{"id":8875,"date":"2018-09-03T09:01:54","date_gmt":"2018-09-03T13:01:54","guid":{"rendered":"https:\/\/blogs.nejm.org\/hiv-id-observations\/?p=8875"},"modified":"2018-09-04T08:54:20","modified_gmt":"2018-09-04T12:54:20","slug":"eravacycline-approved-fda-might-used-today-future","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/eravacycline-approved-fda-might-used-today-future\/2018\/09\/03\/","title":{"rendered":"Eravacycline Approved by FDA — How Might It Be Used, Today and in the Future?"},"content":{"rendered":"
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WPA Recreation Project, 1939<\/p><\/div>\n

While last week the world was sunning on the beach, hiking in the woods, eating ice cream, and performing careful tick-checks, the hard workers at the Food and Drug Administration hunkered down in Silver Spring, Maryland to get three<\/em> anti-infectives approved —\u00a0eravacycline<\/a>, doravirine, and doravirine\/TDF\/3TC.<\/p>\n

Maybe they saw the weather reports — hot and humid, this is the D.C. area! — and figured they might as well stay inside. Take advantage of the climate control and finish off these applications!<\/p>\n

Let’s consider the antibiotic approval first.<\/p>\n

As the name suggests, eravacycline<\/strong> is a tetracycline<\/strong> derivative, but with a much broader antibacterial spectrum.\u00a0This includes many highly resistant gram negatives (including some carbapenem-resistant organisms and acinetobacter),\u00a0MRSA, VRE, and anaerobes. Pseudomonas aeruginosa<\/em> is an important exception to its broad coverage.<\/p>\n

The drug’s approval was based primarily on clinical trials demonstrating\u00a0non-inferiority to ertapenem in intra-abdominal infections,<\/a>\u00a0and a\u00a0second study versus meropenem with similar results\u00a0<\/a>— hence this is the indication in the label. Treatment for complicated UTIs vs levofloxacin\u00a0didn’t go well<\/a>, so the drug is not recommended for UTIs. Because eravacycline is hepatically metabolized, there’s no need for dose-adjustment in renal failure.<\/p>\n

As with tigecycline (to which one inevitably draws parallels), gastrointestinal side effects predominate, though appear to be less common — good news, since nausea is far and away the most common dose-limiting side effect for tigecycline. Infusion site reactions are more common than with the carbapenems.<\/p>\n

Encouragingly, the company plans to price the new drug at the lower end for a recently approved antimicrobial<\/a>, bucking a common trend for new drugs.<\/p>\n

So we have this new antibiotic — how will it be used?<\/p>\n

To echo a common refrain of most recently approved agents, eravacycline will not immediately be a first-line option for its approved indication, intra-abdominal infections.<\/p>\n

However, if we get a bit creative, one could envision an important role for eravacycline in certain patient scenarios — with the caveat that some are admittedly speculative and definitely off-label.<\/p>\n

Roughly in order of plausibility (most to least), here are several potential treatment settings for eravacycline:<\/p>\n