Mathematical Modeling of HDV RNA Kinetics Suggests High Peginterferon Lambda Efficacy in Blocking Viral Production: Insights from the LIMT-1 Study

Turkey.We studied TAF use in chronic hepatitis B patients in a real life setting across the country.Method: Treatment-experienced chronic HBV patients were included.Twenty-five sites from 15 cities were enrolled.Patients' demographics, laboratory studies before TAF and during TAF treatment were recorded.Data at baseline, in 6 th month and in 12 th month were compared.Results: The study included 509 treatment-experienced patients.Among patients, median age was 53 years, male 302 (59.3%),HBeAgnegative 348 (86.1%), median ALT 23 U/L, median fibrosis score 2, and HAI 7.They were previously using TDF (83.9%), entecavir (6.8%), lamivudine (5.5%), telbivudine (3.0%), and adefovir (0.8%).Before TAF, teatment duration <6 months 13 (2.9),6-12 months 29 (6.5), >12 months 403 (90.6).Indications to switch were osteoporosis 206 (40.5%), blood phosphate level 108 (21.2%), physicians decision 65 (12.8),glomerular filtration rate (GFR) 62 (12.2%), drug affecting bone mineral density 59 (11.6%), proteinuria/albuminuria 49 (9.6%), transplantation 11 (2.2%), steroids 6 (1.2%), fracture history 2 (0.4), and hemodialysis 2 (0.4%).Among all patients with HBV-DNA <20 IU/ml was 76.0% at baseline (during switch), 88.0% in 6 th month and 84.1% in 12 th month ( p < 0.05).ALT normalization was 72.3% at baseline, 76.9% in 6 th month and 81.0% in 12 th month ( p < 0.05).Creatinine levels and estimated (eGFR) remained stable from baseline to 6 th and 12 th months (0.82 mg/dl, 0.86 mg/dl, and 0.88 mg/dl ( p > 0.05); 95 ml/min, 84.45 ml/min, and 94.0 ml/min ( p > 0.05), respectively).Change in HDL, LDL and total cholestrol at baseline, 6 th month and 12 th month are not significant.Among all patients, TAF was tolerated well.Side effects were headache 7.7%, nausea 3.1%, fatigue 3.1%, and rash 1.0%.Conclusion: Although the majority of the patients were using potent nucleos (t)ide analogs, switching to TAF was associated with improved virologic and biochemical responses.Renal functions and lipid parameters remained stable and the drug was well tolerated.Real life data confirmed the efficacy and safety of TAF in treatmentexperienced chronic hepatitis B patients.