Safety and Effectiveness of Molnupiravir in Japanese Patients with COVID-19: Final Report of Post-marketing Surveillance in Japan

Infectious Diseases and Therapy, Journal Year: 2024, Volume and Issue: 13(1), P. 189 - 205

Published: Jan. 1, 2024

Molnupiravir is an orally available prodrug of N-hydroxycytidine that received special approval for emergency treatment coronavirus disease 2019 (COVID-19) in Japan December 2021 and full April 2023. To assess the real-world safety effectiveness molnupiravir Japanese patients with COVID-19, we conducted nationwide post-marketing surveillance to collect data at registered institutions Japan. The were collected from 27, 2021, May 2, All reported adverse events analysis. Adverse drug reactions (ADRs) assessed by treating physicians. Effectiveness was composite hospitalization or all-cause death outpatients oxygen/mechanical ventilation initiation inpatients. observation period through day 29. Of 3214 enrolled survey, 3179 analyzed safety. At baseline, 52.31% (1663/3179) male, median (range) age 69.0 (18–107) years, 82.38% (2619/3179) COVID-19 vaccines, 95.72% (3043/3179) had risk factors severe illness. severity baseline mild 86.44% (2748/3179) moderate I 10.22% (325/3179). A total 205 ADRs occurred 5.50% (175/3179) patients; > 0.5% diarrhea (1.86% [59/3179]) rash (0.69% [22/3179]). Seven serious seven patients. In analysis population, incidence 29 1.14% (34/2988), related 0.40% (12/2988). cumulative endpoint 2.34% (47/2006) 4.60% (38/826) This large-scale survey showed safe effective settings highly vaccinated including older those comorbidities.

Language: Английский

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Lessons from COVID-19 in Taiwan's long-term care facilities: A narrative review

Journal of the Formosan Medical Association, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 1, 2025

The coronavirus Disease 2019 (COVID-19) pandemic has disproportionately impacted long-term care facilities (LTCFs), revealing vulnerabilities due to residents' advanced age, comorbidities, and facility infrastructures. In Taiwan, the Central Epidemic Control Center implemented a range of strategies protect LTCF residents. These included early containment measures allow time for preparing pharmaceutical intervention, establishment infection prevention control guidelines, implementation comprehensive screening testing protocols, prioritization vaccination both residents staff, expansion national stockpile oral antiviral agents. Measures also addressed protective personal equipment shortages, staffing challenges, integration between social healthcare services, accessibility anti-viral All were made adjusted based on community prevalence, evolving knowledge about virus, balancing negative impacts multifaceted efforts effectively mitigated transmission, maintained essential supported demonstrating critical importance coordinated, adaptive in managing impact COVID-19 vulnerable populations LTCFs. By learning from pandemic, we can develop more effective resilient responses future epidemics LTCFs Taiwan.

Language: Английский

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Oral Molnupiravir and Nirmatrelvir/Ritonavir for the Treatment of COVID-19: A Literature Review with a Focus on Real-World Evidence

Infectious Disease Reports, Journal Year: 2023, Volume and Issue: 15(6), P. 662 - 678

Published: Oct. 25, 2023

Vaccines remain the cornerstone of medical prevention and are highly effective in reducing risk severe disease death due to coronavirus 2019 (COVID-19). In context expanding therapeutic armamentarium against COVID-19, molnupiravir (Lagevrio) ritonavir-boosted nirmatrelvir (Paxlovid) were developed, constituting first oral treatments acute respiratory syndrome 2 (SARS-CoV-2). this narrative review, we retrospectively inquired into clinical trials real-world studies investigating efficacy these agents. Overall, have demonstrated both agents hospitalization rates COVID-19 patients. As per current recommendations, their use is suggested patients with mild moderate symptoms who at high developing disease. Nevertheless, limited data exist regarding specific subpopulations, such as immunocompromised patients, those kidney disease, pregnant women, children.

Language: Английский

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Effectiveness and Optimal Timing of Azvudine in COVID-19 Patients: A Multi-center Retrospective Study in Beijing, China

Research Square (Research Square), Journal Year: 2023, Volume and Issue: unknown

Published: July 14, 2023

Abstract Background: Clinical effectiveness of Azvudine against coronavirus infection and optimal time for initiation treatment to hospitalized COVID-19 patients are not fully understood. Methods: This is a multi-center retrospective cohort study, five clinical centers the Chinese People’s Liberation Army General Hospital participated. From omicron pandemics, 6218 confirmed with from December 10, 2022, February 20, 2023, were retrieved this study. After exclusions propensity score matching , 428 recipients controls included follow-up 28 days. The primary outcome was all-cause mortality during days hospitalization, secondary proportion improvement up day 28. Results: group had lower crude death rate when compared control (2.82 per 1000 person-days vs. 4.52 person-days; HR: 0.63, 95%CI: 0.40-1.00; P =0.038). Notably, incidence significantly higher in who received within 5 onset symptoms, (Median days: 9 10; =0.007). Subgroup analyses showed that chronic lung disease corticosteroid acted as protective factors (P =0.010; =0.050). Conclusions: improving seen, symptoms found be significant. Additionally, findings revealed effect disease.

Language: Английский

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Effectiveness and safety of molnupiravir in the intended-use population: an observational cohort study

Clinical Microbiology and Infection, Journal Year: 2024, Volume and Issue: 30(10), P. 1305 - 1311

Published: June 27, 2024

Language: Английский

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Oral Agents and SARS-CoV-2 Vaccine Effectiveness against Severe COVID-19 Omicron Events in Patients Requiring Maintenance Dialysis

Kidney360, Journal Year: 2024, Volume and Issue: 5(3), P. 445 - 450

Published: Feb. 1, 2024

Manley, Harold J.; Li, Nien Chen; Hsu, Caroline M.; Weiner, Daniel E.; Miskulin, Dana; Harford, Antonia Johnson, Doug; Lacson, Eduardo Jr. Author Information

Language: Английский

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Analysis of the course and outcomes of COVID-19 at different stages of the pandemic in hemodialysis patients

Nephrology and Dialysis, Journal Year: 2024, Volume and Issue: 26(3), P. 334 - 349

Published: Sept. 20, 2024

The purpose of this study was a comparative analysis the characteristics course and outcomes COVID-19 in HD patients at different stages pandemic, focusing on use immunomodulatory therapy. Materials methods. retrospective included 897 with (mean age 60.7 years, M 58.5%) who were hospitalized Moscow City Hospital № 52. Group 1 ( n =720) consisted infected between end March 2020 April 2021, group 2 =177) May-December 2021. Each divided into subgroups based treatment approaches. Subgroup 1a =231) initial period pandemic did not receive adequate therapy, while 1b =489) late stage, treated IL-6 receptor blockers corticosteroids. In 2, 108 2a received similar 69 2b neutralizing monoclonal antibodies early disease. Results. Mortality rates 20.1% 14.7%, respectively p <0.09). incidence unfavorable outcome highest lowest (31.2% vs 5.8%, <0.01). Subgroups comparable (14.9% 20.4%), despite more severe lung damage according to CT data 2a. these patients, immunomodulators frequently combined therapeutic plasma exchange (TPE). Independent risk factors for an progression pulmonary pathology, transformation 1-2 3-4, high comorbidity index. Conclusions. drugs imprtoved effectiveness CKD5D. cases, most favorable achieved combination immunobiological drugs, corticosteroids, TPE. An even significant reduction mortality observed following introduction clinical practice. predictors index 3-4.

Language: Английский

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Assessment of pharmacokinetics and tolerability following single‐dose administration of molnupiravir in participants with hepatic or renal impairment

Clinical and Translational Science, Journal Year: 2024, Volume and Issue: 17(12)

Published: Nov. 27, 2024

Individuals with chronic liver or kidney disease are at increased risk of severe COVID-19. Molnupiravir is an orally administered antiviral authorized for the treatment mild-to-moderate COVID-19 in adults progression to disease. Two nonrandomized, open-label, single-dose, multicenter, phase 1 trials were conducted investigate effects hepatic and renal impairment on tolerability pharmacokinetics molnupiravir (800 mg) its metabolite β-D-N4-hydroxycytidine (NHC; NCT05386589/NCT05386758). The impact urinary excretion NHC was also assessed. 90% CI geometric mean ratio plasma area under concentration-time curve (AUC) from zero infinity <2.0 participants moderate versus healthy mean-matched controls. Comparable values observed other pharmacokinetic parameters-including AUC 0 12 h, last measurable concentration, peak concentration-in Urinary low impairment; clearance numerically lower those impairment. In both trials, all adverse events mild intensity resolved by study completion. There no clinically relevant treatment-related safety evaluations. Overall, generally well-tolerated, similar profiles participants, supporting use treating these individuals without need dose adjustment.

Language: Английский

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2．感染症

Nihon Toseki Igakkai Zasshi, Journal Year: 2023, Volume and Issue: 56(12), P. 546 - 550

Published: Jan. 1, 2023

coronavirus disease 2019： COVID 19) の 第 8 波が収束した時期で，次々と 19 に関する 新たな論文が公開される状況であった．このため 2022 year in review では，2022 年 1 月から発表時点までの についての論文紹介を行った．今回，第 68 回日本透析医学会学術集会のセッション，2022 で発表した論文の一部を紹介する． Ⅰ．慢性腎臓病患者，透析患者，腎移植患者に おける新型コロナワクチン接種の免疫原 性と忍容性および安全性について (RECO-VAC Immune response Study) 1) 本研究は，医師主導の前向き多施設研究であり， CKD ステージ G4/5 (eGFR ＜30 mL/min/1.73m 2 ) 162 人，透析患者 159 人，腎移植患者 288 人，コントロー ル 人を対象として，mRNA 1273 vaccine 図 ブースター接種後の抗体価および T 細胞応答 (文献 より引用して作成) ＊ ：p ≦0.05， ＊＊ ≦0.01， ＊＊＊ ≦0.

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