Ninth International Congress on Drug Therapy in HIV Infection Glasgow, UK - 9-13 November 2008

J Int AIDS Soc 2008, 11(Suppl 1):42 doi:10.1186/1758-2652-11-S1-O42

JF Delfraissy¹, S Moreno², J Sanz-Moreno³, G Carosi⁴, V Pokrovsky⁵, A Lazzarin⁶, G Pialoux⁷, A Balogh⁸, E Vandeloise⁸ and G Leleu^9
1 CHU Bicêtre, Paris, France ² Dept of Infectious Diseases, Hospital Ramon y Cajal, Univ de Alcalá, Madrid, Spain ³ Hospital Univ. Principe De Asturias, Madrid, Spain ⁴ Spedali Civili, Brescia, Italy ⁵ Central Research Institute of Epidemiology, Moscow, Russian Federation ⁶ Ospedale San Raffaele, Milan, Italy ⁷ Hopital Tenon, Paris, France ⁸ Bristol-Myers Squibb, Braine-l'Alleud, Belgium ⁹ Bristol-Myers Squibb, Rueil Malamaison, France

PURPOSE OF THE STUDY: Once-daily (QD) atazanavir/ritonavir (ATV/r) + 2NRTIs has proven efficacy with favourable lipid and GI profiles in treatment-experienced and -naïve HIV patients (pts). Data are needed on effective simplified treatment strategies.

METHODS: AI424136 (INDUMA) is a randomised, open-label, multicentre study to assess non-inferiority (15% margin) of 48-week maintenance phase (MP) with ATV 400 mg QD vs. ATV/r 300/100 mg QD (1:1), both + 2NRTIs (excl. TDF), in patients with confirmed HIV-1 RNA < 50 c/mL- after a 26–30 week induction phase (IP) with ATV/r + 2NRTIs in treatment-naïve pts. Primary endpoint was proportion of pts with HIV-RNA < 50 c/mL through week 48 of MP. Secondary end-points included, percent with HIV RNA < 400 c/mL, CD4 cell count change, and safety of MP.

SUMMARY OF RESULTS: 252 pts entered IP (median CD4 245 cells/mm³; median HIV-RNA 4.95 log₁₀ c/mL), during which 30 pts discontinued (nine for AEs). At the end of IP (EoI), 50 were not suppressed and were continued on ATV/r regimen (not described here), and 172 were randomised to MP. Demographics and EoI subject characteristics for MP were well-balanced: median CD4 390 cells/mm³; half of pts were on 3TC+ABC. Through week 48 of MP the ATV arm demonstrated similar (non-inferior) efficacy compared to the ATV/r arm. (Table 1). During MP, mean change in CD4 cell count at week 48 was +92 (SE = 18.1) cells/mm³ for ATV/r and +100 (SE = 14.7) cells/mm³ for ATV; discontinuations prior to week 48 were: ATV/r 14%; ATV 8%. Seven pts on ATV/r and 11 on ATV experienced virological rebound, none had emergence of PI resistance. AEs led to discontinuation in 5% and 1% of pts on ATV/r & ATV, respectively. Lab grade 3–4 total bilirubin was reported in 47% and 14% on ATV/r & ATV, respectively. Mean percent triglyceride change from EoI to week 48 of MP was +9.8 vs. -27.0 for ATV/r & ATV, respectively. The percent of pts who shifted into higher NCEP categories from EoI to week 48 of MP was higher in ATV/r than ATV for total cholesterol (23 vs. 10) and triglycerides (20 vs. 3).

CONCLUSION: These results are consistent with the proven efficacy of atazanavir in naïve pts and suggest that for those pts who have achieved undetectability under ATV/r, switching to unboosted ATV may be an option that results in simplification of treatment regimen.

2008-11-10
1758-2652-11-S1-O42

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