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Augusto Semprini | Bernard Hirschel | Charge virale indétectable | Faire un bébé quand on est séropositif | Pietro Vernazza | Reda Sadki

HIV and the desire to conceive

23 mai 2012 (Baseline)

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“What should we now tell patients ?” was a question asked from the floor after the presentation in Rome this July of the large HTPN 052 study, which showed that people living with HIV who started treatment immediately substantially protected their HIV negative sexual partners from acquiring HIV. Researchers reported a 96 percent reduction in risk of HIV transmission if HIV treatment was started immediately.

Many HIV affected couples that want to become parents are not waiting for an answer. The vast majority of children born to positive parents are conceived naturally, with or without the help of clinicians.

‘What does at least 96% protection against transmission mean to couples wanting to conceive ? “It’s as close to zero as you can get - but it’s not zero.”’

Dr Augusto Semprini, the founder of sperm washing in Milan, Italy was curious about what happened to the couples who came for advice and counselling but never went ahead with the process, ‘no shows’ as they are known in the trade. He traced 500 couples – and found half (250) of them had had children by natural means.

Many of these couples are missing out on advice on how to minimize even a negligible risk and negotiate often-difficult choices. Reda Sadki, of the French activist group, Comité des Familles, representing families living with HIV, agrees that in their experience pre-conception counselling is the exception and not the rule, ‘usually a woman turns up at the clinic pregnant.’

That question “what do we now tell patients ?” was asked by Pietro Vernazza from St Gallen Hospital, Switzerland, also one of the authors of the Swiss Statement, which attempted to answer this when it was published in January 2008. The Swiss Statement laid out parameters for minimising infection : a stable heterosexual couple with no detectable viral load in the positive partner for at least 6 months, no STIs and timed intercourse. It looked for HIV transmission, found none and concluded in the above circumstances an HIV positive individual was ‘sexually non-infectious.’

The radical challenges of the Swiss Statement have not yet been reflected in clinics says Sadki, ‘we feel that HTPN 052 has been used in France to discourage couples from attempting natural conception. The doctors said “wait till we see what that comes up with”. After the Swiss cohort findings, this result is not a surprise to us.’

Once couples are in the consulting room, says Sadki, they can face a lack of reliable information, and can be coloured by a individual clinician’s viewpoint. ‘It is inexcusable for doctors to be reluctant to talk about the risk of HIV transmission in natural unprotected conception. In some cases I think it is criminal - if a couple then lose the opportunity to start a family. Even a couple who are both positive are recommended to use condoms – it feels as if it’s a punishment for being HIV.’

It’s not just the clinics that cannot absorb what the risk levels are. ‘When I ask “what do you think the transmission risk is if you have sex tonight ?” says Vernazza, ‘the answer ranges from 50% to 100% – way, way above the reality.’

One comparison - the risk of death from passive smoking is far higher than transmitting HIV within the Swiss guidelines - can be hard to grasp in the real world. Similarly hepatitis C transmission via vaginal sex has occurred in a handful of cases, yet no national guidelines recommend that heterosexual couples living with hepatitis C change the way they protect themselves by using condoms.

This is the heart of the matter – balancing risk. HTPN 052 showed that in the group of positive people who took immediate therapy, just one partner of a positive person out of 886 couples sero converted, compared to 27 people who acquired HIV if treatment initiation by the positive partner was delayed. Crucially even that one couple, it transpires, could be excluded, as it seems the positive partner might have been sero-converting when the trial began. The transmitting partner entered the study with a viral load of 87,202 copies and was below 400 copies by day 28. It is possible the transmission to the HIV negative partner occurred in the first few weeks of the study.

What does at least 96% protection against transmission mean to couples wanting to conceive ? BASELINE asked the trial’s lead investigator Myron Cohen. ‘It’s a huge issue, a negative women and a positive man, it’s not 1 in 100, it’s not 1 in 1000, is it 1 in 100,000 as some models suggest ? To use homogenous numbers is a really bad idea. It’s as close to zero as you can get - but it’s not zero.’

In the UK, the 2008 BHIVA (British HIV Association) guidelines state, ‘Current evidence supports a more open discussion of this option [timed unprotected intercourse] with the couple to quantify, as far as reasonably possible, the risk in individual cases to enable them to make an informed decision.’ So what do HIV doctors in the UK think ? Dr. Mark Nelson, Chelsea and Westminster Hospital ; ‘When I am asked, I say “there is a very small risk to natural conception.” It’s not that helpful, I know this is sitting on the fence. But this is the reality. I cannot know if a patient is being adherent to their meds to remain undetectable.’

With freedom comes responsibility, as they say. When the Swiss Statement came out many couples living with HIV welcomed it as an opportunity to control their own health and lives. ‘We need this discussion about risk and behaviour,’ says Pietro Vernazza, ‘how do we make decisions about our sexual life. If I’m living with a partner and she takes drugs for HIV, I know exactly her adherence. I know exactly her virus. I have been talking with her doctor.’ He adds, ‘It’s a different situation than having sex with a partner who just tells me, “I’m suppressed.”’

The Seminal Question

However viral load ‘fully suppressed’ is generally measured in the blood, what about in semen ? The Assisted Conception Unit at Chelsea and Westminster say on their website ; “…. couples ask about the safety of conceiving naturally. Unfortunately, even in men with negative viral loads, semen can still carry HIV … We therefore strongly recommend that couples wishing to conceive safely continue to have protected intercourse and use sperm washing as a safer alternative.”

However French virologists are studying the semen samples of positive men from fertility clinics. The 2010 French expert guidelines say, “Latest data indicate that the phenomenon of persistence of HIV in semen in men largely disappeared with current treatments.” The report speculates that newer HIV drugs such as tenofovir and abacavir achieved higher penetration in the genital tract.

“Latest data indicate that the phenomenon of persistence of HIV in semen in men largely disappeared with current treatments.”

At the Necker-Cochin hospital in Paris, the team led by virologist Christine Rouzioux assessed the frequency of detection of HIV RNA (HIV’s genetic material) in the semen of men on HAART whose blood viral load was undetectable for at least 6 months from 2002 – 2009. They found that the prevalence of HIV RNA in semen samples was 3.7% (17/455) over the entire period, but the prevalence actually decreased between 2002 and 2005 (from 15% to 1%) and no cases were observed after 2005.

Although hindsight is 20:20, it is a sobering thought that the high cost of sperm washing, the lower rates of conception, and the fact that some couples remain childless – may be avoidable in the majority of cases.

Fertility Options Opening but Still Limited

Even if more couples continue along the natural conception route there is still a need for assisted conception for sero-different couples. A recent study by Pietro Vernazza, presented in Stockholm in July 2011 to fertility experts and about to be published in the journal AIDS, showed that in 53 couples - man positive, woman negative - offered the option of natural conception using pre-exposure prophylaxis and timed intercourse – 70% conceived a child - usually after 6 unprotected cycles, levelling off at 75% of couples pregnant after two years of timed unprotected intercourse. The remaining 25% will need help with conception.

When the sero-different couple consists of a positive woman and a negative man other methods of natural conception are available - self-insemination can be done at home, commonly called the “turkey baster” method. However mother-to-child transmission has to be addressed, although timely treatment with antiretrovirals has an exceedingly high success rate at reducing this.

If you decide to take the sperm washing route, there are three main methods of assisted conception :
- IUI : A sample of washed sperm is placed inside the womb. Usually done when there are no apparent fertility issues.
- IVF : egg is removed from the woman and fertilized by the washed sperm and put back into the womb
- ICSI : Sperm washed but egg injected with a single sperm before re-implantation in the womb

Liverpool and Manchester United

Up until now Chelsea and Westminster Assisted Conception Unit has been the only UK fertility centre to openly offer HIV couples sperm-washing. Now the fertility clinic at Liverpool Royal Women’s Hospital has opened up a separate unit, and will be offering sperm washing for couples, positive men - negative. (France in comparison has eight clinics across the country and state funded separate laboratory facilities). Hand-in-hand with this move are commissioning guidelines, the first of their kind in the UK they say, from the Association of Greater Manchester Primary Care Trusts. The guidelines look at clinical eligibility, age barriers and number of cycles, which will be six IUI cycles, a decision based, say Manchester, as an infection control issue.

‘No person or embryo is known to have acquired HIV at a fertility clinic from a HIV sample.’

The Manchester consortium say they are seeing increased demand for reproductive care for HIV positive couples and are minimizing onward transmission of HIV which they point out would save between £0.5 and £1 million for each infection avoided over a lifetime.

The guidelines say that same sex couples are not excluded from access to the programme and would be considered on a case-by-case basis, for example a male-male partnership with a surrogate would be considered although the NHS will not be involved in or responsible for surrogacy arrangements.

George House Trust in Manchester has welcomed the new arrangements, Lynda Shentall told BASELINE : ‘From a cost point of view it’s a great move as it means that patients don’t have to travel to London for treatment. We now have a better process for making decisions more quickly so that eligible patients get access to treatment more quickly.’

The decision to use a fertility clinic for a sero-different couple in the UK can be a world of whispers and rumours. Many clinics do not say they offer treatment to men or women living with HIV, unless approached directly. How many cycles a couple is eligible for from the NHS is a postcode lottery.

In 2001 the BMJ suggested that UK IVF clinics discriminated against HIV positive men and women. 63% of responding clinics said they would refuse treatment. Also in 2001 Ade Apoola then at Whittall Street clinic in Birmingham said IVF clinic discrimination was rife and funding was a lottery.

An article in the Daily Mail recently carried the headline ‘IVF Clinics Could Carry Risk of HIV’ quoted Dr Carol Gilling-Smith of the Chelsea and Westminster ACU as saying in a survey she had carried out, only 2 out of 69 clinics had ‘separate’ facilities for treating HIV positive couples. The paper concluded that healthy tissue was at risk from ‘HIV contaminated’ samples.

No person or embryo is known to have acquired HIV at a fertility clinic from a HIV sample. ‘I don’t think this is a helpful article,’ says Stuart Lavery of Hammersmith IVF, ‘I don’t think it’s necessary to have separate labs, but you do need separate storage.’ An embryologist at a London IVF clinics, says ‘we are as confident as we can be and follow HFEA (Human Fertilisation and Embryology Authority) guidelines. They employ a double ‘Witness’ system for handling samples, no more than one sample at in a work area at a time, cleaning down after each procedure.

All hospitals deal with the risks of HIV to both staff and patients on a daily basis. According to the HFEA, anyone undergoing IVF would be protected from infection just like all the other thousands of patients going through surgery or having treatment every day.

For those couples that decide to go the natural route - for the first time in the UK pre-exposure prophylaxis (PrEP) is available for couples wanting to conceive.

Dr Yvonne Gileece, reports that Brighton has experienced an increasing demand for requests to conceive naturally. Now Brighton and Birmingham Heartlands are providing 1-2 doses of either tenofovir or Truvada to be taken before and after unprotected sex, at the most fertile time of the month. Again this service is not consistent across the country although in London, St Mary’s offer the service, Chelsea and Westminster don’t.

It’s a ‘belt and braces’ approach to lowering transmission risk says Gileece, and there are huge psychological benefits to PrEP for couples that have used condoms for many years, says Vernazza.

Across the board people don’t want to let go of the condom.

Photos


Myron Cohen présente les résultats de l'étude HPTN052

Myron Cohen présente les résultats de l’étude HPTN052

L'article de Baseline sur le web

L’article de Baseline sur le web

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L’article de Baseline sur le web (PDF, 390 ko)

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