Efficacy and Safety of Combination Therapy of Natural Human Interferon Beta and Ribavirin in Chronic Hepatitis C patients
ABSTRACT The aim of this study was to evaluate the efficacy and safety of combination therapy of natural human interferon-beta and ribavirin for patients for whom prior interferon therapy was discontinued due to depression induced by interferon-alpha.
Inclusion criteria were as follows; 1) HCV-genotype 1b, 2) serum HCV RNA level of ≥100 KIU/mL, 3) stopping the prior interferon-alpha monotherapy or combination therapy of interferon-alpha and ribavirin due to the appearance of depression. A total of 14 were enrolled in this prospective cohort study. The treatment period of combination therapy was 48 weeks. Depression states, reflected by Beck depression inventories and Hamilton depression rating scale, were assessed during combination therapy. Nonparametric procedures were employed for the analysis of background features of the patients with sustained virological response (SVR) and without SVR. A p value of <0.05 was considered to indicate a significant difference.
Five of 14 patients (37.5%) had SVR by the intention to treat analysis. The SVR rate in patients who showed negative HCV RNA at 12 and 24 weeks after the initiation of combination therapy was 100% (4/4) and 83.3% (5/6), respectively. All of the patients continued the combination therapy owing to disappearance of severely adverse events contained the exacerbation of depression. Combination therapy did not yield a statistical difference in Beck depression inventories and Hamilton depression rating scale.
The combination therapy of IFN-beta and ribavirin is a possible therapy selection for the patients for whom interferon therapy was discontinued due to depression induced by interferon-alpha.
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ABSTRACT: Aim: To evaluate the efficacy of reduction therapy of natural human interferon (IFN)-β and ribavirin in elderly patients with hepatitis C virus (HCV) genotype 1b and high viral load who had complications of anemia, low bodyweight (<50 kg), diabetes mellitus and/or hypertension. Methods: Inclusion criteria were age of 65 years or older, HCV genotype 1b, and serum HCV RNA level of 5.0 logIU/mL or higher. A total of 23 subjects with hemoglobin level of less than 13 g/dL, low bodyweight, diabetes mellitus and/or hypertension were enrolled in this study (reduction-dose group). IFN-β was administrated i.v. at a dose of 6 million units daily for 4 weeks initially, followed by three times a week for 44 weeks. Ribavirin was given daily for 48 weeks at a decreased dose of one tablet per day compared to the ordinary dose described based on bodyweight. As a control, another 22 patients without anemia, low bodyweight and/or complications treated with the standard dose of ribavirin (standard-dose group) were enrolled. Results: Patients' rates with further dose reduction or discontinuation of treatment was 26.1% (6/23) in the reduction-dose group and 77.3% (17/22) in the standard-dose group. The sustained virological response (SVR) was 39.1% (9/23) in the reduction-dose group and 27.3% (6/22) in the standard-dose group (P = 0.404). Based on genetic variations near the IL28B gene (rs8099917), SVR was 44.1% (15/34) in patients with TT and 0% (0/11) in patients with TG (P = 0.008). Conclusion: The reduction therapy of IFN-β and ribavirin in elderly HCV patients with genotype 1b, high viral load, IL28B gene (rs8099917) of TT who had complications of anemia, low bodyweight, diabetes mellitus and/or hypertension is one possible selection of treatment.Hepatology Research 04/2012; 42(10):949-57. DOI:10.1111/j.1872-034X.2012.01008.x · 2.22 Impact Factor
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ABSTRACT: Aim: To evaluate the efficacy of natural human interferon (IFN)-β and ribavirin in elderly patients infected with hepatitis C virus (HCV) genotype 2 and high virus load. Methods: Inclusion criteria were age of 65 years or older, HCV genotype 2 and serum HCV RNA level of 5.0 logIU/mL or more. A total of 33 were enrolled in this retrospective cohort study. IFN-β was administrated i.v. at a dose of 6 million units daily for 4 weeks initially, followed by three times a week for 20 weeks. Ribavirin was given daily for 24 weeks at the dose described based on bodyweight. Fifteen patients were given a standard dose of ribavirin (standard group). Eighteen patients were given a reduction dose of ribavirin that decreased by one tablet per day compared to the standard group (reduction group). Results: Of the 33 study patients, no patient stopped the treatment due to treatment-related adverse events. The dose of IFN-β was reduced in three patients: Two patients belonged to the standard group and one patient belonged to the reduction group. The dose of ribavirin was reduced in 11 patients during combination therapy: nine patients belonged to the standard group and two patients belonged to the reduction group. The sustained virological response (SVR) was 72.2% (13/18) in the reduction group and 80.0% (12/15) in the standard group. There was no significant difference in SVR rate between the reduction and standard groups (P = 0.699). Conclusion: The reduction therapy of IFN-β and ribavirin in elderly chronic hepatitis C patients with genotype 2 and high virus load is one selection of treatment.Hepatology Research 08/2012; 42(8):750-6. DOI:10.1111/j.1872-034X.2012.00982.x · 2.22 Impact Factor
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ABSTRACT: BACKGROUND AND AIM: The most important factor influencing the effect of PEG-IFN/ribavirin therapy (PEG) for chronic hepatitis C genotype 1b with high-viral-load is the IL28B genotype. We investigated the usefulness of lead-in twice-daily IFN-β/ribavirin therapy (IFN-β), and the early HCV-RNA dynamics was compared between PEG and IFN-β groups according to the IL28B genotype. METHODS: 46 patients were randomly allocated to PEG and IFN-β groups, and HCV-RNA dynamics in an early phase of treatment were analyzed. RESULTS: The patients with minor IL28B genotype was 6/23 and 8/23 in IFN-β and PEG groups, respectively. In the patients with IL28B major genotype, viral load reduction was marginally greater in IFN-β group than in PEG group. In contrast, in the patients with the IL28B minor genotype, viral load reduction was significantly and numerically greater in IFN-β group than in PEG group at 1 week (2.07 vs. 0.76 log IU/ml, p=0.038), 2 weeks (2.73 vs. 1.01, p=0.009), 4 weeks (2.72 vs. 1.55, p=0.059), and 12weeks (4.56 vs. 3.24, p=0.104). The sustained response (SVR) rates in the IL28B major genotype were similar between IFN-β group (47.1%, 8/17) and PEG group (53.3%, 8/15). In contrast, the SVR rates in the IL28B minor genotype were numerically higher in IFN-β group (50.0%, 3/6) than in PEG group (12.5%, 1/8), though not statistically significant. CONCLUSION: It was suggested that lead-in twice-daily IFN-β/ribavirin treatment followed by PEG-IFN/ribavirin combination therapy may modify the HCV-RNA dynamics compared to that by PEG-IFN/ribavirin therapy, and it is particularly useful for the IL28B minor genotype.Journal of Gastroenterology and Hepatology 11/2012; 28(3). DOI:10.1111/jgh.12039 · 3.63 Impact Factor