[WePe3.2C01] THERAPEUTIC DRUG MONITORING (TDM) FOR NEVIRAPINE (NVP) IN A ONCE DOSING REGIMEN (OD) IN HIV PATIENTS WHO HAD INTERRUPTED ANTIRETROVIRAL THERAPY (TARV): 48 WEEKS OF FOLLOW UP

3rd International AIDS Society Conference on HIV Pathogenesis and Treatment

Rio de Janeiro - July 24 - 27, 2005

THERAPEUTIC DRUG MONITORING (TDM) FOR NEVIRAPINE (NVP) IN A ONCE DOSING REGIMEN (OD) IN HIV PATIENTS WHO HAD INTERRUPTED ANTIRETROVIRAL THERAPY (TARV): 48 WEEKS OF FOLLOW UP

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WePe3.2C01

Martinelli C., Fiorelli C., Giuntini R., Leoncini F.
Infectious Diseases Unit, Azienda Ospedaliera Universitaria Careggi, Florence, Italy

INTRODUCTION: We investigated the pharmacokinetics (PK) of NVP in a once-a-day regimen containing 2 NRTIs (nucleoside reverse transcriptase inhibitors) in order to evaluate if therapeutic ranges are respected; the second goal is to evaluate immuno-virological efficacy and tolerability of this regimen.

METHODS: 20 HIV-1 positive patients (15 M, 5 F), with median age of 47 years (32 – 63), who had been interrupting treatment for 4 months (3 – 6) because of personal decision or long-term side effects were enrolled. They started therapy with NVP 400 mg + 2 NRTIs (TDF + 3TC or DDI) OD; all drugs were taken in the morning. Baseline CD4 count was 351/mm³ (305 – 720) and viral load was 4.7 log₁₀ copies/ml (3.2 – 5.7). A genotypic essay was performed for all patients, with no resistances towards any of the drugs used in the new therapy. PK parameters for NVP were determined at 12 and 24 hours post-dose, every 4 weeks (first 24 weeks) and then every 8 weeks, as well as clinical, immunological and virological data. TDM for NVP was measured using a validated HPLC-assay, considering the therapeutic range between 2300 µg/l (C_trough) and 8000 µg/l (C_max).

RESULTS: At week 48, 17/20 patients were still on therapy. PK data demonstrated that NVP OD remained between therapeutic range; mean and median values were 3540/3485 µg/l for C_trough and 4599/4589 µg/l for C_max. Median CD4 cell count was 722/mm³ (520 – 980) with viral load undetectable (<50 copies/ml, bDNA) during the whole follow up. No hepatic toxicity nor other side effects of grade II/IV were observed. Three patients stopped therapy, one because of cutaneous rash and two because of virological failure.

CONCLUSIONS: PK results show that NVP 400 mg OD is safe and effective, as also demonstrated by immuno-virological outcomes. OD administration increases adherence and improves patients' quality of life.

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Clinical | WePe3.2C01 | Canio Martinelli
Pharmacological Monitoring Of Arv Therapy

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