title: Long-term lamivudine for chronic hepatitis B and cirrhosis: A real-life cohort study.
abstract: OBJECTIVE
  To investigate clinical outcomes of chronic hepatitis B (CHB) and liver cirrhosis (LC) patients under whole-course management with lamivudine (LAM).
  
  
  METHODS
  This was a retrospective-prospective cohort study based on two nonrandom cohorts of Chinese patients (LAM group and history control group). Two hundred thirty-eight patients with LAM treatment for at least 12 mo under whole-course management were included in the LAM group. The management measures included regular follow-up and timely adjustment of the therapeutic regimen according to drug-resistance and relapse. Two hundred thirty-eight patients with CHB or LC without any antiviral treatment and with follow-up over 12 mo were included in the history control group. The LAM and control group patients were 1:1 matched by propensity score method to ensure both patients were similar in general datum, sex, age, E antigen, and diagnosis. The incidence rates of endpoint events [LC, hepatocellular carcinoma (HCC), and death] were compared between the LAM and control groups.
  
  
  RESULTS
  Hepatitis B virus-DNA < 1000 copies per mL rate and rate of alanine transaminase < 1.3 of the upper normal limit in LAM and control groups were 89.1% vs 18.5% (P < 0.05) and 89.8% vs 31.1% (P < 0.05), respectively. Viral breakthrough occurred in 77 patients (32.4%); the one-, three-, and five-year cumulative rates were 6.8%, 33.1%, and 41.3%, respectively. In total, 44.5% (106/238) of patients had once stopped LAM, and 63 (59.4%) of them developed virologic relapse; the relapse rate of patients with and without reaching Asian Pacific Association for the Study of the Liver endpoint criteria were 52.4% and 69.8%, respectively. Six CHB patients in the LAM group developed LC compared to 47 patients in the control group; the three-, and five-year cumulative rates of CHB at baseline of LAM were lower than those of the control group: 0.7% vs 12.0% and 1.8% vs 23.8% (P < 0.01), respectively. The incidence of HCC in CHB at baseline of LAM was lower than that of the control group; the three-, and five-year cumulative rates were 0% vs 3.2% and 1.1% vs 3.2% (P = 0.05), respectively. The incidence of HCC in LC at baseline of LAM was lower than that of the control group: 9.8% (5/51) vs 25.0% (12/48), and the three-, and five-year cumulative rates were 4.5% vs 20.7% and 8.1% vs 37.5% (P < 0.01), respectively. The mortality rate in the LAM group was lower than the control group.
  
  
  CONCLUSIONS
  Standardized long-term LAM treatment in combination with comprehensive management can reduce the incidence rates of LC and HCC as well as hepatitis B virus-related deaths.
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Ming-Hua
authors.initials: MH
authors.lastname: Su
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Ai-Lian
authors.initials: AL
authors.lastname: Lu
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Shi-Hua
authors.initials: SH
authors.lastname: Li
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Shao-Hua
authors.initials: SH
authors.lastname: Zhong
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Bao-Jian
authors.initials: BJ
authors.lastname: Wang
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Xiao-Li
authors.initials: XL
authors.lastname: Wu
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Yan-Yan
authors.initials: YY
authors.lastname: Mo
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Peng
authors.initials: P
authors.lastname: Liang
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Zhi-Hong
authors.initials: ZH
authors.lastname: Liu
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Rong
authors.initials: R
authors.lastname: Xie
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Li-Xia
authors.initials: LX
authors.lastname: He
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Wu-Dao
authors.initials: WD
authors.lastname: Fu
authors.affiliation: Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
authors.forename: Jian-Ning
authors.initials: JN
authors.lastname: Jiang
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000821:virology; D002681:China / Q000453:epidemiology; D004334:Drug Administration Schedule; D024882:Drug Resistance, Viral; D019694:Hepatitis B, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D015994:Incidence; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects; D008103:Liver Cirrhosis / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality / Q000821:virology; D008113:Liver Neoplasms / Q000401:mortality / Q000821:virology; D008297:Male; D008875:Middle Aged; D057216:Propensity Score; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D012189:Retrospective Studies; D012307:Risk Factors; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D019259:Lamivudine
keywords: Hepatitis B virus; Lamivudine; Liver cirrhosis; Management; Outcome; Therapy