Leukocyte interferon-α and ribavirin for treatment of chronic hepatitis C patients intolerant to pegylated-interferon

Adinolfi, Luigi Elio; Durante‐Mangoni, Emanuele; Salzillo, Marta; Marrone, Aldo; Tripodi, Marie‐Francoise; Restivo, Luciano; Merola, A.; Zampino, Rosa; Ruggiero, Giuseppe

doi:10.1007/s11739-009-0290-z

Cited by 3 publications

(3 citation statements)

References 14 publications

(24 reference statements)

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“…First, DM adversely affects the HCV patients and is associated with increased liver steatosis and fibrosis [24]. Secondly, HCV patients associated with DM are less responsive to interferon therapy [25] and showed an increased prevalence of liver cancer [26].…”

Section: Discussionmentioning

confidence: 99%

Tumor Necrosis Factor-a and Iron Overload Are Associated with Insulin Resistance in Hepatitis C in Egyptian Patients

Hassan¹,

Mohamed²,

Ahmed³

et al. 2010

Am. J. Biomed. Sci.

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Background: There are evidences of an increased incidence of insulin resistance (IR) in patients with hepatitis C virus infection. Several mechanisms have been proposed to explain the increased IR in hepatitis C.Aims: To evaluate tumor necrosis factor-alpha (TNF- and iron overload as potential mediators of IR development in chronic HCV patients.Patients and Methods: Study groups consisted of four groups: patients with HCV infection (n = 35), patients with hepatitis C and diabetes mellitus (HCV+DM) (n = 31), patients with DM (n = 36), and healthy controls (n = 30). The homeostatic model assessment (HOMA) was the criteria used to quantify the degree of IR.Results: HOMA indices were significantly higher in the HCV, HCV+DM and DM groups compared to the healthy controls (P < 0.001 for each). TNF-α was significantly higher in HCV and HCV+DM groups compared with DM and healthy controls (P < 0.001 for each). TNF- was significantly higher in HCV+DM group compared with HCV group (P < 0.05). Furthermore, TNF-α was positively correlated with HOMA indices in HCV and HCV+DM groups (r= ~ +0.900, P < 0.001). Serum ferritin had a positive correlation with HOMA indices in HCV and HCV+DM groups (r= ~ +0.800, P < 0.001).Conclusion: TNF- and iron overload may explain in part the development of IR in chronic HCV patients.

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Section: Discussionmentioning

confidence: 99%

Tumor Necrosis Factor-a and Iron Overload Are Associated with Insulin Resistance in Hepatitis C in Egyptian Patients

Hassan¹,

Mohamed²,

Ahmed³

et al. 2010

Am. J. Biomed. Sci.

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“…The current standard of care, pegylated interferons (peg‐IFNs) in combination with ribavirin, is suboptimal, with fewer than 50% of HCV genotype‐1 patients achieving a sustained viral response (SVR). Furthermore, adverse events that require premature withdrawal from therapy are reported in 10% to 14% of participants in peg‐IFNs registration trials 7 . An additional 60% of HCV patients are ineligible for therapy because of contraindications.…”

Section: Aims: a Prototypementioning

confidence: 99%

“…Furthermore, adverse events that require premature withdrawal from therapy are reported in 10% to 14% of participants in peg-IFNs registration trials. 7 An additional 60% of HCV patients are ineligible for therapy because of contraindications. New effective and tolerable treatments are needed for patients who do not achieve SVR or are not able to undergo or tolerate the standard-ofcare treatment.…”

Section: Aims: a Prototypementioning

confidence: 99%

Antiviral Information Management System (AIMS): A Prototype for Operational Innovation in Drug Development

Jadhav

Neal

Florian

et al. 2010

The Journal of Clinical Pharma

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This article presents a prototype for an operational innovation in knowledge management (KM). These operational innovations are geared toward managing knowledge efficiently and accessing all available information by embracing advances in bioinformatics and allied fields. The specific components of the proposed KM system are (1) a database to archive hepatitis C virus (HCV) treatment data in a structured format and retrieve information in a query-capable manner and (2) an automated analysis tool to inform trial design elements for HCV drug development. The proposed framework is intended to benefit drug development by increasing efficiency of dose selection and improving the consistency of advice from US Food and Drug Administration (FDA). It is also hoped that the framework will encourage collaboration among FDA, industry, and academic scientists to guide the HCV drug development process using model-based quantitative analysis techniques.

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Natural leukocyte interferon alpha (Alfaferone) combined with ribavirin in the treatment of patients with HCV-related cirrhosis: our experience

et al. 2011

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BackgroundThe aim of the study was to evaluate the efficacy and safety of combined treatment with natural leukocyte interferon alpha (Alfaferone) plus ribavirin in patients with HCV-related cirrhosis.Patients and methodsTwenty-three patients (15 women, 8 men) aged 17–68 years hospitalized in 2005–2008 were included in the study. Seventeen patients who qualified for treatment were Child-Pugh class A patients and 6 others were class B. Seventeen patients had genotype 1b and 6 genotype 3a infection. Thirteen patients were naïve, retherapy concerned 8 patients, and in two cases the continuation of treatment had been stopped because of adverse events following the use of pegylated interferons. The treatment was continued for 48 weeks regardless of HCV genotype. Normalized AlAT activity (<40 U/l) was the measure of biochemical efficacy of the treatment, while virological efficacy was reflected by an undetectable viral load in plasma. Both measurements were conducted immediately after the end of treatment (EOT) and after a 6-month follow-up period (SVR). Therapeutic safety was evaluated by the monitoring of the adverse events of the treatment.ResultsAbnormal AlAT levels prior to treatment were detected in 20/23 patients. During therapy normalized levels were achieved in 50% of them, and after 6 months they were sustained in 9/20. EOT was achieved in 6/19 patients and SVR in 3 patients. Mild psychiatric disorders were the most frequently detected adverse events (12 patients). Thrombocytopenia and leucopenia existing prior to treatment did not intensify during the treatment. Severe adverse events caused by the drug resulted in the discontinuation of treatment in three patients (urinary tract infections, depression, myasthenia gravis), of whom two patients were Child-Pugh class A and one was class B. In one patient treatment was discontinued because of HCC.ConclusionNatural leukocyte interferon alpha is well tolerated by patients with HCV-related cirrhosis and coexisting thrombocytopenia and leucopenia.

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Leukocyte interferon-α and ribavirin for treatment of chronic hepatitis C patients intolerant to pegylated-interferon

Cited by 3 publications

References 14 publications

Tumor Necrosis Factor-a and Iron Overload Are Associated with Insulin Resistance in Hepatitis C in Egyptian Patients

Tumor Necrosis Factor-a and Iron Overload Are Associated with Insulin Resistance in Hepatitis C in Egyptian Patients

Antiviral Information Management System (AIMS): A Prototype for Operational Innovation in Drug Development

Natural leukocyte interferon alpha (Alfaferone) combined with ribavirin in the treatment of patients with HCV-related cirrhosis: our experience

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