Hepatitis A virus (HAV) RNA detection in Polish blood donors and likely transmissions through blood components during the 2017-2019 epidemic.

BACKGROUND: In Poland, hepatitis A virus (HAV) RNA screening was performed in plasma for fractionation usually immediately before shipment. OBJECTIVE: Our goal was to study epidemiology, rate of transfusion transmitted HAV during epidemic (2017-2019), and viral characteristics of infected plasma donors. STUDY DESIGN AND METHODS: HAV RNA was tested in 1,866,590 donations from 1,210,423 donors using RT-PCR in mini pools of 96 (MP96) or TMA in MP16. Virological characteristics included RNA level (RL), antibody testing, and sequencing. RESULTS: Twenty-one HAV infections were identified (1.13/100,000 donations; 95% confidence interval [95% CI]: 0.74-1.72) and (1.73/100,000 donors; 95% CI: 1.35-2.65). The Blood Transfusion Centers were also informed about three donors, who were hospitalized for hepatitis A soon after their blood donation. In addition, we identified a donor, who had reactive result for HAV after receiving HAV vaccination. He tested positive twice 10 days after receiving the first and the second dose. The highest RL was 16 million IU/ml, mean 1,706,905 IU/ml, and median 220 IU/ml. The longest detectable RL lasted for 113 days. HAV-infected donors were seronegative (36%) or IgM positive (64%). We followed up on 12 HAV contaminated blood components issued for transfusion. In two out of seven identified patients viral transmission was confirmed (28.6%). CONCLUSION: Based on our results, we propose a 6 month deferral after HAV infection and 14 days post HAV vaccination. The infectivity rate was below 30%. The HAV RNA testing could be considered as an additional safeguard against HAV transmission at the time of increased incidence of HAV infections in the general population.

Seronegative hepatitis C virus infection in Polish blood donors-Virological characteristics of index donations and follow-up observations.

Nucleic acid testing (NAT) was implemented in Poland in 1999 for screening of plasma for fractionation and for all blood donors in 2002. To analyze seronegative NAT-positive samples representing hepatitis C virus (HCV) window-period (WP) in the years 2000 to 2016 and to determine infection outcome. We analyzed results of 17 502 739 donations screened in minipools (6-48) or individually. Index samples underwent viral load (VL) quantification, genotyping and Ag, and anti-HCV re-testing using chemiluminescence (CMIA), electrochemiluminescence (ECLIA), and fourth-generation enzyme-linked immunosorbent assay (IV EIA) assays. HCV-seronegative infections were identified in 126 donations (7.2/mln donations; 95% confidential intervals, 6.0-8.6). Frequency of NAT yields was decreasing over time. Of the initial 126 seronegative index cases 106 were retested: 32.1% were reactive in IV EIA, 11.3% in ECLIA, and 1.9% in CMIA. The lowest VL correlated with absent anti-HCV and HCV Ag, while VL was highest when the antigen was detectable and then it decreased when anti-HCV appeared at a level detectable by sensitive third generation tests while retesting. The proportion of genotype 1 was 38.9% in samples positive only for HCV RNA and 71.4% in samples that were anti-HCV reactive in re-testing. In parallel, genotype 3 frequency was 50% in the former group and 21% in the latter. NAT is an effective measure to limit HCV transmission by transfusion and IV EIA seems to have higher clinical sensitivity than ECLIA. Samples representing likely successive phases of early HCV infection were characterized by different genotype distribution probably due to very early elimination of genotype 3.

Assessment of Synvisc treatment in osteoarthritis.

Background. Viscosupplementation is a relatively new method for the treatment of osteoarthritis (OA). The main goal of this project was to assess the safety and clinical utility of Hylan G-F20 (Synvisc(R)) in the treatment of pain associated with osteoarthritis of the knee. The type and frequency of additional therapies used during Synvisc(R) treatment were also assessed. It was a prospective project designed for monitoring Synvisc(R)-prescribing habits in usual medical care.
Material and method. One hundred ninety knee joints in 187 patients were studied (OA symptoms were bilateral in 3 women). Synvisc(R) was indicated for the local treatment of pain in osteoarthritis of the knee. After the diagnosis, Synvisc(R) therapy was started at the recommended dose of 2 ml per intra-articular injection once
a week (at 1-week intervals), three injections in total. The data collected, including medical history, physical examination, radiographic examination and treatment efficacy (overall assessment performed at each visit), were recorded on case report forms designed to facilitate statistical analysis. The physicians completed visual Analogue Scale (VAS) for overall assessment of OA pain at each visit. The clinical outcome was recorded after the end of therapy. The patient data were collected by physicians taking part in this project only.
Results. In 156 cases (82.1%) either a substantial improvement or subsidence of symptoms was observed. In 34 cases (17.9%) the improvement was small or there was no change in the patient's condition. There were local adverse reactions in 2 patients (1.07%). There was no need to cease the treatment, to hospitalise a patient or to start any additional treatment. In 167 patients (89.3%) there was no need to start any non-pharmacological concomitant treatment.
Conclusions. In summary, Synvisc(R) viscosupplementation should be rated among the safest and most effective methods for the treatment of OA, for it alleviates OA-related pain, thus reducing the need for NSAIDs and steroid injections. The use of Synvisc(R) in OA patients alleviates pain regardless of sex and age, the effect being the most pronounced in patients with low- and medium-grade radiographic changes.