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Two industry-sponsored, randomized, international trials were conducted in different populations of patients with chronic hepatitis B.
In the first study, 537 hepatitis B e antigen (HBeAg)-negative patients received 48-week courses of peginterferon alfa-2a plus placebo, peginterferon alfa-2a plus lamivudine, or lamivudine alone. At baseline, all exhibited elevated serum alanine aminotransferase (ALT) levels and necroinflammatory changes on liver biopsies. At 72 weeks, patients who received peginterferon monotherapy and peginterferon-plus-lamivudine combination therapy were significantly more likely than those who received lamivudine therapy alone to have suppression of HBV DNA to <20,000 copies/mL (43% and 44% vs. 29%) and normalization of s…