AEGiS-13IAC: Effects of HAART regimen as exclusive treatment of slow-proliferating kaposlaes sarcoma.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Effects of HAART regimen as exclusive treatment of slow-proliferating kaposlaes sarcoma.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. TuOrB302)

Renato M, Mongiovetti M, Vaccher E, Nasti G, Fasan M, Mena M, Di Gennaro G, Schioppa O, Tirelli U
M. Renato, Policlinico San Matteo, Istituto Malattie Infettive, Via Taramelli 5, 27100 Pavia, Italy, Tel.: +39 038 250 2959, Fax: +39 038 250 2959, E-mail: rmaserati@smatteo.pv.it

OBJECTIVE: To determine the efficacy of HAART alone in the treatment of slow-proliferating Kaposi's sarcoma (KS).

METHODS: A prospective study was started in June 1997 to enroll HIV+, HAART-naive patients (pts) with KS (stage I to III, NYU). Enrolled pts were evaluated at baseline and then at fixed time points for the usual clinical, virological and immunophenotypical parameters. Progression, stability or regression of KS was determined according to Krown scale.

RESULTS: 53 pts were enrolled in this study (50 M, 3 F, aged 24-65 yrs, mean 39). At baseline mean CD4+ cell count was 174/ 51- L and HIV-RNA in plasma (b-DNA) 184.282 cp/mL. Twenty-two out of 53 pts had been treated with different NRTIs before this study. HAART regimens included 1 PI (IDV in 25 cases; HG-SQV in 19; RTV in 7) and 2 NRTIs. One pt received HG + SQV + RTV + 2NRTIs and 1 HG + SQV + NFV + NVP. At week 48, 45 pts were evaluable (5 dropped, 3 lost) showing 31 (69%) objective response (complete remission 36%) and 14 (31%) stable (ST) or progressing (PR) KS lesions. CD4+ cell count variation from BL was + 1532% in PR+CR pts vs + 49% in ST + PR cases (p = 0.038). Mean HIV-RNA at week 45 was 5.447 cp/mL, with no differences between the groups. Previous CDC 93 stage and level of CD4+ cells at baseline (> or > 200/mcL) did not correlate with response. Conversely, 10 out of 21 pts treated with HG-SQV-based HAARTs progressed vs 4/32 in the RTV or IDV groups (p = 0.0093, Fisher exact test).

CONCLUSION: Slow-proliferating KS may be controlled by HAART alone in the majority of pts. It is very likely that the use of HG-SQV (the only formulation available in Italy) limited the responses rate in this cohort. Supported by ISS and AIRC grants.

Keywords: AEGIS, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, HIV Protease Inhibitors, HIV Infections, Anti-HIV Agents, HIV, Sarcoma, Kaposi, Drug Therapy, Combination, CD4-Positive T-Lymphocytes, Prospective Studies, Italy, Human, therapy, drug therapy
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