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AABB > Press Room > Comments

Comments to CDC on Public Service Guideline for Reducing Transmission of HIV, HBV and HCV Through Solid Organ Transplantation - 12/22/11 

December 22, 2011

Office of Blood, Organ and Other Tissue Safety
Division of Healthcare Promotion
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Rd, NE, MailstopA-07
Atlanta, GA 30333

Re: Docket No. CDC-2011-0011 "Public Service Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Solid Organ Transplantation"

Dear Dockets Manager:

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

AABB does not generate Standards directly related to solid organ transplantation but AABB member institutions, and their patients, are affected by the availability of organs for transplantation. AABB also recognizes that 35-40% of organ donors are also tissue donors and the resultant implications for availability of tissue for transplantation. We appreciate the opportunity to provide comments to the proposed guidelines for reducing transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) through solid organ transplantation. In particular, our observations are focused on donor assessment recommendations that rely on risk factors listed in Table 3. Factors identified in the literature to be associated with increased likelihood of recent HIV, HBV or HCV in infection.

Sexual Contact: Persons who have had sex with ≥2 partners in the preceding 12 months

Recommendations in the "Summary of Recommendations" include:

Donor Assessment 2. To ascertain whether potential organ donors are average risk or at increased risk for having HIV, HBV, or HCV, prospective living donors and next-of-kin, as well individuals familiar with deceased donors (ie, life partners, cohabitants, friends, healthcare provider), should be interviewed in a confidential and sensitive manner about behaviors that may have increased the potential donor's probability of HIV, HBV or HCV infection. (Refer to Table 3 for risk factors) (Category IB – Strong recommendation supported by low to very low quality evidence according to Table 2. Categorization Scheme for Recommendations.)

Donor Assessment 3. For prospective living donors with a history of behaviors associated with an increased risk of acquiring HIV, HBV or HCV identified during evaluation, individualized counseling and a detailed discussion of specific strategies to prevent exposure to these viruses should occur; however, in most circumstances a discussion of strategies to avoid these behaviors should be provided. (Refer to Table 3 for risk factors) (Category 1 – Recommendations not linked to a key question and had no systematic review of the literature performed, but a critical outcome was determined to result in a net benefit.)

Blood donors are carefully screened for many behavioral factors that are purported to have some level of risk for HIV, HBV, or HCV. While the behavioral factors currently identified for use in screening blood donors have varying amounts of evidentiary support it is important that such evidence exist, especially when the recommendations further include individualized counseling and detailed discussion with living donors. The categorization assigned to this recommendation (see above) appears to indicate a lack of evidence that a particular number of sexual partners within a particular timeframe is a reason to identify a potential donor as unsuitable. It is supported by "low to very low quality of evidence". This criterion is not used for screening donors of Whole Blood or Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and we would vigorously oppose any such recommendation if it were introduced in a draft recommendation for blood and HCT/P donors without evidence that it identifies donors with known risk. Credibility is paramount when engaging in a donor counseling session – it is very important to have additional supplemental results to confirm a reactive screening test, and credible scientific / medical literature when high risk behavior or other types of risk exposures are being discussed.

Intranasal use of an illicit drug (eg, cocaine, heroin) in the preceding 12 months

Recommendations in the "Summary of Recommendations" include:

Donor Assessment 2. To ascertain whether potential organ donors are average risk or at increased risk for having HIV, HBV, or HCV, prospective living donors and next-of-kin, as well individuals familiar with deceased donors (ie, life partners, cohabitants, friends, healthcare provider), should be interviewed in a confidential and sensitive manner about behaviors that may have increased the potential donor's probability of HIV, HBV or HCV infection. (Refer to Table 3 for risk factors) (Category IB – Strong recommendation supported by low to very low quality evidence according to Table 2. Categorization Scheme for Recommendations.)

In 1997, following publication of the Conry-Cantilena study (Conry-Cantilena C, van Raden M, Gibble J, et al. Routes of infection, viremia, and liver disease in blood donors found to have hepatitis C infection. N Engl J Med 1996;334:1691-96) AABB issued an Association Bulletin recommending that member institutions review the published data and decide whether these data warranted the introduction of an additional donor history question and associated donor deferral policy. Later the AABB Standards for Blood Banks and Transfusion Services required that donors be asked about intranasal use of cocaine. The AABB questionnaire for blood donors was modified to include "In the p ast 12 months have you taken (snorted) cocaine through your nose?" A yes response resulted in a 12 month exclusion from blood donation. However, AABB reversed its position following publication of the REDS (Retrovirus Epidemiology Donor Study) analysis (Murphy EL, Bryzman SM, Glynn SA, et al. Risk factors for hepatitis C virus infection in United States blood donors. Hepatology 2000;31:567-762) published in 2000. The study "…did not find that intranasal drug inhalation was an independent risk factor", and noted that excluding donors who report intranasal drug inhalation as their only risk was likely not warranted. Subsequently the criterion was dropped from the AABB Standards (20th ed) and from the AABB donor history questionnaire. The Food and Drug Administration does not have a policy on assessment of blood and HCT/P donors for intranasal drug use. Given the REDS findings, the "low to very low quality of evidence" supporting the recommendation in the PHS draft guidelines, and the lack of availability of organs for transplant, it seems unwise to recommend this criterion for use in solid organ donor assessments.

AABB recognizes that these draft guidelines address transmission of HIV, HBV, and HCV through solid organ transplantation with a goal of further reducing the transmission rates. We have commented on only two items contained in the draft and are aware of many other concerns that are being addressed by other individuals and entities, including the American Association of Tissue Banks. AABB also recognizes that the CDC is concerned with reducing transmission of other infectious agents through solid organ transplantation and note CDC participation in the Chagas Transplant Working Group and the recommendations published in the recent article in the American Journal of Transplantation (Chin-Hong PV, Schwartz BS, Bern C, et al. Screening and Treatment of Chagas Disease in Organ Transplant Recipients in the United States: Recommendations from the Chagas Transplant Working Group. Am J Trans 2011;11:672-80.) WNV continues to be an issue for concern in the US and we believe that regional transplant networks have made requirements for this testing.

Thank you for the opportunity to offer these comments. AABB looks forward to continuing to work with CDC and other PHS agencies on initiatives that improve the safety of patients and donors. Questions concerning these comments may be directed to me at acarrgreer@aabb.org.

Sincerely,

M. Allene Carr-Greer
Director, Regulatory Affairs

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