Controlled trial with human lymphoblastoid interferon among HBeAg and anti-HBe-positive chronic hepatitis B patients in Egypt.

In a randomized controlled trial, sixty chronic hepatitis B liver disease patients (HBsAg +ve and HBV-DNA +ve) were randomly allocated into 2 groups. The first group comprised of 30 patients who were subdivided into 2 subgroups according to the HBeAg/anti-HBe system. One subgroup was HBeAg-positive (12 patients) and the other was anti-HBe-positive (18 patients). All were given human lymphoblastoid IFN alpha (Wellferon-R) at a dosage of 5 MU, thrice weekly for 4 months. The other 30 patients served as a control group, six of whom were lost during the study. The initial response was loss of HBV-DNA in 66.6% of the HBeAg +ve subgroup (8/12 patients), 33% in the anti-HBe subgroup (6/18 patients) and in 8% in the control group (2/24 patients). Patients and controls were followed up for 8 months after the end of IFN therapy. A sustained response (loss of HBV-DNA) 8 months after discontinuation of IFN was attained in 5/12 patients (41.6%) of the HBeAg-positive subgroup compared to none (0/24) in the control group (p < 0.05). In the anti-HBe subgroup, a sustained response in 2/18 patients (11%) compared to none (0/24) in the controls was not significant. We conclude from this study that (Wellferon-R) at a dosage of 5 MU given thrice weekly for 4 months was significantly better (p < 0.05) than no treatment in producing a sustained response among the HBeAg +ve subgroup of patients. On the other hand, in the anti-HBe subgroup the outcome of the previous schedule was not significantly better than in controls due to the small numbers involved although 2 patients did have a sustained response.