Background and objectives: Entecavir is a nucleoside analog used in the treatment of chronic hepatitis B. The efficacy of ETV has not been studied in the Saudi population. The objective of the study was to find undetectable HBV DNA after 48 weeks completion of ETV treatment in real-life versus clinical trial patients.
Design and setting: A retrospective study in a tertiary care center in Saudi Arabia of patients treated from 2006 January to 2010 June.
Patients and methods: Of 43 eligible patients, 24 patients were treatment-naïve and 19 were treatment refractory.
Results: Mean HBV DNA viral load was 51 million IU/mL prior to treatment and decreased to 0.16 million IU/mL at 48 weeks. Mean HBV DNA log10 IU/mL was 6.3 before treatment and decreased to 2.3 log10 IU/mL(P=.001) at 48 weeks. After 48 weeks treatment, ALT significantly decreased from a mean ALT of 88.7 U/L before treatment to 37.5U/L (P=.04). After 48 weeks, the HBV DNA was undetectable in 14 (58.4%) in treatment-naïve patients and in 6 (31.6%) treatment-refractory patients. At 48 weeks 17 (60.7%) of HBeAg-negative patients and 3 (20%) HBeAg-positive patients achieved undetectable HBV DNA (P=.003). When the treatment was extended for a median of 24 months (range 12 months to 60 months), 29 (67.4%) achieved undetectable HBV DNA. Among 29 patients who achieved undetectable HBV DNA, the treatment refractory patients reached undetectability within a mean of 32.4 (18.6) months and treatment-naïve patients in a mean of 18.8 (10.5) months(P=.01). Two (13.3%) of HBeAg-reactive patients converted to HBeAg-negative status and one patient (2.3%)lost HBsAg.
Conclusion: After treatment with entecavir, HBV DNA undetectable at 48 weeks in 58.4% of naïve patients.The response rate was better in HBeAg-negative and treatment-naïve patients compared to HBeAg-positive and treatment-refractory patients.