Sequential HBV Treatment With Tenofovir Alafenamide for Patients With Chronic Hepatitis B: Week 96 Results From a Real-world, Multicenter Cohort Study

Abstract

\n Background and AimsOutcome data of sequential hepatitis B virus treatment with tenofovir alafenamide (TAF) are limited. We aimed to assess the effectiveness and renal safety of TAF in chronic hepatitis B (CHB) patients who were previously treated with entecavir (ETV), tenofovir disoproxil fumarate (TDF), or nucleos(t)ide analog (NA) combination. MethodsThis multicenter, retrospective, cohort study included 458 consecutive CHB patients who switched to TAF monotherapy after at least two years of treatment with another NA. The longitudinal virological/laboratory responses were evaluated up to 96 weeks after switchover. Chronic kidney disease (CKD) was defined as an estimated glomerular filtration rate (eGFR)<60 mL/min/1.73m2. ResultsThe proportions of HBV DNA suppression (HBV DNA<20 IU/mL) at week 96 were 99.0%, 97.8%, and 98.4% in the prior ETV (n=198), TDF (n=137), and NA combination (n=123) groups, respectively. Almost all patients with HBV DNA of 20-2000 IU/mL at baseline achieved HBV DNA suppression at week 96. On multivariable generalized estimated equation (GEE) analysis, a low quantitative hepatitis surface antigen (qHBsAg) level at baseline was associated with a lower follow-up qHBsAg level (coefficient 0.81, P<0.001). The eGFR showed greater improvement in patients with CKD compared to those with non-CKD according to the multivariable GEE analysis (coefficient 21.7, P<0.001). However, the increase of eGFR reached a peak between weeks 24 and 48. ConclusionsBased on this longitudinal data analysis up to 96 weeks, sequential NA therapy with a switch to TAF is a good option to better achieve high viral suppression and renal safety.