In this study, an international team of researchers assessed the durability of serologic responses following lamivudine treatment. They studied 40 subjects with chronic hepatitis B and hepatitis B e antigen (HBeAg) seroconversion following treatment.
Patient follow-up began a median of 4.3 months after completion of therapy in previous trials.
The team tested for HBeAg and hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV) DNA, and alanine aminotransferase (ALT). They measured these at months 2, 4, 6, 9, and 12 of year 1, and every 6 months thereafter.
The researchers found that after a median of 36.6 months of follow-up, HBeAg seroconversion was demonstrated at the last visit by 77% of the patients.
|3-year durability of HBeAg seroconversion was 64%.|
In a post hoc analysis which included 65 patients with HBeAg seroconversion, the team found that 3-year durability of HBeAg seroconversion was 64%. This was measured from the time immediately after discontinuing lamivudine therapy.
They also identified 23% of patients as HBsAg negative at the last assessment.
Furthermore, 74% of patients with baseline undetectable HBV DNA and normal ALT maintained these responses at the last visit.
In addition, 20% were retreated for reappearance of HBV markers. The team determined that 7 out of 8 patients showed biochemical and/or virologic improvement, which included regained HBeAg seroconversion in 2.
No safety issues of concern emerged.
Dr Jules Dienstag’s team concluded, “Most HBeAg responses achieved during lamivudine therapy were durable, and most responders experienced prolonged clinical benefit after HBeAg seroconversion and subsequent discontinuation of lamivudine”.
“Lamivudine retreatment for reappearance of hepatitis B markers can achieve resumption of viral suppression.”