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 patients. In addition the histological improvement favoured the combination therapy.

Supportive favourable results from a small study in naïve patients were reported using interferon alfa-2a (3 MIU 3 times per week) with ribavirin.
For other information on pharmacodynamic properties please refer to the SmPC for Ribavirin.

Follicular Non-Hodgkin's lymphoma

The efficacy of Roferon-A in addition to cytotoxic chemotherapy (CHOP-like regimen of cyclophosphamide, vincristine, prednisone and doxorubicin) was assessed in 122 patients with clinically aggressive low-grade or intermediate-grade non-Hodgkin's lymphoma and compared with 127 controls receiving the same chemotherapy regimen. The two regimens produced comparable objective responses, but the regimen including Roferon-A had a greater effect in prolonging the time to treatment failure (p<0.001), the duration of complete response (p<0.003).

Renal Cell Carcinoma

1) Combination with vinblastine

The efficacy of Roferon-A, given in combination with vinblastine, was compared with vinblastine alone. The combination of Roferon-A plus vinblastine is superior to vinblastine alone in the treatment of patients with locally advanced or metastatic renal cell carcinoma. Median survival was 67.8 weeks for the 79 patients receiving Roferon-A plus vinblastine and 37.8 weeks for the 81 patients treated with vinblastine (p=.0049). Overall response rates were 16.5% for patients treated Roferon-A plu