New Guidance Assists HIV Drug Development: Changes Affect Approvals for Antiretroviral Drugs
January 29, 2003
The Food and Drug Administration has issued new guidance to assist sponsors in the clinical development of drugs to treat HIV. The guidance specifically addresses FDA's current thinking about designs of clinical trials that use HIV RNA measurements to support accelerated and traditional approvals of antiretroviral drug products.Adapted from:
To evaluate the feasibility of using HIV RNA levels as a study endpoint, a collaborative group of pharmaceutical, academic and government scientists investigated relationships between treatment-induced changes in HIV RNA and clinical endpoints from ongoing and completed antiretroviral trials. In analyses of more than 5,000 patients in multiple trials, scientists found a clear association between initial decreases in plasma HIV RNA levels and reduction in the risk of clinical progression and death. The relationship held across a range of patient characteristics including pretreatment CD4 counts and HIV RNA levels, prior drug experience and treatment regimen. Based on the data, the Division of Antiviral Drug Products advisory committee agreed that treatment-induced decreases in HIV RNA levels were highly predictive of meaningful clinical benefit and that HIV RNA measurements could serve as endpoints in trials designed to support both accelerated and traditional approvals.
The division proposed basing accelerated approvals on studies that show a drug's contribution toward shorter-term reductions in HIV RNA (such as 24 weeks) while traditional approvals be based on trials showing a drug's contribution toward durability of HIV RNA suppression (e.g., for at least 48 weeks). The advisory committee agreed and recommended that changes in CD4 cell counts be consistent with observed HIV RNA changes when considering antiretroviral drug approval.
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.