3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

PHARMACOKINETICS AND SAFETY OF A DOUBLE BOOSTING REGIMEN OF ATAZANAVIR (ATZ), PLUS LOPINAVIR (LPV), PLUS MINIDOSE RITONAVIR IN MULTIDRUGTREATED HIV-INFECTED PATIENTS

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WePeLB3.2C01

Azuaje C.¹, Lopez R.¹, Ribera E.², Falco V.², Imma O.¹, Crespo M.¹, Diaz M.¹, Pou L.¹, Monterde J¹, Pahissa A.^1
1Hospital Universitari Vail d'Hebron, Barcelona, Spain, ²Hospital Vali d'Hebron, Barcelona, Spain

INTRODUCTION: Management of treatment-experienced HIV patients has become complex and therapy may need to include two protease inhibitors at therapeutic doses. The alm of this pilot study was to describe the pharmacokinetic (PK) profile of ATZ and LPV when combined and used with low-dose ritonavir, and 24-weeks evaluation safety and virological response.

METHODS: Fifteen patients with multiple prior virological failures were recruited. Each patient received ATZ (300 mg qd), LPV/RTV (400/100 mg bid) and one to three other ARV drugs (NRTIs or T-20), according to genotypic resistance testing. At steady state, patients came to hospital for assessment of the PK profile. Concentrations of all drugs were determined by HPLC.

RESULTS: Median baseline characteristics: age 40 yr (34 – 42), male sex 12/14, HIV-1 RNA 4,88 log copies/mL (4,12 – 5,18), CD4 T-cell count 275 cells/mm³(205 – 361), RTI mutations 9, PI mutations 8. After 4, 12 and 24 weeks, HIV RNA was below 50 copies/mL in 5/14 (35%), 7/12 (58%) and 8/9 (89%), patients, respectively. CD4+ count increased by a median of 110 cells/µL after 24 weeks. PIs were not discontinued in any patient because of side effects. Three patients had mild jaundice. At six months there was in increase in indirect bilirubin of 1.84 mg/dL. Median (IQR) PK parameters for ATZ: AUC_{0 – 12h} 48.59 (25.11, 63.46) µg/mL⋅h, C_max 3.55 (2.13, 4.27) µg/mL, and C_trough 0.98 (0.66, 1.88) µg/mL. Median (IQR) PK parameters for LPV: AUC_{0 – 12h} 113.02 (97.69, 134.21) µg/mL⋅h, C_max 11.99 (10.70, 14.66) µg/mL, and C_trough 9.97 (6.99, 12.09) µg/mL. The only patient with virological failure at 24 weeks of treatment presented low concentrations of ATZ and LPV (C_trough 0.28 and 2.50 µg/mL, respectively).

CONCLUSIONS: Treatment with atazanavir plus lopinavir/ritonavir is well tolerated and provides elevated plasma concentrations of both PIs. This combination could be a good option for patients with multiple treatment failures in whom it's difficult to design effective therapy.

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WePeLB3.2C01 | C. Azuaje
Pharmacological Monitoring of ARV Therapy

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