10   Clinical Course and Prognostic Factors of AIDS- Associated Progressive Multifocal Leukoencephalopathy (PML) in Patients Treated with HAART (GESIDA 11/99).

J. Berenguer*¹, P. Miralles¹, J. Arrizabalaga², E. Ribera³, F. Dronda⁴, J. Baraia⁵, P. Domingo⁶, M. Marquez⁷, F. J. Rodriguez-Arrondo², F. Laguna⁸, R. Rubio⁹, J. López-Aldeguer¹⁰, V. De Miguel¹¹, and the Gesida 11/99 Study Group.
¹Hosp. G. Marañón, Madrid;²Hosp. Aránzazu, San Sebastián;³Hosp.Vall d´Hebrón, Barcelona;¹Hosp. G. Marañón, Madrid;²Hosp. Aránzazu, San Sebastián;³Hosp. Vall d´Hebrón, Barcelona;⁴Hosp. Ramón y Cajal, Madrid;⁵Hosp. Basurto, Bilbao;⁶Hosp. Sant Pau, Barcelona;⁷Hosp. Málaga;⁸Hosp. Carlos III, Madrid;⁹Hosp. 12 Octubre, Madrid;¹⁰Hosp. La Fé, Valencia; and¹¹AEC GESIDA, Madrid, Spain.

Background:We analyzed survival, neurologic function and prognostic factors of patients with AIDS- associated PML treated with HAART.

Methods:118 patients with PML treated with HAART from 11 centers in Spain were included in the study. The diagnosis of PML was established by brain biopsy and/or PCR confirmation in 42 patients and by clinical characteristics and neuroimaging findings in 76 patients.

Results:Of the 118 patients, 98 were males, 81 were IVDA and 42 had had prior AIDS-defining conditions (ADCs). At diagnosis of PML the median CD4 cell count was 85/mL and the mean HIV viral load was 4.78 log copies/mL. In 38 patients symptoms of PML followed the initiation of HAART. MR imaging revealed supratentorial lesions in 93 patients and infratentorial lesions in 70. Cidofovir therapy was administered to 44 patients. As of June 2000, 43 patients had died, 36 as a consequence of PML and 7 from unrelated causes. Related deaths occurred at a median time of 12 wk after the diagnosis of PML. Neurologic function of the 75 survivors (after a median follow-up of 114 wk) was categorized as cure or improvement in 33, stabilization or worsening in 40 and unknown in 2. In a Cox regression analysis, CD4 cell count at diagnosis (HR of death = 0.991; 95% CI 0.983—0.999) and cidofovir therapy (HR of death = 0.214; 95% CI 0.050—0.925) were significantly associated with survival. Age, sex, risk group, prior ADCs, HIV viral load, localization of PML lesions, confirmation by brain biopsy and/or PCR, and development of PML symptoms after HAART were not associated with death.

Conclusions:We found that one third of patients with PML died despite HAART and that neurologic function improved in approximately half of the survivors. Higher CD4 cell count and cidofovir therapy were associated with survival.