Dolutegravir Approval Signals a Beginning and the End of Something Very Special

August 12, 2013

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.

As anticipated, the FDA approved dolutegravir today for HIV treatment, the third integrase inhibitor now available.

This was about as surprising as the arrival of Royal Baby Prince George. We knew dolutegravir was coming soon, just not exactly when or what it would be named.

Here's a short list of the data we have thus far on this drug from various comparative clinical trials:

Plus, results from another phase III study -- vs boosted darunavir -- should be available soon.

About the only downsides of this drug are first, that there is currently no single-pill initial treatment (said to be in the works), and second, that the brand name is still another mysteriously unpronounceable choice selected by marketing gurus undoubtedly paid much more than we are.

("Tivicay." Let's see, is it Tivi-SAY, or Tivi-KAY? Or TI-visay or TI-vikay? Or maybe it's a long I on the first syllable, as in "tie ..." Gosh, who knows. Better call the people who know how to say Intelence and Stribild and Fulyzaq.)

Pronunciation aside, this is the beginning of this extraordinarily promising antiviral agent.

But it's the end of a remarkable stretch of HIV drug development, one that started in 2006 with darunavir, then marched through with maraviroc, raltegravir, etravirine, rilpivirine, and elvitegravir. The availability of these drugs, now with dolutegravir, means that pretty much anyone who takes their medications will achieve virologic suppression.

Because after the tweak of tenofovir -- TAF -- what's next?

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 Journal Watch. Journal Watch is a publication of the Massachusetts Medical Society.

Reader Comments:

Comment by: Richard (Florida) Wed., Sep. 18, 2013 at 8:53 pm UTC
To my surprise today at a Spring Study visit, I was told that I have been given Dolutegavir along with Truvada for nearly the last four years. I knew I was taking Truvada, but up until today the Dolutegavir was just a number. I can tell you that with the combined therapy, I went to undetectable status in 7 days. I have had NO side effects from the therapy from day one to current. All of my numbers remain excellent. Undetectable with a T Count of 670. For me, a nice jump from a viral load count of over 100000 and a T Count of less than 200 when I started the study. It was just as exciting that my insurance company recognized this drug and has agreed to pay for my Dolutegavir along with my Truvada with little co pay. I'm glad to have been a part of this wonderful study and knowing how effective this now approved drug is.
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Comment by: TonyDewitt (Newark, NJ) Tue., Sep. 17, 2013 at 1:28 pm UTC
Doctor Sax,

With all due respect, not everyone who takes these medications achieve virologic suppression, so the need exists for new medications for patients who are desperately in need. One medication that is stuck in the pipeline is the attachment inhibitor BMS-663068, which has shown great promise in clinical studies. Another class of medication that has not entered clinical development is phosphonated carbocyclic 2'-oxa-3'-aza-nucleosides (PCOANs), which have also shown promise as antiretroviral drugs. Why should drug development stop now when better drugs are still awaiting development?
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Comment by: Patient (Harare, Zimbabwe) Tue., Aug. 27, 2013 at 2:46 am UTC
Hello Dr Paul E Sax, This is awesome news. Hopefully one day we will be able to be completely cured. I have been on Atripla since September last year, can I switch to Tivicay since it's superior to Atripla or there is no need.
My viral is less than 20 but my CD4 count is rather low, 385.
Kindly advise
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Comment by: Mothikeng (South Africa) Thu., Aug. 22, 2013 at 4:15 pm UTC
The ship of Aids is sinking, its good i like it
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Comment by: David (Detroit) Mon., Aug. 19, 2013 at 2:57 pm UTC
Since you brought it up, what *IS* the pronunciation?
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Comment by: nath (nigeria) Sat., Aug. 17, 2013 at 10:56 pm UTC
I just want to know is this new drug approved by FDA called the tivicay. Can it cure h.i.v? Because they are saying that is end.
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Comment by: Jimmy Shutters (Norwalk, CT) Fri., Aug. 16, 2013 at 8:12 am UTC
Doctor, Don't be ridiculous!! They will certainly develop new HIV Meds, you are short sighted and not thinking before you speak. And most certainly there will be an effective once a month injection available soon. The research continues for new drugs and delivery methods...
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Comment by: larona (Gaborone,Botswana) Fri., Aug. 16, 2013 at 5:24 am UTC
Is it possible to change from atripla to the new drug?
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Comment by: Happy (south africa) Thu., Aug. 15, 2013 at 11:20 pm UTC
This is news to my ears, now I wonder if this new drug will be available in south africa. I was hoping the article would answer the question of what needs after the intoduction of this pill. For those of us on Artripla and we hv seen postive results the qustion is to change over to this new drug or stay where we are. But all said and done there is light at the end of the tunnel.
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Comment by: Zac (Durham, NC) Thu., Aug. 15, 2013 at 11:01 am UTC
With groups throwing around the word "cure" is there any doubt why there are few (no?) new drugs in the pipeline?

I strictly adhere to my medication schedule, resulting in viral suppression, and greatly reduced chances of developing resistances. BUT that very situation means that if I ever do develop resistances, I will probably be of an age where salvage therapy holds much greater risk of failure. Likewise, because of age, I'm anxious that I would not be a candidate for any of the bone marrow transplant based "cures" being developed.
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