Anti-HBV Surface Antigen Monoclonal antibody, Clone IB7

Background. Mother-to-child transmission (MTCT) cannot be completely prevented by the administration of active-passive immunoprophylaxis in pregnant women with hepatitis B virus (HBV) DNA levels <10(6) copies/mL. This study will assess the economic outcomes of expanding antiviral prophylaxis in pregnant women with HBV DNA levels <10(6) copies/mL. Methods. A decision model was adopted to measure the economic outcomes of expanded antiviral prophylaxis at different cutoff values of HBV DNA in HBsAg(+) pregnant women in the context of the United States and China. The model inputs, including clinical, cost, and utility data, were extracted from published studies. Sensitivity analyses were carried out to examine the uncertainty of the model outputs. Quality-adjusted life-years (QALYs) and direct medical costs were expressed over a lifetime horizon. Results. Compared with standard antiviral prophylaxis at HBV DNA >= 10(6) copies/mL, expanded antiviral prophylaxis improved the health outcomes, and the incremental cost of expanded antiviral prophylaxis varied from $2063 in pregnant women with HBV DNA >= 10(5) copies/mL to $14 925 in all HBsAg(+) pregnant women per QALY gained in the United States, and from $1624 to $12 348 in China. The model outcome was considerably influenced by the discount rate, key clinical parameters related to the incidence of MTCT, and efficacy of the prophylaxis strategy. Conclusions. This study indicates that antiviral prophylaxis using tenofovir among pregnant women with HBV DNA <10(6) copies/mL may be a cost-effective option, and the cutoff value of the HBV DNA load for antiviral prophylaxis needs to be tailored.

BACKGROUND A novel coronavirus has caused an international outbreak. Currently, there are no specific therapeutic agents for coronavirus infections. Convalescent plasma (CP) therapy is a potentially effective treatment option. METHODS Patients who had recovered from COVID-19 and had been discharged from the hospital for more than 2 weeks were recruited. COVID-19 convalescent plasma (CCP)-specific donor screening and selection were performed based on the following criteria: 1) aged 18-55 years; 2) eligible for blood donation; 3) diagnosed with COVID-19; 4) had two consecutive negative COVID-19 nasopharyngeal swab tests based on PCR (at least 24 hr apart) prior to hospital discharge; 5) had been discharged from the hospital for more than 2 weeks; and 6) had no COVID-19 symptoms prior to convalescent plasma donation. In addition, preference was given to CCP donors who had a fever lasting more than 3 days or a body temperature exceeding 38.5 degrees C (101.3 degrees F), and who donated 4 weeks after the onset of symptoms. CCP collection was performed using routine plasma collection procedures via plasmapheresis. In addition to routine donor testing, the CCP donors' plasma was also tested for SARS-CoV-2 nucleic acid and S-RBD-specific IgG antibody. RESULTS Of the 81 potential CCP donors, 64 (79%) plasma products were collected. There were 18 female donors and 46 male donors. There were 34 first-time blood donors and 30 repeat donors. The average time between CCP collection and initial symptom onset was 49.1 days, and the average time between CCP collection and hospital discharge was 38.7 days. The average volume of CCP collected was 327.7 mL. All Alanine transaminase (ALT) testing results met blood donation requirements. HIV Ag/Ab, anti-HCV, anti-syphilis, and HBsAg were all negative; NAT for HIV, HBV, and HCV were also negative. In addition, all of the CCP donors' plasma units were negative for SARS-CoV-2 RNA. Of the total 64 CCP donors tested, only one had an S-RBD-specific IgG titer of 1:160, all others had a titer of >= 1:320. CONCLUSION Based on a feasibility study of a pilot CCP program in Wuhan, China, we demonstrated the success and feasibility of CCP collection. In addition, all of the CCP units collected had a titer of >= 1:160 for S-RBD-specific IgG antibody, which met the CCP quality control requirements based on the Chinese national guidelines for CCP.