Clarifying the HOPE Act landscape: The challenge of donors with false-positive HIV results.
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ABSTRACT:
SUBMITTER: Durand CM
PROVIDER: S-EPMC7132607 | biostudies-literature | 2020 Feb
REPOSITORIES: biostudies-literature
Publications
Clarifying the HOPE Act landscape: The challenge of donors with false-positive HIV results.
Durand Christine M CM Werbel William W Doby Brianna B Brown Diane D Desai Niraj M NM Malinis Maricar M Price Jennifer J Chin-Hong Peter P Mehta Shikha S Friedman-Moraco Rachel R Turgeon Nicole A NA Gilbert Alexander A Morris Michele I MI Stosor Valentina V Elias Nahel N Aslam Saima S Santos Carlos A Q CAQ Hand Jonathan M JM Husson Jennifer J Pruett Timothy L TL Agarwal Avinash A Adebiyi Oluwafisayo O Pereira Marcus M Small Catherine B CB Apewokin Senu S Heun Lee Dong D Haidar Ghady G Blumberg Emily E Mehta Sapna A SA Huprikar Shirish S Florman Sander S SS Redd Andrew D AD Tobian Aaron A R AAR Segev Dorry L DL Segev Dorry L DL
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 20191120 2
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Project description:Organs from deceased donors with suspected false-positive HIV screening tests were generally discarded due to the chance that the test was truly positive. However, the HIV Organ Policy Equity (HOPE) Act now facilitates use of such organs for transplantation to HIV-infected (HIV+) individuals. In the HOPE in Action trial, donors without a known HIV infection who unexpectedly tested positive for anti-HIV antibody (Ab) or HIV nucleic acid test (NAT) were classified as suspected false-positive donors. Between March 2016 and March 2018, 10 suspected false-positive donors had organs recovered for transplant for 21 HIV + recipients (14 single-kidney, 1 double-kidney, 5 liver, 1 simultaneous liver-kidney). Median donor age was 24 years; cause of death was trauma (n = 5), stroke (n = 4), and anoxia (n = 1); three donors were labeled Public Health Service increased infectious risk. Median kidney donor profile index was 30.5 (IQR 22-58). Eight donors were HIV Ab+/NAT-; two were HIV Ab-/NAT+. All 10 suspected false-positive donors were confirmed to be HIV-noninfected. Given the false-positive rates of approved assays used to screen > 20 000 deceased donors annually, we estimate 50-100 HIV false-positive donors per year. Organ transplantation from suspected HIV false-positive donors is an unexpected benefit of the HOPE Act that provides another novel organ source.
| S-EPMC6160348 | biostudies-literature
Project description:The HIV Organ Policy Equity (HOPE) Act now allows transplantation of organs from HIV-positive living and deceased donors to HIV-positive individuals with end-stage organ disease in the United States. Although clinical experience with such transplants is limited to a small number of deceased-donor kidney transplants from HIV-positive to HIV-positive persons in South Africa, unprecedented HIV-positive-to-HIV-positive liver transplantations and living-donor kidney transplantations are also now on the horizon. Initially, all HIV-positive-to-HIV-positive transplantations will occur under research protocols with safeguards and criteria mandated by the National Institutes of Health. Nevertheless, this historic change brings ethical opportunities and challenges. For HIV-positive individuals needing an organ transplant, issues of access, risk, and consent must be considered. For potential HIV-positive donors, there are additional ethical challenges of privacy, fairness, and the right to donate. Careful consideration of the ethical issues involved is critical to the safe and appropriate evaluation of this novel approach to transplantation.
| S-EPMC4949150 | biostudies-literature
Project description:Rapid HIV tests provide same-day results and are widely used in HIV testing programs in areas with limited personnel and laboratory infrastructure. The Uganda Ministry of Health currently recommends the serial rapid testing algorithm with Determine, STAT-PAK, and Uni-Gold for diagnosis of HIV infection. Using this algorithm, individuals who test positive on Determine, negative to STAT-PAK and positive to Uni-Gold are reported as HIV positive. We conducted further testing on this subgroup of samples using qualitative DNA PCR to assess the potential for false positive tests in this situation.Of the 3388 individuals who were tested, 984 were HIV positive on two consecutive tests, and 29 were considered positive by a tiebreaker (positive on Determine, negative on STAT-PAK, and positive on Uni-Gold). However, when the 29 samples were further tested using qualitative DNA PCR, 14 (48.2%) were HIV negative.Although this study was not primarily designed to assess the validity of rapid HIV tests and thus only a subset of the samples were retested, the findings show a potential for false positive HIV results in the subset of individuals who test positive when a tiebreaker test is used in serial testing. These findings highlight a need for confirmatory testing for this category of individuals.
| S-EPMC3392728 | biostudies-other
Project description:In the seven years since the HIV Organ Policy Equity (HOPE) Act made HIV-positive organ donation to HIV-positive recipients legally permissible in the United States, there have been fewer HIV-positive organ donations than expected. Organ procurement organizations (OPOs) play a key role in the transplant system and barriers at OPOs may be partly responsible for the relatively low number of HIV-positive donors. To understand potential OPO barriers, we conducted semi-structured interviews with 20 OPO staff members. Interviews were recorded, transcribed, and analyzed using a conventional content analytic approach with two coders. OPO staff had high levels of knowledge about HOPE. Many had evaluated referrals of HIV-positive donors and approached families for authorization. Barriers to HIV-positive organ recovery identified included obtaining authorization for donation, potentially disclosing HIV status to next-of-kin, and fear of HIV infection among those engaged in organ recovery. Strategies to overcome these barriers include providing continuing education about the specific tasks required to procure organs from HIV-positive donors, implementing targeted interventions to reduce fear of infection, and developing partnerships with HIV advocacy and care organizations. Given the central role OPOs play, HIV-positive donations are unlikely to occur in significant numbers unless these barriers can be overcome.
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Project description:With the introduction of the new highly effective antiviral therapies, there has been a dramatic increase in the use of the hepatitis C virus (HCV)-positive livers in HCV-positive recipients. In the majority of studies, HCV positivity was defined as a donor testing HCV Ab positive. In 2015, all Organ Procurement Organizations were mandated to perform and report HCV Nucleic Acid Amplification Testing (NAT) results on all deceased and living donors. Studies are not yet available on how organs are being utilized based on NAT status and whether NAT status affects recipient outcomes. Further studies are needed to maximize the use of these organs.
| S-EPMC5534365 | biostudies-other
Project description:BackgroundAn increase in potential HIV elite controllers (EC) and anecdotal reports of antiretroviral therapy (ART) use among South African blood donors led us to verify EC status.MethodsStored plasma samples from potential EC were tested for ART drugs. Demographic and temporal associations were examined using multivariable logistic regression.ResultsOf 226 potential EC, 150 (66.4%) had detectable ART with increasing prevalence by year (OR = 7.57 for 2016 vs 2010, 95% confidence interval, 1.96-32.17).DiscussionFalse presumptive EC status due to undisclosed ART represents a growing proportion of potential EC donors in South Africa coincident with the country's ART rollout.
| S-EPMC6639597 | biostudies-literature
Project description: Not available
| S-EPMC6003382 | biostudies-literature
Project description:ObjectivesThere is no consensus regarding a possible relation between false positive glucose challenge test (GCT) results and large-for-gestational-age (LGA) infants. This study aimed to clarify the association between false positive GCT results and LGA, after adjusting for potential confounding factors, using a large clinical dataset.DesignRetrospective cohort study.SettingNational Hospital Organisation Kofu National Hospital, which is a community hospital, between January 2012 and August 2019.ParticipantsJapanese women who underwent GCT between 24 and 28 weeks of gestation at the hospital were included. After excluding those with gestational diabetes mellitus, diabetes in pregnancy and multiple pregnancies, subjects were divided into a false positive GCT group (≥140 mg/dL) and a GCT negative group (<140 mg/dL).MethodsObstetric records of patients were examined. The χ2-test and multivariable logistic regression analysis were used to investigate the association between false positive GCT results and LGA.Primary and secondary outcome measuresIncidence of LGA and the association between false positive GCT results and LGA.ResultsThe mean subject age was 31.4±5.5 years, with 43.3% nulliparity (n=974) and 2160 (96.1%) term deliveries. The incidence of LGA was 9.4% (211/2248) and 11.4% (257/2248) of the women had false positive GCT results. False positive GCT results were significantly associated with an increased risk of LGA (OR, 1.51; 95% CI, 1.02 to 2.23), after controlling for maternal age, prepregnancy maternal weight, maternal weight gain during pregnancy and parity.ConclusionsIt appears that there is a significant association between false positive GCT results and LGA. Additional research is required to confirm these results and to investigate appropriate interventions for women with abnormal screens for gestational diabetes mellitus.
| S-EPMC7045087 | biostudies-literature
Project description:BACKGROUNDThe HIV Organ Policy Equity (HOPE) Act allows individuals living with HIV to accept organs from donors with HIV. This practice widens the pool of available organs, but also presents important virological issues, including the potential for HIV superinfection of the recipient, viral persistence in the kidney, and loss of virological control.METHODSWe addressed these issues by performing in-depth longitudinal viral sequence analyses on urine, blood, and urine-derived renal epithelial cells from 12 recipients of HIV+ kidney allografts.RESULTSWe amplified donor-derived HIV-1 env sequences in 5 out of 12 recipients after transplant. These donor-derived env sequences were amplified from recipient urine, urine-derived renal epithelial cells, and plasma between 12 and 96 hours after transplant and remained detectable up to 16 days after transplant. Env sequences were also detected in kidney biopsies taken from the allografts before implantation in 6 out of the 12 transplant cases, indicating the presence of donor virus within the organ. One recipient had a viremic episode 3.5 years after transplantation as a result of antiretroviral therapy (ART) interruption. Only recipient strain viral sequences were detected in blood, suggesting that the donor virus, if still present, was not reactivated during the temporary ART withdrawal.CONCLUSIONSThis study demonstrates that the HIV env sequences in a donor kidney can be amplified from biopsies taken from the allograft before implantation and can be detected transiently in blood and urine samples collected from the organ recipients after transplantation.FUNDINGNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant number R01DK131497.
| S-EPMC11473162 | biostudies-literature
Project description:Virtual screening of the Maybridge library of ca. 70 000 compounds was performed using a similarity filter, docking, and molecular mechanics-generalized Born/surface area postprocessing to seek potential non-nucleoside inhibitors of human immunodeficiency virus-1 (HIV-1) reverse transcriptase (NNRTIs). Although known NNRTIs were retrieved well, purchase and assaying of representative, top-scoring compounds from the library failed to yield any active anti-HIV agents. However, the highest-ranked library compound, oxadiazole 1, was pursued as a potential "near-miss" with the BOMB program to seek constructive modifications. Subsequent synthesis and assaying of several polychloro-analogs did yield anti-HIV agents with EC50 values as low as 310 nM. The study demonstrates that it is possible to learn from a formally unsuccessful virtual-screening exercise and, with the aid of computational analyses, to efficiently evolve a false positive into a true active.
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