Current treatments for chronic Hepatitis B are suboptimal.
Dr George Lau and colleagues compared the efficacy and safety of treatments for Hepatitis B e antigen-positive chronic Hepatitis B treatments.
The investigators searched for improved therapies by comparing pegylated interferon alfa plus lamivudine, and pegylated interferon alfa without lamivudine.
|More patients receiving peginterferon alfa-2a had Hepatitis B DNA levels below 100,000 copies ml-1|
|New England Journal of Medicine|
The investigative team also compared these with lamivudine alone for the treatment of hepatitis B e antigen-positive chronic Hepatitis B.
A total of 814 patients with Hepatitis B e antigen-positive chronic Hepatitis B received 1 of 3 different treatments.
Patients were treated for 48 weeks and followed for an additional 24 weeks.
The investigators gave patients in Group 1 peginterferon alfa-2a 180 µg once weekly plus oral placebo.
The patients in Group 2 received peginterferon alfa-2a plus lamivudine 100 mg daily, and patients in Group 3 received lamivudine alone.
The investigative team reported that the majority of patients in the study were Asian.
The team noted that most patients were infected with Hepatitis B virus genotype B or C.
The investigators found that after 24 weeks of follow-up, more patients in Group 1 and Group 2 had Hepatitis B e antigen seroconversion than limivudine monotherapy.
The team also found that after 24 weeks of follow-up, more patients in Group 1 and Group 2 had Hepatitis B DNA levels below 100,000 copies per milliliter.
The investigators observed that 16 patients receiving peginterferon alfa-2a, alone or in combination, had Hepatitis B surface antigen seroconversion.
The team compared the rate of seroconversion in the group receiving lamivudine alone and found this to be 0.
The most common adverse events were those known to occur with therapies based on interferon alfa.
The investigators noted that serious adverse events occurred in 4%, 6%, and 2% of patients in Group 1, Group 2 and Group 3, respectively.
The team reported that 2 patients receiving lamivudine monotherapy in Group 3 had irreversible liver failure after the cessation of treatment.
Of these 2 patients in the lamivudine monotherapy group, 1 patient underwent liver transplantation, and the other died.
Dr Lau's team concluded, “In patients with Hepatitis B e antigen-positive chronic Hepatitis B, peginterferon alfa-2a offers superior efficacy over lamivudine.”
“The superiority of peginterferon alfa-2a as therapy is on the basis of Hepatitis B e antigen seroconversion, Hepatitis B DNA suppression, and Hepatitis B s antigen seroconversion.”