Eight RCTs were included (n=583 patients). The follow-up periods ranged from 0 to 12 months. The quality of four studies was rated category B and four were category C. Groups were comparable at baseline in all studies. Four studies reported withdrawal rates. None of the studies were blinded and none clearly reported allocation concealment.
Biochemical response: Compared to lamivudine monotherapy, combination therapy with Tα1 and lamivudine was more effective at the end of treatment (RR 1.16, 95% CI 1.04 to 1.30; eight studies) and at the end of 12 months follow-up (RR 5.38, 95% CI 3.13 to 9.25; eight studies).
Virological response: Compared to lamivudine monotherapy, combination therapy with Tα1 and lamivudine was more effective at the end of treatment (RR 1.14, 95% CI 1.05 to 1.23; eight studies) and at the end of 12 months follow-up (RR 1.74, 95% CI 1.07 to 2.84; four studies).
Seroconversion of HBeAg to HBeAb: Compared to lamivudine monotherapy, combination therapy with Tα1 and lamivudine was more effective at the end of treatment (RR 2.98, 95% CI 2.22 to 4.01; eight studies) and at the end of 12 months (RR 5.91, 95% CI 3.15 to 11.10; four studies).
No significant heterogeneity was found for any of these analyses.
Adverse events: No serious adverse events were reported in either treatment group and studies reported no biochemical abnormalities.