Ervebo (Ebola Zaire Vaccine, Live/rVSVΔG-ZEBOV-GP): The First Licensed Vaccine for the Prevention of Ebola Virus Disease

2020 ◽  
Vol 36 (6) ◽  
pp. 243-250 ◽  
Author(s):  
Christopher R. Piszczatoski ◽  
John G. Gums
Keyword(s):  
English Language ◽  
Ebola Virus ◽  
Virus Disease ◽  
Data Extraction ◽  
Ebola Virus Disease ◽  
Cochrane Library ◽  
Effective Vaccine ◽  
Fda Approval ◽  
Study Selection ◽  
Disease Relevance

Objective: To review the clinical data regarding the safety and efficacy of the Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) vaccine for the prevention of the Ebola virus disease. Data Sources: A literature search through PubMed, MEDLINE, and Cochrane Library was conducted for clinical trials published between January 2014 and June 2020 in the English language using the keywords Ervebo, rVSVΔG-ZEBOV, rVSVΔG-ZEBOV-GP, Ebola Zaire, and vaccine. Study Selection and Data Extraction: Articles were selected if they were related to the Food and Drug Administration (FDA) approval of Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) or provided novel data regarding this entity. Twelve articles noted in the FDA approval were chosen, along with 2 additional articles identified as providing novel information. Data Synthesis: The findings of the review show that Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) is a safe, immunogenic, and likely effective vaccine for the prevention of Ebola virus disease. Relevance to Patient Care and Clinical Practice: Ebola virus disease is highly infectious and often fatal. There have been multiple large outbreaks in the past 5 years, with no licensed treatments or vaccines. An effective vaccine could largely curtail current outbreaks and prevent further ones. Conclusion: The recent FDA approval of Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) offers the first approved vaccine for the prevention of Ebola virus disease. It has been shown to be safe, immunogenic, and likely effective for use in real-world applications for those at risk of contracting the disease.

Evolution of Equations for Estimating Renal Function and Their Application to the Dosing of New Antimicrobials

2019 ◽  
Vol 54 (5) ◽  
pp. 496-503
Author(s):  
Alison K. Lew ◽  
Ryan L. Crass ◽  
Gregory Eschenauer
Keyword(s):  
Dose Adjustment ◽  
English Language ◽  
Antimicrobial Agents ◽  
Data Extraction ◽  
New Era ◽  
Mdrd Equation ◽  
Language Studies ◽  
Fda Approval ◽  
Literature Searches ◽  
Study Selection

Objective: To address the background and rationale for the recent introduction of the Modification of Diet in Renal Disease (MDRD) equation for renal dose adjustment of antimicrobials and to provide recommendations for pharmacists dosing new antimicrobial agents. Data Sources: Comprehensive MEDLINE and EMBASE literature searches (from August 2018 to October 2019) were performed. Search terms included creatinine clearance, Cockcroft-Gault, MDRD, and glomerular filtration rate and a subsequent search included the preceding terms AND antimicrobials OR antibiotics. Study Selection and Data Extraction: Available English-language studies on the derivation and/or use of the Cockcroft-Gault (CG) and MDRD study equation were evaluated as well as those that specifically discussed their use for dosing antimicrobial agents. Data Synthesis: The US Food and Drug Administration (FDA) approval of delafloxacin and meropenem-vaborbactam in 2017 ushered in a new era in renal dosing of antibiotics, in that both agents are recommended to be dosed by the MDRD equation. Studies demonstrate that the CG and MDRD equations can result in discrepant dosing recommendations. Relevance to Patient Care and Clinical Practice: The renal estimation equation recommended in a new antibiotic label should dictate the dosing of that medication. It is noteworthy that these equations are not interchangeable. Conclusion: Recently approved antimicrobials utilizing the MDRD equation for renal dose adjustment will be interspersed with old and new antimicrobials utilizing the CG equation because of lack of singular guidance by the FDA. This requires pharmacists to be vigilant in evaluating drug labels to determine which equation is recommended and to understand the differences, strengths, and limitations of each equation.

scholarly journals Effects of vaccines in protecting against Ebola virus disease: protocol for a systematic review

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029617 ◽  
Author(s):  
Lindi Mathebula ◽  
Duduzile Edith Ndwandwe ◽  
Elizabeth Pienaar ◽  
Charles Shey Wiysonge
Keyword(s):  
Systematic Review ◽  
Ebola Virus ◽  
Virus Disease ◽  
Data Extraction ◽  
Case Fatality ◽  
Fixed Effect Model ◽  
Ebola Virus Disease ◽  
Pool Data ◽  
Cochrane Central Register ◽  
Clinical Trial Registry

IntroductionEbola virus disease is one of the most devastating infectious diseases in the world with up to 90% case fatality observed. There are at least 13 candidate vaccines developed and being tested to prevent the occurrence of the Ebola virus disease. While none of these candidate vaccines has received regulatory approval for use, one candidate vaccine (rVSVΔG-ZEBOV-GP) has been granted access for emergency use. Two other candidate vaccines (GamEvac-Combi and Ad5-EBOV) have been licensed for emergency use in their countries of origin. The objective of this systematic review is to summarise the effects of the Ebola candidate vaccines in humans.Methods and analysisWe will search for potentially eligible studies, with no language or date restrictions, in the Cochrane Central Register of Controlled Trials, PubMed, Scopus, the WHO International Clinical Trial Registry Platform, and reference lists of relevant publications. The Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effect (DARE) will be searched for related reviews. Two review authors will independently screen search records, assess study eligibility, perform data extraction, and assess the risk of bias; and reconcile their findings. We will pool data from similar studies using Mantel-Haenszel’s fixed-effect model.Ethics and disseminationThis study is exempted from ethical consideration since the data collected are publicly available and at no point will confidential information from human participants be used. We will disseminate our results through publications in peer-reviewed journals and relevant conferences.PROSPERO registration numberCRD42018110505.

scholarly journals Meeting the Challenge of Ebola Virus Disease in a Holistic Manner by Taking into Account Socioeconomic and Cultural Factors: The Experience of West Africa

2015 ◽  
Vol 8 ◽  
pp. IDRT.S31568 ◽  
Author(s):  
Kai-Lit Phua
Keyword(s):  
West Africa ◽  
Ebola Virus ◽  
Virus Disease ◽  
Cultural Factors ◽  
Ebola Virus Disease ◽  
Effective Vaccine ◽  
Human Consumption ◽  
Protective Measures ◽  
International Borders ◽  
Holistic Manner

Even if an effective vaccine against Ebola virus disease (EVD) becomes available, the challenges posed by this disease are complex. Certain socioeconomic and cultural factors have been linked to recent outbreaks of EVD in West Africa. The outbreaks revealed widespread ignorance by laypersons of EVD etiology, mode of transmission, and personal protective measures that can be taken. Lack of trust in the authorities, virus infection during the preparation of “bushmeat” for human consumption, traditional funerary practices, and relatively free flow of goods and people between regions and across international borders may have facilitated the spread of EVD and hindered outbreak control efforts. Inadequacy in health systems of the most seriously affected countries, such as Guinea, Sierra Leone, and Liberia, is also an important factor. The objectives of this article are to argue that EVD should be evaluated in a systematic and holistic manner and that this can be done through the use of the modified Haddon Matrix.

Brexanolone (Zulresso): Finally, an FDA-Approved Treatment for Postpartum Depression

2019 ◽  
Vol 54 (2) ◽  
pp. 157-163 ◽  
Author(s):  
Jason G Powell ◽  
Scott Garland ◽  
Kayla Preston ◽  
Chris Piszczatoski
Keyword(s):  
Postpartum Depression ◽  
English Language ◽  
Data Extraction ◽  
Clinical Information ◽  
Rapid Onset ◽  
Depression Symptoms ◽  
Onset Of Action ◽  
Fda Approval ◽  
Study Selection

Objective: To review the safety and efficacy of brexanolone for the treatment of moderate to severe postpartum depression (PPD). Data Sources: A literature search through PubMed was conducted (January 2012 to July 2019) using the keyword brexanolone for clinical trials published in the English language. Study Selection and Data Extraction: Articles were selected if they were related to the Food and Drug Administration (FDA) approval of brexanolone or provided novel clinical information regarding this drug entity. Data Synthesis: The findings of the review show that brexanolone administered via IV infusion is both an effective and a fairly safe option for the treatment of PPD. Relevance to Patient Care and Clinical Practice: There are several antidepressants currently used to treat PPD; however, this is the first with FDA approval for this indication. The rapid onset of action of brexanolone may offer a quicker relief of these symptoms and may possibly lead to improved quality of life for both the mother and the child. Conclusion and Relevance: The recent FDA approval of brexanolone may offer an effective treatment of moderate to severe PPD and has been shown to rapidly decrease depression symptoms.

scholarly journals Myofascial Release as a Treatment for Orthopaedic Conditions: A Systematic Review

2013 ◽  
Vol 48 (4) ◽  
pp. 522-527 ◽  
Author(s):  
Kristin McKenney ◽  
Amanda Sinclair Elder ◽  
Craig Elder ◽  
Andrea Hutchins
Keyword(s):  
Key Words ◽  
Case Studies ◽  
English Language ◽  
Data Extraction ◽  
Cochrane Library ◽  
Control Group ◽  
Myofascial Release ◽  
Levels Of Evidence ◽  
Study Selection ◽  
Evidence Database

Objective To critically analyze published literature to determine the effectiveness of myofascial release therapy as a treatment for orthopaedic conditions. Data Sources: We searched the following electronic databases: MEDLINE, CINAHL, Academic Search Premier, Cochrane Library, and Physiotherapy Evidence Database (PEDro), with key words myofascial release, myofascial release therapy, myofascial release treatment, musculoskeletal, and orthopedic. No date limitations were applied to the searches. Study Selection: Articles were selected based upon the use of the term myofascial release in the abstract or key words. Final selection was made by applying the inclusion and exclusion criteria to the full text. Studies were included if they were English-language, peer-reviewed studies on myofascial release for an orthopaedic condition in adult patients. Ten studies were eligible. Data Extraction: Data collected were number of participants, condition being treated, treatment used, control group, outcome measures and results. Studies were analyzed using the PEDro scale and the Center for Evidence-Based Medicine's Levels of Evidence Scale. Data Synthesis: Study scores on the PEDro scale ranged from 6 of 10 to 8 of 10. Based on the Levels of Evidence Scale, the case studies (n = 6) were of lower quality, with a rank of 4. Three of the 4 remaining studies were rated at 2b, and the final study was rated at 1b. Conclusions: The quality of studies was mixed, ranging from higher-quality experimental to lower-quality case studies. Overall, the studies had positive outcomes with myofascial release, but because of the low quality, few conclusions could be drawn. The studies in this review may serve as a good foundation for future randomized controlled trials.

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