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1.
Medicine & Science in Sports & Exercise ; 54(9):411-411, 2022.
Article in English | Web of Science | ID: covidwho-2156717
2.
Medicine & Science in Sports & Exercise ; 54(9):153-153, 2022.
Article in English | Web of Science | ID: covidwho-2156598
3.
Journal of Managed Care and Specialty Pharmacy ; 28(10 A-Supplement):S89, 2022.
Article in English | EMBASE | ID: covidwho-2092989

ABSTRACT

"BACKGROUND: Elexacaftor/tezacaftor/ivacaftor (ELX/ TEZ/IVA [Trikafta]) was approved in the US in October 2019 for people with cystic fibrosis (pwCF) aged >= 12 years with at least 1 copy of the F508del mutation in the CFTR gene. ELX/TEZ/IVA clinical trials demonstrated unprecedented improvements in lung function and dramatic reductions in pulmonary exacerbations (PEx), hospitalizations, and intravenous (IV) antibiotic use. While the impact of ELX/TEZ/ IVA on healthcare resource utilization (HCRU) in routine clinical practice has been reported, evidence of its associated impact on US healthcare costs is limited. OBJECTIVE(S): To evaluate the impact of ELX/TEZ/IVA on PEx, HCRU, and healthcare costs in routine clinical practice in the US. To minimize impact of the COVID-19 pandemic, outcomes were assessed prior to the March 2020 COVID-19 national emergency declaration. METHOD(S): Using the IBM MarketScan US Commercial Claims and Encounters (CCAE) database and the IBM Multi- State Medicaid Database (MDCD), we identified pwCF aged >= 12 years who filled >= 1 outpatient prescription for ELX/ TEZ/IVA between October 21, 2019 (ELX/TEZ/IVA US approval) and March 12, 2020. Baseline characteristics were examined during the 6-month period before ELX/TEZ/ IVA initiation (""pre-index""). Annualized all-cause HCRU (inpatient admissions, outpatient encounters, and outpatient prescriptions), PEx requiring hospitalization or IV antibiotics, and all-cause healthcare costs (estimated from reimbursed claims) were compared between pre-index and the period beginning with ELX/TEZ/IVA initiation through March 12, 2020 (""post-index"", up to 5 months). RESULT(S): 851 pwCF in the CCAE and 650 pwCF in the MDCD met the inclusion criteria with a mean age of 27.6 and 21.5 years and annualized rate of PEx pre-index of 0.83 and 1.24, respectively. Annualized mean PEx declined between the pre- and post-index periods in the CCAE (-57% [95% CI -67, -46]) and MDCD (-52% [-62, -40]). Annualized mean number of inpatient admissions were similarly reduced (-57% [-69, -44], CCAE;-55% [-65, -44], MDCD). Corresponding cost reductions for inpatient admissions were -60% (-74, -36) and -70% (-83, -52), yielding inpatient costs savings of $20,201/ year for CCAE and $31,038 for MDCD. Use of outpatient services and outpatient prescriptions were largely unchanged between the pre- and post-index periods. CONCLUSION(S): ELX/TEZ/IVA treatment was associated with substantial reductions in inpatient admissions and PEx, supporting the value of ELX/TEZ/IVA in reducing CF burden and associated inpatient costs."

4.
Annals of Oncology ; 33:S904-S905, 2022.
Article in English | EMBASE | ID: covidwho-2041538

ABSTRACT

Background: CSCC is highly immune-responsive;a prior pilot study demonstrated a high rate of pathologic complete response (pCR) or major pathologic response (MPR, ≤10% viable tumor), using cemiplimab anti-programmed death 1 (PD-1) therapy in the neoadjuvant setting. Here, we present the primary analysis of a confirmatory, open-label, multicenter, Phase 2, single-arm trial of neoadjuvant cemiplimab in pts with resectable Stage II–IV (M0) CSCC. Methods: Pts received cemiplimab 350 mg IV q3W for up to 4 doses before surgery. The primary endpoint was pCR rate per independent central pathologic review (ICPR). Key secondary endpoints included MPR rate per ICPR, objective response rate (ORR;complete response [CR] + partial response [PR]) per RECIST v1.1, investigator-assessed pCR and MPR, safety and tolerability. Results: At data cutoff date of 01 Dec 2021, 79 pts were enrolled (67 male;median age 73.0 yrs [range, 66.0–81.0];ECOG performance status 0 (n=60) and 1 (n=19) with stage II (n=5), III (n=38), or IV(M0) (n =36) disease;62 pts received all 4 doses (median number of doses given (Q1:Q3), 4 (4:4);70 pts underwent surgery. The study met its primary endpoint: pCR was observed in 40 (50.6%) pts (95% confidence interval [CI], 39.1–62.1%). MPR was observed in an additional 10 (12.7%) pts (95% CI, 6.2–22.0%). ORR was 68.4% (95% CI, 56.9–78.4) (5 CR, 49 PR, 16 stable disease, 8 progressive disease (PD), 1 non evaluable. Reasons 9 pts did not have surgery: 3 responders declined surgery, 2 lost to follow-up or noncompliance, 2 had inoperable PD, 2 due to AE. Fourteen (17.7%) pts experienced Grade ≥3 AE. Four pts died due to AEs: 1 exacerbation of cardiac failure, 2 myocardial infarctions, and 1 COVID-19 pneumonia. The most common AEs regardless of attribution (all grades) were fatigue (30.4%), rash maculo-papular (13.9%), diarrhea (13.9%) and nausea (13.9%). Conclusions: The pCR + MPR of 63.3% by ICPR in pts with Stage II–IV (M0) CSCC is the highest observed in a multicenter anti-PD-1 neoadjuvant monotherapy study for any solid tumor type. The safety profile of neoadjuvant cemiplimab is consistent with previous anti-PD-1 monotherapy experience. Ongoing follow-up will describe disease-free survival. Clinical trial identification: NCT04154943. Editorial acknowledgement: Medical writing support was provided by John G Facciponte, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Legal entity responsible for the study: Regeneron Pharmaceuticals, Inc., and Sanofi. Funding: Regeneron Pharmaceuticals, Inc., and Sanofi. Disclosure: N. Gross: Financial Interests, Personal, Research Grant: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Advisory Board: PDS Biotechnology, Shattuck Labs and Genzyme;Financial Interests, Personal, Advisory Role: PDS Biotechnology, Shattuck Labs and Genzyme. D.M. Miller: Financial Interests, Personal, Advisory Role: Castle Biosciences, EMD Serono, Merck KGaA, Merck Sharpe & Dome, Pfizer, Regeneron, Sanofi Genzyme;Financial Interests, Personal, Ownership Interest: Checkpoint Therapeutics;Financial Interests, Personal, Research Grant: Kartos Therapeutics, NeoImmune Tech, Inc., Regeneron Pharmaceuticals, Inc. N. Khushanlani: Financial Interests, Personal, Research Grant: Regeneron Pharmaceuticals, Inc., Bristol Myers Squibb, HUYA Bioscience International, Merck, Novartis, GlaxoSmithKline, Celgene, Amgen;Financial Interests, Personal, Advisory Board: EMD Serono, Regeneron Pharmaceuticals, Inc., Genentech, AstraZeneca (data safety monitoring committee), Merck, Array Biopharma, Jounce Therapeutics, Immunocore, Bristol Myers Squibb, HUYA Bioscience International;Financial Interests, Personal, Other, honoraria: Sanofi;Financial Interests, Personal, Stocks/Shares: Bellicum Pharmaceuticals, Mazor Robotics, Amarin, Transenetrix. V. Divi: Financial Interests, Institutional, Research Grant: Genentech. E.S. Ruiz: Financial Interests, Personal, Advisory Board: Genentech, Leo Pharmaceuticals, Regeneron Pharmaceuticals, Inc., Sanofi;Financial Int rests, Personal, Advisory Role, consulting fees: Genentech, Leo Pharmaceuticals, Regeneron Pharmaceuticals, Inc., Sanofi;Financial Interests, Personal, Member of the Board of Directors: Checkpoint Therapeutics. E.J. Lipson: Financial Interests, Personal, Other, Advisory board and consulting fees: Bristol Myers-Squibb, Eisai, Genentech, Immunocore, Instil Bio, MacroGenics, Merck, Natera, Nektar Therapeutics, Odonate Therapeutics, OncoSec, Pfizer, Rain Therapeutics, Regeneron, Sanofi;Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, Merck, Regeneron. F. Meier: Financial Interests, Personal, Other, Travel support, speaker’s fees or advisor’s honoraria: Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche and Sanofi;Financial Interests, Personal, Research Grant: Novartis and Roche. P.L. Swiecicki: Financial Interests, Institutional, Research Grant: Ascentage Pharma, Pfizer;Financial Interests, Personal, Advisory Board: Prelude Therapeutics, Elevar Therapeutics, Regeneron Pharmaceuticals. J.L. Atlas: Financial Interests, Personal, Advisory Role: Regeneron Pharmaceuticals, Inc., Sanofi, and Bristol Myers Squibb. J.L. Geiger: Financial Interests, Institutional, Research Grant: Alkermes, Debio, Merck, Regeneron Pharmaceuticals, Inc., and Roche/Genentech;Financial Interests, Personal, Advisory Role: Exelixis, Merck and Regeneron Pharmaceuticals, Inc. A. Hauschild: Financial Interests, Personal and Institutional, Other, Institutional grants, speaker’s honoraria and consultancy fees: Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Provectus and Roche;Financial Interests, Institutional, Other, Institutional grants and consultancy fees: EMD Serono, Philogen and Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Advisory Role: OncoSec Medical. J.H. Choe: Financial Interests, Personal, Advisory Role: Exelixis, Coherus Biosciences, Regeneron Pharmaceuticals, Inc. B.G.M. Hughes: Financial Interests, Personal, Advisory Role: AstraZeneca, Bristol Myers Squibb, Eisai, Merck Sharp & Dohme, Pfizer and Roche;Financial Interests, Institutional, Research Grant: Amgen. S. Yoo: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. K. Fenech: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. M.D. Mathias: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. H. Han: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. M.G. Fury: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. D. Rischin: Financial Interests, Institutional, Research Grant: Regeneron Pharmaceuticals, Inc., Genentech, Sanofi, Kura Oncology, Roche, Merck Sharp & Dohme, Merck KGaA, Bristol Myers Squibb, GlaxoSmithKline, ALX Oncology;Financial Interests, Personal, Advisory Role: Merck Sharp & Dohme, Regeneron Pharmaceuticals, Inc., Sanofi, GlaxoSmithKline, Bristol Myers Squibb;Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme, Regeneron Pharmaceuticals, Inc., Sanofi, GlaxoSmithKline, Bristol Myers Squibb. All other authors have declared no conflicts of interest.

5.
Journal of Pain and Palliative Care Pharmacotherapy ; 35(4):228, 2021.
Article in English | EMBASE | ID: covidwho-1868196

ABSTRACT

Background: Chronic pain affects more than 100 million Americans, and opioids used for pain are 85-95% effective when administered for the right patient in the right dose at the right time. Conversions between opioids and routes of administration may be necessary due to pill burden, organ dysfunction, effectiveness, or insurance coverage. Although multiple opioid conversion tables exist, a universally accepted opioid analgesic conversion table does not. OhioHealth's Hospice and Palliative Medicine (HPM) teams utilize an HPM opioid conversion table, but consensus is not yet established. The goal of this study is to determine if there is consensus regarding the HPM opioid conversion table amongst the OhioHealth HPM pharmacists, physicians, and nurse practitioners. Methods: REDCap distributed a survey used to determine if there is consensus regarding the HPM opioid conversion table and to describe consensus differences between healthcare professionals. Data is summarized with means, standard deviations, medians, ranges, counts, and percentages. Consensus is achieved if the lower limit of the 95% confidence interval is greater than 70%. Secondary analyses are completed using descriptive statistics. Results: Forty-two of 53 HPM pharmacists (3), physicians (26), and nurse practitioners (15) responded to the survey. Consensus was reached for 60% (3) of the opioid conversion ratios surveyed. The majority of those surveyed (59.1%) reported utilizing the HPM conversion table with reasons being practice expectation (50%), ease of memorization (43.2%), evidence-based ratios (36.4%), and good clinical outcomes (43.2%). None of those surveyed reported an adverse effect attributed to the conversion ratios. Conclusion: Although consensus was not reached for two conversion ratios tested, consensus was reached for the remaining ratios. Notably, none of the HPM providers experienced an adverse effect, including respiratory depression, attributed to the conversion ratios. Reasons stated for not using the HPM conversion rations were unfamiliarity, difficulty understanding and/or using the ratios, and lack of evidence. Of the 11 respondents that did not use the HPM table, the majority reported 5 years or less of experience within hospice and palliative medicine. Additional education pertaining to evidence for the ratios and discussions regarding concerns may be necessary to reach consensus on all conversion ratios. Although the Delphi method may have been more appropriate to determine consensus, it was not feasible to execute it properly during the current coronavirus pandemic. A more standardized approach to opioid conversions could be established when there is consensus, with the goal of leading to minimization of adverse events resulting from under-and over-estimating opioid dose conversions.

6.
Journal of Cell Signaling ; 2(1):63-79, 2021.
Article in English | MEDLINE | ID: covidwho-1151295

ABSTRACT

The outbreak of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) has led to coronavirus disease-19 (COVID-19);a pandemic disease that has resulted in devastating social, economic, morbidity and mortality burdens. SARS-CoV-2 infects cells following receptor-mediated endocytosis and priming by cellular proteases. Following uptake, SARS-CoV-2 replicates in autophagosome-like structures in the cytosol following its escape from endolysosomes. Accordingly, the greater endolysosome pathway including autophagosomes and the mTOR sensor may be targets for therapeutic interventions against SARS-CoV-2 infection and COVID-19 pathogenesis. Naturally existing compounds (phytochemicals) through their actions on endolysosomes and mTOR signaling pathways might provide therapeutic relief against COVID-19. Here, we discuss evidence that some natural compounds through actions on the greater endolysosome system can inhibit SARS-CoV-2 infectivity and thereby might be repurposed for use against COVID-19.

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