HJAR Jan/Feb 2021

34 JAN / FEB 2021  I  HEALTHCARE JOURNAL OF ARKANSAS   Healthcare Briefs FDAApproves First Treatment for COVID-19 The U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID- 19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care compa- rable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. This approval does not include the entire pop- ulation that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric pop- ulation previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or labora- tory confirmed COVID-19 in hospitalized pedi- atric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical tri- als assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing. “The FDA is committed to expediting the development and availability of COVID-19 treat- ments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn, MD. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an impor- tant scientific milestone in the COVID-19 pan- demic. As part of the FDA’s Coronavirus Treat- ment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.” Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires sub- stantial evidence of effectiveness and a demon- stration of safety for the drug’s intended use(s). In considering approval of a drug, the FDA con- ducts a benefit-risk assessment based on rigorous scientific standards to ensure that the product’s benefits outweigh its risks for the intended pop- ulation. This is different from the standard used in the issuance of an EUA. The approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. UAMS Researchers Awarded $1.3 Million to Conduct SARS-CoV-2 Serological Study in Arkansas Researchers at the University of Arkansas for Medical Sciences (UAMS) have been awarded $1.3 million to study disparities in immune response to SARS-CoV-2, known as COVID-19, through serological testing in Arkansas. Serological testing measures a person’s immune response to an infection in the form of antibod- ies in the blood. The project will contribute to short- and long- term impact of COVID-19 and the pandemic on the physical, psychological, and social health of underrepresented minority men and women in Arkansas. “This study will enable us to determine the duration of immunity response against SARS- CoV-2, which ultimately will determine the pro- gression of the pandemic,” said Wendy Nemb- hard, PhD, chair of the Epidemiology Department in the UAMS Fay W. Boozman College of Public Health and principal investigator on the project. “We also hope to learn the influence of psy- chosocial and behavioral factors on the response over time by race and ethnicity.” The study will follow 450 men and women in Arkansas who are a racially, ethnically, and geo- graphically diverse representative sample of non- institutionalized adults that have been tested for COVID-19 by a real-time reverse transcriptase polymerase chain reaction (RT-PCR). Research- ers will enroll participants between November 2020 and April 2021 and follow the cohort for up to 24 months after testing. The UAMS College of Public Health will lead the effort by recruiting, enrolling, interviewing and following participants for the duration of the study. Study participants will be recruited through data collected by the Arkansas Department of Health. The project is funded by the National Cancer Institute (NCI) through the new national Sero- logical Sciences Network (SeroNet). SeroNet is a major component of NCI’s response to the pandemic and is included in an emergency con- gressional appropriation of $306 million to the institute “to develop, validate, improve, and implement serological testing and associated technologies.” Amanda Potter, APRN, Joins Urgent Care in Fayetteville Amanda Potter, APRN, recently joined Wash- ington Regional Urgent Care in Fayetteville where she provides non-emergency care for all ages. Potter earned a Master of Science in nursing from University of Arkansas for Medical Sciences (UAMS) and a bachelor’s degree in nursing from Southwest Baptist University. She has been with Washington Regional for more than two years, where she previously served as a registered nurse in the emergency department. Arkansas Health Network Appoints Scott Huse as Vice President for Employer Business Development The Arkansas Health Network (AHN), a physi- cian-led, clinically integrated network (CIN) serv- ing Arkansas patients, providers, and employers, announced that Scott Huse has been appointed as its new vice president for employer business development. Huse’s responsibilities will include the overall growth and retention of both direct-to- employer partnerships and provider contracting, as well as network-wide communication functions with AHN’s network-wide stakeholders. “Scott brings a wealth of knowledge and experience to our clinically integrated network Amanda Potter, APRN