Virological, serological and biochemical outcomes through 3 years of entecavir treatment in nucleoside‐naive Chinese chronic hepatitis B patients

Abstract

SUMMARY. Hepatitis B virus (HBV) infection has a high prevalence in China. Entecavir has shown superior efficacy over lamivudine in Chinese nucleoside-naive chronic hepatitis B (CHB) patients over 48 weeks, with continued clinical benefit to 96 weeks. The present study evaluates the long-term efficacy of entecavir in Chinese CHB patients who continued entecavir treatment for 144 weeks. Patients receiving either entecavir 0.5 mg/day (n = 258) or lamivudine 100 mg/day (n = 261) entered the initial 96-week randomized, doubleblind, controlled efficacy study. Patients who did not achieve a consolidated response [HBV DNA <0.7 MEq/mL; alanine aminotransferase (ALT) <1.25 · upper limit of normal; and if hepatitis B e antigen (HBeAg) positive at baseline, loss of HBeAg for ‡24 weeks] or who experienced viral breakthrough or relapse entered a 48-week entecavir rollover study. A total of 160 patients received continuous entecavir for 144 weeks; of these, 89% had undetectable serum HBV DNA, 86% showed ALT normalization, 20% reported HBeAg loss and 8% experienced HBeAg seroconversion. The cumulative rates of HBeAg loss and seroconversion were 36% and 27% at Week 144, respectively. The development of resistance was low, with three patients up to Week 96 and an additional two patients in Weeks 96-144 showing evidence of associated genotypic mutations. Entecavir was well tolerated. Adverse event rates were similar to those in lamivudine-treated patients, but patients receiving entecavir experienced fewer ALT flares. This study demonstrates that entecavir provides durable, long-term suppression of HBV DNA and ALT normalization in Chinese CHB patients, and is associated with low rates of emerging resistance. The results are consistent with the findings using entecavir globally and in Japan.

Hepatitis B surface antigen loss and sustained viral suppression in Asian chronic hepatitis B patients: A community‐based real‐world study

“…In our large multicentred cohort consisting almost entirely of Asian adults, we found that antiviral treatment (ETV or TDF in 94% of patients) over a median duration of almost six and one‐half years resulted in a 4.58% overall rate of HBsAg loss, 4.44% in HBeAg‐positive patients and 4.71% in HBeAg‐negative patients. The loss in HBeAg‐negative patients is striking in comparison with multiple previous studies in which HBsAg loss with antiviral therapy has ranged from 0% to 0.7% in HBeAg‐negative patients treated with ETV, TDF or TDF/FTC . It is not clear why significantly higher rates of HBsAg loss were seen among our cohort of HBeAg‐negative patients.…”

“…Two studies have shown no sAg loss in NUC‐treated Asian patients after 3‐5 years of therapy. In 160 Chinese patients who received continuous entecavir (ETV) therapy for 3 years, there was no HBsAg loss in either HBeAg‐positive or HBeAg‐negative patients . In a subgroup analysis of 94 HBeAg‐positive Asian patients included in the overall long‐term ETV cohort, it was shown that with 5 years of ETV therapy there was still no HBsAg loss …”

Clinical utility of entecavir for chronic hepatitis B in Chinese patients

“…Overall, these results demonstrate superior antiviral efficacy of entecavir compared with lamivudine, adefovir, and telbivudine, and support the current Asian-Pacific treatment guidelines recommendation to use entecavir as a first-line therapeutic option for patients with CHB. In addition, a number of studies in the People’s Republic of China have directly compared entecavir with other nucleos(t)ide analogs that are currently recommended, including lamivudine, adefovir, and telbivudine 21–29…”

“…Entecavir has demonstrated efficacy superior to that of lamivudine in a number of studies comparing the two therapies in Chinese patients with CHB 21–24. A multicenter study evaluated the long-term efficacy of entecavir in patients who continued entecavir therapy for up to 144 weeks 21.…”

“…A multicenter study evaluated the long-term efficacy of entecavir in patients who continued entecavir therapy for up to 144 weeks 21. A total of 519 patients received either entecavir or lamivudine in an initial 96-week randomized, double-blind, controlled efficacy study.…”