[WePe3.2C10] Dual boosted atazanavir/lopinavir/ritonavir containing regimen in HIV-1 infected pretreated patients : plasma trough concentration and efficacy results

3rd International AIDS Society Conference on HIV Pathogenesis and Treatment

Rio de Janeiro - July 24 - 27, 2005

DUAL BOOSTED ATAZANAVIR/LOPINAVIR/RITONAVIR CONTAINING REGIMEN IN HIV-1 INFECTED PRETREATED PATIENTS: PLASMA TROUGH CONCENTRATION AND EFFICACY RESULTS

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WePe3.2C10

Duvivier C.¹, Peytavin G.², Ait-Mohand H.¹, Wirden M.³, Ktorza N.⁴, Agher R.⁴, Calvez V.³, Katlama C.¹
¹Department of Infectious Diseases, Pitié Salpétrière Hospital, Inserm U720, Université Pierre et Marie Curie, Paris, France, ²Clinical Pharmacology Department, Bichat-Claude Bernard Hospital, Paris, France, ³Virology Department, Pitié Salpétrière Hospital, Université Pierre et Marie Curie, Paris, France, ⁴Department of Infectious Diseases, Pitié Salpétrière Hospital, Université Pierre et Marie Curie, Paris, France

INTRODUCTION: Combination of PI is now more frequently used particularly in antiretroviral-experienced patients. We evaluated PK and efficacy of the ritonavir(r) boosted atazanavir (ATV) and lopinavir (LPV) combination.

METHODS: Prospective open-label study. Treatment-experienced patients (pts) were given dual boosted r/ATV-LPV containing-regimen. Genotypic resistance test (GRT) was assessed at baseline. CD4 count, VL, bilirubine, t-cholesterol and triglycerides levels were recorded. PI C_min were measured between W4-W12 by validated SPE-HPLC. Adequate range was defined for ATV as 150-850ng/mL and LPV as 3000 – 7000ng/mL. Virological success was considered as viral load (VL) <400 cp/mL. Preliminary results at W12 are presented.

RESULTS: Twenty patients (16 men) were enrolled. The study is ongoing (W4:20 pts, W12:16 and W24:13 pts). Median [range] baseline parameters were as follows: VL:4750 cp/mL [50 – 750000], CD4: 222/mm³ [16 – 700], number of prior NRTI: 6 [2 – 7], NNRTI: 1 [0 – 2] and PI: 2 [0 – 5]. GRT showed in 17/20 pts a median number of 4 NRTI, 1 NNRTI and 6 PI resistance mutations. 70% had prior LPV-exposure. Eleven pts received r/ATV/LPV (100mg bid/300mg qd/400mg bid) with NRTIs and 9 pts received r/ATV/LPV alone. One pt was lost to follow-up. Five pts discontinued therapy before W12 (failure: 2; GI-disorders: 1; poor adherence: 1 and patient's will: 1). Median ATV C_min was 494 ng/mL [87 – 2696] and LPV C_min 6998 ng/mL [1186 – 14271]. ATV and LPV C_min were adequate in 85% and 89% of pts respectively. Median VL decrease was -0.59 log₁₀ cp/mL [-2.57;2.09]. The rate of virological success was obtained in 65% at W4 and 50% at W12. Three pts undetectable at baseline remained so at W12. Hyperbilirubin level was oberved in 5 pts (grade 2 = 3; grade 3 = 2) and 1 pt had triglyceridemia grade 3. Complete all follow-up and GIQ will be presented.

CONCLUSIONS: These results showed no detrimental pharmacological interaction between ATV and r/LPV. This dual PI appears an effective and safe therapy.

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Clinical | WePe3.2C10 | Claudine Duvivier
Pharmacological Monitoring of ARV Therapy

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