COMMENTARY

Here's What's New in the HIV Treatment Guidelines

Paul E. Sax, MD

Disclosures

April 20, 2018

Hi. This is Dr Paul Sax from Brigham and Women's Hospital and Harvard Medical School.

Today I'd like to review a recent revision to the Department of Health and Human Services (DHHS) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. The DHHS guidelines, in reviewing the recent approval of bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC), decided to add this to its list of recommended regimens for most patients starting therapy. This means that there are now five regimens recommended for initial therapy for most patients (all of them integrase-based), and they are:

Five regimens are listed, but many of us in clinical practice already think that two of these are better than the other three regimens, and those are DTC/TAF/FTC (a two-pill regimen) and BIC/TAF/FTC (a single-tablet regimen).

Why are these two regimens best? I'm not speaking on behalf of the guidelines; I'm giving my opinion. I think they are the best for the following reasons:

  • With the raltegravir and elvitegravir options, if treatment failure occurs, then resistance to integrase inhibitors and nucleoside reverse transcriptase inhibitors (NRTIs) can occur. The higher resistance barrier of the dolutegravir and bictegravir treatments is a real advantage. So far in clinical trials of triple drug therapy with dolutegravir and bictegravir, there has not yet been a case of treatment-emergent resistance.

  • The elvitegravir regimen contains cobicistat, a pharmacokinetic booster with a significant number of drug-drug interactions. As a result, clinicians have to be very careful not to prescribe concomitant medications that may interact. All of us who have been doing this for a while have had patients with significant drug interactions, some of them potentially very serious. That's another disadvantage of the elvitegravir choice.

With respect to the abacavir option (abacavir, lamivudine, dolutegravir), the abacavir cardiovascular risk data recently got stronger (data that were presented at CROI[1]). Furthermore, abacavir requires pretreatment HLA-B*5701 testing, does not treat hepatitis B, and among the single-tablet options, abacavir/lamivudine/dolutegravir is the largest. A problem with raltegravir is that it is two pills, so it can't be coformulated.

The last thing is to look at the NRTI choices again. The tenofovir alafenamide option versus tenofovir disoproxil fumarate appears to be safer from a renal and bone perspective.

That leaves us with these two regimens, DTG/TAF/FTC and BIC/FTC/TAF, both of which are very good choices. Which one you choose in clinical depends on how you view two different issues:

  • Is a single pill option required or better for your patient? If so, the bictegravir option is preferred.

  • How do you view the importance of long-term clinical trial data and real-world clinical practice data? The dolutegravir option may be preferred.

Over time, we will see whether one of these two emerges as better than the other, but right now they are very similar in all clinical trial outcomes and are likely to be similar in real-world outcomes as well, although that remains to be seen with bictegravir.

Before I leave the DHHS guidelines, I want to mention one other thing. The DHHS guidelines have been overseen by Dr Martin (Marty) Hirsch for many years. Marty has done an exceptional job. It comes down to two skills that he has. One is that he is superb at establishing consensus when there are divergent opinions in the room. Having been on the DHHS guidelines panel in the past, I can tell you that sometimes that is the case; people don't always agree, and Marty is great at hearing these different views and coming to some sort of consensus. The other skill is that he is an exceptionally good editor. That gigantic document is read in toto by Marty, who looks at every word and every sentence, and tries to make it read as perfectly as he can. And he does a terrific job. Marty has decided not to run for re-election in this important position of overseeing the DHHS guidelines—I gather he has better things to do—but I want to thank him for the great work he's done on them over the years. I hope he at least provides some informal advice to the guidelines going forward.

That's a review of the recent revision of the DHHS guidelines as well as a thank you to Dr Martin Hirsch. Thanks for listening.

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