[36] BIKS STUDY (LOPINAVIR/RITONAVIREFAVIRENZ COMBINATION): COMPLETE 24-WEEK RESULTS

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] BIKS STUDY (LOPINAVIR/RITONAVIREFAVIRENZ COMBINATION): COMPLETE 24-WEEK RESULTS

[AUTHOR(S):] V. Ferré¹, C Allavena¹, I Poizot-Martin², G Beck-Wirth³, P Perré⁴, F Raffi¹, I Cohen Codar⁵ and the BIKS Study Group
¹University Hospital of Nantes, France; ²Hospital Sainte Marguerite, Marseille, France; ³Hospital E Muller, Mulhouse, France; ⁴Centre Hospitalier «Les Oudairies», La Roche/Yon, France; and ⁵Abbot, France

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 36
Antiviral Therapy 2003; 8(Suppl. 1):S193

[ABSTRACT:] Background: NRTIs are associated with significant long-term toxicities and cross-resistance. NRTI-sparing regimens need to be assessed as alternative HAART regimens.

Methods: The BIKS Study is an ongoing multicentre, open-label, controlled trial to assess the combination of LPV/r (533.3/133.3 mg) BID and EFV 600 mg QD in HIV-1 infected patients (pts). Pts have to be NNRTI naïve and, if PI experienced, have less than five LPV associated mutations (2001 ANRS algorithm) in the protease gene.

Results: 86 pts have been enrolled, with the following baseline characteristics: 65 ARV-naïve/21 ARVexperienced (12 PI-naïve), mean CD4 cell count 307/mm³, mean HIV RN: 4.84 log₁₀ cp/ml (>5 log₁₀ cp/ml in 42% of the pts). After a median follow up of 36 weeks, premature discontinuation occurred in 14 pts, due to CNS side effect (n=3), cutaneous rash (n=3), non compliance or lost to follow up (n=3), others (n=5). From baseline to week 24, the mean HIV RNA decrease was –3 log₁₀ cp/ml. Plasma HIV RNA was <400 cp/ml in 92% of the pts and <50 cp/ml in 76% of the patients at W24 (on-treatment analysis). The mean increase in CD4 (cells/mm³) was +162 at W24. On intent-to-treat analysis, 87% of the patients had HIV-RNA <400 cp/ml at W24. Viral rebound occurred in 4 pts: 2 pts had blips (HIV RNA <400 cp/ml on subsequent control), 1 was not compliant and 1 had confirmed virologic failure. Grade 3/4 clinically relevant adverse events have been notified in 34 pts (40%) including CNS symptoms (n=17), diarrhoea (n=11), cutaneous rash (n=4). Grade 3/4 hypercholesterolaemia, hypertriglyceridaemia and asymptomatic hepatic cytolysis have been observed in 29, 13 and 3 pts, respectively. After an initial increase between baseline and W4, the median change in fasting triglycerides and total cholesterol at W24 was +0.88 and +0.62 g/l, respectively. Median increased in LDL/HDL ratio was +0.27 at W24. The dual combination of LPV/r-EFV shows a similar immuno-virological efficacy to a NRTI-based HAART regimen with an acceptable tolerability. Durability of antiviral effect will be assessed at W48 of follow-up.

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