31940
document
A pilot study of extended duration peginterferon alfa-2a for patients with hepatitis B e antigen-negative chronic hepatitis B . OBJECTIVES Forty-eight weeks of peginterferon alfa-2a is the approved regimen for chronic hepatitis B ( CHB ) . Standard interferon is more effective for hepatitis B e antigen ( HBeAg ) -negative CHB when given for longer than 1 yr . This study evaluated peginterferon alfa-2a for 60 wk , alone or in combination with lamivudine . METHODS Thirteen patients with HBeAg-negative CHB received peginterferon alfa-2a ( 180 microg/week ) for 60 wk or peginterferon alfa-2a ( 180 microg/week ) for 12 wk followed by 48 wk of peginterferon alfa-2a plus lamivudine . The primary end point , sustained virologic response ( SVR ) , was defined as a reduction in hepatitis B virus deoxyribonucleic acid ( HBV DNA ) of > or=2 log10 copies/mL and HBV DNA < 20,000 copies/mL at 24 wk of follow-up ( week 84 ) . Hepatitis B surface antigen ( HBsAg ) concentrations were analyzed and compared to changes in HBV DNA . RESULTS SVR was achieved by 9/13 patients ( 69 % ) . At week 84 , HBV DNA was undetectable by polymerase chain reaction in 5/13 ( 38 % ) patients , and 3 additional patients had a sustained 2-3 log reduction in HBV DNA . Five patients demonstrated a > 90 % decrease in HBsAg concentration at week 60 , including 3 with undetectable HBV DNA at week 84 and a fourth who met criteria for SVR . CONCLUSIONS Sixty weeks of peginterferon alfa-2a with or without lamivudine resulted in a higher rate of SVR compared to historical controls with HBeAg-negative CHB treated with 48 wk of pegylated interferon . Larger studies are necessary to assess if longer duration therapy is more effective than the standard regimen and results in a greater decline in HBsAg concentration .
31941
Intervention_Pharmacological
peginterferon alfa-2a
31942
Intervention_Pharmacological
peginterferon alfa-2a
31943
Intervention_Pharmacological
peginterferon alfa-2a
31944
Intervention_Pharmacological
peginterferon alfa-2a
31945
Intervention_Pharmacological
peginterferon alfa-2a
31946
Intervention_Pharmacological
peginterferon alfa-2a plus lamivudine .
31947
Intervention_Pharmacological
peginterferon alfa-2a
31948
Intervention_Pharmacological
pegylated interferon .
31949
Outcome_Physical
sustained virologic response ( SVR )
31950
Outcome_Physical
hepatitis B virus deoxyribonucleic acid ( HBV DNA )
31951
Outcome_Physical
HBV DNA <
31952
Outcome_Physical
Hepatitis B surface antigen ( HBsAg ) concentrations
31953
Outcome_Physical
HBV DNA .
31954
Outcome_Physical
SVR
31955
Outcome_Physical
HBV DNA
31956
Outcome_Physical
log reduction in HBV DNA .
31957
Outcome_Physical
HBsAg concentration
31958
Outcome_Physical
HBV DNA
31959
Outcome_Physical
SVR .
31960
Outcome_Physical
SVR
31961
Participant_Condition
hepatitis B e antigen-negative chronic hepatitis B
31962
Participant_Condition
chronic hepatitis B
31963
Participant_Condition
CHB
31964
Participant_Sample-size
Thirteen
31965
Participant_Condition
HBeAg-negative CHB
31966
Participant_Condition
HBeAg-negative CHB