Abstract
Real-world data on treatment outcomes or the quality of large-scale chronic hepatitis B (CHB) treatment programs in sub-Saharan Africa (SSA) is extremely difficult to obtain. In this study, we aimed to provide data on the prevalence and incidence of mortality, loss to follow-up (LFTU), and their associated factors in patients with CHB in three treatment centres in Eritrea. Additional information includes baseline clinical profiles of CHB patients initiated on nucleos(t)ide analogue (NUCs) along with a comparison of treatment with Tenofovir disoproxil fumarate (TDF) vs. TDF + Lamuvudine (LAM) using specific biochemical, haematological and virologic parameters. A multicenter retrospective cohort study was conducted on CHB patients in Asmara, Eritrea (2018-2021). Demographic, clinical, and laboratory information was collected from medical records using a structured checklist. Relevant parametric and nonparametric statistics were employed to explore treatment outcomes and to evaluate differences between groups. Where appropriate, Kaplan-Meier (KM) curves and univariate and multivariate Cox regression models were implemented. A two-sided p-value < 0.05 was considered significant. A total of 413 patients with HBV (median age (IQR) at diagnosis: 39 (IQR: 28-50 years; females: 118(28.6%); followed for a total of 22,921 person days) were studied. HBV/HIV co-infection was observed in 15(3.6%) and baseline ALT and AST were elevated in 99(31.2%) and 101(32.8%), respectively. The Fibrosis-4 (FIB-4) index estimates suggested that cirrhosis was highly likely in 33 (14%) patients with 49 (20.8%) patients in the indeterminate FIB-4 score category. During the follow-up period, 4.6% (95% CI: 2.5-6.6%) died, while 23.9% (95% CI: 19.8-28%) were LTFU. In the adjusted Cox proportional hazards model, LTFU were independently associated with baseline serum HBV DNA (IU/mL) (aHR = 1.3, 95% CI 1.04-1.7; p-value = 0.02); Not initiated on NUC (aHR = 3.9, 95% CI: 1.1-13.7, p-value = 0.02); and FIB-4 Score (aHR = 1.05, 95% CI: 1-1.1; p-value = 0.01). Of the 413 patients enrolled in the study, 98 cases (23.73%) were initiated on treatment. In the head-to-head comparison of the results in TDF and TDF + LAM after 12 weeks of treatment, VR was observed in 14(45.2%) vs. 17(54.8%), respectively, translating into an overall VR of 60.7% (95% CI 46.9-74.6). Furthermore, VR in TDF vs. TDF + LAM were similar, 14(45.2%) vs. 17(54.4%) respectively, p-value = 0.3). This study uncovered multiple systems- and patient-centered gaps in the three HBV treatment programs in Asmara, Eritrea. These include late presentation, high incidence of LTFU, inconsistencies in routine data, and poor data management. Interventions should target improvements in laboratory infrastructure, adherence to patient monitoring guidelines, HBV literacy, better tracking of patients, and documentation of patient's information.