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TITLE: A Phase I/II Study of Recombinant Human Interleukin-12 in
Patients With Chronic Hepatitis C.
Interleukin-12 (IL-12) plays a central role in mounting an
effective cellular immune response directed towards elimination of
intracellular pathogens. The present open-label, multicenter,
dose-escalation phase I/II study was designed to assess
tolerability, pharmacokinetics, pharmacodynamics, and efficacy of
subcutaneously administered recombinant human interleukin-12
(rHuIL-12) in the treatment of chronic hepatitis C. Sixty patients
(42 men, 18 women, aged 24-60) were treated with 0.03 mug/kg (n =
16), 0.1 mug/kg (n = 14), 0.25 mug/kg (n = 15), or 0.5 mug/kg
rHuIL-12 (n = 15) for 10 consecutive weeks. rHuIL-12 was generally
well tolerated, with 2 patients (3.3%) being withdrawn from
treatment for adverse events. Treatment was associated with
temporary decreases in neutrophils and lymphocyte counts and with
elevations in serum transaminases and bilirubin. Serum IL-12 levels
observed were higher at 0.5 mug/kg compared with 0.25 mug/kg doses,
suggesting a dose-related increase in systemic exposure of IL-12.
Measurable levels of interferon gamma (IFN-gamma) were also
observed at the highest dose of 0.5 mug/kg. At the end of treatment
hepatitis C virus (HCV) RNA was detectable in all patients. A more
than 50% decrease in pretreatment HCV RNA levels was observed in 3
of 16 patients of the 0.03-mug/kg dose group, in 3 of 14 of the
0.10-mug/kg dose group, in 6 of 15 of the 0.25-mug/kg dose group,
and in 8 of 15 patients of the 0.5-mug/kg dose group. Although in
several cases serum alanine transaminase (ALT) levels decreased
either during or after treatment, ALT normalization was observed in
only 4 patients at the end of treatment and in 5 patients at the
end of follow-up. Significant anti-rHuIL-12 antibody titers were
not detectable in any patient. In conclusion, antiviral activity of
rHuIL-12 in patients with chronic hepatitis C does not appear
advantageous in comparison with other currently available
treatments.
AUTHOR: Zeuzem S, Hopf U, Carreno V, Diago M, Shiffman M, Gr
ne S, Dudley FJ, Rakhit A, Rittweger K, Yap SH, Koff RS, Thomas HC,
Medizinische Klinik II, Klinikum der Johann Wolfgang
Goethe-Universitat, Frankfurt, Germany.
SOURCE: Hepatology 1999 Apr;29(4):1280-1287
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