June 4th, 2017

Can’t HIV Serodiscordant Couples Now Just Have Children the Regular Way?

Cartoon people getting important counseling about having children.

MMWR just published a paper entitled, Strategies for Preventing HIV Infection Among HIV-Uninfected Women Attempting Conception with HIV-Infected Men — United States, and it’s both a welcome and a very strange document indeed.

It’s welcome because it acknowledges that serodiscordant couples may wish to have children without the use of an HIV-negative sperm donor. Advances in HIV prevention mean they can drop their categorical recommendation against insemination with semen from HIV-infected men, one they originally made in 1990.

But it’s strange because, right alongside treatment of the HIV-positive man with antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) for the woman, is a fairly lengthy data summary on “sperm washing”, a strategy many would argue has outlived its usefulness.

This is the short version of the procedure:

Another strategy that can be used in conjunction with HAART and PrEP is collection and washing of the male partner’s sperm to remove cells infected with HIV, followed by testing to confirm the absence of HIV prior to intrauterine insemination (IUI) of the female partner or in vitro fertilization (IVF).

Does one really need to put couples through this expensive and time-consuming process when the risk of transmission is unmeasurably tiny, if not zero, if the man is on suppressive ART and the woman is taking PrEP? Can you imagine the number needed to treat to prevent one additional case of HIV transmission with sperm washing in addition to ART and PrEP?

It’s like wearing a belt, suspenders, and using duct tape to keep your pants up (which is probably not the best analogy when discussing something that has to do with sex, but I’m going with it).

As a quick reminder:

  • HPTN 052:  Zero transmissions from infected partner if HIV RNA suppressed.
  • PARTNERS Study:  Zero transmissions from infected partner if HIV RNA suppressed — this while the couples were practicing “condomless sex” (otherwise they couldn’t be part of the study).
  • PrEP Studies:  Among adherent participants, > 90% efficacy despite high risk behavior or high community risk.

Now we don’t want to tempt the Gods of Never Say Zero with hubris about this unmeasurably low risk, but I clearly wasn’t the only one who found the paper’s emphasis on sperm washing peculiar.

Here’s a take from Ben Young, Senior Vice President/Chief Medical Officer of the International Association of Providers of AIDS Care:

(“U=U” stands for “undetectable equals uninfectious”.)

Just for fun, I thought I’d check in with Pietro Vernazza, architect of the 2008 controversial “Swiss Statement” that has, for the record, turned out to be 100% correct.

Here was his response:

I was shocked about the report. In Switzerland, we have not seen any new infections among couples trying to conceive without using any additional safeguards (aside from treatment of the infected partner). The Swiss statement is very widely accepted.

And then, because what the hell, we deserve it, he added this:

But what should we say? We also don’t understand how a country can withdraw from the Paris agreement, or try to build a wall to Mexico, or to withdraw health insurance for their citizens.

Hey, I’m a huge fan of our CDC, this odd report notwithstanding. But on these issues, you’ll get no defense from me!

And just curious — is there anyone out there still strongly advocating sperm washing for serodiscordant couples wanting to have children?

 

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10 Responses to “Can’t HIV Serodiscordant Couples Now Just Have Children the Regular Way?”

  1. Joel Gallant says:

    Bravo Pietro! It’s an absurd recommendation. Since sperm washing–if it’s still being performed at all–requires not only expense but also travel, a couple using both treatment and PrEP for prevention is more likely to die in the process of accessing the procedure they are to transmit HIV!

  2. John Cafardi says:

    Thanks for bringing some attention to this.

    In addition to the points you mentioned above, there is another practical barrier to implementing this recommendation.

    As assisted reproductive technology (another ART that makes my lectures to the OB/GYN residents even more confusing) usually isn’t covered by insurance, there can be significant added cost with following this recommendation. Furthermore, many of the reproductive endocrinology groups that I have contacted about this have chosen not to offer this service, as it requires purchasing separate equipment for use with “infectious specimens”.

    They politely deferred, and then suggested a referral out of state, which, of course, is simply not possible for most patients.

    Of course “nearly zero” isn’t “zero”, but how much time/resources/energy/worry will be spent on driving the (already very low) risk down just a little bit more?

    Obviously, this is a detailed conversation that needs to be had with every serodiscordant couple attempting conception, but to place an expensive, difficult and time-consuming step with very low theoretical benefit in the process, seems like something that should be reconsidered.

  3. Jeanne Marrazzo says:

    Paul, thanks for this. While most government (at least CDC)-issued guidelines contain their fair share of painful soft-peddling and qualifications, this one really seems behind the times and most out of touch with reality. Not addressing the differential access issues to this procedure seems especially tone deaf (I’m especially fired up about THAT particular aspect after reading that reprehensible article on “don’t call what we do concierge care” in the NYT today–see my comments at @DrJeanneM!).

  4. omar sued says:

    I was also surprised and I also agree we should not continue exposing couples to such as painful, stressful, expensive treatment. I read thoroughly trying to find what is the recommendation regarding the time on PrEP for women. Given the results of the intermitent PrEP, and the perhaps the limited additional value of PrEP considering the male is undetectable one could argue that recommend start TDF-FTC during 20 days before the conception is too much. And also, some consider continue this drugs during one month after the intercouse, as PEP. I consider this to long. What would be your recommendation?

    • Santiago says:

      Thank you Omar for bringing this up. For how long must we give PrEP to women of infected (but undetectable) partners, before conception? Many couples have trouble conceiving. In that case should she be on PrEP for as long as they have unprotected-wanting-to-conceive-sex?

  5. As many other physicians worldwide I also appreciate the excellent service the CDC provides with most of their data summary, timely epidemiological information and recommendations. However, this one was completely out of time.
    We would have appreciated to have a CDC recommendation supporting sperm washing for HIV serodifferent couples back in the 90ies. But now, with full suppression of viral replication under ART, this recommendation is not more than an anachronistic joke.
    Regarding the zero-risk arguments: Never in life we expect zero risk. If we would, we would never go swimming in the sea, drive a car or climb a mountain.
    I propose that CDC folks should start to understand what really makes us happy in life: like hiking in the Swiss alps or enjoy a biking tour along the Swiss lakes. But unfortunately, folks at CDC might never learn, since they would have to board an airplane to do so…. Certainly – compared to zero risk – a very risky venture!

  6. Lealah Pollock says:

    Thank you, Paul and Pietro! While it’s great to have a “seal of approval” from the CDC for sperm washing for couples affected by HIV who need assisted reproductive technologies for reasons unrelated to HIV, it is way overkill to recommend it on top of treatment as prevention and PrEP. We’re trying to normalize living, and reproducing, with HIV, and help patients who want families do so in a safe way that supports their values and needs. Insisting on an expensive and unavailable technology to reduce “essentially zero risk” to “absolutely zero risk” takes us backward.

  7. jean anderson says:

    I wanted to express an alternative perspective and give some history that I think informs understanding of this paper and should inform any response to it.
    I agree that the paper could have done a better job in emphasizing the primary roles of TasP +/- PrEP and the issues of cost and access in this situation (these are mentioned but not emphasized as primal). There are also some inaccuracies and out of date references. Two of the authors, Dawn Smith and Denise Jamieson, however, are long-time leaders in the area of HIV in women and HIV prevention and certainly understand these issues very well. The first author is a reproductive endocrinologist/infertility physician and I think clearly is approaching this topic thru the lens of assisted reproductive technologies.

    I think the history that should be understood is the 1988 CDC recommendation against insemination of semen from HIV-infected men, a recommendation that has never been rescinded and that has been used as a pretext or rationale to withhold these services from couples ever since . Dr. Jamieson, who is currently chief of the Women’s Health and Fertility branch in the Division of Reproductive Health at CDC, has advocated for changing this very out of date and unjust recommendation. Dr. Smith is a CDC and national leader in PrEP implementation. As most of you know, changing such recommendations is not a simple thing and requires consensus input, and this has simply not been a priority for CDC.I view this paper, all of whose authors are CDC folks, as an attempt to right this wrong and confirm that semen processing and insemination from men with HIV can be used safely.
    With this background, I think the focus going forward should be to reemphasize TasP and PrEP as key tools and also focus on situations where semen processing/IUI may be indicated. Approximately 25% of infertility overall is male factor infertility and we know that men living with HIV have higher rates of semen abnormalities-semen processing and IUI may be a key intervention in some cases when spontaneous conception has not occurred. We also know that there can be discordance between plasma and genital tract virus, even in the presence of ART and this technique offers another option to minimize risk.

  8. Natasha Davies says:

    To the authors and commenters,

    As a safer conception service provider working in a resource limited setting in Johannesburg, South Africa, I was very relieved to see this blog and the responses in the comments from others working in the field. While I do acknowledge Jean Anderson’s explanation of where the CDC article came from, I do still think it risks causing a great deal of confusion amongst providers and clients, perhaps creating a resurgence of fear that natural condomless conception attempts with ART and/or PrEP cover may not actually be that safe. Undermining provider confidence in offering these strategies has worldwide public health implications when those of us in resource limited settings are struggling to get the message out there to other providers and those affected by HIV that TASP really does work and that PrEP is now an additional option which might provide the belt and braces approach for those who remain anxious despite having a partner established on ART with sustained viral suppression or where partner viral load is not known or not undetectable. I agree with Lealah Pollock that we are now in a phase of the HIV epidemic where the greater challenges are overcoming stigma and barriers to access to care and putting out a message that those who are well and virally suppressed on ART may well still be infectious only risks refuelling the stigma fire. Of course the risk is not absolutely zero, as Prof Vernazza says, but the risks associated with medicalised assisted reproductive technologies are not zero either. For an HIV affected couple with normal fertility, apart from anything else, are their chances of conceiving not higher per cycle attempted with correctly times natural conception attempts than they are with any available assisted reproductive technology approach? Should we be creating medical infertility in these couples? And subjecting them to high costs in the meantime – it strikes me as a new form of discrimination in some ways that we would discourage couples with absolutely minimal risks from using natural conception just like any other couple. Of course, there will be individuals and some couples who will need this approach and it should always be available as one of many options but it should be a balanced discussion which enables HIV affected individuals and couples to make an informed CHOICE which is right for them.

    Interestingly, there is also an oversight in terms of the importance of other STIs in the article. Considering their impact on higher HIV transmission/acquisition rates and their significant contribution to female infertility, shouldn’t we rather be shifting our public health emphasis to improving affordable, effective screening, point of care diagnostics and treatment for STIs rather than perpetuating an agenda of costly interventions which only a tiny proportion of the population can actually afford?

    Thanks again for all taking the time to respond to the CDC article – reassuring indeed.

  9. Andrew Pavia says:

    Another great insight from Paul triggering a thoughtful discussion. Jean Anderson’s comments put some perspective on the need to consider the role of assisted reproductive technology as a service that should be available to HIV serodiscordant couples who need it for infertility issues. However, that doesn’t completely excuse the final editing that does not put the options in perspective. That is treatment as prevention plus PreP is inexpensive, accessible, supported by the large studies Paul cited, and normalizes couples desire to have children. Sperm washing is expensive, difficult to access, and supported by rather limited data.

    I am a proud ex-CDC employee and have participated in many guidance consultancies. Sometimes writing by committee and the final editing the during Bataan death march that manuscripts take through clearance gets in the way of the clarity and common sense the authors originally intended.

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