Advisory Meeting May 10 on Tenofovir/FTC for PrEP, and a Proposed "Niche" for its Use

May 10, 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.

From Bloomberg News:

Gilead Sciences Inc.'s pill Truvada was safe and effective when used to protect uninfected people from getting HIV, U.S. regulators said in a report indicating the main concerns are when and how it should be used. ... The FDA asked its advisers to suggest who should get Truvada; what testing would be needed for administration; and what educational material should be used for patients and doctors. The advisers will meet May 10 to discuss the drug, the subject of debates over its appropriate use and cost.

As I've mentioned before, I have no doubt whatsoever that TDF/FTC works for PrEP, provided the person actually takes the med. And while it's not yet approved for this indication, nothing has stopped clinicians from prescribing it already. There's even a CDC "Guidance" on the practice that's now over a year old. Remember, we give TDF/FTC all the time for post-exposure prophylaxis.

Despite the favorable data on PrEP and the availability of TDF/FTC, however, the use of TDF/FTC for PrEP has been quite limited, for a whole lot of reasons -- including the need to find providers to do it (most HIV-negative patients are cared for by individuals unfamiliar with prescribing HIV meds), the cost of TDF/FTC, and concerns about long-term toxicity. Plus (and this is a biggie), people who are the biggest risk-takers when it comes to HIV exposures (and are the best candidates for PrEP) may not be so great at medical follow-up.

So here's a scenario where I think PrEP makes a whole lot of sense:

  • Serodiscordant heterosexual couple
  • Pregnancy desired
  • Infected partner already on ART, HIV RNA fully suppressed
  • Couple stops using condoms
  • Uninfected partner takes PrEP until conception

It's not such a radical idea, as shown in this study from Switzerland.

In so many ways it's better than what we're recommending now, which is artificial insemination if the woman is infected (or a home-brew lower tech method), and sperm washing followed by assisted reproduction technologies (e.g, in vitro fertilization) if the man is infected. Sure, this reduces the risk of transmission 100% in the former and probably 100% in the latter. But these are costly interventions, coverage from insurance plans is variable, and not all fertility programs offer them.

So the question is whether, in the post-052, post-Partners PrEP era, these recommendations still make sense for all couples who want to have children.

My opinion is that they don't. Serodiscordant couples who want children should be given all the options -- including all the pros and cons -- and then be guided in how to have children most safely and efficiently.

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.

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