LP33 : Efficacy of interferon +/– nucleos(t)ide analog treatment in children with chronic hepatitis b, in the immunotolerant phase confirmed by liver biopsy

Introduction: Ledipasvir/Sofosbuvir (LDV/SOF) single tablet regimen (STR) is approved in Europe for the treatment of chronic hepatitis C (CHC) patients with genotypes (GT) 1, 3 and 4. The ION-3 study showed that 8 weeks (8w) of LDV/SOF treatment was noninferior to 12 weeks in previously untreated GT1 patients without cirrhosis with no benefit for the addition of Ribavirin. According to the SPC 8w may be considered in this population. The aim of the present analysis is to characterise the population receiving 8w LDV/SOF and to describe outcomes in clinical practice. Material and Methods: The first CHC patients treated with 8w LDV/SOF in a single centre in Germany, and for whom sustained virological response after 4 weeks of follow-up (SVR4) will be available in April, were included in the analysis. Baseline characteristics, prior treatment history, safety and effectiveness were investigated. The analysis was performed using descriptive statistics. Results: 46 patients met the inclusion criteria for this analysis. These patients initiated 8w treatment with LDV/SOF between 24/11/2014 to 27/01/2015. No patient had ribavirin added to the STR. The mean (SD) age was 50.9 (12.4) years and 56.5% were males. The genotype distribution was 52%, 44% and 4% for GT1a, GT1b and GT4, respectively. At entry, 98% of patients had no cirrhosis, one patient had compensated disease. The METAVIR stage distribution of non-cirrhotic patients at baseline was 39.1%, 32.6%, 19.6% and 8.7% for F0, F1, F2 and F3, respectively. Median (range) HCVRNA at baseline was 5.86 (Q1-Q3 5.38–6.22; Min-Max 3.74–6.67) log10 IU/ml, no patient had HCVRNA ≥6 million IU/mL. No patient was HIV co-infected and one patient was HBV coinfected. Overall, 98% of the patients were treatment-naive. One patient had relapsed after previous IFN/RBV therapy. At baseline, co-morbidities were reported in 93% of patients, with depression (16%) and arterial hypertension (16%) being most common. Up to date, no discontinuations or relevant Adverse Drug Reactions have been observed. Complete results regarding SVR4, adverse events and discontinuations will be available at the time of presentation. Conclusions: 8w LDV/SOF is predominantly prescribed according to the SPC for treatment-naive non-cirrhotic CHC patients with HCVRNA u003c6 million IU/mL at baseline. Preliminary results indicate that LDV/SOF is a safe, well tolerated treatment option with no adverse drug reactions or discontinuations reported so far.