We conducted a general drug use investigation to assess the real-world safety and clinical outcomes of sotrovimab treatment in Japan. Patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were included in the investigation if they had risk factors for severe SARS-CoV-2 infection, did not require oxygen supplementation for SARS-CoV-2 infection, and would receive sotrovimab for the first time. The maximum observation period per patient was 29 days, starting from the day of sotrovimab administration: inpatients who were discharged or transferred to another hospital before day 29 were observed until the day of discharge or transfer, and outpatients were observed on the day of sotrovimab administration. Safety was evaluated through reports for any adverse drug reactions, and the clinical outcome endpoint was the percentage of patients who showed progression of SARS-CoV-2 infection (progressors) among the inpatients. Between January 31, 2022, and February 28, 2023, a total of 635 patients were enrolled in this investigation within 14 days of sotrovimab administration via a central enrollment method. During the median follow-up of 7.5 days, adverse drug reactions were reported in 1.6% (10/635) of the patients in the safety analysis set (including 142 outpatients): pyrexia in 7 patients, COVID-19 pneumonia in 2 patients, and dyspnoea, respiratory disorder, oropharyngeal pain, and eczema in 1 patient each. The percentage of progressors in the clinical outcome analysis set was 1.2% (6/489), with 1.5% (2/132) during the Omicron BA.1 dominant period, 1.0% (2/209) in the Omicron BA.2 dominant period, and 1.4% (2/148) in the Omicron BA.5 dominant period. This investigation found no new safety or clinical outcome concerns for sotrovimab treatment in the real-world setting during the Omicron BA.1, BA.2, and BA.5 dominant periods.
Presenting with bilateral hemianopia and diagnosed by optic pathway system biopsy invasive fungal sinusitis can affect cranial nerves, including the optic nerve. Differential diagnosis is challenging in cases in which the typical imaging findings of fungal sinusitis are absent. Aspergillus spp. are the most common cause of invasive fungal sinusitis. Spread to the central nervous system (CNS) can lead to CNS aspergillosis, which is associated with a significant mortality risk, especially in immunocompromised hosts when the initial treatment is delayed. Identifying the species and conducting susceptibility testing are crucial for choosing the appropriate antifungal drugs for treatment. However, owing to the low sensitivity of Aspergillus spp., appropriate selection of the specimen collection method is crucial to obtain reliable results. In this report, we describe a case of CNS aspergillosis in a 77-year-old male patient who presented with bitemporal hemianopsia as the initial symptom while receiving chemotherapy and steroid therapy for multiple myeloma. Despite absence of the typical imaging findings of invasive fungal sinusitis, a biopsy of the optic pathway system confirmed the diagnosis of Aspergillus sphenoid sinusitis with intracranial extension. In cases of CNS aspergillosis secondary to invasive sinus fungal infection, neurological manifestations can precede radiological evidence. Patients at risk of CNS aspergillosis require prompt sinus biopsy when neurological manifestations suggest the possibility of invasive fungal sinusitis. A biopsy near the optic chiasm in addition to the nasal sinuses may provide valuable information in patients presenting with bilateral hemianopsia.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been identified as the cause of a worldwide pandemic. Ultraviolet (UV) light is regarded as a very powerful tool against SARS-CoV-2. However, there is little information regarding the effects of UV of inactivating viruses flowing in a flow path box. Herein, we showed that the human coronavirus 229E variant, which is closely related to SARS-CoV-2, in aerosol in the flow path box was efficiently inactivated by UV irradiation. In addition, the inactivating effect of UV was consistent regardless of the size of the flow pass box. This study suggests the effectiveness of a flow pass box equipped with ultraviolet lamps, as a countermeasure to prevent the spread of virus infection via aerosol.