Susceptibility to hepatitis B virus infection in adults living in Spain.

BACKGROUND: A protective hepatitis B virus (HBV) vaccine has been available for four decades. Universal HBV vaccination of infants is recommended by the WHO since the 1990s. Furthermore, HBV immunization is advised for all adults with high-risk behaviours and no seroprotection. However, HBV vaccine coverage remains globally suboptimal. The advent of new more efficacious trivalent HBV vaccines has renewed the interest in HBV vaccination. At present, the extent of current HBV susceptibility in adults remains unknown in Spain. METHODS: HBV serological markers were assessed on a large and representative sample of adults in Spain, including blood donors and individuals belonging to high-risk groups. Serum HBsAg, anti-HBc and anti-HBs were tested in specimens collected during the last couple of years. RESULTS: From 13 859 consecutive adults tested at seven cities across the Spanish geography, overall 166 (1.2%) had positive HBsAg. Past HBV infection was recognized in 14% and prior vaccine immunization in 24%. Unexpectedly, 37% of blood donors and 63% of persons belonging to high-risk groups had no serum HBV markers and therefore were potentially HBV susceptible. CONCLUSION: Roughly 60% of adults living in Spain seem to be HBV susceptible. Waning immunity might be more common than expected. Hence, HBV serological testing should be performed at least once in all adults regardless of risk exposures. HBV vaccine full courses or boosters should be administered to all adults lacking serological evidence of HBV protection.

Overt and occult hepatitis B among immigrants and native blood donors in Madrid, Spain.

BACKGROUND: The risk of transfusion-transmitted viral infections is very low in developed countries. Recent massive migration flows from highly hepatitis B virus (HBV), hepatitis C virus (HCV) and/or HIV endemic regions to Europe may have changed this scenario. METHODS: During 2017 and 2018, a total of 491,753 blood donations (291,762 donors) were evaluated at the Madrid Regional Transfusion Center. All were tested for hepatitis B surface antigen (HBsAg), anti-HCV and anti-HIV, as well as for HBV-DNA, HCV-RNA and HIV-RNA. RESULTS: Overall, 35 donors were positive for HIV-RNA and 26 for HCV-RNA. HBV markers were found in 111 (0.022%) donors, split out into three categories: HBsAg+ (n = 93; 0.019%), occult B infection (OBI) (n = 17; 0.003%), and acute HBV window period (n = 1; 0.0002%). All 17 OBI donors were positive for anti-HBc and confirmed as viremic in repeated testing. Viral load amounts were uniformly below 100 IU/mL. Ten OBI donors were repeated donors and look-back studies could be completed for eight of them. Fortunately, none of all prior recipients experienced transfusion transmitted hepatitis B. Compared with HBsAg+ donors, OBI donors were more frequently native Spaniards (76% versus 40%) and older (median age 52 versus 42 years old). CONCLUSION: Active HBV infection is currently found in 0.022% of blood donations (0.038% of donors) in Madrid. This rate is 3-fold greater than for HIV and/or HCV. On the other hand, HBsAg+ donors are 3-fold more frequent than OBI donors and more often immigrants than native Spaniards. No transfusion-transmitted HBV infections were identified during the study period, including retrospective checking of former recipients of OBI donors.

Occult hepatitis B and HIV infection.

INTRODUCTION: Occult hepatitis B virus (HBV) infection, so-called occult B infection (OBI), is defined by the recognition of HBV-DNA in the absence of serum hepatitis B surface antigen (HBsAg). The HBV-DNA genome in OBI is fully replication competent and produced in the liver, characteristically with low-level HBV-DNA fluctuations in the bloodstream. The OBI status remains between chronic (HBsAg +) and resolved (anti-HBs +) phases in the natural history of HBV infection. METHODS: The clinical interest in OBI has increased because of its potential for overt HBV reactivation under immunosuppression as well as for HBV transmission, well established in recipients of blood transfusions and/or organ transplants. RESULTS: Given the shared transmission routes for HIV and HBV, earlier reports claimed that OBI was more frequent in AIDS patients. By contrast, the current scenario shows that OBI is negligible in the HIV population. One explanation is that HBV immunization and recall vaccination campaigns have been very active in this group. A second and most important reason points to the wide use of antiretroviral regimens that include anti-HBV active agents, that is, tenofovir, lamivudine, and/or emtricitabine. They are recommended either as treatment for all HIV carriers or as pre-exposure prophylaxis for uninfected individuals at risk. The consequences are that HBV reactivations associated with HIV-related immunodeficiency have become very rare. Furthermore, HBV suppression with these antivirals has markedly reduced the likelihood of transmission from OBI carriers and/or acquisition by uninfected exposed individuals. CONCLUSION: Enthusiasm unabated, however, new tenofovir-sparing antiretroviral regimens are becoming popular and might account for a resurgence of OBI in the HIV setting.

Analysis of the Spanish CCR5-∆32 inventory of cord blood units: lower cell counts in homozygous donors.

The possibility to use CCR5-∆32 umbilical cord blood to cure HIV infection in patients in need of a hematopoietic transplant has been suggested. The less stringent HLA compatibility needed in this type of transplant facilitates the search of a suitable donor having the CCR5-∆32 mutation. To achieve an inventory of CCR5-∆32 cord blood units, the 20,236 best cell quality units of the Spanish Registry were genotyped. Furthermore, their CD34+ and total nucleated cells counts, blood type, gender, HLA and donor's geographical and ancestral origin were analyzed. The results showed 130 (0.64%) units homozygous for the deletion, 2,646 (13.08%) heterozygous and 17,460 (86.28%) did not present the mutation. Interestingly, a significant lower amount of CD34+ cells was found in the CCR5-∆32 homozygous units. In addition, a significant association was found among donor's ancestral origin and the mutation, with a higher percentage of CCR5-∆32 units with a European ancestry. In summary, identification of a relatively high number of CCR5-∆32 units is feasible and will facilitate the development of clinical trials for HIV cure in patients requiring hematopoietic transplantation. Further studies are required to understand the significance of lower cell counts within the CCR5-∆32 homozygous group and its clinical impact.

Hematomas in multicomponent apheresis: searching for related factors.

BACKGROUND: The objective of this study was to identify donation variables that could be related to the development of hematoma during multicomponent apheresis collections (MACs). STUDY DESIGN AND METHODS: This is an observational retrospective study where 1375 donors donated 5177 MACs during a 2-year period with two different machines (Amicus Crescendo [AC], Baxter Healthcare Corp.; and Trima Accel [TA], Gambro BCT). Variable data were recorded prospectively. In the multiple logistic regression analysis, generalized estimating equations were used with an exchangeable correlation matrix to take into account the nonindependence of several measurements from the same donor. RESULTS: During the study period, 170 procedures failed due to hematoma (3.3%). Several variables were related to hematoma development in the adjusted model: operator experience (less than 500 procedures supervised vs. more; odds ratio [OR], 1.66; 95% confidence interval [CI], 1.19-2.31), previous apheresis donations (first time vs. more than 16 donations; OR, 2.87; 95% CI, 1.52-5.45), vein canalized (basilic vs. intermediate antebrachial or cephalic; OR, 1.42; 95% CI, 1.04-1.94), diastolic blood pressure (units divided by 10 mmHg; OR, 0.79; 95% CI, 0.66-0.94), and type of machine used (TA high return limit configuration [RLC] setting configuration vs. AC; OR, 1.94; 95% CI, 1.27-2.96; TA low RLC setting configuration vs. AC; OR, 1.24; 95% CI, 0.83-1.84). CONCLUSIONS: Our study suggests that hematoma in MAC is not a random event. Appropriate machine configuration in the TA could reduce the hematoma rate to a level comparable with that of the AC. Operator training and donor blood pressure are also interesting variables for study because these could be modified to reduce the hematoma rate.

Acute hepatitis B virus window-period blood donations detected by individual-donation nucleic acid testing: a report on the first two cases found and interdicted in Spain.

BACKGROUND: Mathematical models predict that, in Spain, a significant number of blood units will be obtained during the window period of the hepatitis B virus (HBV) infection. Routine nucleic acid testing (NAT) on individual blood units may provide experimental data to evaluate such a theoretical risk. STUDY DESIGN AND METHODS: Between February and July 2005, a total of 34,631 individual units were screened for HBV DNA by a multiplex transcription-mediated amplification (TMA) test. Units that repeatedly reacted in the test, but did not react for HBV surface antigen (HBsAg), were submitted to additional testing by both molecular and conventional assays, and the donors were recalled for follow-up studies and the collection of clinical and epidemiologic data. RESULTS: Confirmatory testing and follow-up studies identified 2 blood units donated during the HBV infection window period (1/17,316 units studied). Sequencing of amplification products obtained by nested polymerase chain reaction (n-PCR) revealed two HBV strains from genotypes D/ayw3 and F/adw4q-, but did not identify HBsAg mutants. The HBV DNA concentration in the index donations was estimated to be below the n-PCR detection level (180 IU/mL), in both cases. One donor developed acute hepatitis 2 months after donating blood, but the other remained asymptomatic and displayed normal alanine aminotransferase levels at follow-up. CONCLUSIONS: The HBV infection window period is a real issue in the setting of Spanish blood transfusions. NAT of individual units by TMA would make a significant contribution to improving the safety of the blood supply in Spain. Additional studies involving a larger number of units and longer periods of time are required, however, to ascertain the true incidence of the problem in this country.

A randomized crossover trial comparing three plateletpheresis machines.

BACKGROUND: The aim of the study was to compare three different apheresis machines with the same donors regarding the processing time required to obtain a 3.5 x 10(11) platelet (PLT) dose and acceptance by donors. STUDY DESIGN AND METHODS: A randomized crossover trial was performed to evaluate the differences between the Amicus Crescendo (Baxter Biotech Corp.), the MCS Plus (Haemonetics Corp.), and the Trima Accel (Gambro BCT). Donations from 51 donors were compared for time adjusted to obtain a standard 3.5 x 10(11) PLT dose (TSD3.5), efficiency, adverse reactions, yield, leukodepletion, machine accuracy, and donor preferences. Processing times were measured by chronometer. The same vein access was used during all three processes in each donor. In the statistical analysis, to take into account the nonindependence of several measurements from the same donor, generalized estimating equations were used with an autoregressive correlation matrix. RESULTS: The Accel produced a TSD3.5 (mean +/- SEM) of 47.9 +/- 1.0 min; the Amicus, 60.3 +/- 1.0 min; and the MCS Plus, 66.7 +/- 1.0 (p < 0.0001). The Amicus presented the greatest efficiency (87.5%; p < 0.0028). The MCS Plus demonstrated the highest capacity for leukodepletion (p < 0.0002) despite one process presenting more than 1 x 10(6) white blood cells per unit. The MCS Plus also measured the processing time with the greatest accuracy. No severe adverse effects were observed. The donors preferred the Accel (61%) followed by the Amicus (35%) and the MCS Plus (4%; p < 0.0001) and the processing speed was the most highly valued measure (55%). CONCLUSIONS: The Accel is the fastest and, because of this advantage, the machine preferred by donors. The Amicus was the most efficient and the MCS Plus was the only one not to underestimate the processing time.

A comparison of PLT collections from two apheresis devices.

BACKGROUND: The aim of this study was to compare two apheresis devices (COBE Trima and COBE Spectra, Gambro BCT). STUDY DESIGN AND METHODS: The study compares 103 Trima procedures with 61 Spectra procedures. The comparison of single-donor PLTs (SDPs) separation parameters and anticoagulant infusion to the donors were the primary targets. Yield and residual amounts of WBCs of SDPs were secondary targets. Residual amounts of WBCs were measured with the Nageotte method. RESULTS: Trima and Spectra groups were comparable before apheresis. Two procedures were terminated before completion in the Trima group owing to vein damage. Trima infused more anticoagulant--352 +/- 104 mL versus 297 +/- 75 mL (p < 0.01)--and was quicker than Spectra. The time to obtain 3.5 x 10(11) was (median) 55.8 minutes for the Trima machine and 80.3 minutes for Spectra machine (p < 0.001). Regarding leukoreduction, all the SDPs had fewer than 1 x 10(6) WBCs per unit except for one in product obtained by the Trima machine. CONCLUSIONS: The Trima machine is faster and more efficient than the Spectra machine, and both machines allow standard leukoreduced SDPs to be obtained. Although donors receive a higher anticoagulant infusion with the Trima machine, their tolerance is acceptable.