Sixth International Congress Drug Therapy in HIV Infection 17-21 November, 2002 Glasgow, UK

Purpose of the study: Well tolerated compact regimens may limit the drawbacks of HAART due to the complexity of daily dosing schedule and to the occurrence of metabolic adverse events.

Methods: A prospective, randomized, study was performed in patients chronically treated with PIs, showing a stable viremia < 50 copies/ml. Patients randomly continued the PI included in their treatment or substituted it with efavirenz (EFV) or abacavir (ABC). All patients continued the same NRTIs. Primary endpoints were viral rebound (> 500 copies/ml) and metabolic alterations (grade 3 American Heart Association) on two consecutive samples and the occurrence of grade 4 (WHO) adverse events. Analysis was performed according to the intention-to-treat.

Summary of Results: 209 patients (69 ABC; 70 EFV; 70 PI) were enrolled. Demographic characteristics, time on a stable triple drug HAART and time with an undetectable viral load were similar in the 3 groups. At baseline all patients had a viral load below the limit of detection (50 copies/ml) and the mean CD4 counts were 649 (ABC), 597 (EFV) and 544 (PI). After 104 weeks 35 (ABC), 29 (EFV) and 62% (PI) of cases interrupted treatment (P < 0.001). Causes of interruption were unevenly distributed. Viral rebound was observed more often in the ABC group (7/69 patients) but did not signifi- cantly differ among groups. Adverse events counted for 25 (ABC), 26 (EFV) and 54% (PI) of interruptions (P < 0.001). A steady increment over time of CD4 T-cell mean counts was observed in all groups (P < 0.001). Triglycerides mean levels were unaffected by ABC or EFV and significantly increased in the PI group +89 mg/dl (P < 0.01). Cholesterol mean values significantly decreased in the ABC group (-21 mg/dl; P < 0.01), while a marginal increment was observed in the EFV group (+13 mg/dl; P < 0.05) and a more sustained one in the PI group (+18 mg/dl; P < 0.01).

Conclusions: 2 years after switching from a PI-based HAART to a simplified triple PI-sparing regimen a sustained virological suppression is maintained. ABC and EFV based therapies minimize the risk of metabolic alterations and allows continuing HAART in a higher proportion of subjects. The risk of virological failures with ABC is limited to pretreated patients and to the first months after the switch

Presenting author: Franco Maggiolo

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1 Ospedali Riuniti, Bergamo, Italy.

2002-11-17
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