[WePeB5829] Simplified antiretroviral therapy with zidovudine, lamivudine and abacavir as salvage therapy for heavily non-adherents patients

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] Simplified antiretroviral therapy with zidovudine, lamivudine and abacavir as salvage therapy for heavily non-adherents patients

[AUTHOR(S):] H Knobel, A Guelar, G Vallecillo, A Gonzalez, P Saballs¹, A Carmona², S Marco³

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. WePeB5829

BACKGROUND: Non-adherence to antiretroviral therapy appears to be a strong predictor for virologic failure. Simplification strategies were explored in the setting of an initial therapy and switching from a successful HAART. This study evaluated the effectiveness of a simplified regimen for heavily non-adherent patients who had previously failed HAART.

METHODS: We conducted a prospective open-label pilot study among antiretroviral-experienced patients. Inclusion period: July 2000 to July 2001. The treatment schedule was: Combivir™+ Abacavir™ BID and switched to Trizivir™ BID since it was licensed in Spain. Eligible patients had to have plasma HIV-RNA > 5000 copies/ml, previous treatment containing 2 NRTIs + PI, severe non-adherence to the regimen (self reported less than 50 % of prescribed doses in the previous 3 months, or withdrawal from therapy). Genotype resistance studies were performed at baseline in 20 patients. We present the results of the 24-week follow-up.

RESULTS: Baseline characteristics of the 50 enrolled patients: mean age 37 years; 72% male; mean viral load 4.3 log/ml; mean CD4 214 cells/ml; IDU: 84%; methadone maintenance program 56% group C of CDC: 42%. Previous failures to HAART: 1:48%, 2:36%, 3:14%, and 4:2%. No mutation associated to resistance to NRTIs or PI was founded. In the intention-to-treat analysis 44% of patients achieved viral load below 500 copies/ml (66.5% on-treatment). The mean viral load dropped 1.6 log (95% CI: 1.1-2.1) and the mean CD4 increased: 124 cells (95% CI: 59-179). Adverse events were founded in 22%; mortality: 6%; lost of follow-up: 40%. Adherence greater than 90% of prescribed drugs: 50% of patients.

CONCLUSIONS: In the setting of heavily non-adherent patients this simplified combination therapy containing 3 NRTIs obtained acceptable results on salvage therapy. However, to improve them, more aggressive interventions in support of adherence are needed.

Presenting author: H Knobel

1Dept. Infectious Diseases. Hospital del Mar, Dept. Infectious Diseases, Hospital del Mar, Paseo Maritimo 25-29, 08003 Barcelona, Spain

2Dept. Pharmacy. Hospital del Mar, Barcelona, Spain

3Glaxo Smith Klein, Madrid, Spain

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