Nationwide retrospective study of hepatitis B virological response and liver stiffness improvement in 465 patients on nucleos(t)ide analogue

Abstract

BACKGROUND Hepatitis B virus (HBV) nucleos(t)ide analog (NA) therapy reduces liver disease but requires prolonged therapy to achieve hepatitis B surface antigen (HBsAg) loss. There is limited North American real-world data using non-invasive tools for fibrosis assessment and few have compared 1 st generation NA or lamivudine (LAM) to tenofovir disoproxil fumarate (TDF). AIM To assess impact of NA on virological response and fibrosis regression using liver stiffness measurement (LSM) ( i.e. , FibroScan ® ). METHODS Retrospective, observational cohort study from the Canadian HBV Network. Data collected included demographics, NA, HBV DNA, alanine aminotransferase (ALT), and LSM. Patients were HBV monoinfected patients, treatment naïve, and received 1 NA with minimum 1 year follow-up. RESULTS In 465 (median 49 years, 37% female, 35% hepatitis B e antigen + at baseline, 84% Asian, 6% White, and 9% Black). Percentage of 64 ( n = 299) received TDF and 166 were LAM-treated with similar median duration of 3.9 and 3.7 years, respectively. The mean baseline LSM was 11.2 kPa (TDF) vs 8.3 kPa (LAM) ( P = 0.003). At 5-year follow-up, the mean LSM was 7.0 kPa in TDF vs 6.7 kPa in LAM ( P = 0.83). There was a significant difference in fibrosis regression between groups ( i.e. , mean -4.2 kPa change in TDF and -1.6 kPa in LAM, P < 0.05). The last available data on treatment showed that all had normal ALT, but more TDF patients were virologically suppressed (< 10 IU/mL) ( n = 170/190, 89%) vs LAM-treated ( n = 35/58, 60%) ( P < 0.05). None cleared HBsAg. CONCLUSION In this real-world North American study, approximately 5 years of NA achieves liver fibrosis regression rarely leads to HBsAg loss.

Non-Invasive Measurement of Hepatic Fibrosis by Transient Elastography: A Narrative Review

“…A recent retrospective study evaluated 465 HBV patients treated with lamivudine (median baseline LS 8.7 KpA) and tenofovir (median LS baseline 11.7 KpA) and who were monitored for at least one year after the end of therapy. The mean decline in LS was greater in the tenofovir group (−4.2 KpA, median LS 7.0 KpA) than in the lamivudine group (−1.6 KpA, median LS 6.7 KpA), and was paralleled by a more effective control of hepatic cytolysis and a greater HBV negativization rate in the tenofovir group (90%) [ 61 ]. Similarly, another recent retrospective study evaluated the LS dynamics in HBV patients who were treated with nucleos(t)ide analogues (NAs) and monitored annually for 64 months.…”