BACKGROUND AIMS: To identify risk factors associated with liver complications in patients with chronic hepatitis B infection in an unselected cohort of hepatitis B patients in southern Spain. METHODS: A prospective open-cohort study was conducted on 437 patients with uncomplicated chronic hepatitis B infection in two hospitals in Málaga, southern Spain. The follow-up time ranged from 0.5 to 31.5 years (mean: 13.8 ± 9.5 years
median: 11.4 years). The aim of this study was to evaluate the occurrence of the initial liver complication during follow-up, which is defined as the emergence of liver cancer or complications resulting from portal hypertension. Survival curves were obtained using a time-to-event method through Kaplan-Meier analysis. Multivariate Cox regression was conducted to estimate the hazard ratios of risk factors associated with complications after adjusting for multiple variables. The follow-up of the patients was carried out under conditions of usual clinical practice. Based on the weighted adjustment of these factors, we developed a Hepatitis B Complication Score (HBCS) from which it was possible to identify patients with low and high risk of complications during follow-up. RESULTS: 33 out of 437 patients (7.55%) experienced liver complications, 12 (36.3%) were secondary to portal hypertension, and 21 patients (63.7%) developed liver cancer. A Multivariate Cox regression identified the following independent risk factor: Age above 45 years: HR 7.10 (2.9-17.3)
low platelet count: HR 4.88 (2.1-10.9)
hepatitis C coinfection: HR 4.68 (2.0-10.9)
Male gender: HR 4.64 (1.5-14.2)
alkaline phosphatase above 147 UI/mL: HR 4.33 (2.0-8.9)
and Child score above 5 points: HR 3.83 (1.7-8.4). The Risk of Complications Score (HBCS) was developed with a high predictive capacity AUROC 0.92 (0.87-0.97). CONCLUSION: An HBCS score greater than 3.07 points identifies patients at high risk of developing complications and with an increased risk of liver and all-cause mortality.