Long-term gastrointestinal outcomes of COVID-19

Xu, Evan; Al‐Aly, Ziyad

doi:10.1038/s41467-023-36223-7

Cited by 90 publications

(93 citation statements)

References 53 publications

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“…We examined the risk of post–acute death and hospitalization and a composite outcome of death or hospitalization. We also studied individual post–acute sequelae—which were selected based on prior evidence—including ischemic heart disease, dysrhythmia, deep vein thrombosis, pulmonary embolism, fatigue and malaise, liver disease, acute kidney injury, muscle pain, diabetes, neurocognitive impairment, dysautonomia, and shortness of breath and cough. Individual sequelae were defined based on inpatient and outpatient International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnosis codes and laboratory results; death was defined based on vital status data; and hospitalization was defined based on inpatient encounter data.…”

Section: Methodsmentioning

confidence: 99%

Association of Treatment With Nirmatrelvir and the Risk of Post–COVID-19 Condition

2023

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ImportancePost–COVID-19 condition (PCC), also known as long COVID, affects many individuals. Prevention of PCC is an urgent public health priority.ObjectiveTo examine whether treatment with nirmatrelvir in the acute phase of COVID-19 is associated with reduced risk of PCC.Design, Setting, and ParticipantsThis cohort study used the health care databases of the US Department of Veterans Affairs (VA) to identify patients who had a SARS-CoV-2 positive test result between January 3, 2022, and December 31, 2022, who were not hospitalized on the day of the positive test result, who had at least 1 risk factor for progression to severe COVID-19 illness, and who had survived the first 30 days after SARS-CoV-2 diagnosis. Those who were treated with oral nirmatrelvir within 5 days after the positive test (n = 35 717) and those who received no COVID-19 antiviral or antibody treatment during the acute phase of SARS-CoV-2 infection (control group, n = 246 076) were identified.ExposuresTreatment with nirmatrelvir or receipt of no COVID-19 antiviral or antibody treatment based on prescription records.Main Outcomes and MeasuresInverse probability weighted survival models were used to estimate the association of nirmatrelvir (vs control) with post–acute death, post–acute hospitalization, and a prespecified panel of 13 post–acute COVID-19 sequelae (components of PCC) and reported in relative scale as relative risk (RR) or hazard ratio (HR) and in absolute scale as absolute risk reduction in percentage at 180 days (ARR).ResultsA total of 281 793 patients (mean [SD] age, 61.99 [14.96]; 242 383 [86.01%] male) who had a positive SARS-CoV-2 test result and had at least 1 risk factor for progression to severe COVID-19 illness were studied. Among them, 246 076 received no COVID-19 antiviral or antibody treatment during the acute phase of SARS-CoV-2 infection, and 35 717 received oral nirmatrelvir within 5 days after the positive SARS-CoV-2 test result. Compared with the control group, nirmatrelvir was associated with reduced risk of PCC (RR, 0.74; 95% CI, 0.72-0.77; ARR, 4.51%; 95% CI, 4.01-4.99), including reduced risk of 10 of 13 post–acute sequelae (components of PCC) in the cardiovascular system (dysrhythmia and ischemic heart disease), coagulation and hematologic disorders (pulmonary embolism and deep vein thrombosis), fatigue and malaise, acute kidney disease, muscle pain, neurologic system (neurocognitive impairment and dysautonomia), and shortness of breath. Nirmatrelvir was also associated with reduced risk of post–acute death (HR, 0.53; 95% CI, 0.46-0.61); ARR, 0.65%; 95% CI, 0.54-0.77), and post–acute hospitalization (HR, 0.76; 95% CI, 0.73-0.80; ARR, 1.72%; 95% CI, 1.42-2.01). Nirmatrelvir was associated with reduced risk of PCC in people who were unvaccinated, vaccinated, and boosted, and in people with primary SARS-CoV-2 infection and reinfection.Conclusions and RelevanceThis cohort study found that in people with SARS-CoV-2 infection who had at least 1 risk factor for progression to severe disease, treatment with nirmatrelvir within 5 days of a positive SARS-CoV-2 test result was associated with reduced risk of PCC across the risk spectrum in this cohort and regardless of vaccination status and history of prior infection; the totality of findings suggests that treatment with nirmatrelvir during the acute phase of COVID-19 may reduce the risk of post–acute adverse health outcomes.

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Section: Methodsmentioning

confidence: 99%

Association of Treatment With Nirmatrelvir and the Risk of Post–COVID-19 Condition

2023

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“…To adjust for confounding we specified a set of covariates, 10 which were selected on the basis of the probability of a prescription for molnupiravir being issued and also the probability of hospital admission or death from previous research findings; covariates were assessed within three years before study enrollment when we chose the values before and closest to the date of study enrollment. 3 11 12 13 14 15 16 17 18 19 20 21 22 A directed acyclic graph guided the selection of covariates 10 (see supplementary figure S1). The covariates were age, race (White, Black, and other), sex, deprivation (area deprivation index), BMI, smoking status (current, former, and never), covid-19 vaccination status (not vaccinated, one or two vaccine doses, booster), history of SARS-CoV-2 infection, calendar week of the SARS-CoV-2 infection in 2022, influenza vaccination status, short term use of steroids (<30 days), long term care, eGFR, systolic and diastolic blood pressure, cancer, cardiovascular disease, chronic lung disease, dementia, diabetes, hyperlipidemia, and liver disease.…”

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Molnupiravir and risk of hospital admission or death in adults with covid-19: emulation of a randomized target trial using electronic health records

Bowe

Al‐Aly

2023

BMJ

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Objective To emulate a randomized target trial to estimate the association between the antiviral drug molnupiravir and hospital admission or death in adults with SARS-CoV-2 infection in the community during the omicron predominant era who were at high risk of progression to severe covid-19. Design Emulation of a randomized target trial using electronic health records. Setting US Department of Veterans Affairs. Participants 85 998 adults with SARS-CoV-2 infection between 5 January and 30 September 2022 and at least one risk factor for progression to severe covid-19: 7818 participants were eligible for and treated with molnupiravir and 78 180 received no treatment. Main outcomes measure The primary outcome was a composite of hospital admission or death at 30 days. The clone method with inverse probability of censoring weighting was used to adjust for informative censoring and balance baseline characteristics between the groups. The cumulative incidence function was used to estimate the relative risk and the absolute risk reduction at 30 days. Results Molnupiravir was associated with a reduction in hospital admissions or death at 30 days (relative risk 0.72 (95% confidence interval 0.64 to 0.79)) compared with no treatment; the event rates for hospital admission or death at 30 days were 2.7% (95% confidence interval 2.5% to 3.0%) for molnupiravir and 3.8% (3.7% to 3.9%) for no treatment; the absolute risk reduction was 1.1% (95% confidence interval 0.8% to 1.4%). Molnupiravir appeared to be effective in those who had not been vaccinated against covid-19 (relative risk 0.83 (0.70 to 0.97) and absolute risk reduction 0.9% (0.2% to 1.9%)), had received one or two vaccine doses (0.69 (0.56 to 0.83) and 1.3% (0.7% to 1.9%)), and had received a booster dose (0.71 (0.58 to 0.83) and 1.0% (0.5% to 1.4%)); in those infected during the era when the omicron subvariant BA.1 or BA.2 was predominant (0.72 (0.62 to 0.83) and 1.2% (0.7% to 1.6%)) and when BA.5 was predominant (0.75 (0.66 to 0.86) and 0.9% (0.5% to 1.3%)); and in those with no history of SARS-CoV-2 infection (0.72 (0.64 to 0.81) and 1.1% (0.8% to 1.4%)) and with a history of SARS-CoV-2 infection (0.75 (0.58 to 0.97) and 1.1% (0.1% to 1.8%)). Conclusions The findings of this emulation of a randomized target trial suggest that molnupiravir might have reduced hospital admission or death at 30 days in adults with SARS-CoV-2 infection in the community during the recent omicron predominant era who were at high risk of progression to severe covid-19 and eligible for treatment with molnupiravir.

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“…Covariates were selected based on previous knowledge and assessed within the three years of T 0 unless otherwise specified. 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Figure S1 shows the directed acyclic graph which guided the selection of covariates. 28 Personal and health factors were selected, including age, self-reported race (white, black, and other), sex (from self-reported sex), area deprivation index, body mass index, and smoking status (current, former, and never).…”

Section: Methodsmentioning

confidence: 99%

Nirmatrelvir and risk of hospital admission or death in adults with covid-19: emulation of a randomized target trial using electronic health records

Bowe

Al‐Aly

2023

BMJ

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Objective To estimate the effectiveness of nirmatrelvir, compared with no treatment, in reducing admission to hospital or death at 30 days in people infected with the SARS-CoV-2 virus and at risk of developing severe disease, according to vaccination status and history of previous SARS-CoV-2 infection. Design Emulation of a randomized target trial with electronic health records. Setting Healthcare databases of the US Department of Veterans Affairs Participants 256 288 participants with a SARS-CoV-2 positive test result and at least one risk factor for developing severe covid-19 disease, between 3 January and 30 November 2022. 31 524 were treated with nirmatrelvir within five days of testing positive for SARS-CoV-2 and 224 764 received no treatment. Main outcome measures The effectiveness of starting nirmatrelvir within five days of a positive SARS-CoV-2 test result versus no treatment in reducing the risk of admission to hospital or death at 30 days was estimated in those who were not vaccinated, in those who received one or two doses of vaccine, and those who received a vaccine booster and, separately, in participants with a primary SARS-CoV-2 infection or reinfection. The inverse probability weighting method was used to balance personal and health characteristics between the groups. Relative risk and absolute risk reduction were computed from cumulative incidence at 30 days, estimated by weighted Kaplan-Meier estimator. Results Among people who were not vaccinated (n=76 763; 5338 nirmatrelvir and 71 425 no treatment), compared with no treatment, the relative risk of nirmatrelvir in reducing admission to hospital or death at 30 days was 0.60 (95% confidence interval 0.50 to 0.71); the absolute risk reduction was 1.83% (95% confidence interval 1.29% to 2.49%). The relative risk and absolute risk reduction, compared with no treatment, were 0.65 (0.57 to 0.74) and 1.27% (0.90% to 1.61%), respectively, in people who received one or two doses of vaccine (n=84 620; 7989 nirmatrelvir and 76 631 no treatment); 0.64 (0.58 to 0.71) and 1.05% (0.85% to 1.27%) in individuals who received a booster dose of vaccine (n=94 905; 18 197 nirmatrelvir and 76 708 no treatment); 0.61 (0.57 to 0.65) and 1.36% (1.19% to 1.53%) in participants with a primary SARS-CoV-2 infection (n=228 081; 26 350 nirmatrelvir and 201 731 no treatment); and 0.74 (0.63 to 0.87) and 0.79% (0.36% to 1.18%) in participants who were reinfected with the SARS-CoV-2 virus (n=28 207; 5174 nirmatrelvir and 23 033 no treatment). Nirmatrelvir was associated with a reduced risk of admission to hospital or death in those aged ≤65 years and > 65 years; in men and women; in black and white participants; in those with 1-2, 3-4, and ≥5 risk factors for progression to severe covid-19 illness; and in those infected during the omicron BA.1 or BA.2 predominant era, and the BA.5 predominant era. Conclusions In people with SARS-CoV-2 infection who were at risk of developing severe disease, compared with no treatment, nirmatrelvir was associated with a reduced risk of admission to hospital or death at 30 days in people who were not vaccinated, vaccinated, and had received a booster vaccine, and in those with a primary SARS-CoV-2 infection and reinfection.

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Long-term gastrointestinal outcomes of COVID-19

Cited by 90 publications

References 53 publications

Association of Treatment With Nirmatrelvir and the Risk of Post–COVID-19 Condition

Association of Treatment With Nirmatrelvir and the Risk of Post–COVID-19 Condition

Molnupiravir and risk of hospital admission or death in adults with covid-19: emulation of a randomized target trial using electronic health records

Nirmatrelvir and risk of hospital admission or death in adults with covid-19: emulation of a randomized target trial using electronic health records

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