African Journal of
Pharmacy and Pharmacology

  • Abbreviation: Afr. J. Pharm. Pharmacol.
  • Language: English
  • ISSN: 1996-0816
  • DOI: 10.5897/AJPP
  • Start Year: 2007
  • Published Articles: 2285

Full Length Research Paper

Monotherapy versus combinations of nucleos(t)ide in treatment-naive hepatitis B decompensated cirrhotic patients: A nested case-control study

Lei Li1#, Wei Liu2#, Yuhan Chen1, Peng Li1,Feili Wei3, Chunlei Fan1, Peiling Dong1, Bing Li1, Dexi Chen3 and Huiguo Ding1*    
1Department of Gastroenterology and Hepatology, Beijing You’an Hospital Affiliated with Capital Medical University, Beijing 100069, China. 2Department of Internal Medicine, Beijing Ji Shui Tan Hospital Affiliated with Peking University,Beijing, Beijing 100035, China. 3Viral Laboratory of Liver Diseases Research Institute, Capital Medical University, Beijing 100069, China.    
Email: [email protected]

  •  Accepted: 03 January 2013
  •  Published: 22 August 2013

Abstract

The data are limited on the long-term clincial outcome of monotherapy versus combinations of nucleos(t)ide analog (NUCs) for hepatitis B related decompensated cirrhotic patients. This study was to evaluate the efficacy in treatment-naive patients using NUCs monotherapy or combinations. Three hundred and six patients with decompensated hepatitis B cirrhosis were selected from cirrhosis cohort and divided into treatment-naive (n = 260) and control groups (n = 46). Antiviral therapies included monotherapy of lamivudine (LAM, n = 39), adefovir (ADV, n = 73), telbivudine (LDT, n = 36), entecavir (ETV, n = 48), and combinations of LAM+ADV (n = 39) or LDT+ADV (n = 25). Of these patients, 193 in antiviral therapy and 39 in control group were included for analysis over two years. The cumulative drug-resistance rate at two year was higher in the LAM (37.9%), ADV (21.2%), LDT (23.3%) than in the ETV monotherapy (2.6%), and with combinations of LAM+ADV (8.7%) or LDT+ADV (6.3%), respectively, P < 0.001. Serum hepatitis B virus (HBV) DNA undetectability in the ETV and the LDT+ADV group was higher than in the LAM, ADV and LAM+ADV group at over two years (P < 0.05). The child-pugh score (CPs) in the antiviral therapy group was decreased at two years (P < 0.05). In the control group and drug-resistant patients, however, CPs was increased. The two years cumulative incidence of liver failure in the antiviral therapy group was significantly less than the control group (OR 24.9, 95%; CI 6.5 to 94.7, P = 0.001). The total cumulative survival rate in the antiviral therapy group was higher than in control group (OR 4.2, 95%; CI 1.4 to 12.9, P = 0.017). The combinations of NUCs therapy and ETV momotherapy are optimum management for hepatitis B related decompensated cirrhotic patients.

 

Key words: Hepatitis B, decompensated cirrhosis, nucleos(t)ide analogs, hepatocellular carcinoma, drug resistance.