316   Use of Trizivir To Simplify Therapy in HAART- Experienced Patients with Long- Term Suppression of HIV-RNA: TRIZAL Study (AZL30002)—24- Week Results.

C. KATLAMA* ¹ , N. CLUMECK ² , S. FENSKE ³ , J. MALLOLAS ⁴ , A. LAFEUILLADE ⁵ , and L. BEAUVAIS ⁶ . 
C. Katlama*¹, N. Clumeck², S. Fenske³, J. Mallolas⁴, A. Lafeuillade⁵, and L. Beauvais⁶.
¹Hosp. Pitié-Salpêtrière, Paris, France;²CHU Saint-Pierre, Brussels, Belgium;³Hamburg, Germany;⁴Hosp. Clín. i Provincial, Barcelona, Spain;⁵Hosp. Chalucet, Toulon, France; and⁶Glaxo Wellcome, France.

Background:HIV treatment may be limited by regimen complexity, long-term side effects and poor adherence. Trizivir (abacavir, lamivudine, zidovudine) can be administered as one tablet twice daily without restrictive dietary requirements and is an option to simplify therapy.

Methods:Patients (pts) with plasma HIV-1 RNA <50 c/mL at screening and no history of virologic failure were eligible. Primary endpoint was treatment failure defined as virologic failure (2 consecutive HIV-1 RNA values >400 c/mL) or premature discontinuation of randomized treatment at 24 and 48 weeks. Treatment adherence and patient satisfaction were measured via a patient self-report questionnaire (PMAQ7).

Results:209 patients were randomized to receive either TZV (106 pts) or continue HAART (CH, 103 pts). The most common pre-study regimen was 2 NRTIs + PI (63%). At 24 weeks, treatment failure occurred in 21 pts (20%) with TZV arm vs 17 (17%) with CH. Adverse events were the most frequent reason for treatment discontinuation in both arms; the incidence of hypersensitivity reaction with TZV was 10%. Significant decreases in fasting total cholesterol (TC) and triglycerides (TG) occurred in TZV arm (median change from baseline TC: -0.8 mmol/L vs -0.25 mmol/L (p < 0.001); TG: -0.08 mmol/L vs +0.08 mmol/L (p = 0.005). Aggregated adherence determinants index improved significantly (p = 0.02) between baseline and week 24 in the TZV arm. Patients reported that TZV was easier to take compare to CH (p < 0.0001).

Conclusions:24 week data suggests that switching HAART to a simplified compact regimen such as Trizivir is an effective treatment strategy with the added benefit of an improvement in patient satisfaction with treatment.