Do We Really Need Primary Prophylaxis for OIs Anymore?

April 30, 2012

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.

I'm currently on the inpatient consult service and just saw a guy who fits the typical profile of many hospitalized HIV patients in 2012:

  • Low CD4 (in this case, 120)
  • Irregular to non-existent outpatient care before admission (lots of no-shows, cancellations, etc)
  • Has received several prescriptions for antiretroviral therapy but for a whole variety of reasons, hasn't been taking it

The medical specifics are otherwise unimportant -- he didn't have an HIV-related reason for being in the hospital. Instead, I want to focus on a question from the resident caring for him as she prepared his discharge papers:

Hi Dr. Sax, question on Smith -- you mentioned he should restart HAART [ugh, I didn't say HAART], but not Bactrim for PCP prophylaxis. Should we add that to his discharge meds?

Now the textbook answer is clearly yes, anyone with a CD4 < 200 should receive PCP prophylaxis, and that's what these fine guidelines would say.

But I deliberately didn't include it, for two key reasons. First, what this man needs to do is take HIV therapy, and I wanted the regimen to be a simple as possible. Why clutter it with that giant Bactrim tablet?

Second, assuming we can actually get him on ART, do we have any evidence whatsoever that primary prophylaxis for PCP is still necessary? All the studies of PCP prophylaxis were done way before we had effective HIV therapy -- in fact, this one (for you history buffs) was done in the mid-1980s, before we had any antiretrovirals at all.

I posed this question to OI Guidelines guru John Brooks, who answered the following:

A randomized trial to address the question (i.e., PCP incidence among persons starting ART at CD4 <200 with vs. without Bactrim) would be ideal, but I would bet the number of participants required to demonstrate no difference in risk would be enormous, especially  since (we hope!) folks would remain "at risk" for only a short period of time ... As you probably know, cohort studies have tried to address the issue; I think only the Swiss Cohort has been able to successfully complete an analysis. We have tried with HOPS data, but incidence of the key prophylaxed OIs (PCP and MAC) was so low recently that we can't get enough endpoints!

And that bolded statement right there is exactly my point. (The emphasis is mine, but John included his own exclamation point.) Effective HIV therapy drops OI incidence so sharply that prophylaxis is probably not necessary, and certainly is much less important than ART.

So if you get the question on the ID boards -- should someone with a CD4 of 120 be on PCP prophylaxis? -- the answer is yes.

In real life, however, I'm not so sure it's still the right thing to do.

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

Reader Comments:

Comment by: Prossy (Kampala Uganda) Sat., May. 5, 2012 at 12:50 am UTC
I have always wondered why i have to see my doctor every 3 months yet, i have only been infected for 2 years now. I am a nutritionist and know how take care of myself. I learnt that the bactrim i take is to prevent OI. But i feel that i am exausting my liver too early, considering that i will start ART anyway . Surely does someone who takes care of their hygiene and wellbeing need that tablet everyday? Cant I just wait and start ART?
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Replies to this comment:
Comment by: harleymc (Sydney, NSW) Sat., Aug. 18, 2012 at 3:43 am UTC
Hi Prossy,
Hope you are keeping well.

I'm a long-term survivor who has been on treatments for a long time.

I made a decision to stop treatments (the reasons are irrelevant to this discussion) and also discontinued blood tests. After two years I felt no sicker than when I was on medications and then over a six week period more than 40 Kaposi's Sarcoma lesions appeared. Back to the doctor and found that my CD4 tcells (at approx 400 while on treatment) were down to 10.

If it had been PCP rather than KS that presented, there is a high probability that I'd be dead. I grabbed my second chance at health and am now on ARTs and Dapsone (I have a Bactrim intolerance).

The point of this is that our external health does not provide a reliable indicator to the continual damage being done to our immune system.

If you can tolerate the Bactrim and can afford it then it is a cheap insurance. Keep those visits to the doctor going too, you never know the life you save could be yours.

Hugs from Australia

Comment by: Jason (San Francisco, CA) Fri., May. 4, 2012 at 3:18 pm UTC
Hey Paul, I'm glad you're not my doctor. I'd be dead by now.
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Comment by: Paul (Johannesburg, South Africa) Fri., May. 4, 2012 at 4:29 am UTC
When I started ARVs my CD4 count was 99. I started on Viramune and Combivir and within a month I was undetectable. Never took any meds for OI like Bactrim. Same with my wife. Her CD4 was 198 when she started. This was back in 2003. Actually we have never taken anything extra besides our ARVs.
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Comment by: Neal Rzepkowski, MD (Cassadaga, NY) Tue., May. 1, 2012 at 11:15 pm UTC
Thanks Paul for helping us to "think outside the box", instead of doing things the "way we always have". (Which isn't very long in the case of HIV) The quality of care guideline in NY need to catch up with current advancements, not only in OI prophylaxis guidelines, but in the recommended frequency of monitoring. We don't need to keep seeing patients with undetectable VL and CD4 > 600 for the past 4 years every 3 or 4 months anymore. Thanks for keeping us "ahead of the curve".
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