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Sustained Efficacy and Tolerability of Raltegravir after 240 Weeks of Combination ART in Treatment-Naive HIV-1 Infected Patients: Final Analysis of Protocol 004
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Reported by Jules Levin
6th IAS Rome, Italy July 17-20, 2011
E. Gotuzzo1, B.-Y. Nguyen2, M. Markowitz3, F. Mendo4, W. Ratanasuwan5, C. Lu2, S. Bhanja2, H. Teppler2, and the Protocol 004 Part II Study Team
1Hospital Nacional Cayetano Heredia, Lima, Peru; 2Merck Research Labs, North Wales, PA, United States; 3Aaron Diamond AIDS Research Center, New York, NY, United States; 4Hospital Nacional Edgardo Rebagliati, Lima, Peru; 5Siriraj Hospital, Bangkok, Thailand
from Jules: 72% on RAL vs 67% on EFV completed the study....71.9% had <400 copies/ml after 240 weeks on RAL vs 65.8% on EFV.....68.8% on RAL had <50 c/ml vs 63.2% for EFV......Significant predictors for CD4 cell count (at 0.05 critical value) at each time point were: (1) baseline CD4 count and (2) log HIV RNA decline at week 8.....fasting LDL >190 2.7% on RAL, 5.9% on EFV.....fasting total cholesterol >300 1.3% on RAL, 8.3% on EFV.....fasting tryglicerides >750 1.9% on RAL, 8.3% on EFV.....pancreatic amylase >2xULN 3.8% on RAL, 0% on EFV....Creatine Kinase >10xULN 9.4% on RAL, 5.4% on EFV....mean change in cholesterol +11.7 mg/dL on RAL, +26.4 mg/dL on EFV (p=0.014)......meacn change of LDL-C +2.1 mg/dL on RAL, +20.7 mg/dL on EFV (p=0.302)......mean change of HDL-C +4.5 mg/dL on RAL, +55.2 mg/dL on EFV.......mean change in tryglicerides -0.5 mg/dL on RAL, -0.6 mg/dL on EFV (p=0.722)
References
1. ISENTRESS (raltegravir) Prescribing Information, 2009.
2. J. Rockstroh et al., 18th Conference on Retroviruses and Opportunistic Infections, Feb 2011, Abstract #K-135.
3. J. Eron et al., 17th Conference on Retroviruses and Opportunistic Infections, Feb 2010, Abstract #K-128.
4. E. Gotuzzo et al., 17th Conference on Retroviruses and Opportunistic Infections, Feb 2010, Abstract #K-127.
5. J. Lennox et al., Lancet 2009;374:796-806.
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