Efficacy, safety, and tolerance of low-dose, long-term interferon-alpha 2b and zidovudine in early-stage AIDS-associated Kaposi's sarcoma.

Seventeen male homosexual outpatients with limited but progressive AIDS-associated Kaposi's sarcoma (KS) of skin, lymph nodes, oral cavity, and gastrointestinum were consecutively enrolled in an open, nonrandomized, prospective study. Patients received low-dose IFN-alpha 2b (3 MIU t.i.w.) in combination with 250 mg ZDV b.i.d. After remission of KS, continuation of treatment as maintenance therapy was provided. Eleven (65%) of 17 patients had a complete (CR) or partial remission (PR) of KS lasting more than 24 months in four patients. Response to treatment was strongly dependent on pretreatment values of CD4+ lymphocyte counts, CR and PR occurred only in patients with pretreatment levels higher than 250 CD4+ lymphocytes per microliter. Treatment was generally well tolerated and without severe hematologic side effects attributable to the addition of IFN-alpha 2b to ZDV treatment. This study suggests that a combination of low-dose IFN-alpha 2b and ZDV is therapeutically effective and well tolerated in early stages of progressive KS.