An ongoing dialogue on HIV/AIDS, infectious diseases,
May 16th, 2016
Lots of College Graduations ID Link-O-Rama
For those of us living and working in Boston, we are most definitely smack dab in the middle of college graduation season — which means traffic is crazy, restaurants are booked, and energetic young adults are everywhere wearing gowns and funny hats. In other words, a good excuse for an ID Link-o-Rama: FDA advises against use of fluoroquinolones for uncomplicated […]
November 8th, 2015
New HIV Treatment “ECF-TAF” is Really All About the “TAF” Part
HIV providers and patients recently got this news from the FDA: The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. (Disclosure: I have been […]
September 28th, 2014
New FDA HIV Drug Approvals Unlikely to Have Much Impact, Unless …
If you’re an ID doc based in the USA, you probably received notice last week that two new HIV drugs were approved — cobicistat and elvitegravir. And if you’re wondering what the big deal is, welcome to the club. In fact, the Canadians beat us to the punch with more significant approval, the co-formulated darunavir/cobicistat, branded […]
August 28th, 2013
Poll: At $14,105/year, Is Dolutegravir Fairly Priced?
The recently approved once-daily integrase inhibitor dolutegravir is now in pharmacies and, like every new HIV drug, the price — around $14k/year — has generated some controversy. For the record, here are the per-year wholesale acquisition costs of the three FDA-approved integrase inhibitors. Raltegravir: $12,976 Elvitegravir: $13,428 (once disentangled from the price of TDF/FTC) Dolutegravir: $14,105 If […]
July 14th, 2013
Will Dolutegravir Instantly Become the Integrase Inhibitor of Choice in Patients with Treatment Failure?
Here’s the short answer : Yes. Probably. And here’s why. In a randomized, double blind clinical trial just published in the Lancet — it’s called SAILING — once-daily dolutegravir was compared to twice daily raltegravir in treatment-experienced patients. The site investigators could choose one or two other fully active agents to develop an optimized background regimen (OBR). […]
October 28th, 2012
Dolutegravir and the 88% Rule
In the latest treatment-naive trials of elvitegravir and dolutegravir, there’s a striking consistency in the results of the “test” regimen. Here are the studies, with the percentage of responders by treatment arm: Study 102: TDF/FTC/EFV (84%) vs. TDF/FTC/EVG/c (88%) — non-inferior Study 103: TDF/FTC + ATV/r (87%) vs. TDF/FTC/EVG/c (90%) — non-inferior SPRING-2: TDF/FTC or ABC/3TC […]
August 28th, 2012
“Quad” Approved by FDA
We now have a third single-pill treatment available for HIV treatment, co-formulated tenofovir/emtricitabine/elvitegravir/cobicistat. From the FDA announcement: The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection. Stribild contains two previously approved HIV […]
March 15th, 2012
CROI 2012 Really Rapid Review — with CROI 2013 Dates!
Some highly subjective highlights — a Really Rapid Review™– from this year’s Number One Greatest Super Scientific HIV Conference, the 19th Conference on Retroviruses and Opportunistic Infections (CROI), which ended last week in Seattle: Need more evidence that maintaining a CD4 cell count > 500 is beneficial? This compelling analysis from the SMART and ESPRIT studies found that […]
July 28th, 2011
Really Rapid Review — IAS 2011 Rome
Just back from IAS 2011 (which was followed, I’m thrilled to say, with a visit to perhaps the most beautiful region in the world). Here is a Really Rapid Review™ of the meeting, with apologies ahead of time for lack of organization and (even more likely) leaving out something important. FYI, the abstracts are online […]