Uno studio a 48 settimane mostra come l’ormone della crescita ricombinante aumenti i CD4 totali e naive versus un braccio di controllo con la sola terapia antiretrovirale. Ricordiamo ai nostri lettori che le autorità regolatorie hanno bocciato l’uso di questo farmaco in europa.
In this government-sponsored study (ACTG 5174), researchers and multiple US sites evaluated the immunologic effects of recombinant growth hormone/rGH (Serostim) on HIV positive subjects with incomplete immune reconstitution on HAART.
Sixty subjects on HAART were randomized to receive rGH 1.5mg SC QD +HAART for 48 weeks (ARM A) or continue HAART alone for 24 wks followed by addition of rGH 3.0 mg SC QD for 24 wks (ARM B).
Eleven subjects in ARM A underwent thymus CT scans at baseline and wk 24 to evaluate thymus size.
• All subjects had been on HAART for > 1 year, entry CD4 <350 and HIV viral load (VL) <400 and maintained VL <400 c/ml through week 48.
• Baseline median total CD4 for ARM A and B were 223 and 219, respectively.
• Six subjects went off study prior to week 48.
•Arm A trended toward increases in total (p=0.054) and naïve (p=0.099) CD4 cell count from baseline to week 24 while ARM B had no significant change.
• By wk 48, both arms had significant increases in total and naïve CD4 cells.
• From baseline to week 48, median change in total and naive CD4 for ARM A and B were +36, +26 and +55, +23 respectively (p< 0.002 for each).
• In ARM B, the median change in naïve CD4 # from BL to wk 24 (HAART alone) was 5, the change from wk 24 to 48 (HAART + rGH) was 24, (median difference in changes: 24; p<0.001). Seven of 11 (64%) in ARM A had increased thymus size from baseline to week 24 (p=0.06).
Based on the results, the authors conclude, “Treatment with rGH is associated with significant increases in total and naïve CD4 count compared to HAART alone.”
“Treatment with rGH is associated with an increase in thymus size.”
“This is the first randomized clinical trial to demonstrate immunologic effects of rGH combined with HAART.”
K Smith and others (ACTG 5174 Protocol Team A). Treatment with growth hormone leads to improvement in total and naïve CD4 lymphocyte recovery in HIV-infected subjects with incomplete immune reconstitution on HAART. Abstract TuOa0203 (oral). 3rd IAS Conference on HIV Pathogenesis and Treatment. July 24-27, 2005. Rio de Janeiro, Brazil.