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The 800-mg Darunavir Tablet Arrives, and Scoring the Top Protease Inhibitors

By Paul E. Sax, M.D.

November 18, 2012

The FDA has approved an 800-mg tablet of darunavir for treatment naive patients. This single tablet will obviously replace the two darunavir 400-mg tablets in first-line therapy. (Yes, my math is that good.) Darunavir will still require 100-mg ritonavir boosting plus two NRTIs to make a complete regimen.

Once upon a time I might have thought this was no big deal, but patients love taking fewer pills, even if it's only reduced by one.

More importantly, it brings the darunavir-based regimen pill burden into parity with boosted atazanavir, with both now at three -- PI (one), ritonavir (two), and TDF/FTC or ABC/3TC (three). What was once a win for atazanavir -- fewer pills -- is now a wash.

(I should mention here parenthetically that some day this could all be one pill made up of darunavir, cobicistat, FTC, and the recently named "TAF" -- a.k.a., tenofovir alafenamide, GS-7340.)

So let's assume you're starting with a boosted-PI based regimen; which of these two "preferred" PIs should you choose, atazanavir or darunavir? Pending the results of ACTG A5257 -- which is a fully-powered three-way comparison of atazanavir vs. darunavir vs. raltegravir -- we have to make some inferences from existing data:

Note I didn't include the "sequencing" argument -- you know, that darunavir is our most important PI in patients with extensive PI resistance, so we should save it for that setting, using atazanavir as the initial PI. First, very few patients get high-level PI resistance cases these days, and second, all the prior sequencing arguments (e.g., nelfinavir before lopinavir, d4T before AZT, nevirapine before efavirenz) have been more about marketing than science. And some were just wrong.

Cost is another factor I didn't include, since the prices of these drugs are pretty close, vary by payor, and also differ based on region. Given how similar they are clinically, it seems to me that if one were significantly cheaper that would make a big difference.

In sum, as you can see from my list above, I have atazanavir vs. darunavir as a draw.

What do you think?

Paul Sax is Clinical Director of Infectious Diseases at Brigham and Women's Hospital. His blog HIV and ID Observations is part of Journal Watch, where he is Editor-in-Chief of Journal Watch AIDS Clinical Care.




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