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Comparison of interruption and re-treatment with recombinant human growth hormone (r-hGH) with an induction-maintenance-re-induction regimen in patients (pts) with HIV-associated adipose redistribution syndrome (HARS): effects on trunk fat (TF) at 48 weeks (wks)
Presented by Stephen Brown, United States.
Brown S.1, Moe A.2, Freedland E.S.3
1AIDS Research Alliance, Los Angeles, United States, 2UCLA, Los Angeles, United States, 3EMD Serono Inc., Rockland, United States
Objective: An open-label extension to a phase III study with r-hGH examined whether the optimal approach to long-term management of HARS was interruption and retreatment (DD-AD-DD) vs induction-maintenance-re-induction (DD-PL-DD). This analysis examined the effects of DD-AD-DD vs DD-PL-DD on TF and glucose tolerance in HARS pts.
Methods: 326 HARS pts with normal glucose tolerance were randomized to r-hGH (Serostim®, EMD Serono) 4mg daily dose (DD) induction (n=243; 207M, 36F) or placebo (PL, n=79) for 12 wks. At Wk 12, pts initially randomized to DD were re-randomized to intermittent retreatment (n=93) consisting of PL for 24 wks then r-hGH 4mg daily (DD) for 12 wks, or maintenance reinduction (n=91), alternate day r-hGH 2mg (AD) for 24 wks then 4mg daily (DD) Wks 36-48. Endpoints included TF on DXA scan and standard (75g) 2-hour oral glucose tolerance test (120-glucose).
Results: At wk 12, mean TF decreased on DD but not PL (–2.2±1.7 vs +0.2±1.3kg; p<0.001). From wk 12 through 36, mean re-gain of TF was less on r-hGH AD than PL (+1.5±1.5kg vs +2.1±1.8kg; p<0.016). There were no between-group differences in mean 120-glucose. From wk 36 through 48, TF decreased on r-hGH in both groups (–1.9±1.6, p<0.001 in DD-PL-DD, n=66; –1.4±1.1kg, p=0.039 in DD-AD-DD, n=60), with no between-group difference (p=0.587). Mean 120-glucose increased significantly only in DD-PL-DD (+18.3±40.5 vs +3.8±46.5 mg/dL in DD-AD-DD, p=0.015 between groups).
Conclusions: After 12 wks r-hGH induction therapy in HARS pts, similar TF reductions were observed during 36 wks of either DD-PL-DD or DD-AD-DD. However, elevated 120-glucose was greater for DD-PL-DD, possibly related to the greater rebound in TF during Wks 12–36. Therefore, induction-maintenance-re-induction may be preferable to interruption and retreatment with r-hGH.
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