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•ø -, -J _,f- the virus. GM-CSF has been used to rescue patients with leukopenia effect on patients with chronic hepatitis C infection. Future studies on high dose interferon therapy but its efficacy as monotherapy for with higher dosage and longer duration of therapy or in combination 4 C has not been tested. In this study with interferon therapy are needed to prove its clinical efficacy as an the treatment of chronic hepatitis we administered rhGM-CSF to ten patients who have failed previ alternative and br adjuvant therapy for patients with chronic hepa ous interferon alpha 2-b treatment to study its anti - HCV effect and titis C. GM-CSF could also play a role in the treatment of those to assess side effects. The dosage given is low at 125 mcg/m2 patients with chronic hepatitis C who have significant leukopenia subcutaneously. The therapy was well tolerated with no significant and were excluded from interferon therapy. side effects. No dose reduction was needed and no patient withdrew from the study. The leukocytosis occurred as expected and eosino Acknowledgment:TheauthorswouldliketothankDr.RodneyWilliamsforhisidea Mr.Peter Hsinand Ms.Sharon Laifortheirtechnical philia was observed in two patients. Local injection site irritation and helpfulcriticism,to assistance. was common but generally manageable. Other side effects such as flu-like symptoms were much milder compared to that of the References: interferon therapy these patients had experienced previously, even 1. LieschkeGJ, BurgessAW.Granulocytecolony-stimulatingfactorand granulocyte-macrophage colony-stimulatingfactor(partI).NEngiJ Med1992;327:28-35, during the daily rhGM-CSF administration in the first two weeks of 2. MartinJ, Bosch0, Moraleds6, at al. PilotStudyofRecombinantHumanGranulocyte-macrophage the trial. Colony-stimulatingFactorintheTreatmentofChronicHepafitisB.Hepatology1993;18:775-80. 3. MartinJ, GuirogaJA, BaltolomeJ, at al. AntiviralEffectof RecombinantHumanGranulocyte The reduction in the viral RNA during the treatment was signifi niacrophageColony.stimulatingFactorinPBMCsofPatientswithChronicHepatitisB.Hepatology cant in the majority of the patients especially during the daily dosing 1993;18(Partll):118A 4. MartinJ,QuirogaJA,Bosch0, etal.ChangesinCytokineProductionDuhngTherapywithGranulocyte period. ALT was also noted to have improved in eight of the ten macrophageColony-stimulatingFactorinPatientswithChronicHepatitisB.Hepafology1994:20:1156- patients with normalization in three patients. These effects may be 61 5. CarrenoV, QuirogaJA. BiologicalResponseModifiersin ChronicHepatitisC. J. Hepatol.1995; due to cytokine production by the GM-CSF effect. GM-CSF has 22(Suppl.l(:122-26 KillsHerpesVirus-infectedbutnotNormal beenshowntoincreasetheliberationofTNF-alpha(TumorNecrosing 6. KoffWC,FansAV.HumanTumorNecrosisFactor-Alpha Cells.LymphokinesRes,1988;5:215-21 Factor Alpha), Interleukin-2 which themselves have potent anti- 7. TugH,VogelW,TratkiawiczJA,at al. PilotStudyofNaturalHumanlnterleukin-2inPatientswith viral ChronicHepatitisB. lmmsnomodulatoryandAntiviralEffects.J. Hepatol1993;19:259-67 activity. 8. HladikF,TratkiewiczJA,TilgH.at al.BiologicActivityofLowDoselL-2TreatmentinVivo.Molecular In summary,678 123the administration of rhGM-CSF in the doses used is AssessmentofCytokineNetworkInteraction.J. Immunol1994;153:1449-54 safe and’ well tolerated.’ The treatment seems to exert an anti-viral
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