The integrase inhibitor raltegravir (Isentress) has been approved by the medicines regulatory authority in the United States for use by people starting HIV treatment for the first time.
On July 9th, the Food and Drug Administration (FDA) announced that it had granted approval for the use of raltegravir in combination with other antiretrovirals by treatment-naive patients. The use of the drug had previously been restricted to treatment-experienced patients.
Approval for first-line use was based on the results of the 48-week STARTMRK study that showed that raltegravir was non-inferior to efavirenz (Sustiva), when taken with FTC and tenofovir by patients initiating HIV therapy. At the end of the study, 87% of individuals treated with raltegravir had an undetectable viral load (below 50 copies/ml) compared to 82% of those taking efavirenz. Increases in CD4 cell counts were also comparable in the raltegravir and efavirenz treated patients.
Research indicates that raltegravir appears to cause only mild to moderate side-effects, with 4% of individuals who took the drug in the STARMRK study reporting headache and 3% nausea.
Raltegravir’s approved dose is 400 mg twice daily with or without food.
The European licence for raltegravir currently restricts its use to treatment-experienced patients but an application for first-line use in Europe is currently under review.