal effects in HBV

Anti-viral therapy did not increase any risk for renal disease among patients with hepatitis B virus infection, with or without renal risk factors before treatment, according to study data.

“Renal impairment during the course of anti-viral treatment of hepatitis B still needs to be clarified whether it is related to anti-viral nephrotoxicity or pre-existing risk factors for renal disease,” the researchers wrote.

To determine any risk factors for renal impairment during anti-viral treatment for HBV, researchers enrolled 2,221 treatment-naive patients with chronic HBV from various centers in Turkey, who were receiving treatment with lamivudine, telbivudine (Tyzeka, Novartis), entecavir, tenofovir (Viread, Gilead Sciences) or adefovir. The Modification of Diet in Renal Disease formula was used to calculate the glomerular filtration rate (GFR) of each patient. Approximately 895 patients underwent anti-viral treatment for at least 24 months and had “repeated measures” at baseline and 1, 6, 12 and 24 months of follow-up, according to the research. The patients in the telbivudine and adefovir groups were excluded from the final analyses due to a low number of patients receiving those anti-virals.

Overall, 239 patients (27.9%) with repeated measures had cirrhosis and 65 had decompensated cirrhosis. In patients without cirrhosis and those with compensated cirrhosis, GFR decreased over time among patients who received therapy with tenofovir (P=.001), but remained unchanged among all other groups. In addition, creatinine levels increased over time in the tenofovir group (P=.001), but did not change in any other anti-viral therapy group. Calcium and phosphate serum levels did not change over time in any group. Five patients in the tenofovir group and three patients in the lamivudine group developed transient hypophosphataemia.

Among patients with decompensated cirrhosis, GFR decreased among patients receiving tenofovir therapy (P=.001) and creatinine levels increased in the tenofovir group (P=.001), but remained unchanged in the lamivudine and entecavir groups. Very few patients with decompensated cirrhosis had repeated measures of calcium and phosphate serum, so they were not used in the statistical analysis among this group of patients, according to the research.  

GFR difference was higher in the tenofovir patients compared with other groups at 1 month, but were comparable at other months.

Risk factors for renal disease, including diabetes, coinfection with HIV and active glomerulonephritis, were not found to be independent risk factors for renal dysfunction, according to the research.

“Tenofovir caused a decline in GFR at both short- and long-term follow-ups,” the researchers concluded. “However, that decline was mild and seemed to give a minimal clinical effect.”

The researchers added, “Continuous renal monitoring, including GFR and serum creatinine and phosphate, is necessary while using any anti-viral drug against hepatitis B.”

Disclosure: The researchers report no relevant financial disclosures.