Critical Analysis of Pharmacotherapy Research on Pipeline medicine
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NURS125
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Apr 3, 2024
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Critical Analysis of Pharmacotherapy Research on Pipeline medicine Introduction
The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the U.S. Centers for Disease Control and Prevention (CDC), and Gilead Sciences collaborated to develop Remdesivir (GS-5734). According to Eastman et al., 2020
, Remdesivir was initially developed to treat Ebola virus infections. However, in May 2020, the US Food and Drug Administration (FDA) approved remdesivir as the first antiviral medication for use in treating COVID-19 based on its antiviral activity against SARS-CoV-2 in vitro studies(Eastman et al., 2020).
Purpose, methodology, and findings of the Study
The study on remdesivir was aimed at evaluating its efficacy and safety in treating COVID-19 patients. Randomized controlled trials (RCT) were used, where patients were randomly assigned to receive either remdesivir or a placebo. During the research double-blind and randomized methodology was used to sample adults and pediatric patients with COVID-19 symptoms and were at high risk for progression to severe COVID-19 were randomized to receive a 10-day course of remdesivir (n=197) and a 5-day standard of care(n=200). Patients who received a full course of remdesivir had a statistically significant difference in the clinical status compared to the standard of care. Another double-blind, randomized, placebo-controlled trial's results demonstrated remdesivir's effectiveness in treating hospitalized patients with proven cases of COVID-19 and SARS-CoV-2. The US Food and Drug Administration (FDA) approved Remdesivir for use in treating adults and pediatric COVID-19 patients based on results from three randomized controlled clinical trials. (Eastman et al., 2020)
Pharmacodynamic, pharmacokinetic, and pharmacotherapeutic principles of remdesivir
Remdesivir is a low molecular weight prodrug administered by intravenous (IV) infusion, typically for several days. Remdesivir acts as a nucleotide analog, specifically a prodrug of an adenosine analog. (Mozaffari et al., 2023). Once administered, Remdesivir undergoes rapid hydrolysis by plasma esterase into its active form, GS-441524, which then metabolizes intracellularly into the pharmacologically active nucleoside triphosphate (NTP) form. The active NTP form competes with natural nucleotides. It is integrated into the viral RNA to prevent and obstruct the reproduction of RNA viruses caused by the RNA-dependent RNA polymerase (RdRp) virus. By inhibiting viral replication, remdesivir reduces the viral load within the body, potentially helping to alleviate symptoms and slow the progression of viral infections.(Deb et al.,
2021) Remdesivir and its metabolites are primarily eliminated via urine, with a smaller portion excreted in feces. The elimination half-life (t½) of remdesivir is relatively short, typically ranging from 1 to 2 hours. (Alsowaida et al., 2023).
The potential benefits of remdesivir for the improvement of patient health outcomes
Remdesivir was initially developed to treat Ebola virus infections but gained significant attention
during the COVID-19 pandemic.(Eastman et al., 2020) The role and the efficacy of Remdesivir in different stages of disease management are still under scrutiny; however, it has proven to have the potential to improve patient health outcomes. Remdesivir can potentially contribute to disease prevention and health promotion by inhibiting viral replication. Remdesivir could be used prophylactically in high-risk populations to prevent infection or reduce the severity of
illness. (Mozaffari et al., 2023). The antiviral properties of Remdesivir may help suppress viral replication and reduce disease progression with chronic viral infections like hepatitis and HIV/AIDS by complementing the existing treatment regimen, leading to better management of chronic viral conditions and potentially preventing complications associated with long-term viral
infections. In acute viral infections, including COVID-19, remdesivir has shown a potential to improve patient outcomes by reducing the duration of illness, severity of symptoms, and shorter hospital stays, facilitating the restoration of health and reducing the burden on the healthcare system. Remdesivir can help with symptoms and possibly prolong survival in patients with severe viral diseases when used in palliative care. Remdesivir could be used prophylactically in high-risk populations to prevent infection or reduce the severity of illness.(Mozaffari et al., 2023)
The safety, risks, cautions, and concerns for remdesivir.
While remdesivir has shown promise in treating certain viral infections, including COVID-19, safety, risk, warning, and concern should be considered before using this medication. Remdesivir
and its metabolites are primarily eliminated via the kidneys, with feces excreting a tiny amount of the drug. Renal failure patients may require dosage changes due to the impact of renal impairment on metabolites and remdesivir clearance. It is important to closely evaluate the kidney function during treatment, especially in patients with underlying kidney disease or at risk of developing renal impairment. It is advised to monitor liver function tests while receiving treatment, particularly for individuals with liver disease. Remdesivir is metabolized by hepatic enzymes. Thus, care should be taken with other drugs that could impair liver function or compete
with it for the same metabolic routes. Patients on Remdesivir should have their vital signs, laboratory results, and clinical symptoms regularly watched for indications of side effects or treatment-related problems. (Alsowaida et al., 2023)
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Appraisal on the relevance of the research findings on Remdesivir to Clinical Nurse
Specialist Practice
Research findings on Remdesivir have been pivotal in informing clinical decisions by clinical nurse specialists (CNS) about drug dosage, patient monitoring, and education. The dosage of Remdesivir is constantly changing in response to new findings from pharmacokinetic research, clinical trials, and practical experience. However, Clinicians must stay informed about the latest data on prescribing appropriate dosage of Remdesivir. The research findings have provided the baseline and the recommended dosage of Remdesivir for adults and pediatric patients, which is pivotal in drug administration. The findings on Remdesivir will empower CNS prescribers to inform and educate patients on its mechanism of action, potential adverse effects, and the importance of following treatment guidelines. (Barratt-Due et al., 2021).
References
Alsowaida, Y. S., Shehadeh, F., Kalligeros, M., & Mylonakis, E. (2023). Incidence and potential risk factors for remdesivir-associated bradycardia in hospitalized patients with COVID-19: A retrospective cohort study. Frontiers in Pharmacology
, 14
. https://doi.org/10.3389/FPHAR.2023.1106044
Eastman, R. T., Roth, J. S., Brimacombe, K. R., Simeonov, A., Shen, M., Patnaik, S., & Hall, M. D. (2020). Remdesivir: A Review of Its Discovery and Development Leading to Emergency Use Authorization for Treatment of COVID-19. ACS Central Science
, 6
(5), 672–683. https://doi.org/10.1021/acscentsci.0c00489
Mozaffari, E., Chandak, A., Gottlieb, R. L., Chima-Melton, C., Read, S. H., Lee, E. Y., Der-Torossian,
C., Gupta, R., Berry, M., Hollemeersch, S., & Kalil, A. C. (2023). Remdesivir Is Associated With
Reduced Mortality in COVID-19 Patients Requiring Supplemental Oxygen Including Invasive Mechanical Ventilation Across SARS-CoV-2 Variants. Open Forum Infectious Diseases
, 10
(10). https://doi.org/10.1093/ofid/ofad482