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

---

Clinical effectiveness of molnupiravir in patients with COVID-19 undergoing haemodialysis

International Journal of Antimicrobial Agents, Journal Year: 2023, Volume and Issue: 62(1), P. 106834 - 106834

Published: April 30, 2023

Molnupiravir is an essential oral antiviral agent against coronavirus disease 2019 (COVID-19); however, its real-world effectiveness has not been evaluated in patients undergoing haemodialysis (HD).This multi-centre retrospective study, involving 225 HD with initially mild or asymptomatic COVID-19, was conducted to compare the risks of 30-day COVID-19-related acute care visits between receiving and molnupiravir. Patients who received molnupiravir were stratified by rapid antigen detection (RAD) test results on day 7 after onset assess whether introduction accelerated viral clearance.Thirty-day reported 9.41% 21.74% control groups, respectively, use markedly reduced risk adjusting for baseline characteristics via propensity score weighting [hazard ratio 0.218, 95% confidence interval (CI) 0.074-0.642; P=0.006]. The tolerability enrolled generally acceptable, only 11.88% users reporting adverse events. Moreover, initiation within 1 COVID-19 independent predictor conversion a negative RAD result (odds 6.207, CI 2.509-15.358; P<0.001).Molnupiravir well tolerated decreases medical needs HD. Furthermore, accelerates clearance These findings highlight therapeutic role this vulnerable population.

Language: Английский

---

Executive summary of the consensus statement of the group for the study of infection in transplantation and other immunocompromised host (GESITRA-IC) of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) on the treatment of SARS-CoV-2 infection in solid organ transplant recipients

Transplantation Reviews, Journal Year: 2023, Volume and Issue: 37(4), P. 100788 - 100788

Published: Aug. 11, 2023

Language: Английский

---

Real-World Effectiveness of SARS-CoV-2 Vaccine Booster in Hemodialysis Patients with COVID-19 Receiving Molnupiravir

Viruses, Journal Year: 2023, Volume and Issue: 15(2), P. 543 - 543

Published: Feb. 16, 2023

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine booster is one of the most essential strategies against disease 2019 (COVID-19) in era emerging variants. However, effectiveness SARS-CoV-2 boosters has not much been investigated hemodialysis (HD) patients receiving oral antiviral agents. In this retrospective study involving 258 HD with COVID-19 molnupiravir, we stratified cohort according to vaccination status and compared baseline characteristics risks 30-day composite events (COVID-19-related care visits, hospitalization, or mortality) among groups. Our analysis demonstrated that markedly decreased risk (hazard ratio (95% confidence interval), 0.163 (0.063-0.423) for three vs. ≤ two doses vaccination, p < 0.001; 0.309 (0.115-0.830) four = 0.020). benefits were similar between mRNA-based protein-based those post-booster intervals 120 > days. conclusion, initially mild asymptomatic are prominent, irrespective types.

Language: Английский

---

The Impact and Treatment of COVID-19 in Hemodialysis Patients

Journal of Clinical Medicine, Journal Year: 2023, Volume and Issue: 12(3), P. 838 - 838

Published: Jan. 20, 2023

Patients with coronavirus disease 2019 (COVID-19) undergoing maintenance hemodialysis have a poor prognosis and limited treatment options. This paper outlines the impact of COVID-19, its treatment, efficacy vaccines in Japanese patients review literature. dialysis facilities are at greater risk exposure to severe acute respiratory syndrome 2 than general population due isolation capabilities. Therefore, expected be effective for dialysis. In addition, use available medications is important because options limited. Efforts should made prevent spread infection high-risk while ensuring vaccines.

Language: Английский

---

Medication safety in chronic kidney disease

Current Opinion in Nephrology & Hypertension, Journal Year: 2023, Volume and Issue: 32(5), P. 434 - 438

Published: June 8, 2023

Purpose of review Several drugs cause nephrotoxicity and accelerate progression chronic kidney disease (CKD). The objective this is to summarize recent evidence on that either increase the risk nephrotoxicity, CKD or drug induced harm in patients with CKD. Recent findings Bisphosphonates hypnotics CKD, whereas denosumab does not Tenofovir disoproxil fumarate (TDF) increases renal tubular toxicity adverse effects bone, but alafenamide (TAF) amibufenamide (TMF) have favorable safety profile kidneys bones. Although no dosage adjustment needed for Oral Nirmatrelvir/Ritonavir mild impairment coronavirus 2019, reduced twice daily those moderate impairment. It recommended severe prescribing information recommend use remdesevir below glomerular filtration rate (eGFR) < 30 ml/min studies suggest may be safe effective varying levels severity. Molnupiravir require dose Summary medications development acute injury Close attention select appropriate safer alternatives reduce drug-induced

Language: Английский

---

Risk of severe coronavirus disease 2019 despite vaccination in patients requiring treatment with immune‐suppressive drugs: A nationwide cohort study of US Veterans

Transplant Infectious Disease, Journal Year: 2023, Volume and Issue: 26(1)

Published: Nov. 15, 2023

Abstract Background Patients taking immune‐suppressive drugs are at increased risk of severe coronavirus disease 2019 (COVID‐19), not fully ameliorated by vaccination. We assessed the contributions clinical and demographic factors to despite vaccination in patients medications for solid organ transplantation (SOT), rheumatoid arthritis (RA), inflammatory bowel (IBD), or psoriasis. Methods Veterans Health Administration electronic health records were used identify diagnosed with RA, IBD, psoriasis, SOT who had been vaccinated against acute respiratory syndrome 2, subsequently infected, received within 3 months before infection. The association (defined as hypoxemia, mechanical ventilation, dexamethasone use, death) versus non‐severe COVID‐19 use antiviral covariates was multivariable logistic regression. Results Severe more common (230/1011, 22.7%) than RA (173/1355, 12.8%), IBD (51/742, 6.9%), psoriasis (82/1125, 7.3%). Age strongly associated COVID‐19, adjusted odds ratio (aOR) 1.04 (CI 1.03–1.05) per year. Comorbidities indicating chronic brain, heart, lung, kidney damage also severity, aOR 1.35–2.38. glucocorticoids (aOR 1.66, CI 1.39–2.18). Treatment antivirals reduced example, 0.28 0.13–0.62) nirmatrelvir/ritonavir. Conclusion is substantial drugs, so diseases. comorbidities contribute risk, general population. Oral very beneficial but widely used. image

Language: Английский

---

Coronavirus Disease 2019 Management Strategies in Solid Organ Transplant Recipients

Infectious Disease Clinics of North America, Journal Year: 2023, Volume and Issue: 37(3), P. 475 - 493

Published: March 21, 2023

Language: Английский

---

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

---

Clinical effectiveness of oral antiviral agents for treating non-hospitalized COVID-19 patients with chronic kidney disease

Expert Review of Anti-infective Therapy, Journal Year: 2024, Volume and Issue: unknown, P. 1 - 8

Published: March 25, 2024

Objectives This study examined the effectiveness of nirmatrelvir plus ritonavir (NMV-r) and molnupiravir (MOV) in treating COVID-19 among chronic kidney disease (CKD) patients.

Language: Английский

---