HIV and ID Observations

One of the most important recent studies in HIV has just been “published” in (on?) PLoS ONE.  It’s ACTG 5164, led by Andrew Zolopa, which compared “early” versus “deferred” antiretroviral therapy in 282 patients presenting with acute opportunistic infections.

(Full disclosure: I am on the protocol study team — but am not an author on this paper.)

Take home message:  Starting antiretroviral therapy within 2 weeks of the OI diagnosis significantly reduced the risk of further AIDS complications or death, compared to the group that started 6-12 weeks later.  (For additional details of the study, here’s a nice summary in AIDS Clinical Care.)

When I discussed 5164 with some of my less clinically-inclined colleagues, they wonder why the study was even done — of course starting these severely immunocompromised patients on ART as soon as possible would be better than waiting.

But the clinicians, they were not so sure, and raised appropriate concerns about drug-drug interactions, pill burden, overlapping toxicities, reduced adherence, and — drum roll — the immune reconstitution inflammatory syndrome, or IRIS.

Some of us are terrified of IRIS, and I’m not quite sure why.  Yes, it can be difficult to manage (my sense is that we’re too reluctant to use steroids), and sometimes it’s very confusing exactly what is going on.  And of course there are occasional case reports of severe IRIS, some even leading to death — but always with such cases, I wonder whether the outcome would have been just as poor without ART, just with a different clinical manifestation.

So that’s why it’s particularly gratifying to see this finding in 5164:

IRIS was reported in 23 cases and confirmed in 20: 8 subjects in the immediate arm and 12 in the deferred arm.

Read more of this post »

From the New York Times last week:

Health officials in Los Angeles said Friday that 22 actors in adult sex movies had contracted HIV since 2004, when a previous outbreak led to efforts to protect pornography industry employees.

(snip)

Occupational health officials have long argued that failing to require that performers wear condoms during intercourse and other acts is a violation of safe-workplace regulations.

But Deborah Gold, a senior safety engineer with the California occupational health department, said violations in the pornography industry were so widespread that the state had a difficult time cracking down.

My first response on reading this was amazement that the number was so small – and, remarkably, that number turned out to be even smaller (1 case) when further details emerged in the LA Times:

Los Angeles County public health officials backtracked Tuesday on their statements last week that at least 16 unpublicized cases of HIV in adult film performers had been reported to them since 2004.

Despite their release of data to The Times describing the cases as “adult film performers,” the county’s top health official acknowledged that the agency does not know whether any of those people were actively working as porn performers at the time of their positive test.

(snip)

The county lacks sufficient information to delve deeply into the cases and still has received no formal report on the most recent case.

“The system we have and the laws we have do not facilitate the kind of contact tracing and verification that we’d like to see,” [LA County Health Officer] Fielding said. “AIDS has been treated separately from other STDs.”

Bottom line here:  Aside from this well-researched cluster of cases reported in 2004 in the MMWR, we likely only have a vague idea how many cases of HIV are in, or linked, to this “industry” — which in addition to these semi-regulated companies undoubtedly has a huge underground as well.

And until we get rid of this bit of HIV exceptionalism cited above by Dr Fielding, appropriate contact tracing and partner notification are going to be very difficult indeed.

A:  Depends who you’re asking.

The best guidance I ever received on how to write a good note came from my residency program director, who told us that a note needn’t be encyclopedic to be excellent; in fact, he urged us to get away from the “second-year medical student” style, which typically includes absolutely everything.

Instead, he urged us to write, as concisely as possible, notes that included the following:

1. What is going on with the patient
2. Why we think so
3. What we’re going to do about it

All this gets thrown on its head, however, when you get an email like this one:

Hello Dr. Sax,
Just a reminder that I will be meeting with you to discuss your billing audit results on Thursday 5:30 pm, right after your outpatient session is completed.
Judy

In this meeting, I predict Judy will tell me that the occasional visit I coded as “Level 5″ really should have been “Level 4″, or even “Level 3″ — since even though the case was incredibly complicated and involved reviewing years of treatment history, lab results, and prolonged communication with outside providers and the patient and his family members, I somehow neglected to include the requisite # of “Review of Systems” (10 required), with explicit mention of past, family, and social history, as well as a 9-system physical exam.  Oh, and the sentence:  “Time spent reviewing impression and plan with patient and family:  — minutes.”

Yes, abuses by MDs and hospitals on billing have been well documented.  Cases like this one are obviously serious, and cannot be condoned.  It could be argued that these periodic “compliance reviews” (my session this week with Judy) are merely the just rewards of a previously unpoliced system.

But does anyone think that the current rules we have in place — with these explicit guidelines for what constitutes a complex case based on who knows what (”Review of Systems?”  c’mon!) — is anything other than an invitation to game the system with fancy software, macros, templates, lots of copy-and-paste, and other such tricks?

And what happened to what should be the primary purpose of the note — which is to communicate the critical items of the medical encounter?

That’s the saddest part — it’s gone.

A couple of years ago, an ID-colleague of mine told me about a tough case:  While working in the ICU, an anesthesiologist sustained a pretty severe needle stick.  Approached for HIV testing, the source of the exposure felt threatened by the providers in the ICU, and refused to sign the consent.

The patient then deteriorated and required intubation.  The intensivist, understandably in something of a panic, contacted my colleague for advice.

We’re about to post this case — actual details of which are slightly changed to protect anonymity — in AIDS Clinical Care.   We’ve asked some experts (MD, lawyer, ethicist) on the matter a few key questions, including:

• How would you manage the intensivist who sustained the injury?
• Would you give post-exposure prophylaxis? If so, what specifically would you give, and for how long?
• How would you determine if the source patient has HIV? Would you perform surrogate testing (for example, obtain a CD4-cell count) to assess this? Would you consider testing him without written informed consent?
• If he is tested, would you give him the results after he recovers if the test is negative? If the test is positive?

This case is different from the this one, but many of the issues are related.  (Different from this one too, obviously.)

And it’s a reminder that amidst all the controversy over “opt-out” testing and HIV screening, there’s another big issue out there regarding HIV testing that’s hardly been settled.

As an adult ID/HIV doctor, I must say the clinical impact of H1N1 thus far has been underwhelming, notable more for the calls about prophylaxis or suspected cases than the real thing.

(Last week, one patient with fever and “suspected swine” — hard for people to shake that name — turned out to have … Lyme disease.  Ah, New England in June.)

But for my wife, the pediatrician? There’s a full-blown epidemic out there, with outpatient visit volumes way up, and nearly continuous oseltamivir prophylaxis among her staff.  As in mid-winter, she and her practice partners are routinely making the influenza diagnosis based on symptoms alone.

And while this report suggests the age cut-off for partial immunity to H1N1 is 60, I suspect strongly — based on our highly-anecdotal, two-doctor-family, completely non-scientific observation — that it’s going to turn out to be quite a bit younger.

When giving an overview of HIV pathogenesis to a group of clinicians, Bruce Walker usually asks the assembled if they have any patients in their practice who have undetectable viral loads without antiretroviral therapy.

Generally about three-quarters of the audience has at least one such patient.  They are then asked to refer them to his research cohort, which has a goal of trying to figure out why some patients can control HIV replication without needing antivirals.

But how common is this “controller” phenomenon really?  And how about its immunologic correlate — people with long-term HIV infection but no significant decline in the CD4 cell count?

Nifty paper in AIDS this month trying to answer this question:  Using the French Hospital Database, and starting with over 45,000 potentially eligible patients, the group found that only 69 were “elite controllers” — that is, had >10 years HIV infection, 90% of viral loads <500 cop/mL, and most recent viral load <50 cop/mL.

Stable CD4s were even less common.  Only 25 patients were “elite long-term nonprogressors” — that is, had HIV for more than 8 years, CD4 cells > 600, and no CD4 cell decline.  That’s an prevalence of 0.05%, or 5 for every 10,000 patients.

Medical students and residents sometimes ask me if a particular patient of mine, asymptomatic and not on antiretroviral therapy, is a “long-term nonprogressor.”

I always respond by asking them what specifically they mean by the term — because as this paper shows, when you look for a truly benign course of HIV infection, you need to look pretty darn hard.

Our pal Paul Farmer keeps racking up the titles:

Dr. Paul Farmer, a pioneer in improving health services in the Third World, has been named chairman of Harvard Medical School’s Department of Global Health and Social Medicine …
(snip)
Peter Brown, spokesman for Brigham and Women’s Hospital, said Farmer also had been named to succeed Kim as head of the Division of Global Equity at the hospital, a Harvard teaching facility.

Of course what we we’re all wondering is whether he’ll stop with these, or go on also to accept a senior role in the Obama administration:

After weeks of feeling neglected and anxious that no new administrator has been named, USAID and international development community sources tell The Cable they are excited at reports that Paul Farmer, the legendary cofounder of an innovative group that has delivered healthcare to the poor in central Haiti and beyond, is under consideration to head the U.S. aid agency or serve in a top administration international assistance post that would encompass it.

Regardless of his decision, there is a huge irony here — which is that if ever there were a person in our field who couldn’t seem to care less about titles, it’s this guy.

Which is how it should be, of course.

Don’t look now, Massachusetts, but Connecticut could be next:

AN ACT CONCERNING REVISIONS TO THE HIV TESTING CONSENT LAW. This bill revises the law on consent for HIV-related testing. Specifically, the bill:
1. eliminates the requirement for separate, written or oral consent for HIV testing and instead allows general consent for the performance of medical procedures or tests to suffice;
2. clarifies that HIV testing is voluntary and that the patient can choose not to be tested;
3. eliminates the current requirement for extensive pre-test counseling for all HIV tests;
4. adds a requirement that an HIV test subject, when he or she receives a test result, be informed about medical services and local or community-based HIV/AIDS support services agencies; and
5. provides that a medical practitioner cannot be held liable for ordering an HIV test under general consent provisions.
EFFECTIVE DATE: July 1, 2009

Not surprisingly, it passed unanimously by the Public Health Committee of the state; it was also adopted by the House on May 7, and is currently awaiting action by the Senate.

If it passes, it will be yet another state that is moving more in corcordance with the 2006 HIV testing guidelines. (FYI, nice table of the various states’ laws here.)

I’ve made no secret about how I feel on this issue — most clinicians seem to feel the same — and that I disagree with Massachusetts’ current HIV testing law, which may be the toughest in the nation.  We not only require written informed consent before testing, but the process of getting this changed is hamstrung by the fact that testing and protection of HIV confidentiality are written into the same law.

But I’m an optimist — if California, Maryland, Illinois, several others, and soon Connecticut can make it easier for people to find out their HIV status, so can we.  Stay tuned.

With first-line therapy for HIV being so astonishingly successful, much of what we do in practice is tweak regimens that are by virologic and immunologic standards, working just fine:  Viral load undetectable, CD4 stable.

But not so fast — while one of my colleagues said that if he didn’t change his patients’ regimens, then he’d have nothing to do, the other said he NEVER changed a regimen that was working unless he absolutely had to.

Who’s right?  Both of them, of course.  The regimen might improve in convenience, tolerability, safety, etc, but new side effects could also occur, as well as virologic failure.

So consider these virologically suppressed, clinically stable patients (all recently seen) — would you switch?

1. 50 year old man on ABC/3TC, EFV since 2000.  No renal disease.  Hyperlipidemia, on atorvastatin 80 mg a day.  Father died of an MI age 48.
2. 63 year old man, on EFV + LPV/r for years; past history of neuropathy on d4T and 3TC.  Needs to go on inhaled steroids (preferably fluticasone) to help manage increasingly refractory asthma.
3. 35 year old woman, on TDF/FTC, FPV/r BID — doing ok but missing some PM doses.

Keep in mind, all are doing fine — would you switch?  If so, to what?  Thanks in advance* for the consult.

(*ahem.)

File this under, “physicians behaving badly”:  The nearly universal MD practice of going to work while sick.

The ironic thing is we think we’re being selfless — after all, if we don’t show up, our patients will need to be rescheduled, or someone will need to cover, or some administrative/teaching task will not get done — but let’s imagine for a second that we actually asked our patients what we should do.

Answer:  Go home.  Get better.  Don’t infect me.

Or, to quote the signs that have appeared in our hospital since H1N1 hit, “If you have a cough, sore throat, and fever, please do not enter the hospital unless you are here for care.”

(Patients with these symptoms who are here for care are instructed where to obtain a surgical mask.)

One primary care internist, writing in the New York Times, seems to have kicked the habit:

As a resident, my greatest pride was in never having missed a day for illness. I’d drag myself in and sniffle and cough through the day.  Once, I’m embarrassed to admit, I trudged up York Avenue to the hospital making use of my own personal motion sickness bag every few blocks while horrified pedestrians looked on. Now, though, I see the foolishness of this bravura.

Sadly, I think she’s in the minority.