There are over 20 antiretroviral agents (ARTs) belonging to several classes that have been approved in the European Union. Recent approvals have seen improved tolerability and more convenient dosing regimens thus the therapeutic goal of most patients has changed in recent years as most are now aiming to suppress plasma viral load. However there are still a few patients that do not achieve sustained viral suppression either due to viral resistance or an inability to tolerate certain agents combinations. This changing landscape has pushed the MA towards changing guidance was adopted in 2008. New agents greatly enhance the likelihood that treatment experienced patients can achieve sustained viral suppression and thus the pool of failed patients has been constant dribbling reduced. However new anti-viral therapies are still needed. Existing guidance does not provide a feasible regulatory path the clinical development of such agents.
This concept paper looks at tackling this now complex drug development environment for HIV antiretroviral therapies.
