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Final 5-Year Results of the BENCHMRK Studies: Sustained Antiretroviral Effect of Raltegravir, and Exploratory Analysis of Late Outcomes Based on Early Virologic Response
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Reported by Jules Levin
19th AIDS Conference International, Wash DC July 22-27 2012
J. J. Eron1, D. A. Cooper2, R. T. Steigbigel3, B. Clotet4, H. Wan5, J. Zhao5, T. Ly5, D. Hepler5, P. Sklar5, B.-Y. Nguyen5, and H. Teppler5 for the BENCHMRK-1 and 2 Study Groups
1University of North Carolina, Chapel Hill, NC, USA; 2University of New South Wales, Sydney, Australia; 3SUNY at Stony Brook, Stony Brook, NY, USA; 4University of Barcelona, Spain; 5Merck Research Laboratories, North Wales, PA, USA
CONCLUSIONS
OVERALL ANALYSIS
In HIV-infected, treatment-experienced patients failing prior therapy with triple-class resistance:
· RAL 400 mg b.i.d. plus OBT had durable antiretroviral and immunologic efficacy sustained through 5 years of treatment
· RAL 400 mg b.i.d. plus OBT was generally well tolerated with few
discontinuations due to adverse events
EXPLORATORY ANALYSIS
In RAL/OLRAL patients categorized by early virologic responses (continuous suppression, low level viremia, or intermittent non-suppressed) based on vRNA at week 16-48:
· Patients with low level viremia had higher vRNA and lower CD4 at baseline compared with continuous suppression group
· Rapid viral decay (vRNA <50 copies/mL at least once before week 12) was significantly associated with viral response category in multiple regression analysis
· Patients with LLV demonstrated durable efficacy responses through 5 years of treatment
--Favorable virologic and immunologic outcomes
--Low level of resistance emergence (4/14 virologic failures)
--Time to loss of virologic response (TLOVR ≥400 cp/mL) was not significantly different between LLV and CS groups
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