Telbivudine improves renal function in patients with chronic hepatitis B.
OBJECTIVE
There is a close relationship between chronic hepatitis B virus infection and chronic renal disease. We analyzed changes in renal function using different markers of glomerular filtration rate (GFR) in multiple studies of telbivudine treatment of patients with chronic hepatitis B virus infection.


METHODS
We used serum creatinine-based equations (ie, Cockcroft-Gault, Modification of Diet in Renal Disease, and Chronic Kidney Disease Epidemiology Collaboration) to estimate GFR (eGFR) in adults with chronic hepatitis B virus infection and compensated liver disease who participated in a phase III, randomized, double-blind study comparing the efficacy and safety of telbivudine (600 mg/d) and lamivudine (100 mg/d) for 2 years (the GLOBE study) and in long-term extension studies (4-6 years), as well as in patients with decompensated cirrhosis (2 years).


RESULTS
eGFRs calculated using the Cockcroft-Gault, Modification of Diet in Renal Disease, and Chronic Kidney Disease Epidemiology Collaboration equations were concordant, indicating improved renal function in telbivudine-treated patients during the 2-year GLOBE study (there was an 8.5% increase in mean eGFR, based on the Modification of Diet in Renal Disease equation). Improved renal function was maintained for 4-6 years. Increased eGFR with telbivudine treatment was also observed in patients at increased risk for renal impairment: patients with baseline eGFRs of 60-89 mL/min/1.73 m(2) (+17.2%), older than 50 years (+11.4%), and with liver fibrosis/cirrhosis (+7.2% for patients with Ishak fibrosis score at 5-6). In decompensated patients with high renal risk, eGFR was also improved on telbivudine (+2.0%).


CONCLUSIONS
In global trials of patients with compensated and decompensated cirrhosis, long-term telbivudine therapy was associated with a sustained improvement of renal function-particularly among patients with increased risk of renal impairment. The mechanisms of this renal protective effect remain to be determined.
Auckland City Hospital, Auckland, New Zealand. Electronic address: edgane@adhb.govt.nz.
Edward J
EJ
Gane
Department of Nephrology, Pitié-Salpétrière Hospital, Paris Cedex 13, France.
Gilbert
G
Deray
Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan.
Yun-Fan
YF
Liaw
Department of Gastroenterology and Hepatology, Yong Yoo Lin School of Medicine, National University of Singapore, Singapore.
Seng Gee
SG
Lim
University Department of Medicine, Queen Mary Hospital, Hong Kong.
Ching-Lung
CL
Lai
Albert-Ludwigs Universität Freiburg, Freiburg, Germany.
Jens
J
Rasenack
Southwest Hospital, Third Military Medical University, Chongqing, China.
Yuming
Y
Wang
2(nd) Department of Internal Medicine, Athens University Medical School, Hippokration General Hospital, Athens, Greece.
George
G
Papatheodoridis
Department of Pathology, Saint Louis University, Saint Louis, Missouri.
Adrian
A
Di Bisceglie
CIBERehd, Instituto de Salud Carlos III, Madrid, Spain.
Maria
M
Buti
AP-HP Hôpital Paul Brousse, Centre Hépato-Biliaire, Villejuif, France; Univ Paris-Sud, UMR-S 785, Villejuif, France; Inserm, Unité 785, Villejuif, France.
Didier
D
Samuel
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Alkaz
A
Uddin
Novartis Pharma AG, Basel, Switzerland.
Sophie
S
Bosset
Novartis Pharma AG, Basel, Switzerland.
Aldo
A
Trylesinski
D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005919:Glomerular Filtration Rate; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077712:Telbivudine; D003404:Creatinine; D013936:Thymidine
CHB; CK; CKD; CKD-EPI; Chronic Hepatitis B; Chronic Kidney Disease Epidemiology Collaboration; Chronic Renal Disease; Glomerular Filtration Rate; HBV; HBeAg; IF; Ishak fibrosis score; MDRD; Modification of Diet in Renal Disease; SCr; Telbivudine; chronic hepatitis B; chronic kidney disease; creatine kinase; eGFR; estimated glomerular filtration rate; hepatitis B e antigen; hepatitis B virus; serum creatinine