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|&w&w00&wm�j��0�*���hq�&wx�?}0o}&wE��u6E�&wE�0&w�<m<m&w<m<m<m<m<m0|0|&w<m<m<mo}<m<m<m<mDDDdT�\DDD�\DDD000000����Efficacy of treatment in  INCLUDEPICTURE "http://bloodjournal.hematologylibrary.org/math/12pt/Large/beta.gif" \* MERGEFORMATINET -Thalassemics With Chronic Hepatitis C


Ansari Shahla1*,   MD , Azarkivan Azita 2  MD , Halagi Farideh3 MD
1 Department of hematology&oncnlogy, Ali Asghar Children�s Hospital, 
Iran University of Medical Sciences, Tehran, Iran

2 Department of Thalassemia Clinic, Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran;

3 Department of Radiology, Ali Asghar Children�s Hospital, 
Tehran University of Medical Sciences, Tehran, Iran


* Correspondence:  Shahla Ansari
Tel:  0098 (+21) 2226127	Fax:  0098 (+21) 2220063
Email:   HYPERLINK "mailto:shahladamavandi@yahoo.com" shahladamavandi@yahoo.com




































                                                                                1
Abstract 


-Hepatitis is the infections of a common cause of liver disease among poly Transfused Patients. Patients 


treated with peg interferon alfa (PegIFN) and ribavirin (RBV) combination therapy demonstrate overall 50-


55% sustained viral response (SVR) .We treated 170 of subjects with �-thalassemia major and chronic 


hepatitis C with �-interferon. The aims of this study were to assess the long-term biochemical and virologic 


-efficacy of �-interferon and to evaluatthe influence of HCV type and liver siderosis on the outcome of 


therapy. Thalassemia patients using deferoxamine (DFO) therapy.  They are diagnosed with Hepatitis C 


due to positive PCR-RNA. They are Treated with IFN.The follow up program including tests every 3 


Months and PCR-RNA, AFP ALT,ASTand liver US every 6  months. From the total of 170 patients 59.4% 


-were male and 40.6% were female. Mean age of thalassemia diagnosis was 2.69� 5.403 (1-41) years and 


mean Age of hepatitis diagnosis was 17.37� 7.263 (3-51) years. 92.4 % of Patient�s MT, 0.6 % SS, 2.9% 


TI. The viral genome was 1a,3a. 73.5% of patients had first course of therapy. 75 subjects {59%) were 


complete sustained response and 40.1%were non response.


Conclusions: All patients were able to complete combination therapy, although dose reductions were 


required. Patients with thalassemia and high iron overload can obtain SVR after combination therapy with 


-rates similar to those in the general population and without significant complications. Although transfusion 



  requirements increased in most patients, 



Keywords Hepatitis C (HCV), Cirrhosis, Thalassemia, Iron overload, interferon

                                             1

Introduction:                                                     

-Iron overload and hepatitis C virus infection are the main cause of chronic liver disease in � thalassemia 


patients who�s transfused before the 1990s. [1, 2]Chelation with deferoxamine prevents or reduces iron 


overload and may prevents organ damage due to secondry cirrhosis.[ 3] Hepatitis C (HCV) is an RNA virus 


of flaviviridase family .there are 6 major HCV genotype and more than 50subtypes.in childhood, the virus 


rarely causes symptoms and many cases probably go unrecognized.[ 4] interferon � is the first line  


treatment for patients with HCV Chronic hepatitis.peginterferon �2a for 48 weeks has been shown to 


-results in higher sustained virological responses(SVR) than treatment with INF.[ 5] The aim of the 



therapy is to eradicate the HCV, absence of cirrhosis and short duration of diseases.[ 6] 


In this study we performed prolonged therapy in large thalassemia patients with chronic hepatitis.


Method and material:


These present study evaluated 170thalassemia patients with chronic Hepatitis C, who received INF 


therapy between July 2004 and OCT2010 in two thalassemia centers Ali Asghar Children�s Hospital 


and clinic of thalassemia who were follow up by periodic check up for at least 5 years After INF 


therapy.All patients received regular blood transfusions therapy with deferoxamine. Seropositivity for
                                                                        

anti HCV antibodies to HCV (anti HCV) and liver biopsy performed to showing chronic hepatitis, with 

or without cirrhosis and prior to INF therapy, all specimens were examined by the same pathologist and 


evaluated according to standardized criteria . all patients had received � interferon 6megunits/m2 


subcutaneously ,Three times per week plus ribavirin 15mg /kg /day for 24-48 weeks.(5,6) Treatment 
                                                                   2

with Peg interferon alpha (180ug/week ) produces significantly higher sustain virologic response than 


Treatment with� interferon(table 4)Evaluation of treatment efficacy was based on the effect of IFN on ALT 


levels and on the clearance of HCV-RNA from serum. Sustained virologic response (SVR) was defined 


as ALT normalization persisting during the entire follow-up and negative HCV-RNA at end of follow-


up. Abnormal ALT values during therapy and follow-up or any ALT relapse after stopping IFN were 


considered as no response (NR), even if no serum HCV-RNA was detected at the end of follow-up.


Observing for more than 5 years after INF therapy at regular 6 month  intervals.Each follow up included 


-a physical examination, blood tests and measurements of serum Alpha fetoprotein and ultrasonography 


-was also performed. The Results analyzed with SPSS ver 17, using�2 and T-test.


Results: 


Demographic and clinical characteristics of the patients was 101 Male patients (%59.4) 


and 69 female (%40.6) The mean age at diagnosis Underlying diseases were 5.403 � 2.69 years (range 


1-41 years) and the median age of Patients at time of hepatitis were 17.37 � 7.36 years (range 4-51 43-


years). Underlying diseases of these 170 patients were in (table1).
    

The histologic degree of chronic hepatitis was mild in 59(% 53.6), moderate in 49(44.5%) and sever in 

2. (1.8%) subjects[Table2]
                                                                                 

patients had chronic HCV infection defined by detectable circulation HCV �RNA.


The median viral load in cases was 478569.24 [range 29-5000000 IU/ml].


                                                                             3
42[24.7%]of the HCV-RNA positive were infected by HCV type Ia and 44(25.9%)of theHCV positive 


were infected by 3a .other HCV types( Ib,IaIb,3b.) were found in 15 patients (table 3).75 subjects{59%) 


normalized ALT during treatment or stopping IFN and remained with normal ALT up to the end of the 


post treatment follow-up period (60 months){complete sustained response CSR ). At their last follow-up 


visit, all patients were HCV-RNA negative, thus fulfilling the definition of CSR.52 subjects (40.1%) 


remained with abnormal ALT over the entire treatment and follow-up period(nonresponse NR.(table 5)
 
The mortality rate was 1.2% (95% confidence interval) ; one of them due to heart failure and the other 


had hepatocellular carcinoma whom was not responded to chemptherapy.

 Ethics Statement:


The study was approved by an ethical committee. Investigative procedures were explained to each 


patient or to his/her parents before obtaining written informed consent for inclusion in the study and 


were signed by parents.


DISCUSSION


Patients with �TM (� thalassemia major) received multiple blood transfusions with a high risk of HCV 


transmission. IFN is, to date, the only effective therapy for chronic hepatitis C. Meta-analysis of clinical 


trials has shown that IFN leads to sustained biochemical and virologic response in about 25% of


patients. Features such as the presence of cirrhosis, long disease duration, high levels of HCV viremia, 


and infection by HCV type 1b are strictly related to low response to IFN. Hepatic iron overload has also 
                                                                                    4

been shown to or relate with a poor response to IFN in nonthalassemic patients.


Children with who have other underling illnesses such as thalassemia major may have more significant 


and rapid liver damage[2,5,7]


Our trial confirms and extends previous studies in �TM patients with chronic HCV infection that


reported that a course of IFN can produce a high rate of end-of-treatment response. The sample size of 


-our study also allows us to show good tolerability at the rather high doses used. Over a long follow-up 


period, we were able to show that a high CSR rate follows the end-of-treatment response[2]


FN therapy for chronic hepatitis C in �TM patients should not be stopped after 3 to 4 months if ALT is 


still aised, because Almost 70% of CSR would probably be lost by stopping therapy after 3 months in 


�TM subjects with persistently abnormal ALT.[ 2,7]

Large amounts of iron in the liver clearly reduce response to IFN, but IFN therapy should not be denied 


even if liver iron overload is severe. [8]


HCV is a highly heterogeneous virus with widely varying biologic and clinical behavior. Type 1b has 


been related to a more severe progression of liver disease, Although standard interferon (INF) has better 


efficacy in pediatric patients than in adults, results in children with genotype 1 are poor; response ratesto 
                                                                   

combination treatment with standard INF and ribavirin are better but the treatment requires thrice


-weekly injections. Treatment with weekly pegylated interferons in adults with chronic HCV infection 


-suggests that pegylated interferons may also improve antiviral efficacy in children.[ 5,9]


Treatment among patients with HCV genotype 1 infection, the corresponding CSR rates were 42% and 
                                                                     5

The rate for patients with genotype 2 and 3 infections was about 80 %[ 5]

In patients with chronic hepatitis C, the most effective therapy is the combination of peg interferon per 


week plus ribavirin. The benefit is mostly achieved in patients with HCV genotype 1 infections.[ 9,10]

CONCLUSIONS


Patients with thalassemia and high iron overload can obtain CSR after combination therapy with rates 


similar to those in the general population and without significant complications. Although transfusion 


requirements increased in most patients, the incidence of hemolytic anemia symptoms was higher in the 


groups receiving peg interferon or interferon plus ribavirin than in the group receiving interferon alone.


CONFLICT OF INTEREST



The authors indicated no potential conflicts of interest.






HCV =hepatitis c virus   CSR=complete sustain response    















                                                                  6



References: 


1-Kazuhiko�Hayashi, Takashi�Kumada, Satoshi�Nakano, Isao�Takeda, 



Seiki�Kiriyama, Yasuhiro�Sone, Hidenori�Toyoda.Incidence of hepatocellular carcinoma in chronic 


hepatitis C after interferon   therapy. Hepato-Gasteroentrology. 2002; 49: 508-512.


2-V. Di Marco, O. Lo Iacono, P. Almasio, C. Ciaccio, M. Capra, M. Rizzo, R. Malizia, A. Maggio, C. 

Fabiano, F. Barbaria, and A. Crax�  .Long-Term Efficacy of  INCLUDEPICTURE "http://bloodjournal.hematologylibrary.org/math/12pt/Large/alpha.gif" \* MERGEFORMATINET -Interferon in  INCLUDEPICTURE "http://bloodjournal.hematologylibrary.org/math/12pt/Large/beta.gif" \* MERGEFORMATINET -Thalassemics With Chronic 

Hepatitis C. Blood, 1997; 90: 2207-2212.

3- HYPERLINK "http://bloodjournal.hematologylibrary.org/search?author1=V.+Di+Marco&sortspec=date&submit=Submit" V. Di Marco,  HYPERLINK "http://bloodjournal.hematologylibrary.org/search?author1=O.+Lo+Iacono&sortspec=date&submit=Submit" O. Lo Iacono,  HYPERLINK "http://bloodjournal.hematologylibrary.org/search?author1=P.+Almasio&sortspec=date&submit=Submit" P. Almasio,  HYPERLINK "http://bloodjournal.hematologylibrary.org/search?author1=C.+Ciaccio&sortspec=date&submit=Submit" C. Ciaccio,  HYPERLINK "http://bloodjournal.hematologylibrary.org/search?author1=M.+Capra&sortspec=date&submit=Submit" M. Capra,  HYPERLINK "http://bloodjournal.hematologylibrary.org/search?author1=M.+Rizzo&sortspec=date&submit=Submit" M. Rizzo, Long-Term Efficacy of �-

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                                                                                  7
7-Preston H, Wright TL. Interferon therapy for chronic hepatitis C. Lancet 1996;348:973.

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JJJJJJ�J�J�J�J�J�J�J�JKKKKsKtKzK{K}K~K�K�K�K�KLLfL����������������������������������������������������3h�h�E0J5�B*CJOJQJ\�^JaJph8jh�h�E5�B*CJOJQJU\�^JaJph/h�h�E5�B*CJOJQJ\�^JaJph)h�E5�B*CJOJQJ\�^JaJphh�h�ECJaJh�ECJaJ6fLgL�L�L�L�LMMMuMxM�M�M�M�M�M�M�M"N$N�N�N�N����˩����r�r�rdr�ZM@h�h�E0JCJaJh�h�E0JCJaJh�A0JCJaJh�AB*CJ_H)aJph!h�h�EB*CJ_H)aJphh�EB*CJaJphh�h�EB*CJaJphh�h�ECJaJh�ECJaJ3h�h�E0J5�B*CJOJQJ\�^JaJph/h�h�E5�B*CJOJQJ\�^JaJph8jh�h�E5�B*CJOJQJU\�^JaJph�N�N�N�N�N�N�NRObOjOlOrOtOzO|O~O�O�O���Ĕ����n�t���Ė֖������������ufd�\�\�\�fK!h�h�E0JB*CJaJphh�ECJaJUh�h�EB*CJaJph/h�h�E5�B*CJOJQJ\�^JaJphh�h�E0JCJaJh�h�E0JCJaJh�h�E0JCJaJh�h�E0JCJaJh�h�E0JCJaJh�h�E0JCJaJh�h�E0JCJaJh�h�ECJaJh�h�E0JCJaJ Clemente MG, Congia M, Lai ME, Lilliu F, Lampis R, Frau F, Frau MR, Faa G, Diana G, Dess1 C, 


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                                                           8







Table1. Type of diseases with hepatitis .


Type of diseasesno%Total
Major thalassemia16496.596.5Sickle cell10.692.9Intermedia thalassemia52.995.9Total  170-100
              

















             Table2. Liver histology (Knodell score )

Liver histology            no%mild            5953/6Moderate             4944/5Sever                  21/8total              110100

























Table3. Viral genome in patients with chronic hepatitis C 


Viral genome             no                    %
 1 a                                                                                  42              24.72 a                                                                                    1                 0.63 a                                                                                     44                25.91 a 1 b                                                                                 13                 7.63 b                                                                                         1                  0.6Total                101                  59.4Missing                 69                   40.6Total                   170                    100



                              













SVRNRINF+RIB2320PEG+RIB3319total5639
Table 4-SVRwith peginterferon













genotype3a1b1a1b1aSVR301524NR141818total4421342Table 5-genotype and response to treatment
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