AIM: To compare the efficacy of a combination of a-interferon (IFN-a) and lamivudine with IFN-a alone in the treatment of patients with HBeAg-positive chronic hepatitis B (CHB). METHODS:Sixty-eight treatment-naove patients with HBeAg-positive CHB were randomized to receive either 9 MU of IFN-a2a three times a week and lamivudine 100 mg daily (Group 1), or IFN-a2a alone in the same dosage (Group 2), for 12 months. Serum ALT, HBeAg, anti-HBe and HBV DNA were tested at the end of treatment and 6 months later. Complete response was defined as normal ALT, negative HBeAg and negative HBV DNA, six months after stopping treatment. RESULTS: Of the 68 patients, 64 completed the study. In Group 1 (n=31), mean (SD) ALT levels decreased from 124 (59) IU/L to 39 (18) IU/L at 12 months; corresponding values in Group 2 (n=33) were 128 (57) and 56 (11) IU/L (p< 0.05). Absence of HBV DNA at the end of treatment was more common in Group 1 (28/31) than in Group 2 (22/33; p< 0.022). The number of patients with seroconversion to anti-HBe (4/31 [13%] vs. 4/33 [12%], respectively; p>0.05), as also those with complete response (4/31 [13%] and 4/33 [12%], respectively; p>0.05) six months after completion of treatment was similar in Group 1 and Group 2. CONCLUSION: Combination treatment with IFN-a and lamivudine was better than IFN-a monotherapy in normalization of ALT and clearance of HBV DNA; however, it did not have a better sustained response rate than IFN-a alone.
RCT Entities:
AIM: To compare the efficacy of a combination of a-interferon (IFN-a) and lamivudine with IFN-a alone in the treatment of patients with HBeAg-positive chronic hepatitis B (CHB). METHODS: Sixty-eight treatment-naove patients with HBeAg-positive CHB were randomized to receive either 9 MU of IFN-a2a three times a week and lamivudine 100 mg daily (Group 1), or IFN-a2a alone in the same dosage (Group 2), for 12 months. Serum ALT, HBeAg, anti-HBe and HBV DNA were tested at the end of treatment and 6 months later. Complete response was defined as normal ALT, negative HBeAg and negative HBV DNA, six months after stopping treatment. RESULTS: Of the 68 patients, 64 completed the study. In Group 1 (n=31), mean (SD) ALT levels decreased from 124 (59) IU/L to 39 (18) IU/L at 12 months; corresponding values in Group 2 (n=33) were 128 (57) and 56 (11) IU/L (p< 0.05). Absence of HBV DNA at the end of treatment was more common in Group 1 (28/31) than in Group 2 (22/33; p< 0.022). The number of patients with seroconversion to anti-HBe (4/31 [13%] vs. 4/33 [12%], respectively; p>0.05), as also those with complete response (4/31 [13%] and 4/33 [12%], respectively; p>0.05) six months after completion of treatment was similar in Group 1 and Group 2. CONCLUSION: Combination treatment with IFN-a and lamivudine was better than IFN-a monotherapy in normalization of ALT and clearance of HBV DNA; however, it did not have a better sustained response rate than IFN-a alone.
Authors: Jialing Zhou; Xiaoning Wu; Wei Wei; Hong You; Jidong Jia; Yuanyuan Kong Journal: Int J Environ Res Public Health Date: 2016-07-21 Impact factor: 3.390