May 10th, 2012

Advisory Meeting Today on Tenofovir/FTC for PrEP, and a Proposed “Niche” for its Use

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 Italy 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.

6 Responses to “Advisory Meeting Today on Tenofovir/FTC for PrEP, and a Proposed “Niche” for its Use”

  1. pietro vernazza says:

    hi paul
    great comment! could not agree more. except: despite my Italian name, I live in Switzerland:) cheers pietro Vernazza

  2. Paul Sax says:

    Pietro, my apologies! I’ll edit it in the post.


  3. Stephane Ku says:

    Thanks, Dr. Sax, for such inspiring and considerate thought on PrEP! You might be interested in the Brighton Birmingham PrEP-C (pre-exposure prophylaxis for conception) protocol from the UK group presented at CROI 2012. Can’t wait to implement this in the near future!!! 😀

  4. Byron McCord says:

    Dear Dr. Sax,

    You might respond as to whether or not this very limited indication for PrEP makes sense to you. While volunteering here in Malawi (Africa) with UN Volunteers, performing sometimes blood-splashing, bone-chip-flying orthopaedic surgery with drill bits and knife blades, I tend to take a single Combivir (that’s all I have with me) prior to operating on a known positive patient. I doubt anyone knows or can prove this approach is more effective than standard post-exposure prophylaxis initiated soon after known compromise, but I figure why not stack the deck. It’s only a single pill if I feel nothing happened during the case (although it was a very expensive pill when I bought them several years ago) and I ‘ve never felt any ill effects from Combivir, even when I’ve taken it for several days until a test on a patient, whose status was unknown, returned after the surgery where I’d gotten stuck for one reason or another. So far, I’ve never been compromised during a case in which the patient was positive. I can’t tell if anyone knows how long to take post-exposure prophylaxis when that day finally arrives (may it never). Really appreciate your thoughts on any of this statements.


    Byron McCord

    • Paul Sax says:

      Byron, interesting strategy. I certainly understand your doing this, though as you probably know there are no studies of PrEP in this setting.

  5. S.Murugan Sankarananthan, Tirunelveli, India says:

    Using ART drugs for PrEP, that too a first-line drug like TDF/EM is not advisable. We have to find suitable alternative. Is PrEP with Truvada 100% safe? The individual has to take during conception period. After that? What will happen if the partner is seroconverted in future either due to failure due to PrEP or due to failure to use safe sex practice? They can’t use Truvada as NRTI backbone, which is a great loss to the individual. Very good drugs used in the main stay of treatment should not be wasted like that. Moreover, resistant strains produced in this way may likely to be transmitted to other sexual partners will also pose a social problem in future where we can’t use TDF/EM as first-line NRTI in the management of HIV.

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.