BACKGROUND/AIMS: Alpha-interferon achieves seroconversion in about one third of naive @entity1 . Attempts to achieve seroconversion in @entity1 who have previously failed alpha-interferon have proved disappointing. Combination chemotherapy (alpha-interferon with a @entity2353 analogue) might provide a treatment alternative for these @entity1 . We have undertaken a phase 2 study in 20 @entity1 who had previously failed at least one course of alpha-interferon. The study was designed to assess the safety, tolerability and efficacy of the combination. METHODS: All @entity1 were treated for 16 weeks with alpha-interferon in combination with 12 or 16 weeks of @entity16332 (3'TC). @entity1 were followed for 16 weeks post-treatment. Pharmacokinetic studies were performed to identify/exclude significant pharmacokinetic drug interaction. RESULTS: The combination was well tolerated, and side-effects of the combination were indistinguishable from the recognised side-effects of alpha-interferon. Pharmacokinetic studies performed on days 1 and 29 did not show any significant interaction. All @entity1 achieved @entity97 DNA clearance during treatment, but 19 relapsed at the end of treatment. HBeAg/anti-HBe seroconversion was observed for four @entity1 , but was sustained for a single @entity1 (who also had sustained DNA clearance). CONCLUSIONS: Combination therapy with alpha-interferon and @entity16332 given for 16 weeks appears safe and is well tolerated. However, for this group of @entity1 who had previously failed interferon monotherapy, the efficacy of combination interferon/ @entity16332 therapy appears disappointing, and other treatment strategies should be investigated.

Combination alpha-interferon and XXXX therapy for alpha-interferon-resistant chronic hepatitis B infection: results of a pilot study.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity97 :: ('10407', 'Species') :: ['HBV'] @entity2353 :: ('CHEBI:33838', 'Chemical') :: ['nucleoside'] @entity16332 :: ('MESH:D019259', 'Chemical') :: ['lamivudine', 'Lamivudine']
@entity16332 :: (MESH:D019259,Chemical) :: ['lamivudine']
