Hum. Reprod. Advance Access originally published online on July 16, 2007
Human Reproduction 2007 22(10):2794-2795; doi:10.1093/humrep/dem198
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Letters to the Editor |
Reply: Establishing the safety profile of sperm washing followed by ART for the treatment of HIV discordant couples wishing to conceive
Department of Obstetrics and Gynaecology, Sacco Clinical Sciences Institute, University of Milan Medical School, Via GB Grassi 74, 20157 Milan, Italy
1 Correspondence address. E-mail: enrico.ferrazzi{at}unimi.it
We thank Dr Semprini and colleagues for their interest in our paper (Savasi et al., 2007) and the questions they raise in their letter:(i) inclusion criteria for HIV infected male partners; (ii) patients follow-up and (iii) safety statement.
(i) There is a clear misinterpretation for the criteria adopted for including male partners as they are reported in the Materials and Methods section.
‘Standard laboratory criteria were adopted: (a) CD4+ lymphocytes >200/mm3 at least twice in the 4 months before treatment; (b) stable viral load, with no increase >0.5 log in two successive samples during the 4 months before treatment’.
They understand that we were paradoxically excluding viraemic partners, that is, treating the healthy and excluding those in need of treatment. We hoped the second criterion was indeed quite clear to the readers and the letter by Semprini gives us the opportunity to clarify the concept. This cut-off was included to set a criteria of stable viral load assuming the variation of 0.5 log of viral load (for instance 103–103.5) is enough to spot, over a 4 months period, together with the CD4 count, a condition of a patient who is likely to become a father. As shown in Table 1, we reported the number of patients with viral load below (36%) or above 50 copies/ml (64%) and the interquartile range of viral load. Because of HIV infection becoming a chronic treatable disease, there is a need of multidisciplinary approach and counselling, and for this reason we work closely, as stated in our paper, to infectious disease specialists and psychologists with the aim of including as many patients as possible.
(ii) No seroconversions occurred in our large series. The system employed to follow-up patients was to obtain from the woman an HIV negative result either performed by ELISA (HIV antibody) nor by a PCR method (see Materials and Methods page 2, last paragraph). As most of our treated women (88%) are not resident in our region, they were referred to their local HIV physicians and laboratories to perform the tests. Every treated woman was serologically assessed and all HIV-1 blood tests performed by PCR assays were negative. Not every woman was assessed by PCR, but in some cases the local physician decided to use this method, for example, if the woman successfully conceived. The use of PCR method to assess the presence of HIV in a seronegative individual who was exposed to uninfected semen is still to be discussed. In fact, as reported in our paper we only used negative semen, tested for detectable HIV RNA by real-time PCR assay. The potentiality of a stored blood bank remains at our centre.
Unfortunately, the ‘500 cases’ quoted in his letter, have not been published and cannot properly be added to other reported scientific series which adopted criteria similar to our protocol in order to confirm the efficacy of sperm washing.
(iii) Safety is indeed an ambitious statement in clinical research. Safety could be defined as ‘a judgment of the acceptability of risk, i.e. a measure of the probability of an adverse outcome and its severity, associated with using a technology, for a given patient with a particular health problem, by a trained clinician’ (www.gulfwar.osd.mil/medsearch). In the HIV era, we also discuss the safety of Caesarean section in reducing HIV mother to child transmission to an acceptable risk (Read and Newell, 2005). As stated in our paper (Discussion page 5, line 22) ‘safety issues require a large multicentre trials and until then participants need to understand that no procedure is risk free as all carry a possibility for transmitting infection. The CDC statement of ‘lack of best available evidence’ (Duerr and Jamieson, 2003), should still be compared to the natural transmission risk (Mandelbrot et al., 1997).
References
Duerr A, Jamieson D. Assisted reproductive technologies for HIV discordant couples. Am J Bioeth (2003) 3:45–47.[CrossRef][Web of Science][Medline]
Mandelbrot L, Heard I, Henrion-Geant E, Henrion R. Natural conception in HIV-negative women with HIV-infected partners. Lancet (1997) 349:850–851.[Web of Science][Medline]
Read JS, Newell MK. Efficacy and safety of cesarean delivery for prevention of mother-to-child transmission of HIV-1. Cochrane Database Syst Rev (2005) 19. CD005479.
Savasi V, Ferrazzi E, Lanzani C, Oneta M, Parrilla B, Persico T. Safety of sperm washing and ART outcome in 741 HIV-1-serodiscordant couples. Hum Reprod (2007) 22:772–777. (14 March 2007, date last accessed) www.gulfwar.osd.mil/medsearch/glossary.
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