Nirmaterlvir thành phần kháng virut của Covid-19 (cập nhật đến ngày 15/4/2022)

Cập nhật vào: Thứ sáu - 15/04/2022 12:00 Cỡ chữ Nhỏ Lớn

"Lựa chọn thuốc nào trên bệnh nhân COVID-19?" luôn là một thách thức với các nhân viên y tế. Các liệu pháp kháng virus chủ yếu được sử dụng cho các bệnh nhân mức độ nhẹ đến trung bình, trong giai đoạn virus đang nhân lên và cần phải giảm tải lượng virus trong cơ thể. Đó có thể là thuốc kháng virus phổ rộng (ví dụ: favipiravir, molnupiravir, remdesivir, paxlovid) hoặc các kháng thể đơn dòng đặc hiệu với virus SARS-CoV-2 (ví dụ: casirivimab + imdevimab, bamlanivimab + etesevimab, sotrovimab). Cục Thông tin khoa học và công nghệ quốc gia xin giới thiệu một số bài nghiên cứu đã được xuất bản chính thức và các bài viết được chấp nhận đăng trên những cơ sở dữ liệu học thuật chính thống. Những nghiên cứu công bố trước đó trong năm 2022 được tổng hợp tại đường link cuối bài.

1. Wiley

1. Innovative Randomized Phase 1 Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID-19 Trial of Nirmatrelvir
Ravi Shankar P. Singh, Sima S. Toussi, Frances Hackman, Phylinda L. Chan, Rohit Rao, Richard Allen, Lien Van Eyck, Sylvester Pawlak, Eugene P. Kadar, Frances Clark, Haihong Shi, Annaliesa S. Anderson, Michael Binks, Sandeep Menon, Gianluca Nucci, Arthur Bergman
Clinical Pharmacology & Therapeutics
First published: 07 April 2022
https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1002/cpt.2603

2. Early clinical experience with nirmatrelvir/ritonavir for the treatment of COVID-19 in solid organ transplant recipients
David M. Salerno, Douglas L. Jennings, Nicholas W. Lange, Danielle (Bley) Kovac, Tara Shertel, Justin K. Chen, Jessica Hedvat, Jenna Scheffert, Robert S. Brown, Marcus R. Pereira
American Journal of Transplantation
First published: 12 March 2022
https://onlinelibrary.wiley.com/doi/epdf/10.1111/ajt.17027

3. Using nirmatrelvir/ritonavir in patients with epilepsy: An update from the Israeli chapter of the International League Against Epilepsy
Iris Noyman, Dana Ekstein, Firas Fahoum, Moshe Herskovitz, Ilan Linder, Bruria Ben Zeev, Sara Eyal
Epilepsia
First published: 03 March 2022
https://onlinelibrary.wiley.com/doi/epdf/10.1111/epi.17212

4. Physiologically-Based Pharmacokinetic-Led Guidance for Patients With Cystic Fibrosis Taking Elexacaftor-Tezacaftor-Ivacaftor With Nirmatrelvir-Ritonavir for the Treatment of COVID-19
Eunjin Hong, Lisa M. Almond, Peter S. Chung, Adupa P. Rao, Paul M. Beringer
Clinical Pharmacology & Therapeutics
First published: 16 March 2022
https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1002/cpt.2585

5. Nirmatrelvir/ritonavir use: Managing clinically significant drug-drug interactions with transplant immunosuppressants
Nicholas W. Lange, David M. Salerno, Douglas L. Jennings, Jason Choe, Jessica Hedvat, Danielle (Bley) Kovac, Jenna Scheffert, Tara Shertel, Lloyd E. Ratner, Robert S. Brown, Marcus R. Pereira
American Journal of Transplantation
First published: 11 January 2022
https://onlinelibrary.wiley.com/doi/epdf/10.1111/ajt.16955

6. Effect of nirmatrelvir/ritonavir on calcineurin inhibitor levels: Early experience in four SARS-CoV-2 infected kidney transplant recipients
Aileen X. Wang, Alan Koff, Diana Hao, Natascha M. Tuznik, Yihung Huang
American Journal of Transplantation
First published: 14 February 2022
https://onlinelibrary.wiley.com/doi/epdf/10.1111/ajt.16997

7. Drug Interactions with a Short Course of Nirmatrelvir and Ritonavir: Prescribers and Patients Beware
Mark J. Ratain M.D., David J. Greenblatt M. D.
The Journal of Clinical Pharmacology
First published: 12 April 2022
https://accp1.onlinelibrary.wiley.com/doi/epdf/10.1002/jcph.2060

8. Mass Spectrometric Assays Reveal Discrepancies in Inhibition Profiles for the SARS-CoV-2 Papain-Like Protease
Lennart Brewitz, Jos J. A. G. Kamps, Petra Lukacik, Claire Strain-Damerell, Yilin Zhao, Anthony Tumber, Tika R. Malla, Allen M. Orville, Martin A. Walsh, Christopher J. Schofield
ChemMedChem
First published: 27 January 2022
https://chemistry-europe.onlinelibrary.wiley.com/doi/epdf/10.1002/cmdc.202200016

9. Pandora’s box: Paxlovid, prescribing, pharmacists and pandemic
Jason A. Roberts PhD, BPharm (Hons), BAppSc, FSHP, FISAC, Alison Duncan BPharm, GDipClinPharm, Kelly A. Cairns BPharm, GDipClinPharm, MClinPharm
Journal of Pharmacy Practice and ResearchVolume 52, Issue 1
First published: 10 February 2022
https://onlinelibrary.wiley.com/doi/epdf/10.1002/jppr.1799
10. RNAi to treat SARS-CoV-2—variant proofing the next generation of therapies
Nigel A J McMillan, Kevin V Morris, Adi Idris
EMBO Molecular MedicineVolume 14, Issue 4
First published: 14 March 2022
https://www.embopress.org/doi/epdf/10.15252/emmm.202215811

11. Efficacy and safety of favipiravir plus interferon-beta versus lopinavir/ritonavir plus interferon-beta in moderately ill patients with COVID-19: A randomized clinical trial
Mehdi Hassaniazad, Hossein Farshidi, Abdollah Gharibzadeh, Ali Bazram, Elham Khalili, Afsaneh Noormandi, Mohammad Fathalipour
Journal of Medical Virology
First published: 16 March 2022
https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.27724

12. Molnupiravir: A lethal mutagenic drug against rapidly mutating severe acute respiratory syndrome coronavirus 2—A narrative review
Sri Masyeni, Muhammad Iqhrammullah, Andri Frediansyah, Firzan Nainu, Trina Tallei, Talha Bin Emran, Youdiil Ophinni, Kuldeep Dhama, Harapan Harapan
Journal of Medical Virology
First published: 21 March 2022
https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.27730

2. Sciencedirect

1. Reproductive and developmental safety of nirmatrelvir (PF-07321332), an oral SARS-CoV-2 Mpro inhibitor in animal models
Reproductive Toxicology31 January 2022Volume 108 (Cover date: March 2022)Pages 56-61
N. R. Catlin, C. J. Bowman, G. D. Cappon
https://www.sciencedirect.com/science/article/pii/S0890623822000120/pdfft?md5=fcba2bce695bde3dcbb2033df194579a&pid=1-s2.0-S0890623822000120-main.pdf

2. An updated practical guideline on use of molnupiravir and comparison with agents having emergency use authorization for treatment of COVID-19
Diabetes & Metabolic Syndrome: Clinical Research & Reviews13 January 2022Volume 16, Issue 2 (Cover date: February 2022)Article 102396
Awadhesh Kumar Singh, Akriti Singh, Anoop Misra
https://www.sciencedirect.com/science/article/pii/S1871402122000108/pdfft?md5=abf174b0ba567b1480ed6a5f24defa68&pid=1-s2.0-S1871402122000108-main.pdf

3. Mechanisms and clinical evidence to support melatonin's use in severe COVID-19 patients to lower mortality
Life Sciences 30 January 2022, Volume 294 (Cover date: 1 April 2022), Article 120368
Dun-Xian Tan, Russel J. Reiter
https://www.sciencedirect.com/science/article/pii/S0024320522000686/pdfft?md5=162b5c7d71e3bada3feeb09bfed5f513&pid=1-s2.0-S0024320522000686-main.pdf

4. Availability of oral antivirals against SARS-CoV-2 infection and the requirement for an ethical prescribing approach
The Lancet Infectious Diseases, Available online 29 March 2022, In press, corrected proof
Rafael Dal-Ré, Sören L Becker, Søren Holm
https://www.sciencedirect.com/science/article/pii/S1473309922001190/pdfft?md5=64b5262eb48015f96bc7066878f24f31&pid=1-s2.0-S1473309922001190-main.pdf

5. Drug interaction risk between cardioprotective drugs and drugs used in treatment of COVID-19: A evidence-based review from six databases
Diabetes & Metabolic Syndrome: Clinical Research & Reviews7 March 2022Volume 16, Issue 3 (Cover date: March 2022)Article 102451
Shini Rubina S K, Anuba P A, Sarvesh Sabarathinam
https://www.sciencedirect.com/science/article/pii/S1871402122000650/pdfft?md5=b6fd33ac6cf4d99592460516ff9a87d2&pid=1-s2.0-S1871402122000650-main.pdf

3. Springer

1. Nirmatrelvir Plus Ritonavir: First Approval
Yvette N. Lamb in Drugs (2022)
https://link.springer.com/content/pdf/10.1007/s40265-022-01692-5.pdf

2. Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib
René J. Boosman, Cornedine J. de Gooijer, Stefanie L. Groenland… in Pharmaceutical Research (2022)
https://link.springer.com/content/pdf/10.1007/s11095-022-03244-8.pdf

3. Role of Surfactants on Release Performance of Amorphous Solid Dispersions of Ritonavir and Copovidone
Anura S. Indulkar, Xiaochun Lou, Geoff G. Z. Zhang… in Pharmaceutical Research (2022)
https://link.springer.com/content/pdf/10.1007/s11095-022-03183-4.pdf

4. Efficacy of antiviral therapies for COVID-19: a systematic review of randomized controlled trials
Charan Thej Reddy Vegivinti, Kirk W. Evanson, Hannah Lyons… in BMC Infectious Diseases (2022)
https://link.springer.com/content/pdf/10.1186/s12879-022-07068-0.pdf

5. Serious Cardiovascular Adverse Events Associated with Hydroxychloroquine/Chloroquine Alone or with Azithromycin in Patients with COVID-19: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System (FAERS)
Ying Zhao, Jingru Zhang, Kai Zheng, Sydney Thai… in Drugs - Real World Outcomes (2022)
https://link.springer.com/content/pdf/10.1007/s40801-022-00300-y.pdf

4. Pubmed

1. Efficacy and safety of three new oral antiviral treatment (molnupiravir, fluvoxamine and Paxlovid) for COVID-19：a meta-analysis.
Wen W, Chen C, Tang J, Wang C, Zhou M, Cheng Y, Zhou X, Wu Q, Zhang X, Feng Z, Wang M, Mao Q.
Ann Med. 2022 Dec;54(1):516-523. doi: 10.1080/07853890.2022.2034936.
PMID: 35118917
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8820829/pdf/IANN_54_2034936.pdf

2. Special Considerations for Paxlovid Treatment Among Transplant Recipients With SARS-CoV-2 Infection.
Fishbane S, Hirsch JS, Nair V.
Am J Kidney Dis. 2022 Apr;79(4):480-482. doi: 10.1053/j.ajkd.2022.01.001. Epub 2022 Jan 12.
PMID: 35032591
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8754454/pdf/main.pdf

3. Nirmatrelvir Plus Ritonavir: First Approval.
Lamb YN.
Drugs. 2022 Mar 19:1-7. doi: 10.1007/s40265-022-01692-5. Online ahead of print.
PMID: 35305258
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8933659/pdf/40265_2022_Article_1692.pdf
4. Oral Nirmatrelvir/Ritonavir Therapy for COVID-19: The Dawn in the Dark?
Hung YP, Lee JC, Chiu CW, Lee CC, Tsai PJ, Hsu IL, Ko WC.
Antibiotics (Basel). 2022 Feb 9;11(2):220. doi: 10.3390/antibiotics11020220.
PMID: 35203821
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8868411/pdf/antibiotics-11-00220.pdf

5. Reproductive and developmental safety of nirmatrelvir (PF-07321332), an oral SARS-CoV-2 Mpro inhibitor in animal models.
Catlin NR, Bowman CJ, Campion SN, Cheung JR, Nowland WS, Sathish JG, Stethem CM, Updyke L, Cappon GD.
Reprod Toxicol. 2022 Mar;108:56-61. doi: 10.1016/j.reprotox.2022.01.006. Epub 2022 Jan 31.
PMID: 35101563
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8801796/pdf/main.pdf

6. RNAi to treat SARS-CoV-2-variant proofing the next generation of therapies.
McMillan NAJ, Morris KV, Idris A.
EMBO Mol Med. 2022 Apr 7;14(4):e15811. doi: 10.15252/emmm.202215811. Epub 2022 Mar 14.
PMID: 35285158
https://www.embopress.org/doi/epdf/10.15252/emmm.202215811

7. COVID-19 and the promise of small molecule therapeutics: Are there lessons to be learnt?
Ho WS, Zhang R, Tan YL, Chai CLL.
Pharmacol Res. 2022 Apr 1;179:106201. doi: 10.1016/j.phrs.2022.106201. Online ahead of print.
PMID: 35367622
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8970615/pdf/main.pdf

8. Endothelial cells and blood vessels are major targets for COVID-19-induced tissue injury and spreading to various organs.
Tarnawski AS, Ahluwalia A.
World J Gastroenterol. 2022 Jan 21;28(3):275-289. doi: 10.3748/wjg.v28.i3.275.
PMID: 35110950
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8771611/pdf/WJG-28-275.pdf

9. Can Panax ginseng help control cytokine storm in COVID-19?
Choi JH, Lee YH, Kwon TW, Ko SG, Nah SY, Cho IH.
J Ginseng Res. 2022 Feb 25. doi: 10.1016/j.jgr.2022.02.006. Online ahead of print.
PMID: 35233163
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8876050/pdf/main.pdf

10. Drug interaction risk between cardioprotective drugs and drugs used in treatment of COVID-19: A evidence-based review from six databases.
S K SR, P A A, B S, Kalala KP, Pm A, Sabarathinam S.
Diabetes Metab Syndr. 2022 Mar;16(3):102451. doi: 10.1016/j.dsx.2022.102451. Epub 2022 Mar 7.
PMID: 35279008
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8898923/pdf/main.pdf

11. A Systematic Review of the Global Intervention for SARS-CoV-2 Combating: From Drugs Repurposing to Molnupiravir Approval.
Ashour NA, Abo Elmaaty A, Sarhan AA, Elkaeed EB, Moussa AM, Erfan IA, Al-Karmalawy AA.
Drug Des Devel Ther. 2022 Mar 15;16:685-715. doi: 10.2147/DDDT.S354841. eCollection 2022.
PMID: 35321497
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8935998/pdf/dddt-16-685.pdf

12. Disposition of PF-07321332 (Nirmatrelvir), an Orally Bioavailable Inhibitor of SARS-CoV-2 3CL Protease, across Animals and Humans.
Eng H, Dantonio AL, Kadar EP, Obach RS, Di L, Lin J, Patel NC, Boras B, Walker GS, Novak JJ, Kimoto E, Singh RSP, Kalgutkar AS.
Drug Metab Dispos. 2022 Feb 13:DMD-AR-2021-000801. doi: 10.1124/dmd.121.000801. Online ahead of print.
PMID: 35153195
https://dmd.aspetjournals.org/content/dmd/early/2022/02/13/dmd.121.000801.full.pdf

13. An updated practical guideline on use of molnupiravir and comparison with agents having emergency use authorization for treatment of COVID-19.
Singh AK, Singh A, Singh R, Misra A.
Diabetes Metab Syndr. 2022 Feb;16(2):102396. doi: 10.1016/j.dsx.2022.102396. Epub 2022 Jan 13.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8755553/pdf/main.pdf

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