Public support needed for new FDA HIV drug approval policy #HIV #AIDS
Because there’s so much information here, I’m going to leave this without too much editorial from me.
The AIDS Treatment Activists Coalition (ATAC) is asking people to sign on to a letter in support of a proposed U.S. Food and Drug Administration (FDA) policy that will hopefully make it easier for drugs to be approved for heavily treatment experienced people.
The new guidance under review at the FDA is aimed at helping companies overcome a significant hurdle in HIV drug development: proving that a new drug is effective given the potency of existing drugs.
New drugs with potential for treatment-experienced patients are typically pitted against a placebo, with both the experimental drug and placebo combined with background regimens consisting of approved drugs that may fight a person’s HIV. This study design worked relatively well in the past, because many people had fewer than two other active drugs in their background regimens and, in turn, it was easier to prove the benefits of a new drug compared with placebo in a relatively short period of time.
Today, given the range of potent treatment options, most background regimens studied in trials are highly effective. In turn, it can take many months to determine the efficacy of an experimental treatment, despite the fact that earlier studies not requiring background regimens suggest that the new agent works well against drug-resistant HIV.
What’s more, many researchers believe it is unethical to use a background regimen that has been optimized to achieve maximal viral suppression. Doing so substantially increases the likelihood of rapid resistance to the new agent.
“Demonstrating the superiority traditionally required by the agency to prove effectiveness is now virtually impossible without conducting trials in treatment-experienced patients whose virus is not fully suppressed,” explains Lynda Dee, from AIDS Action Baltimore, in her letter on behalf of ATAC.
The source to the original article is here, where you can sign the petition. I’ve also added a block at the bottom of my site for easy access. Please take two minutes and fill this out, ok? The short version is that it’s very much needed, and every voice counts on this one.