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In 2009, two pivotal trials improved our understanding of raltegravir's utility and its limitations.
In the STARTMRK trial, 566 treatment-naive patients were randomized to receive either once-daily efavirenz or twice-daily raltegravir, each with fixed-dose tenofovir/FTC (JW AIDS Clin Care Aug 10 2009). At 48 weeks, the proportion of patients who achieved viral loads <50 copies/mL was similar between the treatment arms (86% for raltegravir, 82% for efavirenz), but raltegravir reduced viral load significantly faster and was associated with fewer adverse effects. On the basis of these results, raltegravir was approved for use in treatment-naive patients in July 2009 — and in December, the U.S. Department of Health and Human Services added ralte…