FDA panel recommends changes to HIV salvage therapy trials

The US Food and Drug Administration's Antiviral Drugs Advisory Committeehas recommended changes to the clinical trial design requirements for patients with HIV-1 infection who have limited therapeutic options, ie they require salvage therapy or are extensively treatment-experienced. The recommended approach would be similar to that taken when companies are asking for approval for cancer therapeutics that will be used as last-line therapies.

At the moment, the FDA requires that both first- and last-line therapeutics demonstrate clinically that they can, in combination with other antiretroviral drugs, lower viral levels in the blood to below the level of detection of standard HIV tests. Under the new recommendations, applications for approval for last-line agents could be accepted based on data showing a reduction in the amount of circulating virus in the blood, and trials could be shorter, eg as little as 16 weeks' duration.

Panel members also called on pharmaceutical companies to collaborate as they develop drugs, as jointly-designed studies could allow products from more than one firm to be evaluated in a single trial, and might help the sickest HIV patients gain access to new treatments more quickly, according to Bloomberg.