Latest DHHS Guidelines for Initial HIV Therapy Now Include 5 Choices -- but Really 2 Are Best

Paul E. Sax, M.D.
Paul E. Sax, M.D.

On March 28, the Department of Health and Human Services Guidelines issued an update to the HIV treatment guidelines, with a focus on the recent approval of bictegravir/TAF/FTC:

BIC/TAF/FTC is an effective and well-tolerated INSTI-based regimen for initial therapy in adults with HIV, with efficacy that is noninferior to DTG/ABC/3TC and DTG plus TAF/FTC for up to 48 weeks. On the basis of these clinical trial results, the Panel classifies BIC/TAF/FTC as one of the Recommended Initial Regimens for Most Adults with HIV.

Based on this change, there are now five recommended initial regimens for most people:

  1. Bictegravir/TAF/FTC
  2. Dolutegravir/ABC/3TC
  3. Dolutegravir + TAF (or TDF)/FTC
  4. Elvitegravir/cobicistat/TAF (or TDF)/FTC
  5. Raltegravir + TAF (or TDF)/FTC

All are based on an integrase inhibitor and a pair of NRTIs. Four have tenofovir/FTC as the NRTI pair. Three are available as a single tablet, once daily.

But with the important caveat that what follows represents my opinion and not that of these or any other guidelines, one could easily argue that there are really two primary choices here, not five.

And those are dolutegravir + TAF (not TDF)/FTC and, now, bictegravir/TAF/FTC.

Related: Bictegravir at CROI 2018: Switching Studies and Drug Resistance Analyses

Here's why:

  • Raltegravir and elvitegravir both have a lower resistance barrier than dolutegravir and bictegravir. Virologic failure with elvitegravir and raltegravir may select for integrase resistance, usually along with NRTI resistance. This hasn't happened yet in any clinical trial of dolutegravir or bictegravir for initial therapy, at least when given with two NRTIs.
  • Elvitegravir requires the pharmacokinetic booster cobicistat. This greatly increases the drug interactions of this option, some of which are highly clinically significant.
  • Raltegravir is two pills. In addition, it cannot be coformulated.
  • The association between abacavir and cardiovascular disease has become stronger with recent research. In addition, abacavir requires pre-treatment HLA-B5701 testing and does not treat hepatitis B. Furthermore, the coformulation of dolutegravir/ABC/3TC is the largest of the single-pill options for HIV therapy.
  • TAF has a better renal and bone safety profile than TDF. There will likely be cost benefits of TDF/FTC over TAF/FTC eventually, but they are not yet realized in the clinic.

As of April 8, 2018 (the day I'm writing this post), the choice between the two remaining options reflects how we and our patients feel about two issues.

If giving one pill rather than two is most important, then go with bictegravir/TAF/FTC.

If accumulated safety and "real world" experience is most important, then go with dolutegravir plus TAF/FTC.

Hey, isn't HIV treatment simple these days?

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

[Note from TheBodyPRO: This article was originally published by Journal Watch on Apr. 8, 2018. We have cross-posted it with their permission.]