Real-world experience with nucleos (t) ide analogue therapy and patient survival rates in chronic viral hepatitis B Treatment Centers in Asmara, Eritrea: A multicenter retrospective observational cohort study

Abstract

Background Real-world data on treatment outcomes or the quality of large-scale chronic hepatitis B (CHB) treatment programs in sub-Saharan Africa is extremely difficult to obtain. In this study, our aim was to present data on the clinical characteristics of CHB patients and to evaluate results in patients on nucleos(t)ide analogue (NUC) in multiple treatment sites in Asmara, Eritrea. Methodology: A multicenter retrospective cohort study was conducted on CHB patients in government-funded follow-up programs in Asmara, Eritrea (period: 2016–2021). Demographic, clinical, and laboratory information was collected from patients’ cards using a structured check-list. Relevant parametric and nonparametric statistics were employed to evaluate differences between groups. Kaplan–Meier (K-M) estimates and multivariate Cox proportional hazard models were used to explore risk factors for lost follow-up (LTFU). Results 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 of follow-up). Baseline ALT and AST were elevated in 99(31.2%) and 101(32.8%), respectively. Importantly, FIB-4 score and APRI score estimates suggested that prevalence of cirrhosis plus indeterminate and /or cirrhosis possible was 33(14%) + 49(20.8%) and 26(10.6%) + 65(26.4%), respectively. During the follow-up period, 4.6% (95%CI: 2.5–6.6%) died, while 23.9% (95%CI: 19.8–28%) were LTFU. The dominant reasons for treatment eligibility were cirrhosis and elevated HBV-DNA. After 12 weeks of treatment, the overall virologic response (VR) was 50.8% (95%CI: 46.9–74.6). Importantly, VR in TDF vs TDF + LAM were similar, 14/31(45.2%) vs 17/31(54.4%), respectively, p-value = 0.3. However, significant changes in biochemical parameters (ALT, AST, FIB-4, and APRI) were observed in both treatment groups following treatment. In adjusted Cox proportional hazards model, LTFU was 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). Conclusion This study uncovered multiple system- and patient-centered gaps in the three HBV treatment programs in Asmara, Eritrea. Interventions should target improvements in laboratory infrastructure, adherence to patient monitoring guidelines, HBV literacy, better tracking of patients, and documentation of patients’ information.