A Truly Bizarre "Systematic" Review

February 26, 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.

You know that tenofovir, emtricitabine, and efavirenz HIV regimen? The one that's universally listed as one of the "Preferred," or "Recommended" or "First-line" options in all HIV treatment guidelines in the universe?

And the regimen that is easily the most widely used in the USA today?

Well, here's a surprising review from Cochrane Summaries, entitled "Effectiveness and safety of first-line tenofovir + emtricitabine + efavirenz for patients with HIV":

We searched the Cochrane Central Register of Controlled Trials, EMBASE, GATEWAY, LILACS, PubMed, AEGIS, and the WHO prospective clinical trials registry in November 2011 ... Only one study [emphasis mine] involving 517 antiretroviral-naive HIV infected adults was included in this review.

The authors go on to conclude, "The effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV cannot be assessed on the basis of only one trial. Further studies evaluating the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV are needed."


This is so mind-bogglingly wrong that it's almost as if the review appeared in the medical version of The Onion, if there were such a thing.

They write that their inclusion criteria for this review was "Randomized controlled trials that evaluated the effects and safety of TDF + FTC + EFV compared with other HAART regimens, as first-line treatment for patients with HIV."

But maybe they used additional criteria -- such as "Only studies published in a calendar year in which the St. Louis Cardinals won the World Series, and whose first author's last name starts with the 7th letter of the alphabet will be considered for inclusion," as the Gilead 934 study is the only one they chose.

Because for the record, there's also this study (5202).

And this one (STARTMRK).

And this one (ECHO).

And this one (THRIVE).

And this one (ASSERT).

And this one (Altair).

And if you want to include TDf + 3TC + EFV (why not?), there's this one (Gilead 903).

And this one (5142) ...

I'm sure I've left something out. But you get the idea.

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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