Is Omicron really mild? – Comparative analysis of comorbidities and disease outcomes associated with SARS-CoV-2 Omicron (B.1.1.529) and Delta (B.1.617.2) variants

Manchanda, Vikas; Mitra, Srestha; Rafique, Iram; Sharma, Anju; Dhakad, Megh Singh; Saxena, Sonal; Kapoor, Seema; Kumar, Suresh

doi:10.1016/j.ijmmb.2023.100391

Cited by 6 publications

(2 citation statements)

References 26 publications

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“…In this case series, ensitrelvir also demonstrated antiviral activity; viral clearance (defined in the methods section) was achieved by day 5 in 18/32 (56.3%) patients. Viral persistence is an unmet need for patients with COVID-19, particularly for immunocompromised patients[25, 26] and patients with comorbidities[28, 29] for whom COVID-19 infection is associated with negative outcomes[21–23, 48, 49]. Prolonged SARS-CoV-2 infection has been linked with rapid viral evolution[50, 51], and it has also been hypothesized that viral persistence may increase the likelihood of long COVID[52–54].…”

Section: Discussionmentioning

confidence: 99%

“…Booster vaccines and hybrid immunity (immunity developed from both vaccina�on and previous SARS-CoV-2 infec�on) consistently provide high protec�on against Omicron-related severe disease, but their effec�veness wanes over �me [16][17][18]; furthermore, many monoclonal an�bodies previously used to treat people infected with SARS-CoV-2 have demonstrated reduced neutraliza�on and binding affinity to the Omicron variant and its sublineages [19,20]. Pa�ents with severe comorbidi�es are s�ll at increased risk of poor outcomes when infected with the Omicron variant, including progression to severe disease and death [21][22][23]. Addi�onally, pa�ents with severe comorbidity burden and immunocompromised pa�ents, including those on hemodialysis [24], are likely to be at more risk from prolonged viral shedding and viral persistence [25][26][27][28][29].…”

Section: Introductionmentioning

confidence: 99%

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Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2: A Retrospective Chart Review

Yamato,

Kinoshita,

Miyazawa

et al. 2023

Preprint

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IntroductionAntivirals with differing mechanisms of action are needed for COVID-19 treatment; remdesivir is mainly used in hospitalized patients, but additional antivirals are needed in this setting. Ensitrelvir, a 3C-like protease inhibitor, received emergency approval in Japan in November 2022, based on evidence of rapid symptom resolution in non-hospitalized patients, but confirmation of its efficacy in hospitalized patients is lacking.Case presentationsThis case series reports outcomes for all patients who received ensitrelvir whilst hospitalized with SARS-CoV-2 infection at Rinku General Medical Center, Japan (November 2022– April 2023). Thirty-two hospitalized patients received five days of ensitrelvir treatment (375/125 mg). Mean age was 73.5 years and most patients had mild COVID-19. Patients exhibited various underlying diseases, most commonly hypertension (78.1%) and chronic kidney disease (25.0%). Seven (21.9%) patients were on hemodialysis. The most common concomitant medications were antihypertensives (59.4%) and corticosteroids (31.2%); two (6.3%) patients were being treated with rituximab; 27 (84.4%) patients had viral persistence following pre-treatment remdesivir failure. Following ensitrelvir treatment, all patients experienced clinical improvement as assessed by the investigator. No ICU admissions or deaths due to COVID-19 occurred. Viral clearance was recorded in 18 (56.3%) patients by day 5 and 25 (78.1%) patients at final measurement. No new safety signals were observed.DiscussionThis case series represents ensitrelvir clinical efficacy in hospitalized patients with SARS-CoV-2 in a real-world setting. Most patients experienced persistent viral shedding despite pre-treatment with antivirals, and most were considered high-risk due to underlying conditions. Despite this, no patients experienced progression of COVID-19 to severe or critical disease, including those who failed prior remdesivir treatment. The antiviral activity of ensitrelvir demonstrated here indicates it is a viable treatment option for SARS-CoV-2 infection in this setting.ConclusionEnsitrelvir was associated with potent antiviral activity and positive clinical outcomes in high-risk, hospitalized patients with various comorbidities.Trial RegistrationUMIN000051300Key Summary PointsWhy carry out this study?Real-world evidence of ensitrelvir for the treatment of COVID-19, especially in inpatient settings, is required.This was a retrospective cohort analysis, consisting of 32 high-risk hospitalized patients with a range of disease severities and comorbidities, including patients who had experienced remdesivir treatment failure.What was learned from the study?All patients experienced clinical improvement following ensitrelvir treatment, without any worsening COVID-19.Viral clearance was documented in 78.1% of patients at final viral measurement.No new safety signals of ensitrelvir were observed in this analysis.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2: A Retrospective Chart Review

Yamato,

Kinoshita,

Miyazawa

et al. 2023

Preprint

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Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19

Takazono,

Fujita,

Komeda

et al. 2024

Infect Dis Ther

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Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It included high-risk outpatients for severe symptoms who received their first COVID-19 diagnosis between November 2022 and July 2023. The study included outpatients aged ≥ 18 years. The primary endpoint was all-cause hospitalization during the 4-week period from the date of outpatient diagnosis and medication, comparing the ensitrelvir group ( n = 5177) and the no antiviral treatment group ( n = 162,133). The risk ratio and risk difference were evaluated after adjusting patient background distribution by the inverse probability of treatment weight (IPTW) method. Secondary endpoints were incidence of respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death. Results The risk ratio for all-cause hospitalization between the ensitrelvir group ( n = 167,385) and the no antiviral treatment group ( n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was − 0.291 [95% CI − 0.494, − 0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events. Conclusions The incidence of all-cause hospitalization was significantly lower in the ensitrelvir group than in the no antiviral treatment group, suggesting ensitrelvir is an effective treatment in patients at risk of severe COVID-19. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-024-01010-4.

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Ensitrelvir in patients with SARS-CoV-2: A retrospective chart review

Yamato,

Kinoshita,

Miyazawa

et al. 2024

Journal of Infection and Chemotherapy

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Is Omicron really mild? – Comparative analysis of comorbidities and disease outcomes associated with SARS-CoV-2 Omicron (B.1.1.529) and Delta (B.1.617.2) variants

Cited by 6 publications

References 26 publications

Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2: A Retrospective Chart Review

Ensitrelvir Fumaric Acid in Patients with SARS-CoV-2: A Retrospective Chart Review

Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19

Ensitrelvir in patients with SARS-CoV-2: A retrospective chart review

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