Pilot Study of Interferon-alfa+Ribavirin+Interleukin-2 for Treatment of Hepatitis C Virus Genotype 1 Patients with Severe Liver Disease

Hepatitis C genotype 1 is the most difficult type of HCV infection to treat successfully. Using peginterferon plus ribavirin, the current standard of care, only about 40% of HCV patients with hepatitis C experience a sustained virologic response (SVR). For this reason, researchers are looking for other agents to use in combination with interfrorn/ribavirin that might improve the virologic response.

In the current randomized, prospective study, researchers assessed the effectiveness and safety of a triple therapy with conventional (non pegylated) interferon-alfa (IFN-a)-ribavirin-interleukin-2 (IL-2) for the treatment of patients with HCV genotype 1 infection and high viral load who were nonresponders to therapy with conventional IFN/ribavirin therapy.

Results

	Twenty hepatitis C virus (HCV) genotype 1 patients with high viral load and Metavir fibrosis score ?2 without HIV co-infection who were previously nonviral responders to standard treatment with IFN plus ribavirin were intensively re-treated with IFN-alfa-2a (3 millions (M) IU every 2 days) combined with ribavirin (1000-1200 mg/day) for a 24-week period.
	Patients were randomized to receive four cycles of subcutaneous injection of IL-2 (3 MIU/day, 5 days a week every 3 weeks) during either the first 12 weeks (group 1, n = 10) or the last 12 weeks (group 2, n = 10) of combination therapy.
	At the end of triple therapy, six patients (30%) achieved a biochemical response and 4 (20%) a viral response followed by a relapse after triple therapy withdrawal.
	After 12 weeks of therapy, no difference in viral load was observed between the groups.
	The decrease in viral load in group 2 was not raised after the addition of IL-2 to IFN plus ribavirin combination therapy.
	No serious adverse effects were observed.

As a result of these disappointing results, the study authors conclude, "In patients with poor predictive factors of response, the addition of interleukin-2 to interferon alfa/ribavirin combination therapy does not exert a favorable impact on HCV treatment."

See also Low-dose Interleukin-2, Pegylated Interferon Alfa-2b and Ribavirin for the Treatment of HCV in HIV Patients: A Pilot Study

03/14/06

Reference
L Alric and others. Pilot study of interferon-a-ribavirin-interleukin-2 for treatment of nonresponder patients with severe liver disease infected by hepatitis C virus genotype 1. Journal of Viral Hepatitis 13(2): 139-144. February 2006.