Published online November 1, 2007
PEDIATRICS Vol. 120 Supplement November 2007, pp. S159 (doi:10.1542/peds.2007-0846QQQQ)
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IMMUNODEFICIENCY


Potent Antiretroviral Effect of MK-0518, a Novel HIV-1 Integrase Inhibitor, in Patients With Triple-Class Resistant Virus

Joseph A. Church, MD

Los Angeles, CA

ABSTRACT

Grinsztejn B, Nguyen BY, Katlama C, et al. Presented at: the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 27–30, 2006; San Francisco, CA. Abstract H-16706

PURPOSE OF THE STUDY. Although there are >20 antiretroviral agents available in developed countries, multiple factors limit the construction of combinations of drugs that are capable of effective viral suppression. New agents are clearly needed, particularly for individuals with limited options. MK-0518 is a member of a new class of antiretroviral agents, integrase inhibitors. The purpose of this study was to generate preliminary information on the potency of MK-0518 in the treatment of individuals with triple-class–resistant virus.

STUDY POPULATION AND METHODS. There were 178 HIV-infected patients enrolled and assigned to 1 of 3 doses of MK-0518 or placebo. They were followed for 24 weeks, and antiretroviral responses were evaluated.

RESULTS. MK-0518 showed remarkable potency at all doses tested. Approximately 60% of the patients who received active drug achieved <50 copies per mL of plasma HIV RNA. Strikingly, ~50% of the individuals with no active agent left in their background regimens achieved undetectable viral loads. MK-0518 was generally well tolerated at all doses, with headache being the most frequent adverse effect.

CONCLUSIONS. MK-0518 had remarkable potent antiretroviral activity in individuals with limited treatment options. The availability of this new class of antiretroviral drug will markedly enhance the options available for patients who are running out of options.

REVIEWER COMMENTS. Abstracts presented at scientific meetings are usually not appropriate for a "best-articles-published" series. However, the impact of MK-0518 will be extraordinary. With 3 additional new drugs recently or soon to be available, we will soon have the ability to "salvage" patients with multiresistant virus.