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Introduction: Bamlanivimab and etesevimab (BAM + ETE) are monoclonal antibodies (mAbs) effective in reducing COVID-19-related hospitalizations and all-cause mortality in adult participants at increased risk for severe disease. We present pharmacokinetic (PK), efficacy, and safety results from pediatric participants (< 18 years of age) with COVID-19 who were treated with BAM + ETE. Methods: In an addendum to the phase 2/3 BLAZE-1 clinical trial (NCT04427501), pediatric participants received open-label weight-based dosing (WBD, n = 94) based on exposure-matching to the authorized dose of BAM + ETE in adult participants. For efficacy and safety assessments, placebo (n = 14) and BAM + ETE (n = 20)-treated adolescent participants (> 12 to < 18 years of age) from the BLAZE-1 trial were included in the overall pediatric population (N = 128). All participants had mild to moderate COVID-19 upon enrollment and ≥ 1 risk factor for severe COVID-19. The primary objective was to characterize the PK of BAM and ETE in the WBD population. Results: The median age of the participants was 11.2 years, 46.1% were female, 57.9% were Black/African American, and 19.7% were Hispanic/Latino. The area under the curve for BAM and ETE in the WBD population was similar to that previously observed in adults. There were no COVID-19-related hospitalizations or deaths. All adverse events (AE) except one were mild or moderate, with one participant reporting a serious AE. Conclusion: WBD in pediatric participants achieved similar drug exposures compared to adult participants that received the authorized BAM + ETE dose. The pediatric efficacy and safety data were consistent with adults receiving mAbs for COVID-19. Trial Registration Number: NCT04427501. [ABSTRACT FROM AUTHOR]

Introduction: Surgical site infections (SSIs) are among the most common and potentially serious complications after surgery. Staphylococcus aureus is a virulent pathogen frequently identified as a cause of SSI. As vaccines and other infection control measures are developed to reduce SSI risk, cost-utility analyses (CUA) of these interventions are needed to inform resource allocation decisions. A recent systematic review found that available SSI utilities are of "questionable quality." Therefore, the purpose of this study was to estimate the disutility (i.e., utility decrease) associated with SSIs.Methods: In time trade-off interviews, general population participants in the UK (London, Edinburgh) valued health states drafted based on literature and clinician interviews. Health states described either joint or spine surgery, with or without an SSI. The utility difference between otherwise identical health states with and without the SSI represented the disutility associated with the SSI.Results: A total of 201 participants completed interviews (50.2% female; mean age = 46.2 years). Mean (SD) utilities of health states describing joint and spine surgery without infections were 0.79 (0.23) and 0.78 (0.23). Disutilities of SSIs ranged from - 0.03 to - 0.32, depending on severity of the infection and subsequent medical interventions. All differences between corresponding health with and without SSIs were statistically significant (all p < 0.001).Conclusion: The preference-based SSI disutilities derived in this study may be used to represent mild and serious SSIs in CUAs assessing and comparing the value of vaccinations that may reduce the risk of SSIs. [ABSTRACT FROM AUTHOR]

At least half of all HIV infections occur in women. Most women are of childbearing potential; therefore, issues encompassing reproduction and mother-to-child transmission are critical in the management of this population. The efficacy of antiretroviral therapy (ART) is similar in men and women, although rates of adverse events or toxicity may be higher in women, which, in turn, may be related to higher antiretroviral drug levels documented in pharmacokinetic studies. A substantial proportion of women may not derive the benefit of highly active ART because nonsuppressive regimens are commonly used, especially in resource-limited settings, to decrease mother-to-child transmission. The likely emergence of resistant virus can have long-term sequelae for the mother, child, and other exposed individuals. Additional studies are needed of sex/gender-related issues including antiretroviral toxicities, pharmacokinetic profiles of approved and novel agents, ART strategies during pregnancy to minimize HIV resistance, and determination of optimal antiretroviral regimens for women. [ABSTRACT FROM AUTHOR]