
Wall Street Journal - August 18, 2006
Marilyn Chase
While far from conclusive, the studies, presented at the big AIDS meeting here, offered an early look at the potential for two new drug families known as CCR5 blockers and integrase inhibitors. Merck & Co.'s experimental integrase inhibitor MK-0518 elicited the warmest response from scientists and activists, while delegates here pored over early CCR5 data to balance signs of potential risk and benefit.
In one study, 118 patients taking Schering-Plough Corp.'s vicriviroc in a cocktail experienced more "durable drops" in virus levels in their blood, along with rises in CD4 immune cells, than did a placebo group during 24 weeks of treatment.
However, five of the 90 patients on a vicriviroc drug cocktail developed cancers during the study, compared with two of 28 patients on the placebo cocktail, leaving uncertainty about links to malignancy.
Another concern about CCR5 blockers is that they only block one type of AIDS virus -- dubbed R5 virus -- seen early in the course of HIV infection. They don't block a more aggressive type -- called X4 virus -- that arises and runs rampant in full-blown AIDS. Some researchers worry that CCR5 drugs might wipe out the early tamer viruses, creating a vacuum in which the virulent X4 viruses could flourish. Emergence of new X4 viruses occurred somewhat more often in patients taking vicriviroc plus a standard AIDS drug cocktail than in patients taking a placebo plus a cocktail.
In a 186-patient study of Pfizer Inc.'s new CCR5 blocker drug, given to patients who already had both kinds of virus circulating in their bodies, the drug, called maraviroc, didn't trigger any huge upsurge of X4 viruses. But maraviroc plus a standard drug cocktail didn't prove any better than a placebo plus cocktail in the important test of whether it suppressed the virus in the 24-week study.
Merck yesterday announced a world-wide expanded-access program to furnish MK-0518 free to advanced HIV patients needing to switch to the experimental drug.
While Anthony Fauci, a top National Institutes of Health official, counseled caution in interpreting such short studies, AIDS activist Mark Harrington called integrase inhibitors, potentially "the most exciting new treatment class since the protease inhibitors revolutionized HIV treatment 10 years ago."
Write to Marilyn Chase at marilyn.chase@wsj.com
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