Aim: To study the role of lamivudine in improving the efficiency of interferon for the treatment of mutant type chronic hepatitis B.
Methods: Fifteen patients with mutant type chronic hepatitis B were prospectively studied. All patients had liver histology and serology to prove the diagnosis of chronic hepatitis B. Each patient received 4.5 million units of interferon alpha-2a thrice weekly and 100 mg of oral lamivudine daily for 24 weeks. Patients were observed and tested for blood chemistry every week for the initial 4 weeks and every 2 weeks thereafter during the treatment until 24 weeks. After the end of treatment, patients were followed up at 4-week intervals for an additional 6 months. Serum HBV DNA levels were tested using the liquid phase molecular hybridization assay. Those with non-detectable HBV DNA were also tested using the real-time polymerase chain reaction. One patient, who did not finish treatment due to depression, was excluded.
Results: At the end of treatment, 7 (50 %) patients had serum ALT levels within normal limits; 12 (86 %) patients had serum HBV DNA levels <5 pg/mL using the liquid phase molecular hybridization assay, but only 8 (67%) were <20 copies/dL using the real-time polymerase chain reaction. Six months after treatment, only two (14 %) patients had a sustained complete response to the combination therapy with serum ALT level <35 iu/L and undetectable serum HBV DNA levels.
Conclusion: These pilot data showed that lamivudine did not increase the efficacy of interferon in the treatment of mutant type chronic hepatitis B. The liquid phase molecular hybridization assay was not sensitive enough to detect the low HBV DNA levels during combined interferon and lamivudine therapy.