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Abstract
THERAPEUTIC DRUG MONITORING (TDM) OF NELFINAVIR (NFV) AND INDINAVIR (IDV) IN TREATMENT-NAIVE PATIENTS IMPROVES THERAPEUTIC OUTCOME AFTER 1 YEAR: RESULTS FROM ATHENA
BURGER D, HUGEN P, DROSTE J, HUITEMA A
Introduction: Both virological failure and toxicity of regimens containing IDV or NFV have been related to interindividual variability of plasma drug levels. TDM offers the possibility to detect patients with drug levels outside therapeutic ranges, who subsequently can benefit from dose modifications. This may result in improved and sustained therapeutic responses to IDV- and NFV-based regimens.
Methods: ATHENA is a nation-wide cohort study of HIV-infected patients. Within a focus group of 600 patients, subjects are randomized to a group in which TDM results are reported to their treating physician including an advice as to yes/no modify dosages, or to a blinded group who do not receive TDM results. This analysis is limited to treatment-naive patients who started a regimen containing either IDV or NFV. Plasma HIV-1 RNA and plasma drug levels were obtained at regular outpatient visits.
Results: 147 patients have been randomized. After 1 year of follow up significantly less patients in the TDM group had discontinued either NFV or IDV than in the control group: 17.4 vs. 39.7% (p=0.003). This was mainly driven by a significantly lower rate of discontinuation because of virological failure in NFV patients: 2.4% in the TDM group vs. 17.6% in the control group (p=0.02), and by a significantly lower rate of discontinuation because of toxicity in patiens using IDV 800mg TID or IDV 800mg + 100mg RTV BID: 9.5% in the TDM group vs. 40.0% in the control group (p=0.03). In a non-completer = failure analysis of all randomized patients, the TDM group showed a significantly higher proportion of patients with a viral load below 500 copies after 6 (94.2 vs 79.5%; p=0.009) and 12 (78.2 vs 55.1%; p=0.003) months of treatment.
Conclusions: TDM of NFV and IDV in treatment-naive patients improves treatment outcome and should become standard of care.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
30
Suggested Citation
"BURGERD, et al.
THERAPEUTIC DRUG MONITORING (TDM) OF NELFINAVIR (NFV) AND INDINAVIR (IDV) IN TREATMENT-NAIVE PATIENTS IMPROVES THERAPEUTIC OUTCOME AFTER 1 YEAR: RESULTS FROM ATHENA.
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
30"
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