Z Gastroenterol 2012; 50 - P4_23
DOI: 10.1055/s-0031-1295909

Telbivudine treatment improves renal function of Chronic Hepatitis B (CHB) patients

E Gane 1, G Deray 2, T Piratvisuth 3, HLY Chan 4, J Jia 5, H Ren 6, J Rasenack 7, M Manns 8, D Amarapurkar 9, Y Dong 10, A Trylesinski 10
  • 1Auckland City Hospital, Auckland, New Zealand
  • 2Department of Nephrology, Pitie Salpetriere Hospital, Paris, France
  • 3NKC Institute of Gastroenterology and Hepatology, Songklanagarind Hospital, Prince of Songkla University, Bangkok, Thailand
  • 4Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong
  • 5Beijing Friendship Hospital, Capital Medical University, Beijing, China
  • 6The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
  • 7Albert-Ludwigs-Universität Freiburg, Freiburg, Germany
  • 8Hannover Medical School, Hannover, Germany
  • 9Bombay Hospital and Medical Research Center, Mumbai, India
  • 10Novartis Pharma AG, Basel, Switzerland

Complications of CHB including cirrhosis result in nearly 1 million deaths annually. Renal dysfunction is common in decompensated CHB cirrhosis and is associated with high mortality. Nucleot(s)ide treatment improves liver function and survival. Renal dysfunction can reduce clearance of nucleot(s)ides increasing drug-associated toxicities resulting with high mortality. Recently, study on decompensated CHB patients showed significantly improvement of GFR for those receiving telbivudine in comparison to patients under lamivudine. We assessed GFR in compensated CHB patients included in several pivotal telbivudine (LDT) trials. GFR was performed at baseline (BL), Week 52 (W52), W104 and W208 by MDRD (Modification of Diet in Renal Disease): LDT vs. lamivudine (LAM) (n=1370); LDT for 4-years (n=1869); 2 years LDT vs. LAM in decompensated patients (n=232); LDT roadmap study with tenofovir (TDF) add-on (n=105).

avs baseline. P< 0.001. cLDT vs. LAM. P<0.0001. cvs baseline. P=0.005. dLDT vs. LAM. P=0.0231. evs baseline. P<0.0001 fvs baseline. P < 0.01

Treatment duration

Study

Patients #

BLGFR

GFR Change

% of patients with baseline

(MDRD)

from B L

GFR 60–90 shifted to >90

1 year

ACN03

LDT

983

98.1

3.8a

55.5% (n=211)

GLOBE (RCT, double blind)

LDT

680

98.3

5.1b

61.7% (n=256)

LAM

680

99.8

-1.0b

-

A2410

LDT

55

93

6.9C

50.0% (n=22)

LDT+TDF

45

93

7.4C

43.84% (n=16)

real life

LDT+TDF

19

86.7

18.9f

-

2 year

GLOBE (RCT, double blind)

LDT

680

98.3

6.7b

72.3% (n=256)

LAM

687

99.8

-1.8b

-

A2301 decom (RCT, double blind)

LDT

114

105

2.0cl

40.7% (n=27)

LAM

114

101

-4.6:i

31.4% (n=35)

real life

LDT+TDF

19

86.7

18.6f

-

3 year

A2303

LDT

587

95

21

81% (n=268)

4 year

A2303

LDT

511

95

14.9

74% (n=223)

6 year

ACN04E1

LDT

57

87.5

44.1e

94.9% (n=39)

Telbivudine or telbivudine with add-on tenofovir treatment improves GFR in patients with compensated and decompensated CHB. The mechanism of this improvement is not clearly understood.