Available treatments for hepatitis B e antigen (HBeAg)–negative chronic hepatitis B are associated with poor sustained responses.
As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications.
Researchers from several countries compared the efficacy and safety of peginterferon alfa-2a (180 µg once weekly) plus placebo in 177 patients, peginterferon alfa-2a plus lamivudine (100 mg daily)in 179 patients , and lamivudine alone in 181 patients with HBeAg-negative chronic hepatitis B.
Each group of patients was treated for 48 weeks and then researchers followed them for an additional 24 weeks.
The researchers found that after 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy and peginterferon alfa-2a plus lamivudine than with lamivudine monotherapy.
They also found that rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone.
|Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine|
|New England Journal of Medicine|
None of the patients given lamivudine alone were found to have lost Hep B surface antigen compared to 12 of the patients in the peginterferon groups.
The group noted that adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy.
Dr Marcellin commented, "When given peginterferon alfa – 2a, patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, than with lamivudine alone."
He added, "The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates."