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

SAN FRANCISCO, CA—A combination of natural human interferon β (nIFNβ) and ribavirin (RBV) is a safe and effective option for patients with hepatitis C who have depression or thrombocytopenia, according to a study presented at IDWeek. 

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The standard therapy for chronic hepatitis C is pegylated interferon-α + ribavirin. However, psychological problems or cytopenia have been observed during treatment. A previous study by Hiroaki Ikezaki, MD, from Kyushu University Hospital, Fukuoka, Japan, and colleagues showed that 25–40% of patients discontinued treatment due to these adverse effects.

The combination of nIFNβ plus ribavirin is approved in Japan for patients with chronic hepatitis C and depression. This regimen has shown similar efficacy with mild adverse effects. Dr. Ikezaki and colleagues performed a case-control study to compare the efficacy and safety of natural human interferon β + ribavirin with that of pegylated interferon α + ribavirin in the treatment of patients with chronic hepatitis C and depression or thrombocytopenia.

Patients with chronic hepatitis C (N=60) were treated with nIFNβ (6 million units daily for 4 weeks, then three times weekly for 20–44 weeks) + ribavirin. The authors retrospectively selected 60 additional patients treated with pegylated interferon α2b (PEG-IFNα2b) + ribavirin matched by genotype, sex, age, and body weight. Sustained virological response (SVR) was measured at 24 weeks after therapy based on intent-to-treat-analysis.

The patients were categorized as follows:

§   Group X1 (n=42): genotype 1b with nIFNβ + RBV for 48 weeks

§  Group X2 (n=18): genotype 2 with nIFNβ + RBV for 24 weeks

§  Group Y1 (n=42): genotype 1b with PEG-IFNα2b + RBV for 48 weeks

§  Group Y2 (n=18): genotype 2 with PEG-IFNα2b + RBV for 24 weeks

Results showed that the SVR rates of nIFNβ treatment group were equivalent to those of the PEG-IFNα2b treatment group (genotype 1b: 21.4 % vs. 33.3%, P=0.328; genotype 2: 72.2% vs. 88.9%, respectively, P=0.402). The SVR rates for interleukin 28B (IL28B) (rs8099917) TT patients were significantly higher than IL28B TG/GG in group X1 (33.3% and 0.0%, respectively, P=0.017), but not in group X2 (75.0% and 60.0%, respectively; P=0.60).

None of the patients in Group X showed exacerbation of depression or malaise, although 23 (38.3%) had depression prior to treatment. Seven patients developed severe malaise in Group Y, none of whom had depression prior to treatment.

Platelet counts of patients in Group X decreased significantly less than those of Group Y at Week 4, while those of Group X increased to higher than baseline after Week 8, especially in the inosine triphosphate pyrophosphatase (ITPA) (rs1127354) CC patients.

After comparing nIFNβ + RBV with that of PEG-IFNα2b + RBV, Dr. Ikezaki's team concluded that nIFNβ + RBV is a viable treatment option for patients with chronic hepatitis C patients with depression and/or thrombocytopenia.