Fifth International Congress Drug Therapy in HIV Infection 22-26 October, 2000 Glasgow, UK

A NOVEL USE OF ABACAVIR TO SIMPLIFY THERAPY AND REDUCE LONG-TERM TOXICITY IN PI-EXPERIENCED PATIENTS SUCCESSFULLY TREATED WITH HAART: 48-WEEK RESULTS (CNA30017)

M. Youle for the CNA30017 study team
The Royal Free Hospital, Pond St, London, UK

Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.4
AIDS 2000, Oct 22-26;14(Suppl. 4);S7

PURPOSE: Protease inhibitor (PI-containing highly active antiretroviral therapy (HAART) has proven efficacy, but regimens are complex and may have long-term toxicity. Well-tolerated, compact antiretroviral regimens are required to improve the choice of potential treatment options for HIV infection. CNA30017 is a randomised, open-label, comparative trial evaluating the treatment strategy of switch to abacavir (ABC)-containing triple nucleoside HAART versus continued therapy with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTI) + a single PI.

METHODS: Eligible patients had plasma HIV-1 RNA (vRNA) < 50 c/ml at screening and no history of virological failure since initiation of first antiretroviral therapy. 106 patients remained on current 2 NRTI+PI; 105 switched the PI for ABC. Primary endpoint was treatment failure (defined as vRNA > 400 c/ml on two consecutive occasions or premature discontinuation of therapy). Treatment satisfaction was measured via patient self-report (TRaSQ).

RESULTS: At time of analysis (ITT) median follow-up was 45 weeks. Treatment failure was observed in 11 ABC patients compared with 24 receiving PI. Treatment-limiting toxicity accounted for six and 11 failures in the ABC and PI arms respectively, while virological failure occurred in four (ABC) versus two (PI) patients. Genotypic analysis of isolates from ABC patients with viral rebound revealed the M184V mutation only. Early evidence of triglyceride and cholesterol reduction (non-fasting) was seen in the ABC arm at week 16 (median change from baseline –0.21 versus 0.08 (PI) and –0.70 versus –0.16 mmol/l (PI) respectively). Treatment satisfaction improved by 22% compared to baseline in the ABC arm; lifestyle impact improved by 33% (versus no change in either for the PI arm). Treatments were generally well tolerated. Two ABC hypersensitivity reactions (2%) were reported.

CONCLUSIONS: These data demonstrate sustained virological suppression following a switch from PI-containing HAART to simplified, ABC-based triple nucleoside therapy, with a trend to lower triglyceride and cholesterol and increased treatment satisfaction. Viral rebound following switch to ABC was associated with single mutations only, which would allow many salvage options.

Presenting author: M. Youle

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2000-10-22
PL6-4

Originally published in AIDS Volume 14, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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