RESULTS: The primary endpoint—normalization of
alanine aminotransferase levels and clearance of HDV
RNA at week 48--was achieved in two patients in the group receiving
peginterferon alfa-2a plus
adefovir and two patients in the group receiving
peginterferon alfa-2a plus placebo but in none of the patients in the group receiving
adefovir alone. At week 48, the test for HDV
RNA was negative in 23% of patients in the first group, 24% of patients in the second, and none of those in the third (P¼ 0.006 for the comparison of the first and third groups; P¼ 0.004 for the comparison of the second and third). The efficacy of
peginterferon alfa-2a was sustained for 24 weeks
after treatment, with 28% of the patients receiving
peginterferon alfa-2a plus
adefovir or
peginterferon alfa-2a alone having negative results on HDV-
RNA tests; none of the patients receiving
adefovir alone had negative results. A decline in
HBsAg levels of more than 1 log10 IU per milliliter from baseline to week 48 was observed in 10 patients in the first group, 2 in the second, and none in the third (P<0.001 for the comparison of the first and third groups and P¼0.01 for the comparison of the first and second).
CONCLUSIONS: