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November 16th, 2014

Electronic Medical Records and the Demise of the Useful Medical Note

Electronic medical records (EMRs) are much on my mind, as last week at Medical Grand Rounds Robert (Bob) Wachter, chief of the medical service at UCSF, gave a brilliant talk on the unanticipated consequences of our move towards what he calls the “Digital Doctor.”

Bob has thought a lot about this issue, so much so that he’s about to publish a book on the topic. In his talk, after a brief history of how we got to where the vast majority of U.S. physicians use EMRs, he focused on three main consequences:

  1. The fact that doctors now interact as much (if not more) with screens as they do with patients — the “iPatient” phenomenon. The no eye contact problem. The lack of doctors on the medical wards, as we gravitate toward “work rooms” full of computers. You know how pediatricians sometimes get drawings from their school-age patients that include the doctor? He showed a remarkable example, in crayon of course, of a doctor facing away from the artist (the child), the MD staring at a computer screen and typing. From the book: “I’m guessing this one didn’t make it onto the doctor’s Wall of Fame.”
  2. The loss of interaction between doctors when the data are digital rather than something you can hold. Remember that brilliant radiologist who used to go over all chest films on your medical team? Now a radiologist may be reviewing films at home overnight, or in India, reports filed digitally and not requiring any human-to-human contact with the ordering doctor. Radiology rounds are slowly disappearing, along with the time for clinicians to pause — and think collectively — about what the images mean.
  3. The potential for automated systems to amplify medical errors. We’ve grown increasingly reliant on computers to help with decisions, for better and worse. In a taut, complex story involving a series of increasingly unlikely errors, he described how a child received a massive overdose of medication during hospitalization — all the indirect result of how a poorly designed systems can usurp clinician autonomy.

What he didn’t have time to cover (but does so in the book — he shared the excerpt with me), is the powerful effect EMRs have had on clinical notes.

It’s a fact that the note as means of communicating how the patient is doing has all but been destroyed. Notes even from the best clinicians routinely have the following features:

  • A massive amount of repetition. Cut/paste phenomenon #1.
  • “Required” elements that serve no clinical purpose. How useful is a lengthy review of systems? And isn’t a history-directed, targeted physical examination of far greater value than a comprehensive one “done” merely to meet higher billing criteria?
  • Giant chunks of computer-generated data. Cut/paste phenomenon #2. It’s mostly lab and imaging results, with no interpretation of what the data mean.
  • Factual errors. Cut/paste phenomenon #3. In the ambulatory record, one of my favorites is that some children never age:  “Has three children, a son age 10, daughters ages 8 and 1″ — which is then written unchanged in the social history over the next five years. Reminds me of The Simpsons — Bart, Lisa, and Maggie never age either. On the inpatients, we routinely see this: “ID consulted, considering pneumonia, UTI, C diff, disseminated fungal infection as cause for fevers” — then these same words are repeated for many days after some or all of these diagnoses have been ruled out.
  • Sentences whose sole purpose is to avoid getting sued. You know ‘em when you see ‘em. They sound defensive, are depressing to read, and communicate no useful clinical information.
  • Boilerplate text of highly dubious relevance to the individual case. During a mandatory “compliance” review of my notes (shudder — is there anything in modern medicine more painful?), I had someone suggest I add the following phrase to all of my notes: “More than 50% of this 30-minute visit was spent counseling the patient on the chronic nature of his/her condition, the rationale behind the laboratory tests ordered, the importance of taking medications directed, and the directions for making follow-up visits. Contact information provided, and patient’s questions answered.” The rationale? “You don’t do a procedure, so you need to improve the documentation of what you’re doing with your time.” Lovely.

The genesis of this problem, of course, is that the medical note is trying to do too many things at once. Previously a way of summarizing the clinical course of the patient, both for our own individual use and to communicate with other clinicians, it now has other masters with different motivations. Facilitated by EMRs, the note has subsequently evolved into a Jackson Pollock-like canvas of disjointed text, much of it of marginal or no clinical significance, with sections held together only loosely by the name and medical record number at the top of the page or screen.

Here’s a solution that will never happen — let’s have the medical note evolve even further, breaking it down into distinct sections based on their primary purpose. Imagine three tabs on the top of the note; you get to read only the one you want or need:

  1. Clinicians, here’s your section — it includes the stuff you really want to know, such as the history, exam, and lab/imaging results that matter (not all the labs/imaging, thank you), plus what the clinician writing the note thinks is going on, and what he/she plans to do.
  2. Billing compliance folks, read this part — it will have the required review of symptoms (most of them irrelevant), lengthy rubber-stamp documentation of counseling and education, and whatever other parts are required by whatever payor this patient has. And it will be inserted there by someone who’s not a doctor — or even better, by some automated bot — because successfully generating this kind of documentation is not why we went to medical school.
  3. Medicolegal guys, this is for you — lots of defensive phrases here, none of them of any clinical relevance, but they’re here just in case something untoward happens and the case ends up in court.

Have fun.

Next up — an example of an ideal ID consult note, just for old-time’s sake.


November 10th, 2014

Common Curbsides: The Tuberculin Skin Test and IGRA That Don’t Agree

louie may 2014Here’s one I’ve received twice in the past week, plus my answer.

As always, names/some details changed to protect patient confidentiality, plus my annotations in brackets/italics.

Hey Paul,
Quick question [Need I even comment about the "quick question" phrase, and how this unintentionally devalues what ID docs do? OK, I've commented, and yes I'm hypersensitive] – one of my patients, a 38-year-old woman from Serbia, is about to start biologics for rheumatoid arthritis [you can see this is going to be a latent tuberculosis testing question from miles away].
She’s not sure if she got BCG as a child [yep, called that one], so I did both [uh-oh] a PPD and sent a quantiferon gold [note this is not the crazy alphabetizing of the branded interferon gamma release assay (IGRA) products, which for some reason is "QuantiFERON®-TB Gold" or the other one, which just goes with all-caps, "T-SPOT.TB", and throws a period in the middle -- jeeze, marketers]. The PPD is positive at 20 mm, but the quantiferon is negative [of course -- otherwise there's no question]. Her CXR is negative.
My conclusion is that she does not have TB and therefore does not need preventive therapy prior to starting biologics [that's notable -- putting your money down!]. Is that the correct conclusion?
I’m sure this is a very easy question [ah, not so easy after all] as you must get it all the time [second part is most certainly true].
Thank you very much sir [so formal! or maybe he was in the military] for your time.
Archie [not his real name, but it was the name of a dog we had growing up, a long-haired dachshund]

As noted above, nope, not so easy. Let’s consider the variables:

  • She’s from a part of the world with a higher rate of TB than we have here. So the prior probability of latent TB is greater than if she was US-born, though it’s not as high as this.
  • She’s about to get “biologics”, which by convention means some sort of expensive immunosuppressive drug, probably a TNF-inhibitor. These are of course great potentiators of TB, some worse than others.
  • She may have received BCG, which can give you a false-positive tuberculin skin test. But this effect typically wanes over time, and even if she did get BCG, it’s probably not very effective in preventing adult TB.
  • The sensitivity of the skin test vs IGRA is all but impossible to determine — because there is no gold standard for latent tuberculosis.

To summarize, the positive skin test could be a true positive, or could be a false positive from the (maybe) BCG. And the negative IGRA could be a true negative, or could be a false negative because it’s not 100% sensitive.

So what to do? Here was my answer:

Hi Archie,
The problem is that there is no gold standard — either one could be right. You might consider sending a T-SPOT, since it could be a bit more sensitive than the QF. But since biologics are strong potentiators of active TB, in general I’d recommend preventive therapy for a couple of months before she starts it (then completing a full course) since she’s from a part of the world with more TB than we have here.
A formal consult would be reasonable if this isn’t clear, or if you/she want.
PS: we had a dog named Archie when I was a kid.

So my question for you TB specialists out there — since this is such a common question, why doesn’t managing it appear in all the various guidelines and textbooks? Or am I missing it somewhere?

And speaking of dogs, it’s been a while since I showed a picture of Louie.

October 30th, 2014

Why the IPERGAY (Yes, That’s Its Name) Study Could Substantially Increase Use of PrEP

Yesterday, the French IPERGAY study of intermittent pre-exposure prophylaxis (PrEP) was stopped early by the Data Safety Monitoring Board, and for the best reason – the evidence demonstrating that it prevented HIV was overwhelming.

For those who read French, here’s the official announcement. (Scroll down for the English.) And for those who can’t believe the name, it stands for “Intervention Prophylactique pour Et avec les Gays”. Of course.

Here’s a short English version of the study: IPERGAY was a randomized trial of intermittent, “on demand” PrEP vs placebo done in high risk, HIV negative, men who have sex with men (MSM) in France and Canada. The specific strategy tested was:

  • Two tablets of tenofovir/emtricitabine (Truvada) from 2-24 hours before sex
  • One tablet 24 hours later
  • Another tablet 24 hours after that one

So a total of 4 tablets over 3 days for episodic sexual activity, with an option for daily use for more frequent exposures.

We saw the pharmacokinetic data from IPERGAY in Melbourne, which showed that this strategy generated blood levels of tenofovir highly predictive of protection, and that appears to be borne out in these results. The full study detail are not yet available, but encouragingly they are reported to be better than iPrEx (the first study of PrEP in MSM). These results, along with the PROUD trial done in Britain — also stopped early for efficacy — substantially strengthen the data for PrEP in MSM.

So will the results increase the prescribing of PrEP? Even though the FDA has only approved  tenofovir/FTC for daily use for prevention? I say it will, and here’s why:

  1. Patients have been asking about intermittent “on demand” dosing since the first day people were even thinking about PrEP.
  2. Even though iPrEx was a study of daily PrEP, it appears that many study subjects were taking it intermittently — and still were protected if they got drug levels correlating with 4 or more pills/week.
  3. Compared with daily dosing, this IPERGAY strategy will cost less.
  4. It will also reduce drug exposure, and hence likely toxicity.
  5. No one can say “IPERGAY” without smiling. Said with a French accent, of course.

Just like this film clip (it’s Monty Python week). Roll ‘em!

(Hat tip to the excellent Myles Helfand for alerting me to the results.)

October 27th, 2014

IDSA Opposes Mandatory Quarantine of Healthcare Workers, and Andy Borowitz Is A Very Funny Person

Borowitz-Chris-Christie-Doctor-690From the Infectious Diseases Society of America (IDSA):

Strategies to limit the potential for Ebola virus disease transmission from returning healthcare and humanitarian aid workers as well as from other travelers should be based on the best available medical, scientific and epidemiological evidence; be proportional to the risk; balance the rights of individuals and the community; minimize unintended negative consequences; and minimize unnecessary use of limited resources. For these reasons:

IDSA does not support mandatory involuntary quarantine of asymptomatic healthcare workers returning from Ebola-affected areas. This approach carries unintended negative consequences without significant additional benefits.

The bolding is theirs, not mine, but I do agree.

And so, it appears, does Andy Borowitz, who has been spot-on in every one of his (fake) Ebola news pieces for The New Yorker. And today we got two!

First this:

Study: Fear of Ebola Highest Among People Who Did Not Pay Attention During Math and Science Classes

Then this:

Christie Sworn in as Doctor

And lest you think Borowitz limits his medical expertise to scary tropical viruses, his own personal experience with our healthcare system is about as accurate (and funny) a depiction of being a patient as you will see anywhere:

October 25th, 2014

What Makes An Ideal Applicant for a Fellowship in Infectious Diseases?

We’re at the tail end of the ID fellowship interview process, and am pleased to report we’ve seen some outstanding applicants.

They know that our field is the most interesting in medicine, and they view our recent “Epidemic of Epidemics” — to coin a phrase from John Bartlett to describe all this activity (Ebola, MERS, Enterovirus D68, etc.) — as not as a deterrent, but instead an important and fascinating challenge.

Face it: if it’s in the news these days, and it’s health related, there’s a good chance it’s an ID topic. Take a look at this, for example:

In that spirit, I thought I would share a recent email exchange with a former colleague:

Hi Paul,
I just started as program director for an internal medicine residency program in Illinois. I have been doing some career counseling with the residents, and have decided to email specialists I have known along the way with the following two questions about their field:
1. What are the characteristics of an excellent candidate for your fellowship?
2. How important is research experience? Bench vs. clinical?
Hope you’re well,

Here’s my response:

Hi Craig,
We look for the top clinical people, in particular those who relish the “great case” and love taking detailed patient histories (you know, does the patient have any pets, or has he/she been spelunking). They should definitely also enjoy bread-and-butter inpatient ID (which includes plenty of surgical/routine stuff as well as the fascinomas) and HIV and the complexities of transplant patients. It’s great when they express enthusiasm for the minutiae of microbiology (such as has Strep bovis changed its name?) as well as anti-infective agents (another cephalosporin — ceftolozane/tazobactam — is coming soon, am sure you’re thrilled). And they should want to be the local “expert”on all the newsworthy stuff that fills our days.
As for the research, it’s more important that they have a strong idea of what they would like to do. Yes if they have research experience, that’s a bonus, but it’s not required.
And they shouldn’t be going into ID for the $$$, or if they love to do procedures, because if they are, they are not very smart.
Nice hearing from you after all these years!

Sound about right? And what’s the story with Strep bovis anyway?

Speaking of pets and surgical infections, this one never gets old:

October 19th, 2014

Almost Filovirus-Free (That is, Ebola-Free) ID Link-o-Rama

insufferable on facebookIf you’re an ID doctor right now, the filovirus of the moment Ebola is consuming a big chunk of all of your non-clinical time — and this is particularly true for those heavily involved in Infection Control, who are spending every waking hour responding to public hysteria, to various clinicians who seem to have all the answers, and to ever shifting federal, state, and regional guidelines. Thank you for doing this!

So as change of pace, I bring you this Almost Filovirus-Free ID Link-o-Rama, though this ever-challenging epidemic does make an appearance at the end.

  • There’s been a bit of controversy on mandatory flu shots for certain healthcare workers at a certain New England hospital, whatever that could be. In response, I offer this brilliant Mark Crislip essay (it’s actually more of a tirade), which is republished annually by him and quoted by others, and falls easily into the must read now category — you will laugh, you will cry, and if you’re a health care provider you will nod your head with recognition many times, wishing you had the guts to write it yourself.
  • Speaking of vaccines, this coverage of national immunization rates for children in kindergarten reminds us that while vaccine refusers can dangerously cluster within communities, overall the USA is still doing quite well — which is why our outbreaks of vaccine-preventable illnesses are comparably small compared with Western Europe. School regulations requiring vaccination before school entry is policy for the public good at its best — it’s what you’d expect an ID doctor married to a pediatrician to say, but so be it.
  • Enterovirus 68 — which is now known as Enterovirus D68 — is feeling a bit left out of the Panic Virus Hysteria, but here’s some good news: there’s a faster, better test to diagnose the infection, which will no doubt give a much better sense of the full spectrum of disease, and whether it is truly linked to neurologic syndromes.
  • Kudos to my friend, colleague, and co-ID fellow (don’t ask when) Libby Hohmann, whose study of … um … ingesting frozen poop pills (that’s the easiest way to say it) for C diff points to a future treatment of this nasty condition. Sure beats having a colonoscopy (prep and sedation) or a nasogastric tube (mega-yuck) for delivery of the required donor material.
  • On the inpatient ID side, Staph aureus MICs may not matter after all. If you combine this result with the lack of clinical studies correlating vancomycin levels with outcome, and the fact that every ID fellow spends a big chunk of his/her energy chasing these levels until they are perfect, can we have some sanity on this vanco level issue please?
  • And while we’re talking about our oh-so familiar foe Staph aureus, and in particular MRSA, this editorial suggests we reconsider patient isolation for this infection and for VRE. Seems it’s probably unnecessary — with several major medical centers (Cleveland Clinic, Dartmouth-Hitchcock Medical Center, Detroit Medical Centers, others) already stopping this practice. Boy that would be liberating.
  • That editorial was part of a fun-packed JAMA issue that was completely devoted to Infectious Diseases, including a study showing that around half of all hospitalized patients receive at least one dose of an antibiotic. And the most commonly prescribed drug? Vancomycin, followed (in order) by ceftriaxone, piperacillin-tazobactam, then levofloxacin. I wonder what proportion of patients admitted to a medical service get a cardiac ECHO?
  • Guess what? Measuring CD4 cell counts in stable HIV patients on suppressive treatment doesn’t influence treatment decisions. No surprise. The problem, of course, is convincing our patients that the test we’ve been doing for all these years is no longer relevant — easier said than done!
  • OK, Filovirus time. The policy of treating all US Ebola virus disease patients in special biocontainment units has not as far as I can tell been formally enacted, but that’s what’s currently happening. There’s been some confusion about the capacity our system has for doing so, as not all the beds in all the units can be occupied simultaneously, but it seems that it’s a grand total of 11 beds – the NIH has 2, and Emory, Nebraska, and Montana each has 3.

Department of Shameless Self Promotion:  You can now sign up and get notification about the latest post by putting your email address in the box on the right. Not saying you want to do this, just that you can.

And while we’re on the topic of self promotion, here’s a painfully funny takedown of egregious Facebook behavior. Don’t complain that you weren’t warned — because we’ve all been there, done that.

October 15th, 2014

Second U.S. Healthcare Worker with Ebola Further Underscores Urgent Need for Enhanced Preparedness — and Perhaps Designated Care Centers

If you’re like most of us, when you heard that a healthcare worker in Dallas had been diagnosed with Ebola virus disease, you assumed that the exposure occurred during his first visit to the hospital.

That is, before he was diagnosed with Ebola, and before infection precautions had been instituted.

But no, it happened after he was diagnosed, and isolated, and presumably when all the care providers were using infection prevention measures of some sort. The same is true for the second Dallas healthcare worker, and the nurse in Spain, and in none of these cases can a specific breach in precautions be definitively pinpointed as the cause.

Yes, the nurse’s union in Dallas is citing major problems with their protocols, and certainly there were issues in Spain as well. But regardless of what actually happened, these cases emphatically reinforce that safe care for Ebola virus disease is a monumental challenge. Which is why all of us ID doctors are on high alert for the time when such a case occurs, and why yesterday CDC stated they would send out an expert response team to any hospital that has a confirmed case — a decision that makes tons of sense.

I confess the magnitude of this infection control challenge did not fully strike me until last week — this is before the Dallas care providers were diagnosed — when I heard a fascinating, brilliantly clear plenary talk at IDWeek from Bruce Ribner, the doctor in charge of the Emory team that cared for two Ebola patients. If you have half an hour, I cannot recommend this presentation strongly enough.

There’s a shortened text summary here on the IDWeek website, and many of his slides can be downloaded here (they were used for a national teleconference yesterday).

A remaining question — should all Ebola virus disease patients be cared for in designated centers only? The CDC is actively considering this recommendation, which needless to say has huge ramifications for our healthcare system.

Your thoughts?

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October 12th, 2014

Approval of Sofosbuvir/Ledipasvir Was Expected, but Still Is a Huge Advance

As expected, the FDA just approved the first single-pill treatment for hepatitis C genotype 1, a tablet containing 400 mg of sofosbuvir (SOF) and 90 mg of ledipasvir (LDV). For those not following this story closely, sofosbuvir is the pan-genotypic NRTI polymerase inhibitor approved last December to much rejoicing — and controversy about the price. Ledipasvir is the first HCV NS5A inhibitor, and is only available as part of this combination.

The brand name is “Harvoni”, which sounds a bit like an exotic offering on a menu that you need to ask your waiter to explain — “Ancho chile-rubbed Niman Ranch pork chop roasted in soy, ginger, and sesame, served with pan-sauted garlic kale, and garnished with corn and pinapple-harvoni salsa.”

But even though the approval was no surprise, and the brand name will (like all of them) take some getting used to, there’s no denying this is a huge step forward for HCV therapy. Let me list some of the reasons:

Read the rest of this entry »

October 6th, 2014

Back to School: Questions from “ID in Primary Care” Course

Just wrapped our our annual postgraduate course, “Infectious Diseases in Primary Care,” where each year we get together with primary care providers (doctors, nurses, PAs) and review what we hope are the most clinically relevant topics in ID.

And each year we get a great bunch of questions, some of which I’ve listed below (along with an attempt to answer them):

  • I know the zoster vaccine is indicated for people who have had shingles. But how long should I wait after they’ve had it before giving it?
    Of all the questions I get about the zoster vaccine — and trust me, there are lots of them — this is currently the most common by a long shot. (Ha!) Importantly, this question gives me a chance to praise one of the most practical sources of ID information on the internet, the authoritative and incredibly useful “Ask the Experts” section of the Immunization Action Coalition’s web site. Questions like these are posted and concisely answered by, you got it, experts! And here’s what they say on this particular one: “Administering zoster vaccine to a person whose immunity was recently boosted by a case of shingles might reduce the effectiveness of the vaccine. ACIP does not have a specific recommendation on this issue. But it may be prudent to defer zoster vaccination for 6 to 12 months after the shingles has resolved so that the vaccine can produce a more effective boost to immunity.” So there’s my answer.
  • What do you do when the new syphilis test [treponemal ELISA] is positive, but the RPR is negative?
    Depends. First step is to send one of the classic confirmatory tests — we use the TP-PA here, but the FTA-ABS or MHA-TP would be fine too. If that’s negative also, you’re probably dealing with a false-positive ELISA. If it’s positive, and the patient has been treated before, you’re all set — the negative RPR means he/she is cured. But if they’ve never had treatment, then it makes sense to treat for late-latent syphilis. None of this, of course, is based on firm clinical data correlating these strategies with clinical outcomes — welcome to the world of syphilis diagnostics and therapy!
  • Sometimes patients request that we screen them for “every STD.” Would you include HSV serologies?
    Type-specific HSV serologies are very reasonable to send when someone makes this request, provided there is up-front education about what the results mean. Specifically, if someone tests positive for HSV-2, they are considered to have infection with this virus and could potentially transmit it even if they’ve never had symptoms. Furthermore, the positive test can’t indicate when someone acquired HSV-2, and most emphatically says nothing about from whom. And in this context (screening), forget the HSV IgM — it’s a lousy test , with tons of false positives.
  • If someone can’t take doxycycline, and is allergic to penicillin, should I use azithromycin for treatment of Lyme?
    Azithromycin is less effective for Lyme than other treatments (doxycycline, amoxicillin, cefuroxime), so I’d only use azithromycin as a last resort. (Because who wants to use a less effective treatment for anything, especially Lyme. Shudder.) If we really scrutinize those antibiotic allergies, of course, we often find that it’s something very vague or isn’t an allergy at all. (“My mother told me I was allergic, so I guess I’m allergic,” says the 50-year-old man, who confesses he’s not even sure what “allergic” means.) More than 90% — some studies say way more – of those referred to allergists who have “penicillin allergy” turn out not to be allergic based on skin testing. In other words, I can’t imagine a setting where I’d have to use azithromycin for Lyme, though maybe a few doses until you sort out the allergy (or not) issue would be reasonable.
  • A patient of mine had a positive PPD and a negative interferon gamma release assay (IGRA). She said she had a BCG as a child, and she has no symptoms. Which one is right?
    Can you hit the “rewind” button on your clinical encounters with her, and send only the IGRA and skip the PPD? This is one of the settings where IGRA is preferred, the patient with a BCG immunization history, as BCG will not trigger a positive IGRA and might do so for the skin test. That said, now that you have one positive and one negative, there is no way to determine whether the PPD is falsely positive due to the BCG, or the IGRA falsely negative since no test for latent TB is 100% sensitive. In other words, there’s no gold standard, so you’re sort of stuck making a clinical decision. So here’s what I do — in patients with low risk for TB exposure, go with the IGRA, and say the test is negative. If high risk, especially if contemplating something that increases the risk of TB activation (such as TNF-blockers), go with the positive PPD, and, presuming the CXR is negative, prescribe preventive therapy.
  • I know that resistance to azithromycin has increased, but does this mean it actually is less effective than other antibiotics for treatment of community-acquired pneumonia?
    Way back when, before the existence of Z-paks and Zebra puppets and other brilliant azithromycin marketing, pneumococcal resistance to macrolide antibiotics was uncommon. However, the bug is now resistant to azithromycin around a third of the time in the US, with even higher rates in many other countries. While failure of treatment of otitis media with azithromycin due to resistance is well documented, the data with pneumonia are less clear — probably because the causes of pneumonia are more diverse, with a bunch caused by mycoplasma, some viral, some who-knows-what. Nonetheless, I’d be very concerned about using azithromycin as monotherapy for someone with fever, pleuritic pain, a lobar infiltrate, or other clinical features suggestive of bacterial pneumonia, and would definitely not rely on it alone for patients sick enough to be hospitalized.
  • The drug-drug interaction between statins and HIV drugs is scary — which one do you recommend?
    You’re referring, of course, to the fact that metabolism of many statins is inhibited by ritonavir and cobicistat, which can lead to dangerously high statin levels. I’m a fan of using atorvastatin in this setting, and here’s why: it’s less dependent on cyp3A for metabolism than lovastatin or simvastatin, it’s more effective than pravastatin, the drug has been associated with all kinds of clinical benefits (practically every cardiologist on the planet is on it), and it’s generic. For your patients on ritonavir or cobicistat, just start with a low dose (10 mg daily) and titrate up as needed, stopping at 40 mg/day. If you want to face off with the Payor Police, pitavastatin (which has no cyp3A metabolism) is another reasonable option.
  • When is next year’s course?
    Glad you asked!  October 14-16 — mark your calendars! A beautiful time of year to visit Boston.

Hey, our course this year was held between two notable fall holidays for some of you (me) — so enjoy this video. And I totally agree with the “gateway drug” analogy!

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 as Prezcobix — which sounds like one favorite British breakfast cereal.

For the record, here are a few reasons why the FDA approval of elvitegravir and cobisistat will likely have little short-term effect on clinical practice:

  • Elvitegravir is already available as part of TDF/FTC/EVG/COBI.
  • Cobicistat is already available as part of the same single tablet regimen.
  • If not coformulated, elvitegravir alone has no major advantages over raltegravir and dolutegravir.
  • If not coformulated, cobicistat alone has no major advantages over ritonavir. (Though I gather the pill is smaller. Haven’t seen it yet.)

But — what if they cost less? Especially a lot less?

Then maybe.

HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Contributing Editor

NEJM Journal Watch
Infectious Diseases

Biography | Disclosures | Summaries

Learn more about HIV and ID Observations.