1st International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 26–28 June 1999 - San Diego, CA, USA

SERUM LIPID LEVELS IN HIV-POSITIVE ADULTS DURING SAQUINAVIR-CONTAINING COMBINATION THERAPY

Antiviral Therapy 1999; 4(Suppl. 2):52(abstract no. 35)

P Skolnik¹, P Siemon-Hryczyk², J Drake³, F Duff² and N Buss^4
1Tufts University-New England Medical Center, Boston, Massachusetts, USA; and ²Hoffmann-La Roche, Nutley, New Jersey, USA; ³Welwyn Garden City, Herts, UK; and ⁴Basel, Switzerland

BACKGROUND: Hypertriglyceridaemia, hypercholesterolaemia and insulin resistance have been observed in some HIV-positive individuals receiving combination antiretroviral therapy. While these markers are elevated in some, but not all individuals showing clinical symptoms of lipodystrophy syndrome, no causal relationship has been established. Few data have been presented from randomized clinical trials.

OBJECTIVES: To review data on lipid and glucose levels collected in three separate studies of triple combination therapy including the soft gelatin capsule (SGC) formulation of saquinavir, either as the sole PI or in dual PI regimens.

DESIGN: Retrospective analysis of non-fasting serum triglyceride, cholesterol and glucose levels from three clinical trials of combination regimens including saquinavir SGC (dosage differed according to regimen) either as the sole PI or with nelfinavir 1250 mg twice daily or ritonavir 400 mg twice daily. Study participants ranged from totally antiretroviral-naïve through to nucleoside reverse transcriptase inhibitor and PI-experienced (Δ3 months of therapy with hard gelatin saquinavir).

RESULTS: At baseline, 793 participants were included; mean 24 week non-fasting data for 463 patients are summarized in this abstract. Saquinavir SGC as the sole PI had minor effects on triglyceride (-6% to +24%) and total cholesterol levels (+8% to +9%). The dual PI regimen with nelfinavir appeared to have greater effects on triglyceride (+12% to +50%) and total cholesterol levels (+19%). The ritonavir-containing regimen had the greatest effect on triglyceride levels, with mean values more than doubling (+108%; cholesterol not measured). No combination affected glucose levels.

CONCLUSIONS: In these studies, glucose levels appeared unaltered during antiretroviral therapy. Dual PI regimens appeared to affect lipid markers more than single PI regimens. Accepting the limitations of cross-study comparisons, a tentative ranking of the PI-containing regimens studied, based on their effects on serum lipids, is saquinavir SGC <saquinavir SGC plus nelfinavir (1250 mg) <saquinavir SGC plus ritonavir (400 mg). The clinical implications of these observations remain to be established.

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Copyright © 1999 - International Medical Press Ltd. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Medical Editor, International Medical Press, 36 St Mary-at-Hill, London EC3R 8DU, United Kingdom.