Conventional interferon and lamivudine monotherapy are unsatisfactory in treating hepatitis B virus (HBV) infection.
Dr Lik-Yuen Chan and colleagues undertook a study in order to evaluate the efficacy and safety of pegylatedinterferon-2b and lamivudine combination therapy for chronic hepatitis B.
The researchers designed a randomized, controlled, open-label trial to be carried out in an outpatient clinic in a referral center.
The research team enrolled a total of 100 treatment-naive patients with hepatitis B e antigen (HBeAg)–positive chronic hepatitis B and moderately elevated alanine aminotransferase levels.
The primary end point was sustained virologic response (HBeAg seroconversion and HBV DNA level < 500 000 copies/mL) at 24 weeks after cessation of treatment.
The researchers administered a staggered regimen of combination therapy with pegylated interferon-2b given for 32 weeks plus lamivudine (100 mg daily) given for 52 weeks to the first group.
|Rate of sustained virologic response was 36% for the combination treatment group and 14% for the lamivudine monotherapy|
|Annals of Internal Medicine|
The researchers compared the first group to a second group who received lamivudine (100 mg daily) monotherapy for 52 weeks.
The research team found that out of the 100 participants, 96% completed treatment and 80% completed post-treatment follow-up.
In addition, the team noted that the rate of sustained virologic response was 36% for the combination treatment group and 14% for the lamivudine monotherapy group.
End-of-treatment outcomes showed that, compared with monotherapy, patients receiving combination therapy more often had virologic response.
In addition, the researchers found that they had more substantial reductions of HBV DNA and less often had lamivudine-resistant mutants.
The percentages of patients with normalization of alanine aminotransferase levels and histologic improvement did not differ.
The research team observed that adverse effects, such as transient influenza-like symptoms, alopecia, and local erythematous reactions, were more common with combination therapy.
Dr Lik-Yuen Chan concluded, "In patients with HBeAg-positive chronic hepatitis B, staggered combination treatment with pegylated interferon-2b and lamivudine may lead to a higher rate of virologic response than lamivudine monotherapy."