[39] COMPARISON OF PI-BOOSTED INDINAVIR WITH EFAVIRENZ PLUS STAVUDINE REGIMENS IN EASIER (EUROPEAN AND SOUTH AMERICAN STUDY OF INDINAVIR, EFAVIRENZ, AND RITONAVIR)

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] COMPARISON OF PI-BOOSTED INDINAVIR WITH EFAVIRENZ PLUS STAVUDINE REGIMENS IN EASIER (EUROPEAN AND SOUTH AMERICAN STUDY OF INDINAVIR, EFAVIRENZ, AND RITONAVIR)

[AUTHOR(S):] M Stek Jr¹, B Hirschel², J Benetucci³, G Reboredo⁴, D Duiculescu⁵, J Begovac⁶, K Brinkman⁷, D Banhegyi⁸, M Shivaprakash¹ and J Menten¹ for the EASIER study team
¹Merck & Co., Inc., Whitehouse Station, NJ, USA; ²Division des Maladies Infectieuses, HUG, Geneva, Switzerland; ³Hospital Muniz-Fundai, Uspallata, Argentina; ⁴Hospital de Clinicas PETS, Cordoba, Argentina; ⁵Spitalul Clinic de Boli Infectioase si Tropicale, Romania; ⁶Clinical Hospital for Infectious Diseases, Zagreb, Croatia; ⁷OLVF, Amsterdam, the Netherlands; and ⁸ St Laszlo Hospital, Budapest, Hungary

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 39
Antiviral Therapy 2003; 8(Suppl. 1):S194

[ABSTRACT:] Objective: To investigate antiviral activity (vRNA and CD4) and safety of a compact nucleoside-sparing regimen of indinavir (IDV) 800 mg bid, ritonavir (RTV) 100 mg bid, and efavirenz (EFV) 600 mg qhs (Regimen A) versus IDV+RTV+EFV plus stavudine (D4T) 40 mg bid if weight >60 kg or 30 mg bid if <60 kg (Regimen B) in PI-, NNRTI- and D4T-naïve HIV-1+ patients.

Design: Multicentre, randomized, open-label, 48 week comparative trial. Baseline: Regimens A and B enrollment numbers were 47 and 46, % male 70 and 74, VRNA log₁₀ (Mean ±SD) 4.6 ±0.6 and 4.7 ±0.7, and CD4 cells/mm³ (Mean ±SD) 407 ±234 and 322 ±175, respectively.

Results: Changes from baseline at 48 wks. (latest data carried forward) for vRNA log₁₀ (Mean ±SD) and CD cells/mm³ for Regimen A were –2.79 ±0.86 (#44) and +168 ±129 (#44) and –2.50 ±1.22 (#44) and +207 ±207 (#43) for Regimen B, respectively. Observed data for vRNA <400 and <50 cps/ml at 48 weeks were 34/34 (100%) and 25/34 (74%) for Regimen A and 33/36 (92%) and 28/36 (78%) for Regimen B, respectively. ITT (NC=F) data for vRNA <400 and <50 at 48 wks. were 34/47 (72%) and 25/47 (53%) for Regimen A and 33/46 (72%) and 28/46 (61%) for Regimen B, respectively. Over 48 weeks the following frequencies of clinical adverse events were reported for regimens A and B, respectively: drug-related (66 and 54%), nervous system (23 and 33%), psychiatric, e.g. depression (9 and 11%), renal colic/urolithiasis (6 and 9%), and rash (13 and 11%). Discontinuations due to clinical and laboratory AEs were 15% and 2% for regimen A and 11% and 2% for regimen B, respectively. The frequency of discontinuations due to a serious drug-related AE was 6% and 4% with regimens A and B, respectively. Similar degrees of compliance were found for both regimens using pill counts and adherence questionnaires.

Conclusions: At 48 weeks, the compact, IDV/RTV+EFV nucleosidesparing regimen yielded similar promising efficacy and safety data as compared with results achieved using the PI+NNRTI foundation plus D4T.

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