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FDA Approves New Labeling for Raltegravir (Isentress) for Untreated Adults With HIV-1

Updated label includes phase III study data (July 1)

The FDA has approved new labeling for raltegravir (Isentress, Merck) — an integrase inhibitor for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adult patients as part of combination HIV therapy.

The updated prescribing information now includes 240-week results from the phase III STARTMRK trial in treatment-naïve adult patients with HIV-1 infection. In this study, a regimen containing raltegravir was non-inferior to a regimen containing efavirenz at reducing the HIV-1 viral load to undetectable levels (less than 50 copies/mL) at 240 weeks.

Long-term viral suppression (HIV-1 RNA less than 50 copies/mL) was observed in 66% of patients on the raltegravir-containing regimen compared with 60% of those on the efavirenz-containing regimen.

In addition, the raltegravir regimen demonstrated a greater immunologic response than did the efavirenz regimen at 240 weeks. Patients on the regimen containing raltegravir had a mean baseline CD4 cell count of 219 cells/mm3 compared with 217 cells/mm3 for patients on the regimen containing efavirenz. From study entry to week 240, patients on the regimen containing raltegravir had a mean baseline increase in the CD4 cell count of 295 cells/mm3 versus 236 cells/mm3 for patients on the regimen containing efavirenz.

Through 240 weeks of treatment, a low incidence of drug-related adverse reactions of moderate-to-severe intensity occurred in patients treated with raltegravir. These adverse drug reactions, compared with efavirenz, were insomnia (4% in both arms), headache (4% vs. 5%), nausea (3% vs. 4%), fatigue (2% vs. 3%), and dizziness (2% vs. 6%).

Source: Merck; July 2, 2013.

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