المؤلفون: Adinolfi, L.E., Utili, R., Tonziello, A., Ruggiero, G.

المصدر: Gut. May2003, Vol. 52 Issue 5, p701. 5p. 3 Charts.

مصطلحات موضوعية: *HEPATITIS C treatment, *INTERFERONS, *RIBAVIRIN

مستخلص: Background: Fifty per cent of chronic hepatitis C patients are non-responders to interferon. At present, there are no recommended therapeutic options for non- responders. Aims: The safety and long term effect of alpha interferon induction plus ribavirin with or without amantadine in the treatment of interferon non- responsive chronic hepatitis C was evaluated. Patients and methods: A total of 114 consecutive patients were randomly divided into three groups with a final 2:2:1 ratio: group A (44 patients) received interferon alfa 2b, 3 million units (MU), three times a week, and oral ribavirin (1000 mg/day); group B (46 patients) received interferon 3 MU daily for the first four weeks and subsequently 3 MU three times a week, and ribavirin as in regimen A; and group C (24 patients) received interferon and ribavirin as in regimen B, plus oral amantadine hydrochloride (200 mg/day). The duration of treatment was 12 months. Results: The end of treatment response for groups A and B was 25% and 29%, respectively, and for group C, 68% (p<0.005). At the end of one year of follow up, a sustained response was observed for six (25%) patients in group C, one (2%) patient in group A, and two (4%) patients in group B (p<0.002). The triple regimen was well tolerated and did not increase the frequency or severity of side effects. Conclusions: The study demonstrates that for the treatment of interferon non-responder hepatitis C patients, the association of interferon-ribavirin has a negligible long term effect whereas a triple regimen including interferon, ribavirin, and amantadine can be an effective and safe treatment. [ABSTRACT FROM AUTHOR]

المؤلفون: Durante-Mangoni, E.^1,2 emanuele.durante@unina2.it, Ragone, E.^1,2, Pinto, D.^1,2, Iossa, D.^1,2, Covino, F.E.³, Maiello, C.³, Utili, R.^1,2

المصدر: Transplantation Proceedings. Jan2011, Vol. 43 Issue 1, p299-303. 5p.

مصطلحات موضوعية: *HEPATITIS C treatment, *INTERFERONS, *HEART transplant recipients, *RIBAVIRIN, *DRUG efficacy, *HEALTH outcome assessment, *TREATMENT duration, *ECHOCARDIOGRAPHY

مستخلص: Abstract: Background/aim: The combination of pegylated interferon (PEG-IFN) and ribavirin (RBV) is the current treatment for chronic hepatitis C (CHC). The treatment is thought to suppress viral replication and induce viral clearance via immunomodulatory effects. For this reason, concern exists for the use of this treatment in recipients of a solid organ transplantation. We sought to evaluate the safety and efficacy of PEG-IFN/RBV in heart transplant recipients with CHC. Methods: From June 2005 to September 2009, we treated three CHC patients with heart transplantation. PEG-IFN alpha2b and RBV doses and treatment duration were set according to the hepatitis C virus (HCV) genotype and body weight as per current recommendations. Dose reductions were dictated by individual patient tolerability. Cardiac safety was monitored by clinical examinations, echocardiography, and measurement of troponin I and B-type natriuretic peptide, as well as endomyocardial biopsies. Results: All three patients, displayed HCV genotype 1b infection, viral loads of >5 logs, and a Scheuer fibrosis score ≥ 2. Two of them completed the prescribed treatment course becoming sustained virological responders. The other patient had an initial complete virological response, but subsequently experienced a viral breakthrough after reduction of PEG-IFN and withdrawal of RBV due to severe anemia. We observed no cardiovascular adverse events nor rejection episodes. Posttreatment clinical history and examination, electrocardiography, and echocardiography did not show any sign of graft dysfunction. Conclusions: Treatment with PEG-IFN/RBV may be safely offered to stable heart transplant recipients with CHC and signs of liver disease progression. Close monitoring of treatment safety is mandatory. [Copyright &y& Elsevier]

المؤلفون: Marrone, A.¹ aldo.marrone@unina2.it, Zampino, R.¹, Portella, G.², Grimaldi, M.², Mangoni, E. D.¹, Santarpia, L.¹, Ruggiero, G.¹, Utili, R.³

المصدر: Journal of Viral Hepatitis. Mar2005, Vol. 12 Issue 2, p186-191. 6p.

مصطلحات موضوعية: *INTERFERONS, *HEPATITIS B, *ANTINEOPLASTIC agents, *LYMPHOKINES, *GLYCOPROTEINS, *ANTIVIRAL agents, *LIVER diseases

مستخلص: Alpha-interferon (IFN) or lamivudine monotherapy are ineffective in treating chronic HBeAg positive patients with high viral load and low alanine aminotransferase (ALT) levels. We investigated whether priming lamivudine treatment might enhance the antiviral and immunostimulant action of lamivudine/IFN combination in young tolerant patients. Eleven chronic HBeAg positive patients received: 100 mg/day lamivudine for 3 months followed by IFN 5 MU/m2/tiw with lamivudine 100 mg/day for 6 months and then lamivudine alone 100 mg/day for 9 months. Quantitative hepatitis B virus (HBV)-DNA was evaluated during treatment and core-promoter, precore and polymerase HBV mutants were detected by direct sequencing at the end of therapy. Serum HBV-DNA levels dropped during lamivudine monotherapy and in combination with IFN. After IFN withdrawal, viraemia transiently increased to high levels in five of 11 (45%) patients who showed rt M204V/I lamivudine mutant resistant. Two patients cleared HBeAg without anti-HBe seroconversion. One patient presented core-promoter (A1762T/G1764A) and precore stop codon mutations. Hence, three-phase sequential combined lamivudine/IFN treatment reduced HBV-DNA serum level, but did not lead to HBeAg and HBV-DNA clearance in these highly viraemic, normal ALT patients. Lamivudine/IFN combination did not prevent the emergence of YMDD lamivudine resistance. New schedules of antiviral treatments must be evaluated in this population at risk of disease progression. [ABSTRACT FROM AUTHOR]

المؤلفون: Zampino, R¹, Marrone, A¹, Cirillo, G², del Giudice, E. Miraglia², Utili, R¹, Karayiannis, P³, Liang, T. J⁴, Ruggiero, G¹

المصدر: Journal of Viral Hepatitis. May2002, Vol. 9 Issue 3, p183-188. 6p.

مصطلحات موضوعية: *HEPATITIS B, *VIRAL hepatitis, *INTERFERONS

مستخلص: We analysed the hepatitis B virus (HBV) core-promoter (CP) and precore (PC) regions before, during and after interferon treatment in young Caucasian cancer survivors who had acquired HBV infection during chemotherapy for malignancies. Fourteen patients with chronic hepatitis B [hepatitis B e antigen (HBeAg) /HBV-DNA positive] received α-2a interferon (IFN), 5 MU/m2 t.i.w. for 12 months. HBV CP and PC region sequences were analysed following polymerase chain reaction (PCR) amplification. Sera from responders were studied at: T0 (before starting IFN), T1 [at alanine aminotransferase (ALT) peak preceding HBeAg seroconversion], T2 (at ALT normalization), T3 (at end of IFN) and T4 (at one year after IFN) and in nonresponders at time points T0 , T3 and T4 . Amplified HBV-DNA was cloned and sequenced automatically. Six of 14 patients (43%) responded to IFN treatment. Five of the six (83%) responders displayed the double CP mutation A1762T/G1764A always in association with a T1753C change. None of the nonresponders showed these mutations at any time point. The G1896A change creating the PC stop codon mutation was never detected in any of the patients. In our cancer survivors, IFN-induced HBeAg/anti-HBe seroconversion appeared to correlate with CP mutations and was not influenced by previous chemotherapy. These mutations in addition to low HBV DNA levels and elevated ALT can be considered favourable factors of response to IFN-induced anti-HBe seroconversion. [ABSTRACT FROM AUTHOR]