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Background & Aims: Chronic hepatitis D (delta) is a major global health burden. Clinical and virological characteristics of patients with hepatitis D virus (HDV) infection and treatment approaches in different regions world-wide are poorly defined., Methods: The Hepatitis Delta International Network (HDIN) registry was established in 2011 with centres in Europe, Asia, North- and South America. Here, we report on clinical/ virological characteristics of the first 1576 patients with ongoing or past HDV infection included in the database until October 2016 and performed a retrospective outcome analysis. The primary aim was to investigate if the region of origin was associated with HDV replication and clinical outcome., Results: The majority of patients was male (n = 979, 62%) and the mean age was 36.7 years (range 1-79, with 9% of patients younger than 20 years). Most patients were HBeAg-negative (77%) and HDV-RNA positive (85%). Cirrhosis was reported in 48.7% of cases which included 13% of patients with previous or ongoing liver decompensation. Hepatocellular carcinoma (HCC) developed in 30 patients (2.5%) and 44 (3.6%) underwent liver transplantation. Regions of origin were independently associated with clinical endpoints and detectability of HDV RNA. Antiviral therapy was administered to 356 patients with different treatment uptakes in different regions. Of these, 264 patients were treated with interferon-a and 92 were treated with HBV-Nucs only., Conclusions: The HDIN registry confirms the severity of hepatitis delta but also highlights the heterogeneity of patient characteristics and clinical outcomes in different regions. There is an urgent need for novel treatment options for HDV infection., (© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Direct antiviral agents (DAA) showed very good results in terms of efficacy and safety in clinical trials, but real-life data are still needed in order to confirm this profile., Material and Methods: In Romania, through a nationwide government-funded programme in 2015-2016, approx.5800 patients with virus C cirrhosis received fully reimbursed DAA therapy with OBV/PTV/r+DSV+RBV for 12 weeks. We analysed a national prospective cohort enrolling the first 2070 patients, all with genotype 1b. The only key inclusion criteria was advanced fibrosis (Metavir stage F4) confirmed by Fibromax testing (or liver biopsy/Fibroscan). Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12)., Results: Forty patients stopped the treatment because of hepatic decompensation (1.9%), 21 stopped because of other adverse events and one was lost to follow-up. This cohort was 51% females, mean age 60 years (25÷82), 67% pretreated, 70% associated NASH, 67% with severe necro-inflammation (severity score 3-Fibromax), 37% with comorbidities, 10.4% with Child Pugh A6, 0.5% B7. The median MELD score was 8.09 (6 ÷ 22). SVR by intention-to-treat was reported in 1999/2070(96.6%), 55/2070 failed to respond. Liver decompensation was statistically associated in multivariate analysis with platelets< 10 5 /mm 3 (P = .03), increased total bilirubin (P < .001), prolonged INR (P = .02), and albumin<3.5 g/dL (P = .03)., Conclusions: OBV/PTV/r+DSV+RBV proved to be highly efficient in our population of cirrhotics with a 96.6% SVR. Serious adverse events related to therapy were reported in 61/2070(2.9%), most of them liver decompensation (1.9%), related to hepatic dysfunction, and lower platelet count., (© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

With the introduction of direct acting antivirals in the therapeutic armamentarium of hepatitis C (HCV), policy makers have set criteria for treatment eligibility. In Romania, the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir is reimbursed for F4 fibrosis on liver biopsy/Fibromax, or F3 with contraindication to interferon (IFN). Our aim was to assess treatment eligibility and discordance between serological, elastometric and imaging evaluation of fibrosis in a cohort of patients with HCV. We evaluated both newly diagnosed and previously known HCV patients with advanced fibrosis, from our database, during a period of 7 months, between November 1st, 2015 and May 31st, 2016. Clinical, biological, ultrasound, elastography and endoscopy data were collected. Altogether 146 patients were assessed for treatment eligibility. Among them, 61% were females, with a mean age of 60 ± 8 years. Regarding treatment status, 52.5 % were naive, 27.4% nonresponders, 17.81% relapsers and 2.74% intolerant to bitherapy. 54.8% had elevated alpha-fetoprotein and were checked by advanced imaging for exclusion of hepatocellular carcinoma (HCC) - of them, 8 were diagnosed with HCC. On ultrasound, almost 1/2 patients had dilated splenoportal axis and at endoscopy 42% had esophageal varices. Transient elastography (Fibroscan) was done in 88/146 patients: 82.95% were F4, 1.14% F3-F4, 9.09% F3 and 6.82%