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Efficacy and Safety of Atazanavir/RTV vs. Lopinavir/RTV in Treatment-Naïve Patients
with Advanced Disease: CASTLE Study 96-Week Results
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Reported by Jules Levin
5th International AIDS Society, July 19-22, 2009, Cape Town, South Africa
J. Uy,1 R. Yang,2 V. Wirtz,2 L. Sheppard,3 and J. Absalon2 for the BMS AI424138 Study Group
1Bristol-Myers Squibb, Research and Development, Plainsboro, NJ, US; 2Bristol-Myers Squibb, Research and Development, Wallingford, CT, US;
3Bristol-Myers Squibb, Research and Development, Braine-l'Alleud, Belgium
![image002.gif](../images/072809/072809-7/image002.gif)
![image004.gif](../images/072809/072809-7/image004.gif)
![image006.gif](../images/072809/072809-7/image006.gif)
RESULTS
![image008.gif](../images/072809/072809-7/image008.gif)
Figure 1. CVR (HIV RNA < 50 copies/mL) by Baseline CD4 Cell Counts and HIV RNA Strata at Week 96 in (A) the ITT Population CVR (NC = F) and (B) the As-Treated Population CVR (NC = M)
![image010.gif](../images/072809/072809-7/image010.gif)
![image012.gif](../images/072809/072809-7/image012.gif)
Table 1. Discontinuations and Virologic Failures Based on CVR Treatment Outcomes Through Week 96
![image014.gif](../images/072809/072809-7/image014.gif)
Virologic failure is defined as patients who never suppressed on the study through Week 96, discontinued due to insufficient viral load response through Week 96, or rebounded without resuppression
![image016.gif](../images/072809/072809-7/image016.gif)
Analysis of mean change in CD4 cell count according to baseline CD4 count strata and HIV RNA strata are summarized in Table 2
![image018.gif](../images/072809/072809-7/image018.gif)
Tolerability and Safety
The incidence of all treatment-related grade 2 to 4 adverse events and selected grade 2 to 4 treatment-related adverse events (AEs) of clinical interest through Week 96 are summarized by baseline CD4 cell count strata (Figure 3 and Table 3) and baseline HIV RNA strata (Table 4)
![image002.gif](../images/081809/image002.gif)
![image022.gif](../images/072809/072809-7/image022.gif)
![image024.gif](../images/072809/072809-7/image024.gif)
REFERENCES
1. Johnson M, et al. 96-week comparison of once-daily atazanavir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures. AIDS 2006;20(5):711-8.
2. Malan DR, et al. Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients. J Aqcuir Immun Defic Syndr 2008;47(2):161-7.
3. Molina JM, et al. Atazanavir/ritonivir vs lopinavir/ritonavir in antiretroviral-naïve HIV-1-infected patients: CASTLE 96 week efficacy and safety. Poster presented at: The 48th Interscience Conference on Antimicrobial Agents and Chemotherapy/46th Infectious Disease Society of America Conference; 2008; Washington DC.
4. Uy J, etal. Efficacy and safety by baseline HIV RNA and CD4 count in treatment-naive patients treated with atazanavir/RTV and lopinavir/RTV in the CASTLE study. Poster presented at: 9th International Congress on Drug Therapy in HIV Infection; 2008; Glasgow, UK.
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