Infectious DiseaseBackground. Transplanting hepatitis C viremic donor organs into hepatitis C virus (HCV)-negative recipients is becoming increasingly common; however, practices for posttransplant direct-acting antiviral (DAA) treatment vary widely. Protracted insurance authorization processes for DAA therapy often lead to treatment delays. Methods. At our institution, 2 strategies for providing DAA therapy to HCVrecipients of HCV + transplants have been used. For thoracic organ recipients, an institution-subsidized course of initial therapy was provided to ensure an early treatment initiation date. For abdominal organ recipients, insurance approval for DAA coverage was sought once viremia developed, and treatment was initiated only once the insurance-authorized supply of drug was received. To evaluate the clinical impact of these 2 strategies, we retrospectively collected data pertaining to the timing of DAA initiation, duration of recipient viremia, and monetary costs incurred by patients and the institution for patients managed under these 2 DAA coverage strategies. Results. One hundred fifty-two transplants were performed using HCV viremic donor organs. Eighty-nine patients received DAA treatment without subsidy, and 62 received DAA treatment with subsidy. One patient who never developed viremia posttransplant received no treatment. Subsidizing the initial course enabled earlier treatment initiation (median, 4 d [interquartile range (IQR), 2-7] vs 10 [IQR, 8-13]; P < 0.001) and shorter duration of viremia (median, 16 d [IQR,(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29) vs 36 [IQR,[30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47]; P < 0.001). Institutional costs averaged $9173 per subsidized patient and $168 per nonsubsidized patient. Three needlestick exposures occurred in caregivers of viremic patients. Conclusions. Recipients and their caregivers stand to benefit from earlier DAA treatment initiation; however, institutional costs to subsidize DAA therapy before insurance authorization are substantial. Insurance authorization processes for DAAs should be revised to accommodate this unique patient group.
SummaryReasons for performing study: Vaccination is crucial to the control of equine influenza (EI). The study was conducted in an effort to lay the groundwork for achieving international harmonisation of regulatory requirements based on scientific evidence of performance of different vaccination regimes. Objectives: To evaluate the effectiveness of 3 different primary vaccination regimes: vaccination with the minimal intervals permitted by the racing authorities; vaccination in accordance with the manufacturer's instructions and vaccination with the longest intervals permitted by the racing authorities. Study design: Randomised, prospective clinical trial. Methods: The 55 seronegative unvaccinated horses in this study were subdivided by age and randomly allocated one of the 3 vaccination regimes. All groups were sampled each time a group was vaccinated and 3-5 weeks post vaccination. Horses were vaccinated with a subunit immune stimulating complex-based vaccine (Equip FT). Antibodies against EI were measured by single radial haemolysis. Results: Lengthening the vaccination intervals increased the immunity gaps between first (V1) and second (V2) doses, and V2 and third dose (V3) but did not inhibit the response to V2 and V3. The response to V2 and V3 was similar irrespective of the regime. Poor responders to V1 were identified in all age groups included in this study but the greatest number of poor responders was among the yearlings. The 2-and 3-year-old horses responded better to vaccination than the weanlings or yearlings. Conclusions: Longer vaccination intervals permitted by racing authorities increase the periods of susceptibility to EI but they may facilitate strategic vaccination prior to times of increased risk of exposure to virus. The study provides the type of evidence-based data necessary to commence meaningful discussion of international harmonisation of EI vaccination requirements.
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