rogression from the chronic phase of leukaemia to an accelerated or a blastic phase was longer in the Roferon-A group (69 months) than in the conventional chemo-therapy group (46 months) (p<0.001) as was median overall survival (72.8 months versus 54.5 months, p=0.002).
Cutaneous T-cell Lymphoma (CTCL)
The efficacy of Roferon-A was assessed in 169 patients with CTCL, the majority of whom (78%) were resistant to, or had relapsed on, standard therapy. Among the 85 patients eva luable, overall response to treatment was 58% (20% complete response, 38% partial response). Patients with all stages of disease responded to therapy. Median duration of complete response from start of treatment was 22 months, with 94% of complete responders remaining in remission at 9 months.
Chronic Hepatitis B
The efficacy of Roferon-A in the treatment of chronic hepatitis B was assessed in trials involving over 900 patients. In the pivotal controlled study 238 patients were randomised into four groups: patients received either 2.5 MIU / m2, 5.0 MIU / m2, 10 MIU / m2, tiw of Roferon-A or no treatment. Treatment duration was 12-24 weeks depending on response i. e. clearance of HBeAg and HBV DNA from serum. Patients were followed for up to 12 months after treatment was discontinued. There was a statistically significant difference in sustained response [clearance of hepatitis B e antigen (HBeAg) and hepatitis B viral DNA (HBV DNA)] between treated and untreated patients (37% versus 13%). Response differences between various dose groups did not reach statistical significance (33%, 34% and 43% for the 2.5, 5.0 and 10.0 MIU / m2 groups). Serological and virological responses were associated with marked improvement in liver histology after 12 months of treatment free-follow up.
Chronic Hepatitis C
The efficacy of Roferon-A in the treatment of chronic hepatitis C has been assessed in 1701 patients, with 130 untreated or placebo treated controls. At recommended doses, Roferon-A induces complete biochemical response in up to 85% of patients, with response rates maintained for at least 6 months after treatment ranging from 11 to 44% depending on pre-treatment disease characteristics, IFN dose and treatment duration. Biochemical response to Roferon-A is associated with significant improvement of liver disease as shown by eva luation of pre-and post-liver biopsies. For those patients who have a sustained response 3-6 months after end of therapy, response has been reported to be maintained for up to 4 years.
The therapeutic efficacy of Interferon alfa-2a alone and in combination with ribavirin was compared in a double-blind randomised clinical trial in naive (previously untreated) and relapsed patients with virologically, biochemically and histologically documented chronic hepatitis C. Six months after end of treatment sustained biochemical and virological response as well as histological improvement were assessed.
A statistically significant 10-fold increase (from 4% to 43%; p<0.01) in sustained virological and biochemical response was observed in relapsed patients. The favourable profile of the combination therapy was also reflected in the response rates relative to HCV genotype or baseline viral load. Although the sustained response rates in patients with HCV genotype-1 were lower than in the overall population (approx. 30% versus 0% in the monotherapy arm) the relative benefit of ribavirin in combination with interferon alfa-2a is particularly significant in this group of pat |
