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

Shinozaki, Shohei; Watanabe, Asuka; Kimata, Masahiro; Miyazaki, Makoto; Maekawa, Shinichiroh

doi:10.1007/s40121-023-00915-w

Cited by 6 publications

(1 citation statement)

References 25 publications

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“…A study performed in an outpatient population in Quebec, Canada, during a BA.2 and BA.4/5 Omicron surge showed that in unvaccinated or incompletely vaccinated patients, the risk reduction in COVID-19-related hospitalization was 96%, while treatment of vaccinated patients with the antiviral had no significant effect on the risk of hospitalization and disease progression unless the patients were immunocompromised (transplant or neutropenic patients) or were over 70 years old [ 20 ]. A different study showed that Molnupiravir was also safe and effective among vaccinated Japanese patients with COVID-19, including the elderly and those with multiple comorbidities [ 21 ].…”

Section: Introductionmentioning

confidence: 99%

Comparing Molnupiravir to Nirmatrelvir/Ritonavir (Paxlovid) in the Treatment of Mild-to-Moderate COVID-19 in Immunocompromised Cancer Patients

Haddad,

Hachem,

Moussa

et al. 2024

Cancers

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Background: Nirmatrelvir/Ritonavir has been shown to reduce the risk of COVID-19 progression by 88% compared to placebo, while Molnupiravir reduced it by 31%. However, these two agents have not been compared head-to-head. We therefore compared the safety and efficacy of both agents for the treatment of mild-to-moderate COVID-19 in immunocompromised cancer patients. Methods: We identified 240 cancer patients diagnosed with COVID-19 and treated with Molnupiravir or Nirmatrelvir/Ritonavir. Patients were matched using a 1:2 ratio based on age group (18–64 years vs. ≥65) and type of cancer. The collected data included demographics, comorbidities, and treatment outcome. Results: Both groups had comparable characteristics and presenting symptoms. However, dyspnea was more prevalent in the Molnupiravir group, while sore throat was more prevalent in the Nirmatrelvir/Ritonavir group. The rate of disease progression was comparable in both groups by univariate and multivariable analysis. Treatment with Molnupiravir versus Nirmatrelvir/Ritonavir revealed no significant difference in disease progression by multivariable analysis (adjusted OR = 1.31, 95% CI: 0.56–3.14, p = 0.70). Patients who received Nirmatrelvir/Ritonavir, however, were significantly more prone to having drug–drug interactions/adverse events (30% vs. 0%, p < 0.0001). Conclusions: In the treatment of mild-to-moderate COVID-19 in cancer patients, Molnupiravir was comparable to Nirmatrelvir/Ritonavir in preventing progression to severe disease/death and rebound events, and it had a superior safety profile.

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Section: Introductionmentioning

confidence: 99%

Comparing Molnupiravir to Nirmatrelvir/Ritonavir (Paxlovid) in the Treatment of Mild-to-Moderate COVID-19 in Immunocompromised Cancer Patients

Haddad,

Hachem,

Moussa

et al. 2024

Cancers

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Mass spectrometry‐based metabolomics reveals metabolism of molnupiravir may lead to metabolic disorders and hepatotoxicity

Chen,

et al. 2024

Biomedical Chromatography

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Molnupiravir (MO) is a pyrimidine nucleoside anti‐SARS‐CoV‐2 drug. MO treatment could cause mild liver injury. However, the underlying mechanism of MO‐induced liver injury and the metabolic pathway of MO in vivo are unclear. In this study, metabolomics analysis and molecular biology methods were used to explore these issues. Through metabolomics analysis, it was found that the homeostasis of pyrimidine, purine, lysophosphatidylcholine (LPC), and amino acids in mice was destroyed after MO treatment. A total of 80 changed metabolites were detected. Among these changed metabolites, 4‐ethylphenyl sulfate, dihydrouracil, and LPC 20:0 was related to the elevation of alkaline phosphatase (ALP), interleukin‐6 (IL6), and nuclear factor kappa‐B (NF‐κB). The levels of 4‐ethylphenyl sulfate, dihydrouracil, and LPC 20:0 in plasma were positively correlated with their levels in the liver, suggesting that these metabolites were associated with MO‐induced liver injury. MO treatment could increase NHC and cytidine levels, activate cytidine deaminase (CDA), and increase LPC levels. CDA and LPC could increase the mRNA expression level of toll‐like receptor (TLR). The current study indicated that the elevation of hepatic TLR may be an important reason for MO leading to the liver injury.

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Selected Acute Safety Events Following the Use of Nirmatrelvir/Ritonavir or Molnupiravir for COVID‐19: A Nationwide Cohort Study in South Korea

Kim,

Choi,

Bae

et al. 2024

Clin Pharma and Therapeutics

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There had been concerns about the acute complications during or shortly after coronavirus disease 2019 (COVID‐19) treatment with nirmatrelvir/ritonavir (NMVr) and molnupiravir (MOL). This study aimed to compare the risks of selected acute safety events in patients treated with or without NMVr or MOL using the COVID‐19 oral treatment safety assessment data, constructed through the linkage of nationwide databases: National COVID‐19 registry, Real‐time Prescription Surveillance, and National Health Insurance data. We identified all adults diagnosed with COVID‐19 between January and November 2022, and then constructed two cohorts by matching up to four patients without antiviral treatment records to NMVr or MOL users using propensity score matching. Outcomes of interest were incident‐selected cardiac (i.e., atrial fibrillation, other arrhythmia, bradycardia), neurological (i.e., seizure, neuropathy, encephalomyelitis), and miscellaneous (i.e., acute pancreatitis, acute liver injury, dysgeusia) events. A total of 739,935 NMVr users were matched with 2,951,690 comparators and 150,431 MOL users with 759,521 comparators. NMVr users were at lower risk for developing selected cardiac events (hazard ratio 0.74 [95% CI 0.65–0.87] for atrial fibrillation, 0.81 [0.65–0.99] for other arrhythmia, and 0.82 [0.70–0.96] for bradycardia) and dysgeusia (0.58 [0.45–0.74]). For MOL users, the risk was lower for atrial fibrillation (0.72 [0.53–0.96]) and dysgeusia (0.34 [0.18–0.65]). Overall, there were no increased risks of acute complications during and shortly after treatment with oral COVID‐19 antivirals. Rather, the findings underscore their effectiveness in attenuating the risk of potential acute sequelae of COVID‐19.

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

Cited by 6 publications

References 25 publications

Comparing Molnupiravir to Nirmatrelvir/Ritonavir (Paxlovid) in the Treatment of Mild-to-Moderate COVID-19 in Immunocompromised Cancer Patients

Comparing Molnupiravir to Nirmatrelvir/Ritonavir (Paxlovid) in the Treatment of Mild-to-Moderate COVID-19 in Immunocompromised Cancer Patients

Mass spectrometry‐based metabolomics reveals metabolism of molnupiravir may lead to metabolic disorders and hepatotoxicity

Selected Acute Safety Events Following the Use of Nirmatrelvir/Ritonavir or Molnupiravir for COVID‐19: A Nationwide Cohort Study in South Korea

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