Interim report on a phase I/IIa, double-blind, randomized, placebo-controlled trial of a novel antiviral agent, LB80380 in Chinese patients with chronic hepatitis B infection

Abstract

To investigate the safety and antiviral activity of LB80380, a novel guanosine analogue, in HBeAg-positive HBV patients, 28 patients in 4 cohorts (7 per group with 6:1 ratio of LB80380: placebo) were given escalating doses with 30mg, 60mg, 120mg and 240mg daily for 4 weeks. Patients were monitored till week 16. The median age and male:female ratio were 27.5 years and 20:8 respectively. The median follow-up was 8.9 weeks. HBV DNA reductions are depicted in the figure. HBV DNA reduction was greater with 60mg dose and above. HBV DNA returned to the pretreatment levels at a slower rate with higher doses. No serious adverse events were observed. In conclusion, four-week treatment of LB80380 was safe and associated with a reduction of HBV DNA levels greater than those observed with lamivudine and adefovir.