Researchers call for new approach to assessing pipeline drugs for salvage patients

Researchers from four countries have written to the Lancet calling on the pharmaceutical industry, the US Food and Drug Administration (FDA), researchers and the patient community to work together to assess the use of more than one new drug simultaneously to provide more effective so-called salvage therapy.

This growing patient group encompasses those at greatest risk of clinical disease but the pathophysiology of HIV and the available clinical data suggest that the successful outcome of future therapy will be determined by the number of new drugs used as well as the retained susceptibility to previous agents, argue the researchers from Britain, USA, France and Canada.

“Assessment of the use of more than one new drug simultaneously in the subsets of patients who are at greatest risk of clinical disease would, therefore, seem logical,” they write. “For instance, within the TORO (T-20 vs Optimised Regimen Only) studies there was a direct correlation between the success of virological suppression and immunological benefit with the number of active agents within the optimised background therapy used to support enfuvirtide. Unfortunately, to date, planned codevelopment of investigational agents has not occurred, and patients continue to be offered serial monotherapy along with potentially weakening regimens.”

The authors speculate that pharmaceutical companies might be concerned about compromising the clarity of single agent development and a “perceived fear” that the FDA would consider this action inappropriate. However, they say it has been publicly stated that few barriers exist to combining experimental agents in prelicensing studies in such a patient population.

The letter is signed by Mike Youle of the Royal Free Hospital, London, Cal Cohen of the Community Research Initiative, Boston, Massachusetts, USA, Christine Katlama of the Hopital de la Pitie Salpetriere, Paris, France, Dan Kuritzkes of Harvard Medical School, Cambridge, Massachusetts, USA, and Sharon Walmsley of the Toronto General Hospital, Toronto, Canada.

Codevelopment of new antiretrovirals in very treatment-experienced HIV-infected individuals. Lancet. 2004 Sep 18;364(9439):1036-7.