Objective: The roadmap concept of adding-on non-cross resistance antiviral therapy for chronic hepatitis B patients who do not achieve an early virological response at week 24 after treatment was introduced in 2007; aiming to improve long-term viral suppression rate. However, the clinical data to prove this concept are still scarce. This study is to evaluate 2-year efficacy of this approach applied to the real world practice of lamivudine therapy.

Materials and Methods: The data of adult chronic hepatitis B patients in Songklanagarind Hospital from 2004 to 2011 were retrospective analyzed. Inclusion criteria were patients on lamivudine monotherapy at baseline and having regular follow-up for >2 years. Exclusion criteria were patients with coinfection with hepatitis C and/or human immunodeficiency virus, coexisting malignancy, co-prescription with immunosuppressant(s), and pregnancy. Patients who received treatment modification at week 24 were classified as the roadmap group [RG] and the remaining patients were the conventional group [CG]. Treatment outcomes were measured at week 96 in terms of virological response, virological breakthrough, and biochemical response rates.

Results: Of the 3,551 chronic hepatitis B patients during the study period, a total of 253 patients were eligible for the study. Seventy-seven patients (30.4%) were classified as the RG and 176 patients were in the CG. At week 96, patients in the RG achieved a significantly higher rate of undetectable virus compared with the CG (83% vs. 63%, p = 0.002), and less virological breakthrough (17% vs. 32%, p = 0.017). Biochemical response was also high (92% vs.78%, p = 0.066).

Conclusion: Lamivudine therapy with the application of the roadmap concept is an effective approach for chronic hepatitis B treatment in real world practice.

Keywords: Efficacy, Hepatitis B, Lamivudine, Roadmap, Treatment