An Observational Study to Evaluate the Safety and Efficacy of Telbivudine in Adults with Chronic Hepatitis B
Abstract: to assess the safety
and efficacy of telbivudine therapy in adult patients with CHB in Indonesia.
Methods: the study design was prospective cohort study. Multicenter study of
adult CHB patients requiring oral antiviral therapy in daily practice setting.
All patients received 600 mg of telbivudine daily for one year. Recruitment and
decision to start telbivudine therapy was based on clinical indication as
assessed by the participating physicians. The primary end-point was patient
safety (adverse event or serious adverse events); while the secondary
end-points were HBeAg seroconversion, changes of serum HBV DNA levels and serum
ALT normalization. Patients were assessed at week-24 and week-52 of treatment.
Results: a total of 176 cases were eligible for analysis, comprising 104
(59.8%) HBeAg-positive and 70 (40.2%) HBeAg-negative patients. Adverse events
were reported in 7 (4.0%) patients, most of them were mild. HBeAg loss and
seroconversion rate was 28.8% and 14.14% at week-52 respectively. Undetectable
HBV DNA (PCR negativity) was 51.8% at week-24 and 62.7% at week-52. Median HBV
DNA levels were significantly reduced from baseline to week-24 and week-52
treatment (both p<0.001; Wilcoxon’s signed-rank test). Normalization of
serum ALT activity occurred in 85 (73.28%) patients at week-52. Conclusion:
Telbivudine therapy is generally safe and well tolerated among adult Indonesian
patients with chronic hepatitis B. Treatment efficacy in terms of HBeAg loss
and seroconversion, changes of HBV DNA levels and serum ALT normalization were
similar to previous reported studies.
Key words: Alanine
aminotransferase, chronic hepatitis B, HBV DNA, oral antiviral treatment,
telbivudine therapy
Author: Ali Sulaiman,
Laurentius A Lesmana, Nafrialdi Nafrialdi, Helyanna
Journal Code: jpkedokterangg140298
