Long-term lamivudine for chronic hepatitis B and cirrhosis: A real-life cohort study

AIM: 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 thirtyeight 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 m L rate and rate of alanine transaminase < 1.3 of theupper 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 fiveyear 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. CONCLUSION: 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.