Three studies (2 RCTs and 1 open label treatment study, historical controls) were included in the review with 121 participants (67 in the IFN plus thymosin alpha-1 group, and 54 in the IFN-alone group).
Biochemical (ALT) end-treatment response was 44.7% in the intervention group and 22% in the control group (OR 3.1 (CIs not stated); chi-square 6.71; P = 0.01).
Sustained biochemical (ALT) response was 22.4% in the intervention group and 11.1% in the control group (OR not stated) was not statistically significant (p = 0.10).
Virological end-treatment response (2 studies) appears from the figure to be not statistically significant. The numbers for the OR and CIs are not reported in the text.
The biochemical end-treatment response in the IFN plus T-alpha-1 combination arm was 44.7% compared to 22% in the IFN alone treatment group (chi-square 6.71, P = 0.01) which was statistically significant. Sustained biochemical end-treatment response in the IFN plus T-alpha-1 combination arm was 22.4% compared to 11.1% in the IFN alone treatment group (P = 0.10) which was not statistically significant.
Subset analysis of the IFN-naive patients produced an OR = 3.9 (95% CI: 1.64, 7.92) for biochemical end-treatment response. Sustained biochemical response was 2.38 times as likely among those receiving combination therapy (OR 2.38, 95% CI: 0.84, 5.53) which was not statistically significant.
Pooled total patient drop-out was noted in 3 of 67 patients treated with IFN plus T-alpha-1 and 2 of 54 patients treated with alone. These differences are not statistically significant.
Data regarding side-effect profiles were not sufficient to perform a meta-analysis.