Long-term efficacy on Kaposi's sarcoma of highly active antiretroviral therapy in a cohort of HIV-positive patients

Objective: To assess the efficacy of highly active antiretroviral treatment (HAART) on AIDS-Kaposi's sarcoma (KS). Design: Prospective cohort of patients followed for 24 months. Setting: Four referral hospitals of the West Paris metropolitan area. Patients/intervention: Thirty-nine AIDS-KS patients, 42 +/- 9 years old, wh o began HAART (HIV-protease inhibitor and two nucleoside analogues) between March and December 1996, were enrolled. One was lost to follow-up at month 12. Main outcome measures: KS response, using criteria of the AIDS clinical tri als group (ACTG), CD4 cell counts, and plasma HIV-RNA, assessed every 6 mon ths. ACTG TIS staging of KS. Results: Eighteen patients had T-1 KS and 21 T-0 KS. One patient died from KS at month 6. KS improved progressively, with complete and partial respons e rates of 46% and 28% at month 24, respectively. Only six patients were st ill receiving systemic KS therapy at month 24. Complete response was observ ed in 10 of the 19 patients without systemic KS therapy at inclusion. Patie nts with complete response at month 24 had higher CD4 cell counts than othe rs (465 +/- 343 versus 185 +/- 167 x 10(6)/l; P < 0.01), but the proportion of patients with HIV-1 RNA < 500 copies/ml was not significantly different . An increase in CD4 cell counts from inclusion to month 12 of > 150 x 10(6 )/l [odds ratio (OR), 13.4; 95% confidence interval (CI), 2-82] and To KS a t inclusion: [OR, 7; 95% Cl, 1.1 -42] were predictive of complete response at month 24. Conclusions: HAART appears to have prolonged efficacy on AIDS-KS, even with out specific KS therapy, and this effect appears to be linked to the restor ation of immune function. (C) 2000 Lippincott Williams & Wilkins.