An ongoing dialogue on HIV/AIDS, infectious diseases,
August 12th, 2013
Dolutegravir Approval Signals a Beginning and the End of Something Very Special
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:
- Non-inferior to raltegravir in treatment-naive patients.
- Superior (with ABC/3TC) to TDF/FTC/EFV.
- Superior to raltegravir in integrase-naive, treatment-experienced patients.
- The only integrase inhibitor with activity vs virus with raltegravir and elvitegravir resistance.
- Once-daily, no boosting required.
- No food effect.
- Favorable side effect and drug-drug interaction profile.
- Very low risk of resistance with virologic failure.
- Shines your shoes, folds your laundry, and puts out your trash.
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?
What about the renal issues, insomnia, and cost? This drug is not as clean or omnipresent as perceived.
Very nice post Paul.
Let’s hope an affordable version of the drug is produced in the near future for all the patients for whom this drug will be otherwise out of reach.