FDA Priority Review of HIV-fighting drug by Gilead

viaSan Francisco Business Times, by Ron Leuty

A plan to use an approved HIV-fighting drug from Gilead Sciences Inc. as prevention to the AIDS virus will get priority review by the Food and Drug Administration, the agency said Monday.

The move means that the use of Truvada as a way to reduce HIV risk could be approved by June 15, rather than face a standard 10-month agency review.

If approved, Truvada would be the first drug for uninfected people to reduce the risk of acquiring HIV.

But Foster City-based Gilead faces a rough road on its way to winning approval of Truvada as a preventative treatment.

At least one AIDS patient advocacy group has opposed the plan. The Los Angeles-based AIDS Healthcare Foundation has argued that a study of 2,499 gay men showed that Truvada was effective as a preventative 44 percent of the time — not enough to warrant approval by the FDA, it claims — and that men might believe taking the drug is a fail-safe measure and will stop using condoms.

The group has set up a web page, called nomagicpills.org, created mailers and taken out ad space in newspapers to spread its message.

What's more, the FDA news closely follows a finding by researchers at the University of California, San Francisco, and the San Francisco Veterans Administration Medical Center that found that one of Truvada's ingredients, tenofovir, is associated with a significant risk of kidney damage and chronic kidney disease that increases over time.

The study of 10,000 patients used VA electronic health records to find that for each year of exposure to tenofovir, the risk of protein in urine rose 34 percent and the risk of developing chronic kidney disease increased 33 percent.

Protein in urine is a marker of kidney damage.

The study's principal investigator was Dr. Michael Shlipak, chief of general internal medicine at the VA Medical Center and a professor of medicine and epidemiology and biostatistics at UCSF.

Truvada faces a May meeting in front of the FDA’s antiviral drugs advisory committee, Gilead said in a press release. That panel will give a non-binding recommendation to the agency.

A once-a-day pill that combines two AIDS-fighting drugs, Truvada originally was approved by the FDA in 2004 for patients who already have HIV.

The drug, which costs $12,000 a year, registered sales of $1.4 billion in 2011.

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