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Abstract
NFV (625 mg new formulation) boosted with RTV once daily is not an option as compared to twice daily regimen.
Landman r.1, Peytavin G.2, Descamps d.2, Yeni P.3, Katlama C.4, Dellamonica P.5, Girard P.M.6, Lafeuillade a.7, Reynes J.8, Trepo C.9, Michelet C.10, Lamotte c.2, Brun Vezinet F.2
Introduction: Nelfinavir (NFV) clinical efficacy is based on both NFV and its M8 active metabolite plasma concentrations and ritonavir (RTV) is known to significantly boost M8 active metabolite in healthy volunteers
Methods: To compare in an open randomized study, in NFV (250mg x 5) + 2 NRTIs pretreated patients (pts), a switch for NFV/RTV QD or NFV BID new formulation (625 mg) for : virological and immunological efficacy, NFV and NFV+M8 plasma Cmin concentrations and tolerance. 93 pts on NFV with VL< 200 c/ml and NFV Cmin > 800 ng/mL were randomized to receive NFV 625mg x 3 + RTV 100mgx2 QD (n=44) or NFV 625mg x 2 BID (n=49). Intent to treat analysis was performed.
Results: Baseline characteristics, CD4 (407/mm3 +/- 190) and NFV Cmin ( 2561+/- 1614 ng/L) were similar in both groups. At M6: treatment switch or stop: 11/44 (25.0%) in QD and 1/49 (2.0%) in BID (p<5%).VL<200/ml in 34/44 77.3% (QD) and 48/49 98.0% (BID) of patients (p<5%), CD4: 472/mm3 +/- 243 (QD) and 435/mm3 +/- 193 (BID). NFV+M8 Cmin in QD and BID were 1806+/- 1520 (Cmin 24h n=35) and 2503+/- 2473 (Cmin12h n=48) respectively (p<5%) and % of pts with NFV+M8 Cmin > 1000 ng/mL were 34/44 (77.3%) and 42/49 (85.7%) respectively (NS). NFV was well tolerated in both groups except for diarrhea grade I/II (3 in BID versus 8 in QD). At M3 only a slight increase of triglycerides were observed in QD (1.9+/- 1.4 to 2.3+/- 1.4 mmol/L, p<5%).
Conclusions: A switch to NFV new formulation BID allowed a daily pills reduction and virological efficacy. NFV/RTV QD shows a slight increase in mild to moderate diarrhea and triglycerides, a lower Cmin, a lower virological efficacy and a higher switch or stop treatment rate as compared to NFV BID
The 3rd IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
WePe12.3C04
Suggested Citation
"Landmanr., et al.
NFV (625 mg new formulation) boosted with RTV once daily is not an option as compared to twice daily regimen..
Poster Exhibition:
The 3rd IAS Conference on HIV Pathogenesis and Treatment:
Abstract no.
WePe12.3C04"
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