Systematic review of randomized trials reveals uncertain mortality and safety benefits of thymosin-ɑ1 in chronic hepatitis B, highlighting the need for higher-quality evidence.
Key Points
To evaluate the benefits and harms of thymosin-ɑ1 therapy, administered alone or alongside standard co-interventions, in patients with chronic hepatitis B.
Systematic review and random-effects meta-analysis of 10 randomized controlled trials comprising 1349 participants across Bangladesh, China, Italy, Korea, Singapore, and Taiwan.
Evaluated thymosin-ɑ1 against placebo, no intervention, or identical co-interventions (interferon, pegylated interferon, lamivudine, or entecavir) across follow-up durations ranging from six months to five years.
Thymosin-ɑ1 may reduce all-cause mortality (RR 0.53, 95% CI 0.29 to 0.96; 3 studies, 907 participants; very low-certainty evidence) and HBV-related mortality (RR 0.53, 95% CI 0.29 to 0.96; 3 studies, 907 participants; very low-certainty evidence).
Serious adverse events were potentially reduced with thymosin-ɑ1 (RR 0.72, 95% CI 0.53 to 0.99; 5 studies, 1056 participants; low-certainty evidence), whereas evidence regarding HBV-related morbidity (RR 0.86, 95% CI 0.54 to 1.40) and histological improvement (RR 0.51, 95% CI 0.13 to 2.06) remained highly uncertain.