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ABSTRACT

Objective:

To compare the effectiveness of sotrovimab (a neutralising monoclonal antibody) vs. molnupiravir (an antiviral) in preventing severe COVID-19 outcomes in non-hospitalised high-risk COVID-19 adult patients.

Design:

With the approval of NHS England, we conducted a real-world cohort study using the OpenSAFELY-TPP platform.

Setting:

Patient-level electronic health record data were obtained from 24 million people registered with a general practice in England that uses TPP software. The primary care data were securely linked with data on COVID-19 infection and therapeutics, hospital admission and death within the OpenSAFELY-TPP platform, covering a period where both medications were frequently prescribed in community settings.

Participants:

Non-hospitalised adult COVID-19 patients at high-risk of severe outcomes treated with sotrovimab or molnupiravir between December 16, 2021 and February 10, 2022.

Interventions:

Sotrovimab or molnupiravir administered in the community by COVID-19 Medicine Delivery Units. Main outcome

measure:

COVID-19 related hospitalisation or COVID-19 related death within 28 days after treatment initiation.

Results:

Patients treated with sotrovimab (n=3288) and molnupiravir (n=2663) were similar with respect to most baseline characteristics. The mean age of all 5951 patients was 52 (SD=16) years;59% were female, 89% White and 87% had three or more COVID-19 vaccinations. Within 28 days after treatment initiation, 84 (1.4%) COVID-19 related hospitalisations/deaths were observed (31 treated with sotrovimab and 53 with molnupiravir). Cox proportional hazards models stratified by area showed that after adjusting for demographics, high-risk cohort categories, vaccination status, calendar time, body mass index and other comorbidities, treatment with sotrovimab was associated with a substantially lower risk than treatment with molnupiravir (hazard ratio, HR=0.53, 95% CI 0.32-0.88;P=0.014). Consistent results were obtained from propensity score weighted Cox models (HR=0.51, 95% CI 0.31-0.83;P=0.007) and when restricted to fully vaccinated people (HR=0.52, 95% CI 0.30-0.90;P=0.020). No substantial effect modifications by other characteristics were detected (all P values for interaction>0.10).

Conclusion:

In routine care of non-hospitalised high-risk adult patients with COVID-19 in England, those who received sotrovimab were at lower risk of severe COVID-19 outcomes than those receiving molnupiravir.

Full text: Available Collection: Preprints Database: EuropePMC Type of study: Etiology study / Observational study / Prognostic study / Risk factors Topics: Vaccines Language: English Year: 2022 Document Type: Preprint

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Full text: Available Collection: Preprints Database: EuropePMC Type of study: Etiology study / Observational study / Prognostic study / Risk factors Topics: Vaccines Language: English Year: 2022 Document Type: Preprint