HIV and ID Observations

Some miscellaneous recent items from the ID/HIV world jumbling around this Friday:

• Tomatoes are off the hook — it’s the jalapenos that likely caused the recent salmonella outbreak.  Since this is the only time of year that tomatoes are even edible in this part of the world, I for one am quite relieved.  I am sure many are wondering how bacteria could survive on those very hot peppers.
• HLA-B*5701 testing is now “officially” recommended before abacavir use to reduce the risk of hypersensitivity — it’s now in the package insert.  We started doing this test two years ago (at the strong encouragement of some British and Australian colleagues), and it makes all the difference in the world when prescribing this drug — the counseling to patients about the safety of abacavir drops from a 30-minute terrifying review of possible death to a 5-minute, “this could happen, but it won’t.”  Two further thoughts:  1) It’s too bad we didn’t have this tool available sooner (likely lots of debate within the boardrooms of the manufacturer on the pros and cons from a sales perspective); and, 2) Let’s hope that other companies can learn from this lesson and, if such tests are potentially available to improve patient safety, they move ahead quickly to validate them.
• Oh, and the other abacavir label change is related to the DAD data and the possible association between abacavir use and cardiac disease.  Not much has changed since I last covered this issue, but one wonders what we’ll hear soon, either confirming or refuting this association.  (Or likely, both confirming and refuting it.) 
• In other FDA news, an advisory panel was split on whether to recommend approval of doripenem for treatment of nosocomial and ventilator-associated pneumonia — but overall narrowly favored approval.  (No action by the FDA yet.)  Not going to get into details of this particular drug or indication — the FDA’s decision is unlikely to change clinical practice in the short run — but isn’t it peculiar that we have a gazillion (stealing a word from one of our ID Fellows who speaks California-ese) cephalosporins, but only 4 carbapenems?  And no oral option?  Hey, imipenem was approved by the FDA in the mid 1980s!  I asked a medicinal chemist about this a few years ago, and apparently it’s not so easy to synthesize these drugs — but the rise in ESBL-producing gram negatives certainly could (and should) spur further drug development.
• Last, the NIH halted plans to conduct the PAVE 100 HIV vaccine trial.  The reason, obviously, is that this adenovirus-based vaccine strategy is similar in many ways to the one tested in the STEP trial — which showed that the vaccine not only didn’t work in protecting from HIV infection or lowering HIV RNA levels, but led to an increase in the risk of HIV acquisition for those persons vaccinated who had pre-existing adenovirus immunity.  The challenges of developing an effective AIDS vaccine are legion, but here’s a particular tough one:  can you imagine trying to write the informed consent for the next major efficacy trial?  Yikes.

So the New York City Public Health Department would like to have every adult living in the Bronx tested for HIV.  The  Times coverage of the effort cites the best reason for reason for such a move — the high death rates from the disease, and the cause:

Public health officials attribute this [the deaths] to people not getting tested until it is too late to treat the virus effectively, thus turning a disease that can now be managed with medication into a death sentence.

I confess whenever I see the word “Bronx” in the New York Times, my first association has absolutely nothing to do with HIV and frequently makes me unpopular here in Boston.

Baseball connections notwithstanding, this move in the Bronx makes abundant sense, and suggests that we in Massachusetts could learn a thing or two from our neighbors/rivals to the South beyond how to play winning baseball.

(Which the Red Sox have learned very well recently, thank you very much.)

One barrier to expanded testing is the requirement for written informed consent.  Dr. Thomas Frieden, the New York Health Commissioner, said the New York HIV consent law is among the “toughest in the nation.”  It’s arguably even tougher here in Massachusetts, where the requirement for written consent for HIV testing is embedded in the same law that protects HIV confidentiality — the famous Chapter 111, Section 70F law:

Massachusetts General Law Chapter 111, Section 70F provides that a physician, health care provider, or health care facility may not without first obtaining a person’s written informed consent:  1) Test a person for HIV; 2) reveal to third-parties that a person took an HIV test; or 3) disclose to third-parties the results of a person’s HIV test.

When I’ve suggested that these be separated — written consent for testing and disclosure of HIV-related test results are not the same thing, after all — legal experts roll their eyes, saying it just can’t be done (“there he goes again …thinking like a doctor”).  Sorry, can’t help myself, but I don’t see why this law can’t be changed.

So my advice to Massachusetts:  pay attention to what’s going on in the Bronx, and the rest of New York City; and even more importantly, see what’s recently happened in California, Illinois, and Maryland, all of which eliminated the requirement for written informed consent for HIV testing.  The goal?  Make it easier to find the undiagnosed so that they can receive life-saving treatment.  In California, published data already show that this works.  

And may the best team win.

Which is (remarkably as of July 6, 2008), The Tampa Bay Rays.