Dolutegravir and the 88 Percent Rule

October 28, 2012

Paul E. Sax, M.D.

Paul E. Sax, M.D., is director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston.

In the latest treatment-naive trials of elvitegravir and dolutegravir, there's a striking consistency in the results of the "test" regimen. Here are the studies, with the percentage of responders by treatment arm:

  • Study 102: TDF/FTC/EFV (84%) vs. TDF/FTC/EVG/c (88%) -- non-inferior
  • Study 103: TDF/FTC + ATV/r (87%) vs. TDF/FTC/EVG/c (90%) -- non-inferior
  • SPRING-2: TDF/FTC or ABC/3TC + RAL (85%) vs. DTG (88%) -- non-inferior
  • SINGLE: TDF/FTC/EFV (81%) vs. ABC/3TC + DTG (88%) -- ABC/3TC + DTG superior

The last of these, the SINGLE study, is the only one where there's superiority in the primary outcome for the experimental arm, here ABC/3TC + dolutegravir. As the investigators noted, this favorable result was largely due to a significantly higher proportion of subjects in the TDF/FTC/EFV group discontinuing therapy for adverse events (10% vs 2%), as rates of virologic failure were similar between arms. ABC/3TC + dolutegravir also was better than TDF/FTC/EFV from both the immunologic and resistance perspective.

And though cross study comparisons are frowned upon by purists, we can't resist. Just a quick glance at all four of the EVG and DTG arms, and you can easily see that an 88% response rate is the new price of admission for any treatment-naive regimen.

Anything shy of the high 80s, and there has to be something else very special about the treatment -- for example, better tolerability, much lower cost, better long-term safety, helps you become a virtuoso violinist -- to make it compete these days with options for therapy we already have, or will have soon.

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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This article was provided by NEJM Journal Watch. NEJM Journal Watch is a publication of the Massachusetts Medical Society.

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