9th Annual Conference Of The British HIV Association [BHIVA]


24 – 26 April 2003, University of Manchester
Institute of Science & Technology (UMIST)
Manchester


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[TITLE:] EFAVIRENZ: WHAT HAPPENS IN THE LONG-TERM?

[AUTHOR(S):] L Swaden, CA Sabin, FC Lampe, MS Youle, MA Johnson and M Lipman
Royal Free and University College Medical School, London, UK

BHIVA Conf 2003 Apr 24-26;9:O9


BACKGROUND: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) have a known efficacy and side-effect profile. However, much of this is derived from either drug trial data or a relatively short-term follow-up.

METHODS: We analysed an observational cohort of 483 subjects (78% male, 56% gay risk for HIV, 66% Caucasian origin) starting efavirenz (EFV) at our HIV centre from 1996 onwards and followed up for a median of 23.8 months.

RESULTS: At the start of treatment, median CD4 count and HIV RNA viral load (VL) were 176 cells/µl and 5.21 log10 copies/ml, respectively, with 38% being antiretroviral-naïve. Of the 427 subjects with a baseline VL >500 copies/ml, 75% (Kaplan–Meier) achieved a VL <500 within the first 6 months; this occurred after a median of 92 days. Virological rebound (two consecutive VL >500 copies/ml) occurred in 16.7% by 1 year and was associated in multivariable analysis with younger age, starting EFV before 2000 and heavy prior use of NNRTIs or protease inhibitors (PIs). 201 (42%) of subjects stopped EFV; the proportions stopping by 3, 6, 12 and 24 months were 13%, 20%, 31% and 43% respectively (13%, 19%, 27% and 37% in those who were antiretroviral-naïve). The most common causes of this were adverse events (AEs) (n=80), patient choice (n=47) and viral rebound (n=23); 70% of AEs were neuropsychiatric in origin. The incidence of severe AEs did not decrease with prolonged follow-up. Risk factors for stopping due to AEs included concurrent use of PIs and Caucasian origin.

DISCUSSION: EFV is a potent drug, though there is a high incidence of discontinuation due to AEs. These occur at a much later time (years rather than weeks) than reported previously.

PRESENTING AUTHOR:L Swaden

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