Volume 186 - Issue 8
Potential impact of AUSFTA on Australia's blood supply
Author: Wolfgang Frenzel
Med J Aust 2007; 186 (8): 427-430. || doi: 10.5694/j.1326-5377.2007.tb00983.x
Published online: 16 April 2007
Published online: 16 April 2007
In reply: I would like to respond to the letter by Kennedy et al regarding the passive transfer of human T-lymphotropic virus (HTLV) antibodies following Octagam (intravenous immunoglobulin [IVIg]) administration.
Octapharma does not routinely test Octagam for HTLV antibodies — this is in line with Australian regulatory requirements.1 Furthermore, in accordance with global regulatory requirements (including those defined by the Australian Therapeutic Goods Administration), plasma from sources in Europe and the United States is also not routinely tested for HTLV antibodies.2,3
It is important to note that the patients described by Kennedy et al tested positive for HTLV antibodies rather than the HTLV virus, and that the presence of antibodies in the finished product does not pose an infection risk.
As noted by the authors, the manufacturing process for Octagam includes viral inactivation. There are two dedicated viral inactivation and removal steps:
Solvent/detergent treatment, which is a highly effective step for inactivating lipid-enveloped viruses;
Incubation at pH 4 and 37°C for 24 hours.
The combination of these two processes ensures that lipid-enveloped and several non-lipid-enveloped viruses are inactivated.
Since the initial launch of Octagam in Europe in 1993, more than 33 million grams of the product have been infused, corresponding to more than 2.5 million infusions. During this time, there have been no documented cases of viral transmission resulting from the use of Octagam.
Since the launch of Octagam in Australia in 2005, Octapharma has supplied over 600 kg of IVIg, representing about 40 000 infusions to Australian patients.
Therefore, taking into account the steps used to remove and/or inactivate lipid- and non-lipid-enveloped viruses, the fact that there have been no documented cases of transmission of any virus since the launch of Octagam, and that plasma sources and testing meet both Australian and global regulatory requirements, the positive HTLV antibody results reported by Kennedy et al have no bearing on either the quality or safety of Octagam.
Competing interests
Octapharma is the manufacturer of Octagam. I am employed by Octapharma in the role of International Medical Director.
References
- Australian Government Department of Health and Ageing. Therapeutic Goods Administration. Standards for blood components. Therapeutic Goods Order No. 74. 2006. http://www.tga.gov.au/docs/html/tgo/tgo74.htm (accessed Mar 2007).
- Council of Europe. Guide to the preparation, use and quality assurance of blood components. 11th ed. January 2005. Strasbourg: Council of Europe Publishing, 2005. 0_i1091795
- US Food and Drug Administration. Code of Federal Regulations, Title 21, Part 610, Subpart E. Testing requirements for communicable disease agents (4-1-04 edition). Rockville, Md: FDA, 2004. 0_i1091797