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Abstract
A RANDOMIZED STUDY OF TREATMENT SIMPLIFICATION WITH NEVIRAPINE (NVP) OR EFAVIRENZ (EFV) IN PATIENTS RESPONDING TO A PROTEASE INHIBITOR(PI) BASED COMBINATION.
PATTERSON P, KROLEWIECKI A, OCHOA C, PRYLUKA D, PEREZ H, ZALA C, CAHN P
Background: Substitution of a NNRTI (NVP or EFV) for a PI has emerged as a strategy to simplify complex drug regimes in clinical practice. However, no data from randomized studies are available to support the choice of one drug over the other in this clinical setting.
Objective: To evaluate antiviral response and safety in patients switching a protease inhibitor for nevirapine or efavirenz.
Methods: Ongoing randomized clinical trial at a single treatment center. Pts willing to simplify a PI-based regime are offered substitution of PI(s) for open label NVP or EFV if they are NNRTI naïve and have pVL consistently < 50 copies/mL wihtin 6 months prior to study entry. Randomization is stratified by historical pVL levels (< or > 50000) prior exposure to PIs. Backbone nucleosides are not changed. Primary end point of the study is virological failure (two pVL measurements > 500 copies/mL) or treatment-limiting toxicity.
Results: As of Feb 2001, 76 pts (39 to NVP and 37 to EFV) have been enrolled. Age, CD4 and prior nucleoside exposure were similar in both treatment arms. Thirty-nine pts completed 24 weeks follow-up. Six NVP pts (15.4%) reached the study endpoint compared to none EFV pts (p< 0.05). Treatment-limiting toxicity accounted for 5 out of 6 failures in NVP patients ( rash = 2 and hepatitis = 3) Virological failure was 1 (NVP) vs. 0 (EFV). Median CD4 change from BSL to week 24 was + 11 cells in the NVP arm versus - 5 in the EFV arm (p=ns). There were no significant changes in total cholesterol or tryglicerides levels from baseline in both treatment arms. Mild to moderate AE (CNS symptoms) were more common in EFV pts. Overall, both treatments were well tolerated.
Conclusion: These preliminary data suggest that switching from a PI-containing HAART to either NVP or EFV allow a continued control of viral replication. However, in this study treatment-limiting toxicity was higher in the NVP arm.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
58
Suggested Citation
"PATTERSONP, et al.
A RANDOMIZED STUDY OF TREATMENT SIMPLIFICATION WITH NEVIRAPINE (NVP) OR EFAVIRENZ (EFV) IN PATIENTS RESPONDING TO A PROTEASE INHIBITOR(PI) BASED COMBINATION..
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
58"
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