Long-term conventional interferon alpha in combination with lamivudine for chronic hepatitis B: data from Turkey.

Author(s): Yilmaz S, Bayan K, Dursun M, Canoruc F, Pasa S, Saka G

Affiliation(s): Department of Gastroenterology, Dicle University Faculty of Medicine, Diyarbakir, Turkey. drserif@dicle.edu.tr

Publication date & source: 2007-12, Hepatogastroenterology., 54(80):2348-52.

Publication type: Randomized Controlled Trial

BACKGROUND/AIMS: Standard interferon or lamivudine monotherapy has been shown to induce a low response rate in patients with chronic hepatitis B infection. Genotype D represents almost the whole of chronic HBV infection of Turkish population. The aim of this study was to evaluate the efficacy and safety of the long-term interferon-alpha plus lamivudine on these patients, and thereafter the co-effect of maintenance therapy by lamivudine. METHODOLOGY: This prospective study was carried out between the late 1999 and 2005. A total of 37 (24 HBeAg-positive and 13 HBeAg-negative) patients were enrolled in the study. These patients received standard interferon-alpha (9/10 MU) three times sc. a week plus lamivudine 100mg po. daily, for 52 weeks. After the interferon discontinuation, lamivudine monotherapy was assigned to be given until 4-6 months after the occurrence of HBeAg seroconversion in the HBeAg-positive patients and at least three years in HBeAg-negative patients. Response-1 was defined as the response at the end of combination therapy at the 52nd week, and Response-2 as response at the end of the follow-up period under lamivudine monotherapy. An intention-to-treat analysis was performed. RESULTS: Patients' follow-up ranged between 7-67 months, with a mean duration of 29.64 +/- 14.01 months. Twenty-six patients (70.3%) had a Response-1, both virological and biochemical. A biochemical Response-2 was achieved in 24 patients (64.9%), while virological Response-2 in 17 (45.9%). Response-1 and Response-2 were similar between HBeAg-positive and HBeAg-negative patients (p = 0.262 and p = 0.734, respectively). HBeAg seroconversion was achieved only in 8 (33.3%) of HBeAg-positive patients. Clinical resistance to lamivudine developed only in 9 (24.3%) of the patients. Decompensation or hepatocellular carcinoma did not observe in any case. CONCLUSIONS: This study showed the efficacy of the 'long-term' anti-viral maintenance along with the combination therapy in genotype D predominant chronic hepatitis B patients. A low clinical resistance rate to lamivudine was achieved.