BACKGROUND: To compare the impact of telbivudine (LDT) and entecavir (ETV) administration on nephritic function. METHOD: One hundred thirty patients diagnosed with hepatitis B virus (HBV)-related compensated cirrhosis were randomly divided into LDT (600 mg/d) or ETV (0.5 mg/d) groups. RESULTS: The drug resistance rate was higher following LDT treatment compared to ETV treatment (16.9% vs. 1.5%, P=0.0006). The mean creatinine level decreased compared to baseline in the LDT group (0.81 vs. 0.94 mg/dl, P=0.000). The change in median glomerular filtration rate (eGFR) compared to baseline in the LTD and ETV groups was 22.3 and -3.3, respectively, at 2 years (P=0.000). In patients with mild nephritic injury (eGFR< 90 ml/min/1.73m2), the median eGFR increased by 28.0 ml/min/1.73m2 in the LDT group and decreased by 4.3 ml/min/1.73m2 in the ETV group (p=0.000). The eGFR in 88.5% of patients (23/26) from the LDT group increased > 90 ml/min/1.73m2. The percentage of patients with an eGFR > 90 ml/min/1.73m2 increased from 60.0% to 92.3% in the LDT group and from 64.6% to 69.2% in the ETV group. CONCLUSION: In patients with HBV-related compensated cirrhosis, LDT treatment was more effective in protecting nephritic function and was associated with a higher drug resistance rate, but did not contribute to a better outcome compared with ETV treatment.
RCT Entities:
BACKGROUND: To compare the impact of telbivudine (LDT) and entecavir (ETV) administration on nephritic function. METHOD: One hundred thirty patients diagnosed with hepatitis B virus (HBV)-related compensated cirrhosis were randomly divided into LDT (600 mg/d) or ETV (0.5 mg/d) groups. RESULTS: The drug resistance rate was higher following LDT treatment compared to ETV treatment (16.9% vs. 1.5%, P=0.0006). The mean creatinine level decreased compared to baseline in the LDT group (0.81 vs. 0.94 mg/dl, P=0.000). The change in median glomerular filtration rate (eGFR) compared to baseline in the LTD and ETV groups was 22.3 and -3.3, respectively, at 2 years (P=0.000). In patients with mild nephritic injury (eGFR< 90 ml/min/1.73m2), the median eGFR increased by 28.0 ml/min/1.73m2 in the LDT group and decreased by 4.3 ml/min/1.73m2 in the ETV group (p=0.000). The eGFR in 88.5% of patients (23/26) from the LDT group increased > 90 ml/min/1.73m2. The percentage of patients with an eGFR > 90 ml/min/1.73m2 increased from 60.0% to 92.3% in the LDT group and from 64.6% to 69.2% in the ETV group. CONCLUSION: In patients with HBV-related compensated cirrhosis, LDT treatment was more effective in protecting nephritic function and was associated with a higher drug resistance rate, but did not contribute to a better outcome compared with ETV treatment.
Authors: William R Treem; Melissa Palmer; Isabelle Lonjon-Domanec; Daniel Seekins; Lara Dimick-Santos; Mark I Avigan; John F Marcinak; Ajit Dash; Arie Regev; Eric Maller; Meenal Patwardhan; James H Lewis; Don C Rockey; Adrian M Di Bisceglie; James W Freston; Raul J Andrade; Naga Chalasani Journal: Drug Saf Date: 2020-11-03 Impact factor: 5.606