S. Camera

Prevalence of and risk factors for HBV infection in a metropolitan Southern Italian area: Evidence for the effectiveness of universal Hepatitis B vaccination

BACKGROUND Available data on HBV prevalence in Italy are outdated and assessed with studies conducted in small towns. We aimed to evaluate prevalence of and risk factors for HBV infection in the metropolitan area of Naples, 24 years after the introduction of mass vaccination campaign against Hepatitis B in Italy. METHODS A random systematic sample of the adult general population of Naples was selected from the register of 3 general practitioners in 3 different socio-economic districts. Independent predictors of the likelihood of HBV infection were identified by logistic regression analysis. RESULTS Among 900 selected subjects, 772 (85.8%) participated in the study. The overall HBsAg and anti-HBc prevalences were 1.7% and 14.4%, respectively. Both markers were more likely detected in the district at low socioeconomic status than in those at medium-high status (p<0.01). Anti-HBc prevalence linearly increased from 0% in subjects 30 years old or younger to 28.0% in those older than 60 years of age (p<0.01). At multivariate analysis, age >60 years (OR3.38; 95%CI:1.98-5.74), low socioeconomic district of residence (OR3.26; 95%CI:1.72-6.18), and low educational qualification (OR2.73; 95%CI:1.45-5.16) were independent predictors of anti-HBc positivity. CONCLUSION Differences in socioeconomic conditions have played a major role in the past spread of HBV infection in Naples. Hepatitis B vaccination has resulted very effectively in preventing HBV infection, regardless of the district of residence, as none of the subjects in the vaccinated cohorts was exposed to the infection.

Impact of Telaprevir in HCV Patients with Cirrhosis and RVR: Real-Life Data from Boceprevir or Telaprevir based “Triple Therapy” Experience in Southern Italy

Background and Rationale of Study: The real-life data of triple therapy-based treatment in patients with chronic hepatitis C were investigated in this survey of 12 clinical centers of southern Italy. This retrospective study analyzed data from 176 consecutive patients. METHODS 125 (70%) patients were treated with telaprevir, and 51(30%) with boceprevir. There were no differences in demographic characteristics between the groups. The degree of Liver Fibrosis (LF) was evaluated according to Liver Biopsy (LB) and/or Transient Elastography (TE). 53/176 patients (30%) had liver cirrhosis. Sixteen patients (9%) were treatment naïve, and the remaining were not: 92 were non-responders (52, 84%), 63 relapsed (35,79%), and 5 discontinued treatment (2, 8%). RESULTS Overall, the rapid Virological Response (RVR) rate was 67.6%. Of the 103 patients who had follow-up for at least 12 weeks after the end of treatment, 61 (59, 2%) achieved a Sustained Virological Response (SVR). According to multivariate analysis for SVR, RVR was the only independent predictive factor of SVR, irrespective of the degree of LF and the type of response to previous treatments. In telaprevir-treated patients, the rate of RVR was similar in patients with F0-F2, F3 and F4 fibrosis (85%, 84%, 78%, respectively), and the SVR rates among RVR patients was similar irrespective of LF. CONCLUSIONS Data from this real-life study confirm the efficacy reported in clinical trials, although cirrhosis appears to play a smaller role in influencing treatment efficacy. Moreover, RVR is the only independent predictive factor of response regardless of cirrhosis. Based on RVR and for patients with cirrhosis, a shorter therapy might be considered, at least with telaprevir-based therapy.

Optimization of direct anti-viral agent treatment schedule: Focus on HCV genotype 3

Background and aim Direct antiviral agents (DAAs) have led to high sustained virological responses (SVR) in hepatitis C virus (HCV) patients. However, genotype 3 patients respond to treatment in a suboptimal way. This study aims to identify which of the several treatment schedules recommended for genotype 3 would constitute the best option. Methods Twenty-four Italian centers were involved in this real-life study of HCV genotype 3 patients treated with DAAs. To expand the number of cases, we conducted a systematic review of the literature on the outcome of genotype 3 patients treated with DAAs. Results A total of 233 patients with HCV genotype 3 were enrolled. Cirrhotic patients accounted for 83.7%. Overall, the SVR12 rate was achieved by 205 patients (88.0%); the SVR rates were 78.8% after sofosbuvir/ribavirin, 92.5% after sofosbuvir/daclatasvir ± ribavirin, and 100% after sofosbuvir/ledipasvir (seven patients). No difference in rate of SVR was observed in cirrhotic and non-cirrhotic patients (92.2 vs 94.4) using a combination regimen of NS5A and NS5B inhibitors. The systematic review of the literature provided data of 3311 patients: The mean weighted SVR12 rate was 84.4% (CI: 80.4–87.8); the rates varied from 79.0% (CI: 70.9–85.3) with sofosbuvir/ribavirin, to 83.7% (CI: 66.2–93.1) with sofosbuvir/ledispavir, and to 88.2% (CI: 83.3–91.7) with sofosbuvir/daclatasvir. Conclusions Our results reinforce the concept that patients with HCV genotype 3 should no longer be considered difficult-to-treat individuals. The optimal therapeutic regimen for these patients appears to be the combination sofosbuvir/daclatasvir, administered for 12 weeks without the use of RBV in non-cirrhotic patients. In cirrhotics the meta-analytic approach suggests extending therapy to 24 weeks.

Eradication of HCV in Renal Transplant Recipients and Its Effects on Quality of Life

Background The use of direct antiviral agents (DAA) has radically modified the course of HCV hepatitis in renal patients. Aim of this study was to assess the effects of HCV eradication on quality of life (QOL) in renal transplant recipients (RTR), measured by CLDQ and SF-36. Methods Sixteen RTR with well preserved GFR (mean: 60.3±19.3 ml/min) and chronic HCV infection with moderate liver stiffness (9.3±1.7 kPa) were given a sofosbuvir-based regimen for 12 weeks and had a 1 year follow-up. Results At end of treatment (EOT) a complete viral clearance was observed in all the patients, with normalization of most laboratory data and a consistent reduction in liver stiffness. All these parameters remained stable after 1 year, as well as renal function and proteinuria. Questionnaire data showed consistent amelioration in different “emotional” domains at EOT, which persisted after 1 year and were associated with a globally improved QOL, although there was no change in most of the “physical” domains in both questionnaires. One patient under ribavirin developed an acute anemia and withdrew from the study, but no further adverse episode was observed throughout the study. Conclusions Our data, while confirming the efficacy of oral DAA, show that HCV infection represents a heavy psychological burden in renal transplant recipients, greatly alleviated by viral eradication, which determines a significant improvement in QOL that represents an important outcome in management of all transplant recipients. This trial is registered with ISRCTN97560076.

Efficacy and safety of percutaneous laser ablation therapy for treatment of large HCC

of the 49th A.I.S.F. Italian Association for the Study of the Liver Annual Meeting 2016 in Rome, 18 19 February 2016 Percutaneous laser thermal ablation (LA) represents one of currently available locoablative techniques for the treatment of hepatocellular carcinoma (HCC). This study aimed to analyze the efficacy and safety of LA in patient with large HCC. Between January 2009 and December 2012, 53 cirrhotic patients (40/13 Male/Female; mean age 70, range 51–84 yrs; Child-Pugh A/B: 48/5, BCLC stage A/B: 29/24) with at least one nodule of HCC ≥ 40 mm treated with LA were enrolled at the Liver Unit of the “Cardarelli” Hospital of Naples. Forty-one patients (77%) had a single nodule HCC, while 12 patients (23%) had a multinodular HCC. The median size of the main HCC nodule was 50 mm (range 40–75 mm). Response to therapy was evaluated with imaging techniques according to the mRECIST criteria. Survival was calculated from the time of cancer diagnosis to death with values censored at the date of the last follow-up. Thirty-five patients (66%) showed a complete response to LA, while only 18 patients (34%) showed a partial response; none showed stable or progressive disease after treatment. The therapeutic efficacy was similar in nodules sized 40–50 mm in comparison to those larger than 50 mm. The cumulative survival rates were 85.8% and 56.6% at 12 and 36 months, respectively. The disease recurrence was observed in 13 patients (24%) after a median time of 16 months (range 5–40). The recurrence was not related to the size of main HCC nodule. According to safety analysis, only 3 patients (<5%) showed post-ablation complications: fever and mild abdominal pain for a period of at least 10 days. In one patient the fever was associated with ascites and pleural effusion, both successfully treated with diuretic therapy. LA could be considered an efficacious and safe therapeutic option in patients with difficult to treat large HCC. Published on “Digestive and Liver Disease”, an International Journal of Gastroenterology and Hepatology, Vol. 48 Supplement 1 (2016) S. Camera1, G.G. Di Costanzo2, R. Tortora2, L. Addario2, F. Lampasi2, M.T. Tartaglione2, V. Cossiga1, L. Donnarumma1, N. Caporaso1, F. Morisco1 1Dipartimento di Medicina Clinica e Chirurgia, Università “Federico II”, Napoli, Italy 2Unità di Epatologia, AORN “Cardarelli”, Napoli, Italy Ultrasound-guided Laser Thermal Ablation for the Treatment of High-risk sites of Small Liver Cancer

P.1.18: LONG-TERM HCV-ERADICATION. A 20 YEARS CLINICAL, VIROLOGICAL AND BIOCHEMICAL PROSPECTIVE STUDY

Background and aim: In patients with chronic hepatitis C, therapy is considered effective when the sustained virological response (SVR) is achieved. SVR is defined as HCV-RNA negativity in serum 6 months after the end of therapy. Although the persistence of HCV eradication in short or medium-term period (3-5 years) is wellestablished, data about the long-term follow-up are still uncertain. The aim of the study was to evaluate the long-term persistence of HCV eradication in patients with chronic hepatitis C (CHC) who obtained SVR. In particular, we wanted to assess the risk of long-term virological relapse and liver related-complications. Material and methods: From January 1989 to Aprill 2008, 150 consecutive subjects (M/F 100/50, median age 47.69 years, range 22-67) with CHC and SVR after interferon-based therapy, were enrolled in a long-term follow-up study. 137 patients had pre-treatment diagnosis of CHC and 13 patients had cirrhosis. All of the patients received interferon-based therapy, with or without Ribavirin (66 with conventional IFN-monotherapy, 25 with conventional IFN and ribavirin, and 59 with pegylated IFN and ribavirin).The patients were followed with clinical, biochemical, virological and ultrasonographic assessments every 6 months until the 3th year of follow-up and than every 12 months. HCV-RNA assessment in serum was determined by quantitative RT-PCR. Results: The median follow-up was 8.6 years (range: 2-19.8 years). Serum HCV-RNA remained undetectable in all patients, indicating no risk of HCV recurrence, independently from the schedule of therapy used.During the observation period 3 liver-related complications (2 HCC, 1 variceal bleeding) were observed. The incidence rate of complications was 0.23%/person/year. All 3 of the events occurred in patients with pre-treatment cirrhosis. Only 1 out of 150 patients deceased for liver-related causes (HCC) with a mortality rate of 0.077%/person/year Conclusions: In this cohort of CHC patients with SVR, the eradication of the virus lasted up to 20 years after treatment. Thus, patients with CHC and SVR show an excellent prognosis with no risk of viral recurrence and a very low rate of mortality, meaning that they can be considered healed. Patients with pre-treatment evidence of cirrhosis show a rate of liver complications that cannot be neglected.