sofosbuvir 8 weeks chronic hepatitis C treatment

POSTERS national strategies supported by the upcoming WHO Global Strategy on Hepatitis (2016–2021) and technical assistance to MS. LP32 REAL-WORLD EFFECTIVENESS OF LEDIPASVIR/SOFOSBUVIR 8 WEEKS CHRONIC HEPATITIS C TREATMENT P. Buggisch1 , J. Petersen1 , K. Wursthorn1 , P. Atanasov2 , A. Gauthier2 . 1 IFI Institut f¨ ur Interdisziplin¨ are Medizin, Asklepios Klinik St. Georg Haus L, Lohm¨ uhlenstr. 5, 20099, Hamburg, Germany; 2 Amaris, London, United Kingdom E-mail: [email protected] 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) HCV RNA at baseline was 5.86 (Q1-Q3 5.38–6.22; Min-Max 3.74–6.67) log10 IU/ml, no patient had HCV RNA ≥6 million IU/mL. No patient was HIV co-infected and one patient was HBV coinfected. Overall, 98% of the patients were treatment-naïve. 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-naïve non-cirrhotic CHC patients with HCV RNA <6 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. LP33 EFFICACY OF INTERFERON +/− NUCLEOS(T)IDE ANALOG TREATMENT IN CHILDREN WITH CHRONIC HEPATITIS B, IN THE IMMUNOTOLERANT PHASE CONFIRMED BY LIVER BIOPSY H. Zhang1 , S. Zhu1 , Y. Dong1 , L. Wang1 , Z. Xu1 , D. Chen1 , Y. Gan1 , F. Wang1 . 1 The Pediatric Liver Disease Therapy and Research Center, 302 Hospital, Beijing, China E-mail: [email protected] Introduction: To investigate the efficacyof interferon (IFN) monotherapy or in combination with nucleos(t)ide analogs (NA) in pediatric patients with chronic hepatitis B (CHB), in the immunotolerant phase. Material and Methods: Ninety-sevenchildren with CHB (HBeAgpositive and HBV-DNA-positive) aged <18 yrs in the immunoS280

tolerant phase were included in the analysis. Immunotolerance was defined as low necroinflammatory activity (G ≤ 1 on liver biopsy, Scheuer score) and ALT <2×ULN (40 IU/L). Patients with HBV-DNA >7 log IU/mL received IFN (IFNa 3–5 MIU/m2 × body surface area once daily, PegIFNa-2a 104 mg/m2 /wk or PegIFNa-2b 1.5 mg/m2 /wk) plus lamivudine (3 mg/kg/day) or adefovir (2–6 yrs: 0.3 mg/kg/day; 7–11 yrs: 0.25 mg/kg/day; >12 yrs: 10 mg/day). Patients with HBV-DNA ≤7 log IU/mL received IFN monotherapy for 12 wks; if, at Wk 12, HBV-DNA declined ≥2 log IU/mL, treatment was continued, but if HBV-DNA declined <2 log IU/mL, patients received IFN plus lamivudine or adefovir. Treatment duration ranged between 72–144 weeks, with a follow-up period of 24 wks post-end of treatment (EOT). Results: Majority of patients were male (69%) with a mean age of 7.8 years and mean HBV-DNA of 8.76 IU/mL. Eighteen patients (18.6%) received IFN-monotherapy and 79 (81.4%) received IFN/NA combination therapy. At baseline, 39 (40%) patients had ALT levels
Journal of Hepatology 2015 vol. 62 | S263–S864