Dataset Information

Effectiveness of Favipiravir monotherapy in the treatment of COVID-19: real world data analysis from Thailand.

ABSTRACT:

Background

Previous studies showed that Favipiravir, a selective viral ribonucleic acid dependent-ribonucleic acid polymerase inhibitor, exhibited a trend of clinical improvement within 14 days and promoted viral clearance by day 7, without reduction of mortality rate in COVID-19.

Methods

During the COVID-19 pandemic, Department of Medical Services (Thailand) formulated National Clinical Treatment Guidelines for COVID-19 and approved Favipiravir to eight medical centres. After treatment with Favipiravir monotherapy, we compared real-world data analysis to supportive treatment without antiviral agents.

Findings

We analysed 12,888 COVID-19 patients between June 1, 2021, and July 31, 2021. This group study excluded 66 asymptomatic and 4634 COVID-19 patients treated with other antiviral agents. The 4896 mild, 2357 moderate, and 935 severe COVID-19 patients were analysed. All patients neither had previous SARS-CoV-2 infection nor received an mRNA vaccine during study period. Favipiravir monotherapy reduced the 28-day mortality risk in severe COVID-19 by relative risk (RR) = 0.72 (95% CI 0.58-0.91 P = 0.006) after adjustment for aging and hypertension. However, in mild and moderate COVID-19, Favipiravir monotherapy did not significantly reduce 28-day mortality risk by RR = 0.59 (95% CI 0.06-5.43 P = 0.65) after adjustment for aging, and RR = 0.60 (95% CI 0.32-1.13 P = 0.11) after adjustment for aging and obesity, respectively. In the patient with recovery, Favipiravir monotherapy exhibited a shortening time to recovery when compared to supportive treatment without antiviral agents (mean ± SD by 9.6 ± 7.1 vs. 12.9 ± 7.6 days: P < 0.0001, 10.0 ± 5.9 vs. 12.4 ± 5.3 days: P < 0.0001, and 11.2 ± 7.8 vs. 13.1 ± 8.0 days: P < 0.0001 in mild, moderate, and severe COVID-19 respectively).

Interpretation

Real-world data analysis showed that favipiravir monotherapy was superior to supportive treatment without antiviral agents in shortening the recovery time in surviving patients and significantly reducing 28-day mortality risk in severe COVID-19.

Funding

Department of Medical Services, Ministry of Public Health, Thailand.

SUBMITTER: Srisubat A

PROVIDER: S-EPMC9902286 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of Favipiravir monotherapy in the treatment of COVID-19: real world data analysis from Thailand.

Srisubat Attasit A Thanasitthichai Somchai S Kongsaengdao Subsai S Maneeton Narong N Maneeton Benchalak B Akksilp Somsak S

The Lancet regional health. Southeast Asia 20230207

<h4>Background</h4>Previous studies showed that Favipiravir, a selective viral ribonucleic acid dependent-ribonucleic acid polymerase inhibitor, exhibited a trend of clinical improvement within 14 days and promoted viral clearance by day 7, without reduction of mortality rate in COVID-19.<h4>Methods</h4>During the COVID-19 pandemic, Department of Medical Services (Thailand) formulated National Clinical Treatment Guidelines for COVID-19 and approved Favipiravir to eight medical centres. After tre ...[more]

PMID: 36776761

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Project description:BackgroundTreatment guidelines and U.S. Food and Drug Administration emergency use authorizations (EUAs) of monoclonal antibodies (mAbs) for treatment of high-risk outpatients with mild to moderate COVID-19 changed frequently as different SARS-CoV-2 variants emerged.ObjectiveTo evaluate whether early outpatient treatment with mAbs, overall and by mAb product, presumed SARS-CoV-2 variant, and immunocompromised status, is associated with reduced risk for hospitalization or death at 28 days.DesignHypothetical pragmatic randomized trial from observational data comparing mAb-treated patients with a propensity score-matched, nontreated control group.SettingLarge U.S. health care system.ParticipantsHigh-risk outpatients eligible for mAb treatment under any EUA with a positive SARS-CoV-2 test result from 8 December 2020 to 31 August 2022.InterventionSingle-dose intravenous mAb treatment with bamlanivimab, bamlanivimab-etesevimab, sotrovimab, bebtelovimab, or intravenous or subcutaneous casirivimab-imdevimab administered within 2 days of a positive SARS-CoV-2 test result.MeasurementsThe primary outcome was hospitalization or death at 28 days among treated patients versus a nontreated control group (no treatment or treatment ≥3 days after SARS-CoV-2 test date).ResultsThe risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio [RR], 0.61 [95% CI, 0.50 to 0.74]). In sensitivity analyses, the corresponding RRs for 1- and 3-day treatment grace periods were 0.59 and 0.49, respectively. In subgroup analyses, those receiving mAbs when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period. Relative risk estimates for individual mAb products all suggested lower risk for hospitalization or death. Among immunocompromised patients, the RR was 0.45 (CI, 0.28 to 0.71).LimitationsObservational study design, SARS-CoV-2 variant presumed by date rather than genotyping, no data on symptom severity, and partial data on vaccination status.ConclusionEarly mAb treatment among outpatients with COVID-19 is associated with lower risk for hospitalization or death for various mAb products and SARS-CoV-2 variants.Primary funding sourceNone.

Project description:Background and objectiveThe coronavirus disease 2019 (COVID-19) pandemic has been an unprecedented healthcare crisis, one that threatened to overwhelm health systems and prompted an urgent need for early treatment options for patients with mild-to-moderate COVID-19 at high risk for progression to severe disease. Randomised clinical trials established the safety and efficacy of monoclonal antibodies (mAbs) early in the pandemic; in vitro data subsequently led to use of the mAbs being discontinued, without clear evidence on how these data were linked to outcomes. In this study, we describe and compare real-world outcomes for patients with mild-to-moderate COVID-19 at high risk for progression to severe COVID-19 treated with sotrovimab versus untreated patients.MethodsElectronic health records from the National COVID Cohort Collaborative (N3C) were used to identify US patients (aged ≥ 12 years) diagnosed with COVID-19 (positive test or ICD-10: U07.1) in an ambulatory setting (27 September 2021-30 April 2022) who met Emergency Use Authorization (EUA) high-risk criteria. Patients receiving the mAb sotrovimab within 10 days of diagnosis were assigned to the sotrovimab cohort, with the day of infusion as the index date. Untreated patients (no evidence of early mAb treatment, prophylactic mAb or oral antiviral treatment) were assigned to the untreated cohort, with an imputed index date based on the time distribution between diagnosis and sotrovimab infusion in the sotrovimab cohort. The primary endpoint was hospitalisation or death (both all-cause) within 29 days of index, reported as descriptive rate and adjusted [via inverse probability of treatment weighting (IPTW)] odds ratio (OR) and 95% confidence interval (CI).ResultsOf nearly 2.9 million patients diagnosed with COVID-19 during the analysis period, 4992 met the criteria for the sotrovimab cohort, and 541,325 were included in the untreated cohort. Before weighting, significant differences were noted between the cohorts; for example, patients in the sotrovimab cohort were older (60 years versus 54 years), were more likely to be white (85% versus 75%) and met more EUA criteria (mean 3.1 versus 2.2) versus the untreated cohort. The proportions of patients with 29-day hospitalisation or death were 3.5% (176/4992) and 4.5% (24,163/541,325) in the sotrovimab and untreated cohorts, respectively (unadjusted OR: 0.78; 95% CI: 0.67, 0.91; p = 0.001). In adjusted analysis, sotrovimab was associated with a 25% reduction in the odds of hospitalisation or death compared with the untreated cohort (IPTW-adjusted OR: 0.75; 95% CI: 0.61, 0.92; p = 0.005).ConclusionsSotrovimab demonstrated clinical effectiveness in preventing severe outcomes (hospitalisation, mortality) in the period 27 September 2021-30 April 2022, which included Delta and Omicron BA.1 variants and an early surge of Omicron BA.2 variant.

Dataset Information

Effectiveness of Favipiravir monotherapy in the treatment of COVID-19: real world data analysis from Thailand.

Background

Methods

Findings

Interpretation

Funding

Publications

Effectiveness of Favipiravir monotherapy in the treatment of COVID-19: real world data analysis from Thailand.

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