Efficacy and safety of combination therapy of natural human interferon beta and ribavirin in chronic hepatitis C patients

Intern Med. 2011;50(19):2083-8. Epub 2011 Oct 1.

Arase Y, Suzuki Y, Suzuki F, Matsumoto N, Akuta N, Imai N, Seko Y, Sezaki H, Kawamura Y, Kobayashi M, Hosaka T, Saito S, Ikeda K, Kobayashi M, Kumada H.

Department of Hepatology and Okinaka Memorial Institute for Medical Research, Toranomon Hospital, Japan. es9y-ars@asahi-net.or.jp

Abstract

OBJECTIVE: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.

PMID: 21963723 [PubMed - indexed for MEDLINE]

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Natural Human IFN-β + Ribavirin Safe, Effective in Patients with Hepatitis C and Depression

Infectious Disease Week (IDWeek)
October 2-6, 2013
San Francisco, Ca

467. Natural human interferon-beta plus ribavirin treatment toleration by chronic hepatitis C patients with depression or thrombocytopenia

Session: Poster Abstract Session: Prevention and Treatment of Viral Infections

Thursday, October 3, 2013

Room: The Moscone Center: Poster Hall C

Posters IDweek 2013 No467 ikezaki.pdf (275.6 kB)

Background: Natural human interferon-beta (nIFN-beta) seldom causes neurological adverse effects and is recommended for depressive patients with chronic hepatitis C. It also does not often cause thrombocytopenia, in contrast to pegylated interferon-alpha (PEG-IFN-alpha), which often causes thrombocytopenia. Limited data has been reported comparing nIFN-beta and PEG-IFN-alpha when ribavirin (RBV) is combined. This case-control study was done to compare the efficacy adverse effects of a combination of nIFN-beta or PEG-IFN-alpha plus RBV for chronic hepatitis C patients.

Methods: Sixty patients (42 hepatitis C virus genotype 1 and 18 genotype 2) were treated with nIFN-beta plus RBV (48 week course for genotype 1 and 24 week course for genotype 2). Of them, 23 (38.3%) suffered pre-treatment severe depression. Their data was compared with that of 60 age-, sex-, and genotype-matched patients who were treated with PEG-IFN-alpha plus RBV treatment for the same treatment periods. None of the patients in the PEG-IFN-alpha treated group suffered pre-treatment depression.

Results: Sustained virological response rates did not significantly differ between the nIFN-beta and PEG-IFN-alpha treated groups (genotype 1, 21.4 % vs. 33.3 %, P=0.328; genotype 2, 72.2 % vs. 88.9 %, respectively, P=0.402). None of the nIFN-beta-treated patients showed exacerbation of depression or malaise, but 7 (11.7%) of 60 PEG-IFN-alpha treated patients developed severe malaise. The mean percentage of platelet count decrease from baseline to the week 4 of treatment significantly differed between the nIFN-beta and PEG-IFN-alpha groups (-7.1% vs. -26.2%) (P<0.001). Among patients with a baseline platelet count <120×10⁹/L, the percentage of decrease to <80×10⁹/L at week 4 was significantly lower at 50.0% (14 of 28) of the nIFN-beta-treated group than at 88.9% (8 of 9) of the PEG-IFN-alpha-treated group (P=0.035).

Conclusion: nIFN-beta plus RBV treatment was well tolerated by chronic hepatitis C patients with depression or thrombocytopenia.

Hiroaki Ikezaki, MD., Norihiro Furusyo, MD., PhD., Satoshi Hiramine, MD., Eiichi Ogawa, MD., PhD., Masayuki Murata, MD., PhD. and Jun Hayashi, MD., PhD., Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan

Disclosures:

H. Ikezaki, None

N. Furusyo, None

S. Hiramine, None

E. Ogawa, None

M. Murata, None

J. Hayashi, None

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