TUPE025 - Poster Exhibition
Final five-year results of the BENCHMRK studies: sustained antiretroviral effect of raltegravir and exploratory analysis of late outcomes based on early virologic response
J. Eron1, D. Cooper2, R. Steigbigel3, B. Clotet4, H. Wan5, J. Zhao5, T. Ly5, D. Hepler5, P. Sklar5, B.-Y. Nguyen5, H. Teppler5, for the BENCHMRK-1 and 2 Study Groups
1University of North Carolina, Chapel Hill, United States, 2University of New South Wales, Sydney, Australia, 3State University of New York, Stonybrook, United States, 4Fundacion Irsicaixa, Barcelona, Spain, 5Merck Sharp & Dohme, Corp., Whitehouse Station, United States
Background: Final results through 5 years of treatment (the end of the planned follow-up period) are presented for combined data from the two BENCHMRK studies of raltegravir (RAL) 400 mg bid plus optimized background therapy (OBT) versus placebo (pbo) plus OBT.
Methods: Patients failing ART with 3-class resistant HIV were randomized 2:1 to double-blinded (DB) RAL+OBT or pbo+OBT until wk 156, after which all patients received open-label (OL) RAL. Pre-specified efficacy endpoints were vRNA < 50 and < 400 copies/mL (c/mL) and mean CD4 change from baseline. Exploratory analysis of yearly outcomes was extended in patients randomized to RAL and categorized by vRNA levels from wk 16-48 as (1) continuous suppression, CS (< 50 c/mL at all time-points), (2) low-level viremia, LLV (< 400 c/mL at all timepoints; >50 c/mL at least once), or (3) not suppressed, NS (>400 c/mL at least once).
Results: Patients randomized to RAL maintained superior response rates compared with pbo through 5 years of treatment: vRNA < 50 c/mL, 42% vs 16%; vRNA < 400 c/mL, 45% vs 17% (NC=F); mean CD4 increase, 183 vs 61 cells/µL (observed failure approach). Exposure-adjusted rates of drug-related clinical adverse events (AEs) over the entire study period were 20 per 100 patient-years (PYR) in RAL group and 37 per 100 PYR in pbo+OLRAL group; rates of drug-related laboratory AEs were 8 and 11 per 100 PYR, respectively. Exploratory analysis results in patients randomized to RAL are shown below (observed failure approach). Entire study (DB+OLRAL) was completed by 67%, 62% and 30% of CS, LLV and NS groups, respectively.
Conclusions: In patients failing ART with 3-class resistant HIV, RAL maintained favorable efficacy and safety profiles over 5 years of treatment. Viral suppression and CD4 increases were maintained in the majority of patients on RAL in both the LLV and CS groups.
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