Merck antiviral drug MK-0518 reduces HIV viral load by 98%, study says

By Angela McDaniels

Seattle, Nov. 18 - Merck & Co. Inc. said that HIV-positive patients taking MK-0518 during a 10-day monotherapy trial achieved a 98% reduction in viral load across all dosages tested and at least half achieved HIV-RNA copies of 400 per mL or less.

Patients at baseline had HIV-RNA of at least 5,000 copies per mL, the company said.

In the multicenter phase 2 clinical trial, 35 previously untreated patients were given one of four doses of MK-0518 as monotherapy (100 mg, 200 mg, 400 mg, 600 mg) or placebo twice daily for 10 days.

Primary endpoints of the study were the safety and tolerability profiles of MK-0518 and the reduction from baseline in HIV-RNA. MK-0518 therapy was generally well tolerated, the company said.

The data was presented at the European AIDS Clinical Society in Dublin, Ireland.

Based on these results, a 48-week dose-ranging trial of MK-0518 versus efavirenz in combination therapy has been initiated in previously untreated patients.

MK-0518 could be the first in a new class of investigational anti-retroviral therapy called integrase inhibitors that may inhibit the integrase enzyme from inserting HIV viral DNA into the human gene, the company said. Inhibiting integrase from performing this essential function blocks the ability of the virus to replicate and infect new cells.

Despite the availability of drugs to treat HIV/AIDS, an estimated 40 million people are infected worldwide, the company said. AIDS is now the largest infectious disease cause of mortality worldwide, responsible for 3 million deaths each year.

Merck & Co. Inc., based in Whitehouse Station, N.J., is a pharmaceutical company that develops vaccines and medicines in more than 20 therapeutic categories.

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