Hairy Cell Leukaemia

The therapeutic efficacy of Roferon-A in the treatment of hairy cell leukaemia has been demonstrated in a large trial of 218 patients, of whom 174 were eva luable for efficacy after 16-24 weeks of therapy. Response was observed in 88% of patients (complete response 33%, partial response 55%).
AIDS-related Kaposi's Sarcoma

The efficacy of Roferon-A in the treatment of Kaposi's sarcoma was assessed in 364 patients receiving of 3 to 54 MIU per day. Objective response rates were dose-related, ranging from 14% to 50%, with a daily dose of 36 MIU producing the best overall therapeutic benefit (13.3% complete response, 12.2% partial response). High baseline CD4 lymphocyte count was a favourable prognostic factor for response, with 46% of patients with a CD4 count >400/mm³ responding to Roferon-A. Response to Roferon-A therapy was the strongest prognostic factor for survival.
Chronic Myelogenous Leukaemia (CML)

The efficacy of Roferon-A was assessed in 226 patients with chronic phase CML, and compared with 109 patients receiving chemotherapy (hydroxyurea or busulfan). Both groups had favourable features at diagnosis (less than 10% blasts in the blood) and treatment was initiated with interferon within 6 months of diagnosis. Treatment of patients with CML in the chronic phase leads to the same proportion of patients (85-90%) achieving a haematologic response as treatment with the standard chemotherapy regimens. In addition patients treated with Roferon-A resulted in 8% complete cytogenetic response and 38% partial cytogenetic response versus 9% partial cytogenetic response during chemotherapy. Time to progression 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 no