Predictive factors of response to IFN therapy in long-term follow up of children with chronic hepatitis C

Predictive factors of response to IFN therapy in long-term follow up of children with chronic hepatitis C

Papers read by title I C06/101 ] COrd103 INVESTIGATION OF THYROID FUNCTION AND AUTOANTIBODIES IN PATIENTS WITH CHRONIC HEPATITIS B AND C I. Orsag...

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INVESTIGATION OF THYROID FUNCTION AND AUTOANTIBODIES IN PATIENTS WITH CHRONIC HEPATITIS B AND C I. Orsagova, L. Roznovsky, I. Lochman 1 Dept. of Infectious Diseases, University Hospital, Ostrava, Czech Republic. 1Regional Institute of Hygiene, Ostrava, Czech Republic. Background: Thyroid function and some types of autoantibodies were investigated in 94 patients with chronic hepatitis B and C in dependence on antiviral therapy. Material and methods: 24 patients with hepatitis B were treated by interferon-~x and 70 patients with chronic hepatitis C were treated by intefferon~ alone or combination with ribavirin. Thirteen patients with hepatitis C suffered also from congenital coagulopathies (10 hemophilia A, 3 von Willebrand disease). Before, during and after the treatment we investigated following markers: thyroid function (T3, T4, TSH), two types of autoantibodies against thyroid gland, anti-LKM antibodies, antismooth muscle antibodies, four types of antimitochondrial antibodieS, 3 types of nucleic acid antibodies and ANCA antibodies. Results: Mostly mild changes in thyroid function were observed in 42 patients. Autoantibodies against thyroid gland appeared in 7 patients. Other pathological markers of auto-immunity were observed the following: nucleic acid antibodies in 22 individuals, anti-smcoth muscle antibodies in 3, antimitucbondrial antibodies in 4, ANCA antibodies in 1 patient. These findings didn't require preliminary interruption of interferon~ therapy. Serious adverse effects were observed in 3 patients. Clinical apparent hypothyreosis grew up in one woman, hyperthyreosis in one man during the therapy. Muscular disturbance with possible autoimmune hepatitis appeared in the third patient. Conclusions: Presence of some changes in thyroid markers and some types of autoantibedies had no clinical significance and didn't affect the intefferon-~ therapy in most patients with chronic hepatitis B and C.

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2 1 Total 12 7 4 Discussion : Our dates showed a response to IFN therapy in 10 children of 23 treated (43,47%) with low percentage of sustained response 4/23 (17,39%) like others references. We have registrated: 1) 3 of 4 sustained resp. had low viral load pretherapy2) of 12 non respon. 11 pz were genotype lb .Our dates suggests that, also in pediatric age the predictive factors to decide this antiviral therapy are viral load and genotype.

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THE EFFICACY OF COMBINED INTERFERON-ALFA-2B AND RIBAVIRIN THERAPY IN PATIENTS WITH CHRONIC HEPATITIS C. FINAL REPORTS OF A MULTICENTER STUDY WITH 100 PATIENTS IN HUNGARY J. Feh6r, G. Lengyel, T. Bfilint, the Multicenter Study Group National Institute of Internal Medicine, Budapest, Hungary. Roughly 1/5 of patients with HCV could achieve sustained virological response with routine IFN therapy. The aim o f this study was to compare the efficacy and safety of interferon (fiN)alfa 2b in combination with oral ribavirin given for 52 weeks, as a Hungarian parallel arm of the International Hepatitis Interventional Therapy Group. Patients~Methods: The age was strictly limited to 18-55 years, there was no randomisation just 'combination-therapy arm'. The treatment period was 52 weeks and the follow-up lasted for six months. The study was done in 10 Hungarian centers. Hundred patients have been involved into this study, to the following regimen: 3 MU IFN alfa 2b {Intron A/Schering-Plough}three times a week plus 1000-1200 mg ribavirin capsules taken orally every day for 52 weeks. Remission rate was characterized by normalisation of alaninaminotransferuse (ALT) activity and loss of detectable HCV RNA. Liver histology was assessed at starting and ending of the trial. These report focus on the fLrst 100 patients completed the 52 weeks basic therapy course and the follow up period. All patients were assessed for safety, tolerance and efficacy at the end o f weeks 1, 2,4, 6, 8, and every 4 weeks during treatment and 3 and 6 months in the follow up period. Results: Total response at 52 weeks was found in 56 of the 100 patients treated for 52 weeks with the comboregimen. Sustained response was found in 40 percent of patients at the end of 6 month follow UP period. Using historical bacl~up data, it can be concluded that adverse events were more frequent with combo-therapy, than single INF treatment. Conclusion: The above described IFN alfa 2b plus ribavirin combination therapy for 52 weeks is more than twice as effective, as the routine 'single' IFN therapy. Hungarian Mulffcenter Study Group: M. Abonyf, A. Csepregi, L. Dalmi, K. David, ,~ Gervain, K. Hagymhsi, b£ Hordnyi, G. Horvdth, E. Ibrclnyi, K. J/wmay, .Z Lonovics, L Nagy, E. Nemes&nszky,Zs. Ozsvdr, A. Pdr, M. Pusztay, P. PJbiezey, Zs. Schaff, F. Szalay, L. Telegdy, Cry.Tolvaj, T. Toth, Gy. Weiss

C06/104

PREDICTIVE FACTORS OF RESPONSE TO IFN THERAPY IN LONG-TERM FOLLOW UP OF CHILDREN WITH CHRONIC HEPATITIS C M. MarceUiniz, M.R. Sartorelli t, M. Rossi de'Gasperis2, S. Mattia 1, ?. Cardella 2, E Bubola2, C. Efrati 1, D. Menichella 2 IHepatology Unit, Bambino Gesfi IRCCS, Roma. 2Virology Lab, Bambino Gesfi IRCCS, Roma. We investigated 23 paz M 11 - F 12, age between 6 and 18 y( mean 12y). All patients with chronic hepatitis HCV pos.RNA pos. Istology : 15 ECP-3 ECL-5 ECA . Genotype was : 13 pz. with gen.1 ( 11 pz.were lb) and 6 pz with gen.2. ALT were higher than normal in 21 pz.. We treated all children with IFN for 6 months by i.m. injection thrice weekly at dosage of 6 MU/mq.Type of IFN: see in table. Viral load (performed with method of DNA-branched) was performed at the start- at the end of the therapy and after 6-12 and 24 months of follow up We considered reaponders the pz RNA neg. with normal ALT at the end of therapy, while who returned positive was considered relapse. Not responders were paz. with RNA always positive. Patients RNA neg., at 24 m. from the end of therapy were considerated sustained responders.Results (p<0,05) Tot. N'23 Non Resimnders Responders Relapse Susta~ed RecombIFN 7 3 0

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THYROID DYSFUNCTION IN CHRONIC HCV PATIENTS RECEIVED COMBINATION THERAPY WITH INTERFERON AND RIBAVIRIN D. Dimitroulopoulos l, D. Xinopoulos 1, D. Bourganos2, M. Kontou 1, K. Tsakmakidis 1, E. Paraskevas 1 1Gastroenterology Unit, Saint Savvas Anticancer Hospital, Athens, Greece. 2Biochemical Unit, Saint Savvas Anticancer Hospital, Athens, Greece.

Baokground: Thyroid dysfunction has been described in relation to hepatitis C, both in terms of chronic liver disease and interferon therapy. The aim of the present study was to estimate the thyroid dysfunctionand the antithyroidparoxidaseantibodes (ATPO) ~ s in patients with chroric hepatilb C duringa 48 week therapy with dbavirinand interferon. Materlab and Methods: Between June 98 and September 99 a total of 10 patients (9 M, 1F, age range 31-58 years, mean 46) with ~ hepatitis C documented histologically and virdogically, were treated with dbavidn (1000-1200 mg daily per os) based on weight concurrentlyand interferonct(5-10 MU 8 weeks, 3-5 MU 40 weeks daily). All patients were euthyroid before treatment and also were negative for antJthyroidantibodies. Thyroid hormonesand ATPO were measuredbefore treatment and every 4 months duringtherapy. Results: Three (30%) (M) patients developed very high liters ATPO, 2 (20%) withoutthyroidabnormalitiesand one of them (10%) with elevation of TSH after 4 monS~ of therapy. One patient (10%) F presented elevation of thyroid hormones (T4, TSH) without abnormaities of ATPO titers at the eighth monthof therapy. Bethreceived antithyroidtreatment. Conclusion: ~nation therapy appeared not to cause more thyroid abnormalitiesthan the interferonmonotherapy.