EFFICACY, SAFETY, AND TOLERANCE OF LOW-DOSE, LONG-TERM INTERFERON-ALPHA(2B) AND ZIDOVUDINE IN EARLY-STAGE AIDS-ASSOCIATED KAPOSIS-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.