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


METHODS
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.
Yilmaz
Serif
S
Department of Gastroenterology, Dicle University Faculty of Medicine, Diyarbakir, Turkey. drserif@dicle.edu.tr
Bayan
Kadim
K
Dursun
Mehmet
M
Canoruç
Fikri
F
Paşa
Semir
S
Saka
Günay
G
D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000032:analysis; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D011994:Recombinant Proteins; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D014421:Turkey
D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine