One small prospective randomised trial of interferon as monotherapy in AIDS-related KS tested the efficacy of high-dose versus low-dose interferon alfa in AIDS-associated KS.28 Twenty patients were randomised between high-dose intravenous interferon (50 MU/m2 for 5 days on alternate weeks) and low-dose subcutaneous interferon (1 MU/m2 for 5 days on alternate weeks). The objective response rate was 40% in the high-dose arm and 20% in the low-dose arm.28 Many uncontrolled phase II studies have been conducted and these have reported higher response rates for patients with CD4 lymphocyte counts >200 x 106 cells/litre, higher doses of interferon (>20 MU/day) and in the absence of previous opportunistic infections. However, most of these individual studies are small, and the use of a wide variety of interferon doses and schedules makes comparisons difficult. These trials often compare two different doses or preparations of interferon and we found no placebo-controlled randomised trials of interferon in the treatment of KS. In one larger series of 273 patients with AIDS-related KS, CD4 counts >400 x 106 cells/litre were associated with response rates of 45% whereas the response rate for patients with CD4 counts <200 x 106 cells/litre was only 7%.30 Another series of uncontrolled phase II trials with a total of 114 patients given interferon alfa-2b demonstrated higher response rates with high-dose (50 MU/m2 intravenously) than low-dose interferon (1 MU/m2 subcutaneously).31 Patients with early stage disease and without "B" symptoms were more likely to respond.31
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