ABSTRACT
Introduction: Molnupiravir and nirmatrelvir/ritonavir are two new oral antivirals approved for the treatment of COVID-19 infections in adult, non-hospitalized patients at high risk for disease progression. Since their release, they have proven to be an effective strategy to prevent hospitalizations. Although clinical trials granted their efficacy and safety, real-life data on the possible effect of these drugs are lacking [1,2]. Objective(s): To evaluate the real-life safety of oral antivirals for COVID-19 by retrospectively assessing the number and type of adverse drug reactions (ADRs) detected in clinical practice. Method(s): We conducted a retrospective study of patients referred to the outpatient clinic for the early treatment of COVID-19 at the Infectious Diseases Unit of the University Hospital of Padua. Patients' clinical data and ADRs were collected. Each ADR was recorded in the National Pharmacovigilance Network. Data were anonymized and subsequently analyzed through R software. Qualitative variables were expressed as absolute numbers and percentages and compared using the Chi-square test. Quantitative variables were expressed as mean or median and compared by T-test or Mann- Whitney test whenever it was more appropriate. Result(s): 109 consecutive patients with a median age of 73 years were included. 49 were male and 15 were unvaccinated for COVID-19. 74 (67.9%, Group1) patients received nirmatrelvir/ritonavir and 35 (32.1%,) molnupiravir (Group2). Median age was significantly higher for group2. Regarding ADRs analysis, a total of 49 (44.9%) patients reported at least one adverse event, of which 7 belonged to Group 2 and 42 to Group 1 (p<0.01). No statistically significant difference between the two groups was found regarding serious ADRs and ADRs leading to discontinuation of therapy. The most frequent ADR in the nirmatrelvir/ritonavir group was dysgeusia (37.8% of patients in this group) whereas in the molnupiravir group it was nausea (11.4%). For further information see Table 1. Conclusion(s): The evidence emerging from our study suggests a higher frequency of ADRs compared to RCTs, especially in patients treated with nirmatrelvir/ritonavir. In these patients, we observed several cases of dysgeusia, much more than reported in the literature (37.8% vs 5.6%) [2]. Molnupinavir was associated with fewer side effects than nirmatrelvir/ritonavir even if administered to an older population. These findings suggest that molnupinavir may be considered a safe early treatment option in elderly people. Further analysis on larger cohorts, also taking into account possible confounding factors, need to be performed in order to better assess the real-life safety profile of these drugs. (Table Presented).
ABSTRACT
Introduction: Molnupiravir and nirmatrelvir/ritonavir are two new oral antivirals approved for the treatment of COVID-19 infections in adult, non-hospitalized patients at high risk for disease progression. Since their release, they have proven to be an effective strategy to prevent hospitalizations. Although clinical trials granted their efficacy and safety, real-life data on the possible effect of these drugs are lacking [1,2]. Objective: To evaluate the real-life safety of oral antivirals for COVID-19 by retrospectively assessing the number and type of adverse drug reactions (ADRs) detected in clinical practice. Methods: We conducted a retrospective study of patients referred to the outpatient clinic for the early treatment of COVID-19 at the Infectious Diseases Unit of the University Hospital of Padua. Patients clinical data and ADRs were collected. Each ADR was recorded in the National Pharmacovigilance Network. Data were anonymized and subsequently analyzed through R software. Qualitative variables were expressed as absolute numbers and percentages and compared using the Chi-square test. Quantitative variables were expressed as mean or median and compared by T-test or MannWhitney test whenever it was more appropriate. Results: 109 consecutive patients with a median age of 73 years were included. 49 were male and 15 were unvaccinated for COVID-19. 74 (67.9%, Group1) patients received nirmatrelvir/ritonavir and 35 (32.1%,) molnupiravir (Group2). Median age was significantly higher for group2. Regarding ADRs analysis, a total of 49 (44.9%) patients reported at least one adverse event, of which 7 belonged to Group 2 and 42 to Group 1 (p < 0.01). No statistically significant difference between the two groups was found regarding serious ADRs and ADRs leading to discontinuation of therapy. The most frequent ADR in the nirmatrelvir/ritonavir group was dysgeusia (37.8% of patients in this group) whereas in the molnupiravir group it was nausea (11.4%). For further information see Table 1. Conclusion: The evidence emerging from our study suggests a higher frequency of ADRs compared to RCTs, especially in patients treated with nirmatrelvir/ritonavir. In these patients, we observed several cases of dysgeusia, much more than reported in the literature (37.8% vs 5.6%) [2]. Molnupinavir was associated with fewer side effects than nirmatrelvir/ritonavir even if administered to an older population. These findings suggest that molnupinavir may be considered a safe early treatment option in elderly people. Further analysis on larger cohorts, also taking into account possible confounding factors, need to be performed in order to better assess the real-life safety profile of these drugs
ABSTRACT
A variety of dermatological lesions have been described in COVID-19, although the prevalence and pathogenic relationship remain unclear particularly for chilblain-like lesions. Dermatological examination was performed in a prospective cohort of consecutive patients seen at the service for SARS-CoV-2 infection. Out of 417 patients with confirmed SARS-CoV-2 infection [median age 29.5 years (range 15-65); 62.5% males], dermatological lesions were detected in 7 (1.7%). Three patients had acral lesions; their age (range) was 15-29 years; all had a negative nasopharyngeal swab and developed IgG and/or IgM-specific antibodies; all presented none or mild symptoms. A fourth patient remained negative at repeated testing; mother, father and sister had a documented mild COVID-19. Non-acral lesions were observed in four older patients, with severe COVID-19. Chilblain-like lesions may be the sole manifestation of SARS-CoV-2 infection; their presence in asymptomatic school children and adolescents should be considered a potential signal of familial or community spread of the virus.