Viral inactivation with Methylene Blue: Macopharma confirms the efficacy of THERAFLEX MB-Plasma on HIV

Tourcoing, 20th of November 2015

Following the report of a case of apparent failure of viral inactivation with methylene blue, Macopharma contests the analysis provided in the Transfusion journal and asserts the efficacy of their pathogen inactivation procedure on HIV as long as it is used properly.

As announced today in the “Early View” of the Transfusion journal, an article by Alvarez et al. is published online ahead of print, reporting a case of HIV-1 transmission through plasma treated with methylene blue and visible light in Valencia’s blood centre, in Spain. Macopharma has submitted their answer to this “Case Report” to the Transfusion journal for publication in their next edition. Several points can already be clarified to obviate any misinterpretation of this article.

This case, which dates back to more than 10 years ago and has already been mentioned in a congress poster and a review article, is the only case of HIV transmission reported to date since the development and use of methylene blue inactivation, more than twenty years ago.

Following the report of the case in 2009, a deeper investigation was conducted in close cooperation with Valencia’s blood centre. It was not possible to identify the origin of the fault with certainty, due to the very long time span between the transfusion itself and the detection of transmission, but also because the blood centre was not able to provide the necessary internal traceability elements to either confirm or invalidate the fact that the plasma bag had been properly treated prior to transfusion.

However, the studies allowed us to confirm the following:

  • On the one hand, the implicated batch of bags presented no defect, nor did the illumination device used on the concerned bag,
  • On the other hand, HIV-1 cannot escape methylene blue inactivation, even at a very low level of viral particles diluted in a large volume of plasma. Additional investigations led after this case – whose results are included in Macopharma’s reply to the Transfusion journal – demonstrate the full efficacy of the THERAFLEX MB-Plasma procedure.

Accordingly, it appears that in all likelihood, the transmission of HIV-1 could be linked to wrong manipulation, and not to a failure of the THERAFLEX MB-Plasma system.

Nevertheless, Macopharma has implemented additional safety procedures to fully guarantee the quality of the devices provided to users. Macopharma has also renewed the training of staff from Valencia’s blood centre, who is still using methylene blue inactivation today.

To conclude, since 1992, more than 6.5 million units of plasma treated with methylene blue have been transfused in different clinical settings. Macopharma confirms that the THERAFLEX MB-Plasma system provides the highest guarantees in terms of safety and efficacy. Macopharma’s priority remains to meet at best the expectations of their partners and to work towards the safety of transfused patients, as demonstrated by the vote of confidence granted to the THERAFLEX MB-Plasma procedure by 120 customers in 19 countries.

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