AEGiS-14IAC: European and south american study of Indinavir, Efavirenz, and Ritonavir (EASIER).

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

European and south american study of Indinavir, Efavirenz, and Ritonavir (EASIER).

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbPp2208)

Stek M Jr, Hirschel B, Benetucci J, Reboredo G, Begovac J, Banhegyi D, Stankova M, Duiculescu D, Patel K, Shivaprakash M, Georgiou N, Menten J
Merck & Co., Inc., Whitehouse Station, NJ, United States

OBJECTIVES: To investigate antiviral activity (vRNA and CD4) and safety of a compact nucleoside-sparing regimen of indinavir (IDV) 800mg bid, ritonavir (RTV) 100mg bid, and efavirenz (EFV) 600 mg qhs (Regimen A) versus IDV+RTV+EFV plus stavudine (D4T) 40mg bid if weight > 60kg or 30mg bid if <60kg (Regimen B). Design: Multicentre, randomized, open-label, 48 week comparative trial. Baseline: [table: see text]

RESULTS: 24 wk. Change from Baseline (latest data carried forward) [table: see text] vRNA at 24 wks. [table: see text] At 24 weeks the following frequencies of adverse events were reported for regimens A and B, respectively: drug-related (63 & 59%), nervous system (26 & 33%), psychiatric, i.e. depression (6 & 0%), renal colic/urolithiasis (6 & 5%), and rash (20 & 13%). Discontinuations due to clinical and laboratory AEs for regimens A and B respectively were: clinical (17% & 13%), laboratory (3% & 0%). Two cases of serious drug-related AEs in regimen A and 1 case in regimen B resulted in discontinuations. Using pill counts and adherence questionnaires, similar degrees of compliance were found for both regimens.

CONCLUSION: At 24 weeks, the compact, IDV/RTV + EFV nucleoside-sparing regimen yielded similar promising surrogate marker efficacy and safety data as compared with results achieved using the PI + NNRTI foundation plus D4T.

Keywords: AEGIS, Indinavir, Ritonavir, Oxazines, Stavudine, efavirenz

020707
LbPp2208