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San Giovanni Rotondo, Italy

Lawitz E.,University of Texas Health Science Center at San Antonio | Mangia A.,Casa Sollievo della Sofferenza Hospital | Wyles D.,University of California at San Diego | Rodriguez-Torres M.,Fundacion de Investigacion | And 19 more authors.
New England Journal of Medicine | Year: 2013

BACKGROUND: In phase 2 trials, the nucleotide polymerase inhibitor sofosbuvir was effective in previously untreated patients with chronic hepatitis C virus (HCV) genotype 1, 2, or 3 infection. METHODS: We conducted two phase 3 studies in previously untreated patients with HCV infection. In a single-group, open-label study, we administered a 12-week regimen of sofosbuvir plus peginterferon alfa-2a and ribavirin in 327 patients with HCV genotype 1, 4, 5, or 6 (of whom 98% had genotype 1 or 4). In a noninferiority trial, 499 patients with HCV genotype 2 or 3 infection were randomly assigned to receive sofosbuvir plus ribavirin for 12 weeks or peginterferon alfa-2a plus ribavirin for 24 weeks. In the two studies, the primary end point was a sustained virologic response at 12 weeks after the end of therapy. RESULTS: In the single-group study, a sustained virologic response was reported in 90% of patients (95% confidence interval, 87 to 93). In the noninferiority trial, a sustained response was reported in 67% of patients in both the sofosbuvir-ribavirin group and the peginterferon-ribavirin group. Response rates in the sofosbuvir-ribavirin group were lower among patients with genotype 3 infection than among those with genotype 2 infection (56% vs. 97%). Adverse events (including fatigue, headache, nausea, and neutropenia) were less common with sofosbuvir than with peginterferon. CONCLUSIONS: In a single-group study of sofosbuvir combined with peginterferon-ribavirin, patients with predominantly genotype 1 or 4 HCV infection had a rate of sustained virologic response of 90% at 12 weeks. In a noninferiority trial, patients with genotype 2 or 3 infection who received either sofosbuvir or peginterferon with ribavirin had nearly identical rates of response (67%). Adverse events were less frequent with sofosbuvir than with peginterferon. (Funded by Gilead Sciences; FISSION and NEUTRINO ClinicalTrials.gov numbers, NCT01497366 and NCT01641640, respectively.) Copyright © 2013 Massachusetts Medical Society.

Buzzonetti L.,Bambino Gesu Childrens Hospital | Laborante A.,Casa Sollievo della Sofferenza Hospital | Petrocelli G.,Bambino Gesu Childrens Hospital
Journal of Cataract and Refractive Surgery | Year: 2010

We describe a variant of the big-bubble technique in deep anterior lamellar keratoplasty (DALK) assisted by the IntraLase femtosecond laser, which we call IntraBubble. The use of the 60 kHz IntraLase femtosecond laser allows dissection of the pre-Descemet-plane lamella to a predefined corneal depth and creation of a channel in the posterior stroma 50 μm above the endothelium into which a smooth cannula for air injection can be introduced. We lengthened the channel created by the laser using a pointed dissector. Eleven consecutive patients with keratoconus were treated, and all procedures were completed as DALK. The big bubble was achieved in 8 eyes (73%). In 3 cases (27%), intraoperative microperforations occurred and the procedures were completed with hand dissection without complications. This new application of femtosecond laser technology could lead to standardization of the big-bubble technique in DALK. © 2010 ASCRS and ESCRS.

Farci P.,National Institute of Allergy and Infectious Diseases | Niro G.,Casa Sollievo della Sofferenza Hospital
Seminars in Liver Disease | Year: 2012

Hepatitis D is caused by infection with hepatitis D virus (HDV), a defective RNA virus that requires the obligatory helper function of hepatitis B virus (HBV) for its in vivo transmission. Thus, HDV is acquired only by coinfection with HBV or by superinfection of an HBV carrier. The clinical outcome of hepatitis D differs according to the modality of infection. Whereas coinfection evolves to chronicity in only 2% of the cases, superinfection results in chronic infection in over 90% of the cases. HDV is a highly pathogenic virus that causes acute, often fulminant hepatitis, as well as a rapidly progressive form of chronic viral hepatitis, leading to cirrhosis in 70 to 80% of the cases. The clinical picture of HDV disease is evolving as a consequence of a significant change in the epidemiology of HDV infection, which has led to a significant decline in incidence in Western countries, mainly as a result of universal HBV vaccination programs. However, in the face of a declining prevalence in areas of old endemicity like Europe, immigration poses a threat of HDV resurgence. The interaction of HDV with other hepatitis viruses or human immunodeficiency virus is complex and may lead to different patterns in terms of virologic expression and immunologic responses. Multiple viral infections are associated with rapid progression of liver fibrosis and eventually with the development of hepatocellular carcinoma. Hepatitis D is not a vanishing disease, and continuous efforts should be made to improve its prevention and treatment. Copyright © 2012 by Thieme Medical Publishers, Inc.

Niro G.A.,Casa Sollievo della Sofferenza Hospital | Smedile A.,University of Turin
Current Infectious Disease Reports | Year: 2012

Hepatitis delta virus (HDV) is a unique human virus, showing similarities with plant viroids. Although impressive knowledge on virus structure and replication has been achieved, several questions like HBV/HDV interaction and post translational modifications of HD antigens remain to be answered. Potential targets for therapeutic strategies are now emerging. To date, eight major genotypes of the HDV have been identified. The HDV-1 is the prevailing genotype in Europe, but migration phenomena may change this profile. Immune response is likely to play an important role in the pathogenesis of HDV-induced liver disease; few data are available on T cells response either during infection and therapy. HDV usually suppresses HBV replication; recent studies show as viral dominances may change over time. Delta infection leads to severe liver disease, with different patterns of progression to liver fibrosis and decompensation. Beside the association between HDV/HBV and HCC is demonstrated a risk specifically related to HDV remains controversial. © 2011 Springer Science+Business Media, LLC.

Cascavilla N.,Hematology and Stem Cell Transplantation Unit | Bisceglia M.,Casa Sollievo della Sofferenza Hospital | D'Arena G.,Hematology and Stem Cell Transplantation Unit
International Journal of Immunopathology and Pharmacology | Year: 2010

We report a 50-year-old man who presented with a 5-year history of an intermittent widespread pruritic urticarioid rash and fever, fatigue, arthralgia and a monoclonal immunoglobulin-M paraprotein. The patient was initially treated with antihistamines and corticosteroids without the disappearance of symptoms. A skin biopsy from the urticarial rash on the thorax was performed, revealing dermal mononuclear and polymorphonuclear cell infiltrate and normal epidermis. A diagnosis of Schnitzler's syndrome (SS), a rare disorder in which the simultaneous occurrence of monoclonal gammopathy and chronic urticaria is usually observed, was made. After an unsuccessful trial with rituximab at a dosage of 375 mg/sqm weekly for 4 consecutive weeks, the patient was treated with anakinra, an inhibitor of interleukin-1α that is thought to be involved in the pathogenesis of the disease, at a dose of 100 mg daily given subcutaneously. He showed a prompt response to the drug and he is still well and symptom-free after 12 months of follow-up. On the basis of both this experience and the review of the literature we conclude that anakinra may be a promising option for the treatment of SS. However, these results need to be confirmed on a larger number of patients. Copyright © by BIOLIFE, s.a.s.

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