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HIV Drug Development Pipeline Update, Fall 2014 Edition

November 11, 2014


The High Bar for New Drugs

The High Bar for New Drugs

"I don't think any talk about drugs in the pipeline can go on without acknowledging how extraordinarily good our treatments are right now," Sax began.

Clinical trials utilizing popular first-line antiretroviral regimens in the U.S. now regularly boast virologic suppression rates of 90% or higher, even after 96 weeks of therapy, he noted. Even in a true clinical setting, current regimens are highly successful. An examination of the Johns Hopkins HIV Clinical Cohort -- a group of patients living in a large, urban area -- found overall virologic suppression rates of just 37% in the late 1990s. By 2010, that rate had increased to 87%.

Since 2010, the number of highly effective treatment options has grown larger. The past year alone has brought two new integrase inhibitors -- dolutegravir (Tivicay, DTG) and elvitegravir (Vitekta) -- along with a new booster drug, cobicistat (Tybost). These drugs are "very widely used, and some would argue that they're among our best therapies," Sax said. "It's very rare to find people who cannot be virologically suppressed on current treatments."

With HIV treatment success rates so high, what qualities can a new drug exhibit that will make it likely to win U.S. Food and Drug Administration (FDA) approval -- or that will make a pharmaceutical company feel that the drug is worth developing?

This article was provided by It is a part of the publication IDWeek 2014.


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