FDA panel backs HIV drug Selzentry

The Food and Drug Administration (FDA) has recommended the use of Pfizer's Selzentry as an initial treatment for HIV patients, despite continuing concerns over the level of effectiveness of the drug.

Selzentry had been approved earlier as a secondary drug for HIV-infected people who do not benefit from other antiviral treatments. But Pfizer had been seeking its use on patients who were not already under treatment to fight HIV.

In initial studies where it was compared with Sustiva, an antiviral manufactured by Bristol-Myers Squibb, Selzentry failed to prove it was at least as effective.

Of the patients who were tested, 32% given Selzentry did not show a sufficiently effective response, against 24% for Sustiva.

However, after Pfizer repeated the trials using a different method to screen participants it was able to meet the target.

Experts on the FDA panel, while voting 10-4 in favour of approving the drug as a first option for HIV patients, also raised concerns about its effectiveness.

Dr Russell Van Dyke of the Tulane University School of Medicine, said: "It's clearly an active drug, it demonstrated effectiveness. But I'm worried it's not as potent as we might like."

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