[Clinical and immuno-virologic efficacy of the expanded access use of protease inhibitors for HIV-1 advanced disease].
OBJECTIVE
To compare the efficacy and tolerance of additive therapy with protease inhibitors (PI) in patients with advanced HIV infection previously treated with retro-transcriptase inhibitors (RTI).


METHODS
Eighty patients with prior antiretroviral therapy with RTI (zidovudine, ddI or ddc) for more than 6 months were included. Fifteen patients received indinavir, 42 ritonavir and 23 saquinavir. Data were collected at 4, 12 and 24 weeks and included clinical events, tolerability, plasma HIV-1 RNA viral load and CD4+ cell counts. Virologic response was defined if a viral load reduction > 1 log was achieved.


RESULTS
Virological response was observed in 45 patients (56.5%) at 4 weeks and was maintained in most of them at 24 weeks. Viral load below limit of detection was achieved in 11 (15%) patients at 12 weeks. Adverse effects were not uncommon, specially with ritonavir, and 10 patients (12.5%) discontinued treatment. Indinavir was the most efficient drug and statistical differences in decreasing viral load were reached in pairwaise comparison with saquinavir at any time and with ritonavir at 12 and 24 weeks. CD4+ cell counts increased with all three drugs parallel with the decrease of viral load. Four patients died and 12 had opportunistic infections. Proportion of patients without infections in the follow-up was associated with virological response over treatment (p < 0.01).


CONCLUSIONS
The additive therapy with PI in advanced HIV patients can achieve a sustained reduction of viral load and a persistent recovery of CD4+ cell counts with clinical benefits. Within the limits of this study, indinavir seems more interesting in this group of patients in terms of probability pursuit of treatment because of better efficiency and fewer adverse effects.
Gómez-Vera
J
J
Servicio de Enfermedades Infecciosas, Hospital Universitario Virgen del Rocío, Sevilla.
De Alarcón
A
A
Viciana
P
P
Del Nozal Nalda
M
M
Cordero
E
E
Rodríguez-Hernández
M J
MJ
Pachón
J
J
D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000503:physiopathology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D015497:HIV-1; D006801:Humans; D008297:Male; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D019562:Viral Load
D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors
Eficacia clínica e inmunovirológica del uso compasivo de los inhibidores de proteasas en pacientes con infección avanzada por el VIH-1.