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TDF/Baraclude effective for HBV, did not impair renal function
October 21, 2015
HONOLULU — In a controlled study, Baraclude and tenofovir disoproxil fumarate were effective for long-term therapy among patients with chronic hepatitis B infection and did not impair renal function, according to a plenary presentation at ACG 2015.
“To the best of our knowledge, this is the first real-life cohort study that evaluated renal function by the estimation of [estimated glomerular filtration rate], phosphorus level and complete urinalysis in [chronic hepatitis B] patients under [nucleotide analogs] comparing them to a control group,” Rosa Coelho, MD, Centro Hospitalar São João, Porto, Portugal, said during her presentation.
Coelho and colleagues conducted a controlled study in a single center in Porto, Portugal, comparing renal function of three groups of patients with chronic HBV: those receiving Baraclude (entecavir, Bristol-Myers Squibb; n = 51), tenofovir disoproxil fumarate ( TDF; n = 114) and a control group of inactive carriers (n = 30).
“The renal function was assessed before and after antiviral treatment by estimated glomerular filtration rate phosphorus levels and urine sediment,” Coelho said.
The follow-up for all patients was 57 months.
Baseline estimated glomerular filtration rates (eGFR) were higher in the TDF group (84.1 ± 21.5 mL/min) and control group (82 ± 14.4 mL/min) compared with the entecavir group (73.7 ± 27.4 mL/min).
Dose reduction was needed in 16% of patients in the entecavir group and 9% of patients in the TDF group (P = .102). TDF was well-tolerated, according to Coelho; however, 4% of patients required suspension due to renal toxicity. There was no intolerance to entecavir.
The researchers observed an increase in paired eGFR in all 3 groups: entecavir (7.2 mL/min, P = .001), inactive carriers (8 mL/min, P < .001), and TDF (5.7 mL/min, P = .011).
“There were no significant changes in paired serum phosphorus levels or urinary sediment in the three groups,” Coelho said during her presentation.
The changes of eGFR and phosphorus levels were not statistically different between the groups (P = .109; P = .761), respectively.
“Long term therapy with entecavir and TDF did not result in impairment in renal function, similar to the control group, which supports long-time safety of analogue treatment for [chronic hepatitis B], providing that renal function is regularly monitored,” Coelho concluded.
Reference:
Coelho R, et al. Abstract 68. Presented at: ACG; Oct. 16-21, 2015; Honolulu.
Disclosures: The researchers report no relevant financial disclosures.
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