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Practice Changing UpDates

Practice Changing UpDates
Authors:
April F Eichler, MD, MPH
Sadhna R Vora, MD
Literature review current through: Feb 2022. | This topic last updated: Mar 01, 2022.

INTRODUCTION — This section highlights selected specific new recommendations and/or updates that we anticipate may change usual clinical practice. Practice Changing UpDates focus on changes that may have significant and broad impact on practice, and therefore do not represent all updates that affect practice. These Practice Changing UpDates, reflecting important changes to UpToDate over the past year, are presented chronologically, and are discussed in greater detail in the identified topic reviews.

INFECTIOUS DISEASES (October 2021, Modified February 2022)

Booster doses of COVID-19 vaccines for individuals 12 years or older

For individuals ≥12 years of age who received a primary series of a COVID-19 vaccine, we recommend booster vaccination (Grade 1B).

Several countries have introduced booster doses of COVID-19 vaccines because of potentially attenuated vaccine effectiveness due to waning efficacy and variants. The US Food and Drug Administration has authorized and the Centers for Disease Control and Prevention (CDC) recommends a booster dose for all individuals 12 years or older [1-4]. The booster dose is given five months after a primary BNT162b2 (Pfizer) or mRNA-1273 (Moderna) series for most patients (or three months after the primary series for immunocompromised patients) and two months after a primary Ad26.COV2.S (Johnson & Johnson) series. Any vaccine authorized for the patient's age group can be used for the booster dose, regardless of the vaccine used for the primary series; in general, we favor one of the mRNA vaccines over Ad26.COV2.S. We recommend booster doses for eligible individuals, based on trials and observational evidence suggesting improved vaccine efficacy following a booster dose. (See "COVID-19: Vaccines", section on 'Role of booster vaccinations/waning efficacy'.)

INFECTIOUS DISEASES (August 2021, Modified February 2022)

Additional COVID-19 vaccine primary series dose for immunocompromised individuals

For individuals with certain immunocompromising conditions (table 1), we suggest administering a three-dose primary mRNA vaccine series rather than a two-dose series (Grade 2C). Similarly, we suggest an additional mRNA vaccine dose for such individuals who previously received a single Ad26.COV2.S dose (Grade 2C).

COVID-19 vaccines are less effective among patients with certain immunocompromising conditions than in the general population; additional vaccine doses have been associated with improved effectiveness in this population. We agree with recommendations from the Advisory Committee on Immunization Practices (ACIP) in the United States that individuals with such conditions (table 1) receive an additional mRNA vaccine dose as part of their primary COVID-19 vaccine series (eg, following two doses of an mRNA vaccine or one dose of Ad26.COV2.S vaccine) [5,6]. This additional primary series dose is distinct from the booster dose, which such patients should additionally receive, although at a shorter interval than recommended for the general population. (See "COVID-19: Vaccines", section on 'Immunocompromised individuals'.)

INFECTIOUS DISEASES (February 2022)

Tenofovir alafenamide now a preferred NRTI agent for pregnant individuals with HIV

For most treatment-naïve individuals with HIV who are initiating antiretroviral therapy during pregnancy, we suggest tenofovir alafenamide-emtricitabine plus dolutegravir rather than other preferred three-drug combination regimens (Grade 2C).

Recommended antiretroviral regimens for individuals with HIV initiating treatment during pregnancy include two nucleoside reverse transcriptase inhibitor (NRTI) agents in conjunction with either an integrase inhibitor or a booster protease inhibitor. Based on accumulating safety and efficacy data in this population, the United States Department of Health and Human Services has added tenofovir alafenamide (TAF) to the list of preferred NRTIs to use for pregnant individuals with HIV [7]. In a recent trial, regimens containing TAF versus tenofovir disoproxil fumarate (TDF) resulted in similar virologic suppression rates, but TAF was associated with fewer adverse pregnancy outcomes. We generally initiate the NRTI combination of TAF-emtricitabine in this patient population unless there is significant concern for excessive gestational weight gain, in which case a TAF-containing regimen can be used. (See "Antiretroviral selection and management in pregnant women with HIV in resource-rich settings", section on 'Selecting the NRTI backbone'.)

INFECTIOUS DISEASES (November 2021, Modified February 2022)

Treatment of COVID-19 in outpatients at risk for severe disease

For unvaccinated individuals (or those with likely inadequate vaccine response) who have symptomatic mild-to-moderate COVID-19 and are at risk for progression to severe disease (table 1), we recommend early treatment with nirmatrelvir-ritonavir or sotrovimab rather than no therapy (Grade 1B). For immunocompetent, vaccinated individuals who have symptomatic mild-to-moderate COVID-19 and are at high risk for progression to severe disease (table 1), we also suggest treatment with nirmatrelvir-ritonavir or sotrovimab rather than no therapy (Grade 2C).

Nirmatrelvir-ritonavir, the monoclonal antibody sotrovimab, remdesivir, and high-titer convalescent plasma have all been shown to reduce the risk of hospitalization when given early in the course of COVID-19 [8-11]. For outpatient adults who have mild-to-moderate COVID-19 and are at risk for progression to severe disease (table 2), we recommend treatment with either nirmatrelvir-ritonavir or sotrovimab. When these are not available, we consider remdesivir and convalescent plasma, which may be complicated to administer, as alternatives. If none are feasible options, molnupiravir is an alternative, but it may be less effective and potentially teratogenic [12]. Bebtelovimab is an alternative monoclonal antibody that is active against Omicron, but there are limited data to support its use [13]. When supplies are limited, these treatments should be prioritized for immunocompromised individuals expected to have a suboptimal vaccine response and unvaccinated or incompletely vaccinated individuals at highest risk for severe disease (table 3) [14]. (See "COVID-19: Outpatient evaluation and management of acute illness in adults".)

PEDIATRICS (February 2022)

Duration of anticoagulation for low-risk provoked venous thromboembolism in pediatric patients

For pediatric patients with provoked venous thromboembolism who meet low-risk criteria, we suggest six weeks of anticoagulant therapy rather than observation or shorter or longer courses of treatment (Grade 2C).

The optimal duration of anticoagulant therapy for children with venous thromboembolism (VTE) is uncertain. Usual practice has been to treat for three months based largely upon evidence from adult studies. However, a recent clinical trial suggests that six weeks of therapy is sufficient for most pediatric patients with low-risk provoked VTE (ie, attributable to a transient risk factor) [15]. The trial enrolled 417 children with provoked VTE (catheter-associated in 50 percent; infection-related in 30 percent; surgery- or trauma-related in 20 percent) who were randomly assigned to six weeks or three months of anticoagulant therapy. At one year, rates of VTE recurrence were similarly low in both groups (1.1 and 1.6 percent, respectively). Based upon these findings, we now suggest a six-week course of treatment for pediatric patients with provoked VTE who met all of the following low-risk criteria:

No prior history of VTE

The VTE is not severe or life-threatening

The provoking risk factor resolves within six weeks

The thrombus resolves or is nonocclusive within six weeks

For patients with provoked VTE who do not meet these criteria, we continue to suggest three months of therapy. (See "Venous thrombosis and thromboembolism (VTE) in children: Treatment, prevention, and outcome", section on 'Provoked VTE'.)

HEMATOLOGY (January 2022)

Chimeric antigen receptor-T cell therapy for early relapse or refractory diffuse large B cell lymphoma

For patients with early first relapse of diffuse large B cell lymphoma or primary refractory disease, we recommend CD19-directed chimeric antigen receptor-T cell therapy using lisocabtagene maraleucel or axicabtagene ciloleucel, rather than autologous hematopoietic cell transplantation (Grade 1B).

Although autologous hematopoietic cell transplantation (HCT) has long been standard treatment in medically-fit patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), recent phase 3 trials compared transplantation with CD19-directed chimeric antigen receptor (CAR)-T products in these settings. In patients with early first relapse (<12 months after initial therapy) or primary refractory DLBCL, lisocabtagene maraleucel (liso-cel) and axicabtagene ciloleucel (axi-cel) improved event-free and overall survival relative to autologous HCT, with acceptable toxicity [16,17]. By contrast, another CD-19 CAR-T cell product, tisagenlecleucel, did not improve outcomes or toxicity relative to HCT [18]. CAR-T cell therapy is restricted to approved institutions and can be associated with life-threatening cytokine release syndrome and neurologic toxicity. We now recommend liso-cel or axi-cel for early relapsed or primary refractory DLBCL, when available; note that this guidance does not apply to later relapses (≥12 months). (See "Diffuse large B cell lymphoma (DLBCL): Suspected first relapse or refractory disease in medically-fit patients", section on 'Relapse <12 months or primary refractory DLBCL'.)

INFECTIOUS DISEASES (November 2021)

COVID-19 vaccination in children 5 years and older

For children ages 5 to 11 years, we recommend COVID-19 vaccination (Grade 1B).

In October 2021, the US Food and Drug Administration authorized BNT162b2 (Pfizer vaccine) for individuals 5 to 11 years old based on data from randomized trials in over 2000 children in this age group, which demonstrated 91 percent vaccine efficacy against symptomatic COVID-19 and immunogenicity similar to that in adolescents and young adults [19]. There were no cases of vaccine-associated myocarditis in the trials; although the precise risk is uncertain, it is expected to be lower than that seen in older individuals. We agree with recommendations from the Centers for Disease Control and Prevention to give BNT162b2 to children ages 5 to 11 years. Clinicians should be aware that the dose and formulation used for children are different than those for adolescents and adults. (See "COVID-19: Vaccines", section on 'Summary and recommendations'.)

EMERGENCY MEDICINE (ADULT AND PEDIATRIC) (November 2021)

New threshold for elevated blood lead in United States children

For children younger than six years of age in the United States, the reference value for an elevated blood level is 3.5 mcg/L (0.17 micromol/L).

Detectable blood lead levels (BLLs) are associated with neurocognitive deficits in infants and children <6 years old, and targeted screening of at-risk children is recommended. The Centers for Disease Control and Prevention has lowered the blood lead level (BLL) threshold for action to 3.5 mcg/dL (0.17 micromol/L) from the previous level of 5.0 mcg/dL (0.24 micromol/L) [20,21]. At or above this threshold, specific interventions should be taken based upon the degree of BLL elevation (table 4). For children with BLLs below 3.5 mcg/dL, the limit of detection for lead varies by laboratory, and the actual blood lead value may be close to or above the threshold. Thus, some children may need to be retested depending upon age or other risk factors. (See "Childhood lead poisoning: Management", section on 'Approach'.)

NEPHROLOGY AND HYPERTENSION (September 2021)

Glomerular filtration rate estimation without inclusion of a race coefficient

We suggest using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation to estimate glomerular filtration rate (GFR) for the general population (calculator 1).

Previously, the chronic kidney disease epidemiology (CKD-EPI) equation used to estimate glomerular filtration rate (GFR) included a term for race such that, for any given age, sex, and serum creatinine, a Black individual would have a higher estimated GFR. The American Society of Nephrology and National Kidney Foundation reevaluated the inclusion of race in estimating GFR and determined that a revised creatinine-based equation (ie, the 2021 CKD-EPI equation) that did not include race was sufficiently accurate for clinical use [22]. We now suggest using the 2021 revised CKD-EPI equation to estimate GFR (calculator 1). The equation applies to people with stable kidney function. (See "Assessment of kidney function", section on 'Estimation of GFR'.)

PEDIATRICS (August 2021)

Direct oral anticoagulants for venous thromboembolism in children ≥2 years

For most adolescents (≥12 years) with venous thromboembolism, after at least five days of initial parenteral therapy, we suggest a direct oral anticoagulant (DOAC; eg, dabigatran or rivaroxaban) rather than other agents (Grade 2B). For children ages 2 to <12 years old, either a DOAC or low molecular weight heparin is reasonable.

In 2021, the US Food and Drug Administration approved two direct oral anticoagulants (DOACs), dabigatran and rivaroxaban, for treatment of venous thrombosis and thromboembolism (VTE) in children [23,24]. These regulatory approvals were based upon two large multicenter pediatric trials demonstrating that dabigatran and rivaroxaban have similar efficacy and bleeding risk compared with low molecular weight heparin (LMWH) and warfarin [25,26]. Adolescents made up most of the trial populations, and children <2 years were underrepresented. DOACs are an attractive option since they are orally administered and do not require drug monitoring. We now suggest one of the approved DOACs (dabigatran or rivaroxaban) for treatment of VTE in adolescents, after at least five days of initial parenteral therapy. For children ages 2 to 11 years, either a DOAC or LMWH is acceptable. For infants and children <2 years, the efficacy and safety of DOACs remain uncertain, and we continue to suggest LMWH. (See "Venous thrombosis and thromboembolism (VTE) in children: Treatment, prevention, and outcome", section on 'Direct oral anticoagulants'.)

INFECTIOUS DISEASES (July 2021)

Approaches to reduce recurrent Clostridioides difficile infection

For patients with nonfulminant Clostridioides difficile infection (CDI), we suggest fidaxomicin over vancomycin (Grade 2C). For patients with recurrent CDI within six months of a prior episode, we suggest bezlotoxumab in addition to antibiotics (Grade 2C). For patients with a third or subsequent CDI recurrence who are not candidates for fecal microbiota transplant, we suggest suppressive oral vancomycin following treatment of an acute episode (Grade 2C).

New guidelines on management of Clostridioides difficile infection (CDI) were issued by the Infectious Disease Society of America (IDSA) and American College of Gastroenterology (ACG) in June 2021 [27,28]. For patients with nonfulminant CDI, the IDSA guidelines favor use of fidaxomicin over vancomycin; in addition, for patients with recurrent CDI and prior episode in the last six months, the IDSA guidelines favor use of adjunctive bezlotoxumab (with a standard antibiotic regimen). For patients with recurrent CDI who are not fecal microbiota transplantation candidates, the ACG guidelines suggest use of suppressive oral vancomycin following completion of treatment. We are in agreement with these approaches, which have been associated with a modest reduction in risk for recurrent CDI; in the setting of cost constraints, we prioritize them for patients at highest risk of recurrent CDI (age ≥65 years, history of severe CDI, or immunosuppression). (See "Clostridioides difficile infection in adults: Treatment and prevention", section on 'Nonsevere disease'.)

INFECTIOUS DISEASES; EMERGENCY MEDICINE (ADULT AND PEDIATRIC) (February 2021, Modified June 2021)

Adjunctive baricitinib or tocilizumab for COVID-19

For hospitalized adults with COVID-19 who have initiated mechanical ventilation in the prior 24 to 48 hours, we suggest adding tocilizumab to usual care (which includes dexamethasone) (Grade 2B). For hospitalized adults with COVID-19 who have initiated high-flow supplemental oxygen or noninvasive ventilation within the prior 24 to 48 hours, we suggest adding baricitinib or tocilizumab to usual care (Grade 2B). For hospitalized adults with COVID-19 who are receiving low-flow supplemental oxygen and have both progressively increasing oxygen requirements despite dexamethasone and significantly elevated inflammatory markers, we suggest adding baricitinib or tocilizumab to usual care (Grade 2C). However, if availability of these agents is limited, we prioritize them for patients on higher levels of oxygen support.

Results from recent randomized trials suggest adjunctive use of the Janus kinase inhibitor baricitinib or the interleukin-6 pathway inhibitor tocilizumab has a survival benefit in hospitalized adults with severe COVID-19.

In one unpublished randomized trial of patients who were not receiving invasive mechanical ventilation, adding baricitinib to standard of care reduced 28-day mortality; among those on high-flow oxygen or noninvasive ventilation at baseline, mortality was 17.5 versus 29.4 percent with placebo [29].

In two open-label trials that included patients on oxygen support with a C-reactive protein level ≥75 mg/L or patients who had recently started high-flow oxygen or more intensive respiratory support, adding tocilizumab reduced 28-day mortality (28 to 29 percent versus 33 to 36 percent with usual care alone) [30,31].

In the majority of patients, usual care included dexamethasone. Baricitinib and tocilizumab have not been compared directly or studied together. We suggest either baricitinib or tocilizumab as an adjunct to dexamethasone for select patients with severe or critical COVID-19. (See "COVID-19: Management in hospitalized adults", section on 'IL-6 pathway inhibitors (eg, tocilizumab)'.)

PEDIATRICS (June 2021)

Elexacaftor-tezacaftor-ivacaftor for children ≥6 years with cystic fibrosis

For patients ≥6 years old with cystic fibrosis who are homozygous for the F508del variant, we recommend triple therapy (elexacaftor-tezacaftor-ivacaftor) rather than dual therapy (tezacaftor-ivacaftor or lumacaftor-ivacaftor) (Grade 1B). For patients ≥6 years old who have one F508del mutation (heterozygotes) or other eligible mutation based on in vitro data, we suggest triple therapy rather than dual therapy or monotherapy (ivacaftor) (Grade 2C).

Elexacaftor-tezacaftor-ivacaftor is an important therapy for most patients with cystic fibrosis (CF), but its use has been limited to adolescents and adults. The drug combination was evaluated in a 24-week open-label study in 66 children 6 to 11 years old who were homozygous for F508del or heterozygous for F508del with a second minimal function mutation [32]. The safety profile and pharmacokinetics were similar to that in older individuals, and patients experienced improvement in pulmonary function (change in FEV1, 10.2 percentage points; 95% CI 7.9-12.6); respiratory symptoms; sweat chloride; and body weight. On the basis of this study, the US Food and Drug Administration approved this drug for children ≥6 years with CF and eligible genotypes (algorithm 1), and we now recommend treatment in eligible patients starting at the age of six years. (See "Cystic fibrosis: Treatment with CFTR modulators", section on 'Efficacy'.)

ONCOLOGY (June 2021)

Adjuvant olaparib for BRCA carriers with early breast cancer

For BRCA carriers with early-stage, high-risk HER2-negative breast cancer as defined by criteria from the OlympiA trial, we suggest adjuvant olaparib rather than observation (Grade 2B).

Although poly (ADP-ribose) polymerase (PARP) inhibitors are used for individuals with germline pathogenic variants in BRCA1 or BRCA2 and advanced breast cancer, their role in early breast cancer was previously undefined. A randomized trial (OlympiA) was conducted in over 1800 patients with high risk, HER2-negative early breast cancer with BRCA1 or BRCA2 variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy [33]. Patients assigned to the olaparib group had an improvement in three-year disease-free survival relative to the placebo group (86 versus 77 percent). The benefit was observed irrespective of hormone receptor status, and olaparib was generally well tolerated. For BRCA carriers with high-risk disease as defined by criteria from the OlympiA trial (table 5), we now suggest adjuvant olaparib rather than observation. (See "Selection and administration of adjuvant chemotherapy for HER2-negative breast cancer", section on 'Supporting data'.)

CARDIOVASCULAR MEDICINE (June 2021)

Surgical left atrial appendage occlusion for patients undergoing cardiac surgery

For patients who are undergoing cardiac surgery for another indication who have atrial fibrillation and a CHA2DS2-VASc risk score (table 1) of at least 2, we recommend concomitant surgical left atrial appendage occlusion (Grade 1B).

The left atrial appendage (LAA) is the primary source of thromboembolism in patients with atrial fibrillation (AF). When patients with AF undergo cardiac surgery, LAA occlusion is commonly performed with limited supporting evidence. The effects of surgical LAA occlusion were studied in a trial enrolling nearly 4800 patients with AF (with ≥2 risk factors for thromboembolism) undergoing cardiac surgery, in which patients were randomly assigned to surgical LAA occlusion or no occlusion and most continued oral anticoagulation after the procedure [34]. At nearly four years of follow-up, stroke or systemic embolism was about one-third less frequent in the occlusion group than in the no-occlusion group, and perioperative complications were similar in the two groups. These results support use of surgical LAA occlusion as an adjunct to long-term anticoagulation for patients undergoing cardiac surgery for another indication who have AF and a CHA2DS2-VASc risk score (table 6) of at least 2. (See "Atrial fibrillation: Left atrial appendage occlusion", section on 'For patients without contraindication to long-term anticoagulation'.)

NEUROLOGY (April 2021)

Second course of IVIG not beneficial for patients with severe Guillain-Barré syndrome

For patients with Guillain-Barré syndrome treated initially with IVIG who show further deterioration or no improvement, we suggest against retreating with IVIG because it exposes patients to adverse risks without additional benefit (Grade 2C).

For patients with severe Guillain-Barré syndrome (GBS) whose symptoms worsen or fail to improve after a course of intravenous immune globulin (IVIG), a repeat course has sometimes been given, despite uncertain benefit. In a randomized trial of 93 patients with GBS and a poor predicted outcome, those assigned to a second course of IVIG (given two to four days after completion of the first course) had similar disability but more adverse effects, including thromboembolic complications, than those who were assigned to placebo [35]. Based on these data, we suggest against retreating with a second course of IVIG for patients with GBS. (See "Guillain-Barré syndrome in adults: Treatment and prognosis", section on 'Approach to patients who relapse or worsen'.)

ONCOLOGY (April 2021)

Postoperative nivolumab after initial chemoradiotherapy for esophageal and esophagogastric junction cancer

For patients with localized esophageal or esophagogastric junction cancer who have residual disease in the surgical specimen after initial chemoradiotherapy, we suggest nivolumab for one year (Grade 2B), although we discontinue it if disease recurs during treatment.

Patients with localized esophageal or esophagogastric junction (EGJ) cancer who are treated with neoadjuvant chemoradiotherapy and have residual disease at the time of resection remain at high risk for recurrence and death from cancer, yet optimal postoperative management is unknown. In the CheckMate 577 trial of nearly 800 such patients, adjuvant nivolumab for up to one year doubled median disease-free survival compared with placebo (22.4 versus 11 months) without adversely affecting health-related quality of life [36]. Benefits were seen across all patient subgroups (histology, location, initial and posttreatment disease stage) and did not depend on programmed cell death ligand-1 status. Overall survival data are not yet mature. Despite the lack of data on survival, given the morbidity of disease recurrence, we now suggest one year of adjuvant nivolumab for patients with resected esophageal or EGJ cancer who have residual disease in the surgical specimen after initial chemoradiotherapy. This approach has been endorsed by an updated guideline on the treatment of locally advanced esophageal carcinoma [37]. (See "Radiation therapy, chemoradiotherapy, neoadjuvant approaches, and postoperative adjuvant therapy for localized cancers of the esophagus", section on 'After preoperative therapy'.)

EMERGENCY MEDICINE (ADULT AND PEDIATRIC); OBSTETRICS, GYNECOLOGY AND WOMEN'S HEALTH (February 2021)

Levonorgestrel intrauterine device for emergency contraception

For patients who desire an intrauterine device (IUD) for emergency contraception, we suggest a copper IUD or a levonorgestrel 52 mg IUD rather than other hormonal IUDs (Grade 2C).

Until now, the copper TCu380A intrauterine device (copper IUD) was the only IUD option for use as emergency contraception (EC). In a randomized, noninferiority trial in 711 females who presented within five days of unprotected intercourse and had a negative urine pregnancy test, the copper IUD and the levonorgestrel intrauterine device 52 mg (LNG 52) resulted in similar pregnancy rates (0.0 and 0.3 percent, respectively) [38]. Based on this trial, we now suggest either the copper IUD or the LNG 52 IUD to individuals who desire an IUD for EC. Some patients may prefer the lighter menstrual bleeding or amenorrhea associated with LNG 52 IUD use. Use of the LNG 52 IUD represents off-label use for this indication. (See "Emergency contraception".)

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  30. RECOVERY Collaborative Group. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet 2021; 397:1637.
  31. REMAP-CAP Investigators, Gordon AC, Mouncey PR, et al. Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19. N Engl J Med 2021; 384:1491.
  32. Zemanick ET, Taylor-Cousar JL, Davies J, et al. A Phase 3 Open-Label Study of Elexacaftor/Tezacaftor/Ivacaftor in Children 6 through 11 Years of Age with Cystic Fibrosis and at Least One F508del Allele. Am J Respir Crit Care Med 2021; 203:1522.
  33. Tutt ANJ, Garber JE, Kaufman B, et al. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med 2021; 384:2394.
  34. Whitlock RP, Belley-Cote EP, Paparella D, et al. Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke. N Engl J Med 2021; 384:2081.
  35. Walgaard C, Jacobs BC, Lingsma HF, et al. Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial. Lancet Neurol 2021; 20:275.
  36. Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med 2021; 384:1191.
  37. Shah MA, Hofstetter WL, Kennedy EB, Locally Advanced Esophageal Carcinoma Guideline Expert Panel. Immunotherapy in Patients With Locally Advanced Esophageal Carcinoma: ASCO Treatment of Locally Advanced Esophageal Carcinoma Guideline Rapid Recommendation Update. J Clin Oncol 2021; 39:3182.
  38. Turok DK, Gero A, Simmons RG, et al. Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception. N Engl J Med 2021; 384:335.
Topic 16722 Version 10977.0

References

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2 : Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19). Factsheet for healthcare providers administering vaccine. https://www.fda.gov/media/144637/download?utm_medium=email&utm_source=govdelivery (Accessed on November 20, 2021).

3 : US Food and Drug Administration. Emergency use authorization (EUA) of the Janssen COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). https://www.fda.gov/media/146304/download (Accessed on February 03, 2022).

4 : CDC Expands Eligibility for COVID-19 Booster Shots to All Adults https://www.cdc.gov/media/releases/2021/s1119-booster-shots.html (Accessed on November 20, 2021).

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6 : Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html (Accessed on February 24, 2022).

7 : Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new-guidelines (Accessed on January 18, 2022).

8 : Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab.

9 : Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients.

10 : Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19.

11 : Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma.

12 : Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients.

13 : Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients.

14 : Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients.

15 : Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21 Years of Age With Provoked Venous Thromboembolism: The Kids-DOTT Randomized Clinical Trial.

16 : Lisocabtagene Maraleucel (liso-cel), a CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy, Versus Standard of Care (SOC) with Salvage Chemotherapy (CT) Followed By Autologous Stem Cell Transplantation (ASCT) As Second-Line (2L) Treatment in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL): Results from the Randomized Phase 3 Transform Study [#91]

17 : Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma.

18 : Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma.

19 : Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma.

20 : Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma.

21 : Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma.

22 : A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease.

23 : A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease.

24 : A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease.

25 : Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial.

26 : Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial.

27 : Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults.

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29 : ACG Clinical Guidelines: Prevention, Diagnosis, and Treatment of Clostridioides difficile Infections.

30 : Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

31 : Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19.

32 : A Phase 3 Open-Label Study of Elexacaftor/Tezacaftor/Ivacaftor in Children 6 through 11 Years of Age with Cystic Fibrosis and at Least One F508del Allele.

33 : Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer.

34 : Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke.

35 : Second intravenous immunoglobulin dose in patients with Guillain-Barrésyndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial.

36 : Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.

37 : Immunotherapy in Patients With Locally Advanced Esophageal Carcinoma: ASCO Treatment of Locally Advanced Esophageal Carcinoma Guideline Rapid Recommendation Update.

38 : Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception.