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Long term response to therapy of chronic anti-HBe-positive hepatitis B is poor independent of type and schedule of interferon . OBJECTIVE The response rate to alpha interferon ( IFN ) of chronic anti-HBe-positive hepatitis B is variable . We studied whether type , dose , and schedule of IFN , and type and frequency of posttreatment monitoring , influence the response rate . METHODS Seventy-two consecutive anti-HBe-positive chronic hepatitis B patients ( 59 male and 13 female , median age 41 yr ) stratified by sex and histology were randomly allocated to three treatment arms . Twenty-seven patients ( A ) received 10 million units alpha-N1 IFN i.m . t.w . for 24 wk ( total dose : 720 million units ) ; 21 ( B ) received 9 million units alpha-2a IFN i.m . t.w . for 4 wk , followed by 18 million units for 12 wk and 9 million units for 8 wk ( 972 million units ) ; 24 ( C ) received 2 alpha-2a IFN courses ( 9 million units i.m . t.w . for 16 and 12 wk separated by a 6-month interval [ 756 million units ] ) . Primary response was defined by normal ALT and serum HBV-DNA levels below 10 pg/ml at the end of therapy and sustained response by normal ALT ( tested monthly ) , undetectable HBV-DNA and IgM anti-HBc ( < 7 I.U . Paul Ehrlich Institute ) ( tested every 3 months ) during the posttreatment follow-up . RESULTS At the end of treatment , 12 , 8 , and 13 patients from groups A , B , and C , respectively , were responders . At the 18-month follow-up , two patients in group A and only one in groups B and C maintained the response . Overall , after 34 months ( median posttreatment follow-up ) , three patients were long term responders , whereas three showed a sustained remission after relapse . CONCLUSIONS The rate of long term response to interferon of anti-HBe-positive chronic hepatitis B is poor , independent of IFN type , dose , or schedule ; the more stringent the monitoring , the higher the relapse rate .
850
Intervention_Pharmacological
alpha interferon ( IFN )
851
Intervention_Pharmacological
IFN
852
Intervention_Pharmacological
alpha-N1 IFN i.m .
853
Intervention_Pharmacological
alpha-2a IFN i.m .
854
Intervention_Pharmacological
2 alpha-2a IFN
855
Outcome_Physical
response rate to alpha interferon ( IFN )
856
Outcome_Physical
normal ALT
857
Outcome_Physical
serum HBV-DNA levels
858
Outcome_Physical
normal ALT
859
Outcome_Physical
undetectable HBV-DNA
860
Outcome_Other
remission
861
Outcome_Physical
rate of long term response
862
Participant_Condition
chronic anti-HBe-positive hepatitis B
863
Participant_Sample-size
Seventy-two
864
Participant_Sample-size
59
865
Participant_Sex
male
866
Participant_Sample-size
13
867
Participant_Sex
female
868
Participant_Age
41 yr