Comparison of lamivudine - α-interferon combination and α-interferon alone treatments in adult patients with naive HBeAg negative hepatitis B

Abstract

Objectives: This study aimed to compare the efficacy of the α-interferon treatment with α-interferon plus lamivudine for cases of chronic hepatitis B. Materials and methods:Sixty-one HBeAg negative naive chronic hepatitis B patients were randomly evaluated in two groups prospectively. In group 1, 30 patients were simultaneously given α-interferon 2a 9 MU, 3 days a week by s.c. injection plus lamivudine 100 mg a day for 12 months. In group II, there were 31 patients who only was received the same dosage of α-interferon and no lamivudine over the same period of time. Results:In group 1 the initial mean value of alanine aminotransferase (ALT) was 144±59 IU/L and decreased to 38.8±19.3 IU/L; in group II, initial mean values of ALT was 141±52 IU/L and decreased to 53.2±14.7 IU/L at the end of 12 th month of the therapy (P<0.05). Hepatitis B virus DNA (HBV-DNA) clearance was obtained in 13 of 30 patients (43.3%) in group I patients and 15 of 31 (48.4%) in group II at the end of the therapy (p=0.692). The number of patients with complete response was found to be 14 out of 30 (48.4%) in group 1 and 15 out of 31 cases (46.7%) in group II, six months after the end of the therapy (P=0.893).Conclusion: α-interferon and lamivudine combination therapy had a more beneficial effect than α-interferon monotherapy in normalization of ALT and clearance of HBV-DNA; however, the complete response rate at 6 months after the end of the therapy was not statistically significantly different between both groups. J Microbiol Infect Dis 2011;1(2): 58-63Key words: Chronic hepatitis B, HBeAg negative, combination therapy, α-interferon, lamivudineHBeAg negative erişkin hastalarda lamüvidin-alfa-interferon kombinasyonu ile tek başına alfa-interferon tedavilerinin karşılaştırılması ÖZET Amaç: Bu çalışmada kronik hepatit B hastalarında alfa-interferon ile alfa-interferon + lamivudin kombinasyon tedavisinin etkinliğinin karşılaştırılmasını amaçladık. Gereç ve yöntem:Altmış bir HBeAg negatif naif, kronik hepatit B hastası, rastgele, ileriye dönük olarak iki gruba ayrıldı. Birinci grup, 30 hastaya aynı anda haftada 3 gün subkütan alfa-interferon 2a 9 MU ve günlük 100 mg lamivudin 12 ay boyunca verildi. 2. grup, 31 hasta ise sadece aynı dozlarda alfa-interferon aldı ve hiç biri lamivudin kullanmadı. Sonuç: Alfa-interferon ve lamivudin kombinasyon tedavisi ALT normalleşmesi ve HBV DNA'nın temizlenmesinde alfainterferon monoterapisinden daha yararlı etkisi olup, her iki grupta, tedavi sonrası altı ay sonundaki kalıcı yanıt oranları arasında istatistiksel olarak anlamlı bir fark saptanmadı.Anahtar kelimeler: Kronik hepatit B, HBeAg negatif, kombinasyon tedavisi, alfa-interferon, lamivudin Çelen MK, et al. Treatment of HBV infection in adult patients59