| COVID-19 Therapeutics Options by Exposure and Infection Status | 175 | | COVID-19 Therapeutics Options by Exposure and Infection Status | <p><strong>āSARS-CoV-2 Negative (-)</strong></p><table cellspacing="0" width="100%" class="ms-rteTable-7" style="border-spacing:0px;overflow-x:auto;"><tbody style="box-sizing:border-box;"><tr class="ms-rteTableHeaderRow-7" style="box-sizing:border-box;"><th class="ms-rteTableHeaderEvenCol-7" rowspan="1" colspan="1" style="box-sizing:border-box;width:298.5px;"><p><strong>Not Exposed</strong></p></th><th class="ms-rteTableHeaderOddCol-7" rowspan="1" colspan="1" style="box-sizing:border-box;width:298.5px;"><p><strong>Exposed</strong></p></th></tr><tr class="ms-rteTableOddRow-7" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-7" style="box-sizing:border-box;"><p>Pre-Exposure Prophylaxis (PrEP)</p></td><td class="ms-rteTableOddCol-7" style="box-sizing:border-box;"><p>Post-Exposure Prophylaxis (PEP)</p></td></tr><tr class="ms-rteTableEvenRow-7" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-7" style="box-sizing:border-box;"><p>Long-Acting Monoclonal Antibody</p><ul><li><p>Tixagevimab/cilgavimab (Evusheld)</p></li></ul></td><td class="ms-rteTableOddCol-7" style="box-sizing:border-box;"><p>Currently no authorized treatments</p></td></tr></tbody></table><p><br></p><p><strong>SARS-CoV-2 Positive (+)</strong></p><table cellspacing="0" width="100%" class="ms-rteTable-9" style="border-spacing:0px;overflow-x:auto;"><tbody style="box-sizing:border-box;"><tr class="ms-rteTableHeaderRow-9" style="box-sizing:border-box;"><th class="ms-rteTableHeaderEvenCol-9" rowspan="1" colspan="1" style="box-sizing:border-box;width:597px;"><p><strong>Mild to Moderate Illness in Individual at High Risk for Disease Progression</strong></p></th></tr><tr class="ms-rteTableOddRow-9" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-9" style="box-sizing:border-box;"><p>Treatment options, in order of preference:</p><p>1. Nirmatrelvir/ritonavir (Paxlovid)</p><p>2. Remdesivir (Veklury)<br></p><p>If above options are unavailable or not medically appropriate, can consider (in alphabetical order):</p><p>3. Bebtelovimab</p><p>4. Molnupiravir (Lagevrio)</p><div><br><br></div></td></tr></tbody></table><br><div>āU.S. Department of Health and Human Services (HHS) summary table:Ā <a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Documents/side-by-side-overview.pdf" target="_blank">Side-by-Side Overview of Therapies</a>Ā (PDF).</div><div><br></div><div>FDA approved/authorized COVID-19 drug:Ā <a href="https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs" target="_blank">Coronavirus (COVID-19) | Drugs | FDA</a><br></div> | | | |
| Monoclonal Antibodies | 176 | | Monoclonal Antibodies | <p><strong>āDrug: </strong>Bebtelovimab 175 mg given as a single intravenous injection<br></p><p><strong>Route:</strong> Intravenous<br></p><p><strong>Age groups authorized for treatment: </strong>12 years and older and weighing at least 40 kg<br></p><p><strong>Timing of treatment:Ā </strong>As soon as possible, but within 7 days of symptom onset<br></p><p><strong>Treatment effectiveness:</strong>Ā In low-risk adults, 34% <a href="https://www.fda.gov/media/156152/download">relative reduction</a> in viral load compared to placebo and a relative reduction in time to sustained symptom resolution compared to placebo. Currently there is no trial data to determine difference in clinical outcomes between placebo and treatment arms.<br></p><p><strong>Activity against variants currently circulating:</strong>Ā Effective against Omicron, including BA.2 and BA. 4/5Ā subvariants.<br></p><p><br></p> | | | |
| Additional Guidance on Monoclonal Antibodies | 179 | | Additional Guidance on Monoclonal Antibodies | <p>āMonoclonal antibodies are synthetic proteins that block virus from attachment and entry into human cells. With the predominance of the BA.2 Omicron subvariant throughout the United States, only one anti-SARS-CoV-2 monoclonal antibody, bebtelovimab, is currently authorized for COVID-19 treatment.</p><p>Additionally, there is one anti-SARS-CoV-2 monoclonal antibody, tixagevimab/cilgavimab (Evusheld), that is currently authorized for pre-exposure prophylaxis against COVID-19 in individuals who are immunocompromised or have a medical contraindication to COVID-19 vaccines. Notably, Evusheld is not a substitute for vaccination and should not be used in unvaccinated individuals for whom COVID-19 vaccination is recommended and who are anticipated to have an adequate response. Vaccination remains the most effective way to prevent SARS-CoV-2 infection, and it should be considered the first line of prevention.</p><p><strong>General information on monoclonal antibodies:</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/" target="_blank">Anti-SARS-CoV-2 Monoclonal Antibodies | COVID-19 Treatment Guidelines (nih.gov)</a></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/tables/mab-characteristics/" target="_blank">Table 3c: Characteristics of Anti-SARS-CoV-2 Antibody Products | COVID-19 Treatment Guidelines (nih.gov)</a></p></li><li><p><a href="https://www.phe.gov/emergency/mAbs-calculator/Pages/default.aspx" target="_blank">Monoclonal Antibody Calculator</a></p></li></ul><p><strong>Infusion locations</strong><br></p><ul><li><p><a href="https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/" target="_blank">COVID-19 Therapeutics Locator (arcgis.com)</a></p></li></ul><p><strong>Bebtelovimab:</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-monoclonal-antibody-treatment-covid-19-retains" target="_blank">FDA authorization of Bebtelovimab</a></p></li><li><p><a href="https://www.fda.gov/media/156151/download" target="_blank">Bebtelovimab EUA Letter of Authorization</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/156152/download#:~:text=Bebtelovimab%20is%20a%20recombinant%20neutralizing%2cunmodified%20in%20the%20Fc%20region." target="_blank">Bebtelovimab Healthcare Provider Fact Sheet</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/156154/download" target="_blank">Bebtelovimab EUA Frequently Asked Questions</a>Ā (PDF)</p></li></ul><p><strong>COVID-19 Pre-exposure Prophylaxis (with Evusheld)</strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/overview/prevention-of-sars-cov-2/" target="_blank">Prevention of SARS-CoV-2 | COVID-19 Treatment Guidelines (nih.gov)</a></p></li><li><p><a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html?ACSTrackingID=USCDC_2067-DM81188&ACSTrackingLabel=COVID-19%20Preventive%20Medication&deliveryName=USCDC_2067-DM81188#preventive" target="_blank">COVID-19 Preventive Medication</a></p></li></ul><p><strong>Evusheld:</strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-revisions-evusheld-dosing" target="_blank">FDA revisions to Evusheld Dosing</a></p></li><li><p><a href="https://www.fda.gov/media/154704/download" target="_blank">Evusheld EUA Letter of Authorization</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/154701/download" target="_blank">Evusheld Healthcare Provider Fact Sheet</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/156617/download" target="_blank">Evusheld Dear Healthcare Provider Letter</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/154703/download" target="_blank">Evusheld EUA Frequently Asked Questions</a>Ā (PDF)<br></p></li></ul><p><br></p> | | | |
| Antivirals | 177 | | Antivirals | <table cellspacing="0" width="100%" class="ms-rteTable-4" style="border-spacing:0px;overflow-x:auto;"><tbody style="box-sizing:border-box;"><tr class="ms-rteTableHeaderRow-4" style="box-sizing:border-box;"><th class="ms-rteTableHeaderEvenCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:145.672px;"><p><strong>Drug</strong></p></th><th class="ms-rteTableHeaderOddCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:102.328px;"><p><strong>Route</strong></p></th><th class="ms-rteTableHeaderEvenCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:105.75px;"><p><strong>Age groups authorized for treatment</strong></p></th><th class="ms-rteTableHeaderOddCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:96.4688px;"><p><strong>Timing of Treatment</strong></p></th><th class="ms-rteTableHeaderEvenCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:130.031px;"><p><strong>Effectiveness</strong></p></th><th class="ms-rteTableHeaderOddCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:138.75px;"><p><strong>Activity Against Variants Currently Circulating</strong></p></th></tr><tr class="ms-rteTableOddRow-4" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p><strong>Nirmatrelvir with ritonavir (Paxlovid)</strong></p><p>Orally twice daily for 5 days</p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;"><li style="box-sizing:border-box;"><p>For patients with normal/mild renal impairment (eGFR > 60 mL/min): 300 mg nirmatrelvir with 100 mg ritonavir</p></li><li style="box-sizing:border-box;"><p>For patients with moderate renal impairment (eGFR ā„ 30 to < 60 mL/min): 150 mg nirmatrelvir with 100 mg ritonavir</p></li></ul></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Oral</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>12 years and older and weighing at least 40 kg</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>As soon as possible, but within 5 days of symptom onset</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>Compared to placebo,Ā <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate" target="_blank">a relative risk reduction of 89%</a>Ā in hospitalizations or deaths.</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Effective againstĀ Omicron, including BA.2 subvariant</p></td></tr><tr class="ms-rteTableEvenRow-4" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p><strong>Remdesivir (Veklury)</strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;"><li style="box-sizing:border-box;"><p>For adults and pediatric patients weighing ā„ 40 kg: 200 mgĀ IV on Day 1, followed by 100 mgĀ IV daily on Days 2 and 3</p></li><li style="box-sizing:border-box;"><p>For pediatric patients ā„ 28 days old and weighing ā„ 3 kg to < 40 kg: 5 mg/kg IV on Day 1, followed by 2.5 mg/kg IV daily on Days 2 and 3.</p></li></ul></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Intravenous</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>FDA approved for mild to moderately ill adult and pediatric (28 days of age and older weighing at least 3 kilograms) outpatients who are at risk of disease progression.<br></p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>As soon as possible, but within 7 days of symptom onset</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>Compared to placebo,Ā <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116846" target="_blank">a relative risk reduction of 87%</a>Ā in hospitalizations or deaths.</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Effective againstĀ Omicron, including BA.2 subvariant</p></td></tr><tr class="ms-rteTableOddRow-4" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p><strong>Molnupiravir (Lagevrio) 800 mg</strong></p><p>Orally twice daily for 5 days</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Oral</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>18 years and older</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>As soon as possible, but within 5 days of symptom onset</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>Compared to placebo,Ā <a href="https://www.merck.com/news/merck-and-ridgeback-biotherapeutics-provide-update-on-results-from-move-out-study-of-molnupiravir-an-investigational-oral-antiviral-medicine-in-at-risk-adults-with-mild-to-moderate-covid-19/" target="_blank">a relative risk reduction of 30%</a>Ā in hospitalizations or deaths.</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Effective againstĀ Omicron, including BA.2 subvariant<br><br><br></p></td></tr></tbody></table><p><br></p><p><br></p> | | | |
| Additional Guidance on Antivirals | 180 | | Additional Guidance on Antivirals | <p>āAntivirals prevent viral replication through multiple processes. There are currently two oral antivirals, nirmatrelvir/ritonavir (Paxlovid) and molnupiravir (Lagevrio), that are authorized for outpatient treatment of COVID-19. Additionally, remdesivir (Veklury) is an intravenous antiviral that has FDA approval for inpatient and outpatient treatment of COVID-19 in adult and pediatric patients 28 days and older weighing at least 3 kg.</p><p><strong>General Information on antivirals</strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/summary-recommendations/" target="_blank">Antiviral Therapy Summary Recommendations | COVID-19 Treatment Guidelines (nih.gov)</a></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/table--characteristics-of-antiviral-agents/" target="_blank">Table 2f: Characteristics of Antiviral Agents | COVID-19 Treatment Guidelines (nih.gov)</a></p></li></ul><p><strong>Nirmatrelvir/ritonavir (Paxlovid):</strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><strong>Update on Paxlovid:Ā </strong></p><p>With reports of COVID-19 symptom recurrence after treatment with the oral antiviral agent, Paxlovid (nirmatrelvir/ritonavir), the Centers for Disease Control (CDC) issued a health alert on May 24th, 2022 addressing this phenomenon. Although COVID-19 rebound after treatment with Paxlovid has been described in case reports, there is currently no evidence that this rebound is the result of SARS-CoV-2 resistance to Paxlovid. Based on case reports, recurrent symptoms after treatment with Paxlovid appear to be mild. Because the goal of Paxlovid treatment is avoiding progression to severe disease, recurrent mild to moderate symptoms do not indicate treatment failure. Individuals with COVID-19 symptom recurrence show follow CDC and CDPH guidance regarding isolation of infected patients regardless of their treatment status. Paxlovid continues to be recommended for the treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease.</p></li><li><p><a href="https://www.fda.gov/media/155049/download" target="_blank">Paxlovid EUA Letter of Authorization</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155050/download" target="_blank">Paxlovid Healthcare Provider Fact Sheet</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155071/download" target="_blank">Paxlovid Dear Healthcare Provider Letter</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155052/download" target="_blank">Paxlovid EUA Frequently Asked Questions</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155072/download" target="_blank">Paxlovid Dispensing Information for Patients with Moderate Renal Impairment</a>Ā (PDF)</p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/ritonavir-boosted-nirmatrelvir--paxlovid-/paxlovid-drug-drug-interactions/" target="_blank">NIH Paxlovid drug info</a></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/ritonavir-boosted-nirmatrelvir--paxlovid-/paxlovid-drug-drug-interactions/" target="_blank">NIH Paxlovid drug-drug interactions</a></p></li><li><p><a href="https://www.pfizermedicalinformation.com/en-us/drug-interaction-checker?product=PAXLOVID%E2%84%A2+%7c+nirmatrelvir+tablets%3b+ritonavir+tablets" target="_blank">Pfizer Paxlovid Drug Interaction Checker</a></p></li><li><p><a href="https://covid19-sciencetable.ca/sciencebrief/nirmatrelvir-ritonavir-paxlovid-what-prescribers-and-pharmacists-need-to-know-2-0/" target="_blank">Ontario COVID-19 Science Advisory Table</a></p></li><li><p><a href="https://www.fda.gov/media/158165/download" target="_blank">Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers</a>Ā (PDF)</p></li><li><p><a href="https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/management-of-drug-interactions-with-nirmatrelvirritonavir-paxlovid/" target="_blank">Management of Drug Interactions With Nirmatrelvir/Ritonavir (PaxlovidĀ®): Resource for Clinicians (idsociety.org)</a></p></li><li><p><a href="https://emergency.cdc.gov/han/2022/pdf/CDC_HAN_467.pdf?ACSTrackingID=USCDC_511-DM82753&ACSTrackingLabel=HAN%20467%20-%20COCA%20Subscribers&deliveryName=USCDC_511-DM82753">CDC Health Alert Network (HAN) Health Advisory: COVID-19 Rebound after Paxlovid Treatment</a>Ā (PDF)</p></li></ul><p><strong>Molnupiravir (Lagevrio):</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.fda.gov/media/155053/download" target="_blank">Lagevrio EUA Letter of Authorization</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155054/download" target="_blank">Lagevrio Healthcare Provider Fact Sheet</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155101/download" target="_blank">Lagevrio Dear Healthcare Provider Letter</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155056/download" target="_blank">Lagevrio EUA Frequently Asked Questions</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155118/download" target="_blank">Lagevrio Prescriber Checklist</a>Ā (PDF)</p></li></ul><p><strong>Remdesivir (Veklury):</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.gilead.com/-/media/files/pdfs/medicines/covid-19/veklury/veklury_pi.pdf" target="_blank">Veklury Prescribing InformationĀ </a>Ā (PDF)</p></li><li><p><a href="https://www.vekluryhcp.com/downloads/Outpatient_Product_Information_Guide.pdf" target="_blank">Veklury Outpatient Product Information GuideĀ </a>(PDF)</p></li><li><p><a href="https://www.gilead.com/-/media/gilead-corporate/files/pdfs/covid-19/dhcp-letter_peds-labeling.pdf?la=en&hash=EBD10EB91622F6D797DC49C813FE7E01" target="_blank">Veklury Dear Healthcare Provider Letter</a>Ā (PDF)<br></p></li><li><p><a href="https://www.vekluryhcp.com/downloads/Coding_and_Reimbursement_information.pdf" target="_blank">Veklury Coding and Reimbursement information</a>Ā (PDF)<br></p></li></ul><p><br></p> | | | |
| Pre-Exposure Prophylaxis | 178 | | Pre-Exposure Prophylaxis | <p><strong>āDrug: </strong>Tixagevimab 300 mg / 300 cilgavimab mg (Evusheld), given as two separate, consecutive injections<br></p><p><strong>Route: </strong>Intramuscular</p><p><strong>Age groups authorized for treatment: </strong>12 years and older and weighing at least 40 kg<br></p><p><strong>Pre-exposure prophylaxis effectiveness:</strong> Reduced the risk of developingĀ symptomatic COVID-19 byĀ <a href="https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-prophylaxis-trial-met-primary-endpoint.html" target="_blank">77% compared to placebo</a>.<br></p><p><strong>Activity against variants currently circulating:</strong> Effective against Omicron, including the BA.2 and BA.4/5 subvariants<br></p> | | | |
| Clinical Decision Making Guides | 181 | | Clinical Decision Making Guides | <p>Multiple factors must be considered when selecting the appropriate treatment for outpatient with COVID-19. These include patient-specific factors such as clinical/medical conditions and potential drug-drug interactions; and healthcare system factors such as drug availability and feasibility of drug administration.<br></p><p><strong>Treatment Guidelines</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/" target="_blank">COVID-19 Treatment Guidelines (nih.gov)</a></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/nonhospitalized-adults--therapeutic-management/?utm_source=site&utm_medium=home&utm_campaign=highlights" target="_blank">Nonhospitalized Adults: Therapeutic Management | COVID-19 Treatment Guidelines (nih.gov)</a></p></li><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Pages/default.aspx" target="_blank">HHS Clinical Implementation Guide</a>Ā (PDF)</p></li></ul><p>T<strong>reatment Algorithms (Flow Charts)</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Documents/COVID-Therapeutics-Decision-Aid.pdf" target="_blank">HHS Outpatient Therapeutics Decision Aid</a>Ā (PDF)</p></li><li style="box-sizing:border-box;"><p><a href="https://www.idsociety.org/globalassets/covid-19-real-time-learning-network/outpatientroadmap-v10.pdf" target="_blank">IDSA Outpatient Treatment Roadmap</a>Ā (PDF)</p></li></ul><p><strong>Drug Interaction Checker</strong></p><ul><li><p><a href="https://covid19-druginteractions.org/view_all_interactions" target="_blank">Liverpool COVID-19 Interactions (covid19-druginteractions.org)</a></p></li></ul><p><strong>COVID-19 Variant Information</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions" target="_blank">CDC Variant Tracker</a></p></li><li><p><a href="https://covid.cdc.gov/covid-data-tracker/#circulatingVariants" target="_blank">CDC Nowcast Estimates</a></p></li></ul><p><strong>Underlying Medical Conditions</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html" target="_blank">Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals | CDC</a></p></li><li style="box-sizing:border-box;"><p><a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html" target="_blank">COVID-19 Vaccines for Moderately or Severely Immunocompromised People | CDC</a><br></p></li></ul> | | | |
| Locating COVID-19 Therapeutics | 182 | | Locating COVID-19 Therapeutics | <p>āHHS maintains a Therapeutic locator of sites that currently have outpatient therapeutics available.</p><p>The federal government launched the Test to Treat initiative to facilitate expedited access to testing, assessment, and treatment. Through this program, various clinic-based pharmacies provide on-site testing (including the evaluation of at-home test results), clinical assessment, and prescription and dispensing of COVID-19 oral antiviral medications.</p><p>Additionally, the California Department of Public Health (CDPH) and Optum Serve are upgrading testing sites to provide free and confidential testing and oral antiviral treatment to individuals who test positive and are eligible for COVID-19 treatment, including for uninsured, underinsured, undocumented, and unhoused individuals.</p><p><strong>Therapeutics locator</strong></p><ul><li><p><a href="https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/" target="_blank">COVID-19 Therapeutics Locator (arcgis.com)</a></p></li></ul><p><strong>Test to Treat Program ā General Information</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://aspr.hhs.gov/TestToTreat/Pages/default.aspx" target="_blank">Test To Treat (hhs.gov)</a></p></li><li><p><a href="https://aspr.hhs.gov/TestToTreat/Documents/Fact-Sheet.pdf" target="_blank">Fact Sheet: COVID-19 Test to Treat (hhs.gov)</a>Ā (PDF)</p></li><li><p><a href="https://aspr.hhs.gov/TestToTreat/Pages/digital-toolkit.aspx" target="_blank">Test to Treat Digital Toolkit</a></p></li></ul><p><strong>Test to Treat Site Locator</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://covid-19-test-to-treat-locator-dhhs.hub.arcgis.com/" target="_blank">COVID-19 Test to Treat Locator English (arcgis.com)</a></p></li><li><p><a href="https://lhi.care/start" target="_blank">COVID-19 Test Registration (lhi.care)</a></p></li></ul><p><strong>CDPH Test to Treat Locations</strong></p><ul><li><p><a href="/Programs/CID/DCDC/Pages/COVID-19/Test-to-treat-locations.aspx" target="_blank">COVID-19 Test to Treat Locations</a><br></p></li></ul> | | | |
| What treatments are available for post-COVID conditions? | 193 | | What treatments are available for post-COVID conditions? | <p>ā<span data-contrast="none" lang="EN-US">Medical providers will first rule out other medical conditions that could be causing symptoms. They might also run tests to understand which organs are affected such as the brain, nervous system, heart, or lungs. You may be referred to a specialist. Your medical provider may recommend treatments for your symptoms.Ā </span></p><p><span data-contrast="none" lang="EN-US">For example:</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}">Ā </span></p><div><div><ul><li><p><span data-contrast="none" lang="EN-US">Breathing exercises and respiratory therapy can help the lungs recover.</span><span data-ccp-props="{"134233279":true,"201341983":0,"335559739":160,"335559740":259}">Ā </span></p></li><li><p><span data-contrast="none" lang="EN-US">Physical and occupational therapy can help patients get strong enough to return to their daily activities and work. Pacing yourself and not overdoing it is also important.</span><span data-ccp-props="{"134233279":true,"201341983":0,"335559739":160,"335559740":259}">Ā </span></p></li><li><p><span data-contrast="none" lang="EN-US">Counseling or psychotherapy can help patients and loved ones with the mental and emotional effects of COVID-19 and post-COVID conditions.</span><span data-ccp-props="{"134233279":true,"201341983":0,"335559739":160,"335559740":259}">Ā </span></p></li></ul></div><div><p><span data-contrast="none" lang="EN-US">See the "Tools for recovery and rehabilitation" section on the <a href="/Programs/CID/DCDC/Pages/COVID-19/Post-COVID-Conditions-Resources.aspx">Resources for People with post-COVID Conditions (Long COVID)</a> webpage for more information.Ā </span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}">Ā </span></p></div></div> | | | |
| Allocation and Distribution of Therapeutics | 183 | | Allocation and Distribution of Therapeutics | <p>On April 25, 2022, HHS transitioned from a weekly allocation distribution process to a weekly "threshold and replenishment" strategy. This new strategy is similar to the allocation process for vaccines and allows jurisdictions to order treatments throughout the week.<br></p><p>With the new threshold and replenishment strategy, each jurisdiction sets a threshold for Paxlovid, lagevrio, and bebtelovimab and each Monday, the federal government replenishes products equal to the amount ordered the previous week. This means that no supply is swept; threshold reset occurs each Monday to restore the full threshold amount.</p><p>The threshold and replenishment strategy applies to Evusheld as well. However, instead of a weekly threshold reset, Evusheld will follow a monthly schedule.</p><p>Thresholds will be determined using the same methodology as the previous weekly allocation: oral antivirals and Evusheld will continue to be determined on a pro-rata population basis while Bebtelovimab will remain disease-based.</p><p><strong>Weekly state and territory-coordinated distribution method (September 13, 2021 ā April 24, 2022)</strong></p><ul><li><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Distribution/Pages/default.aspx" target="_blank">State/Territory-Coordinated Distribution of COVID-19 Therapeutics (hhs.gov)</a></p></li></ul><p><strong>Threshold and replenishment distribution method (April 25, 2022 ā present)</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Documents/ASPR-Fact-Sheet_Therapeutics-Utilization.pdf" target="_blank">ASPR Therapeutics Distribution fact sheet</a>Ā (PDF)</p></li><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Orders/Pages/default.aspx" target="_blank">COVID-19 Therapeutics Thresholds, Orders, and Replenishment by Jurisdiction | HHS/ASPR</a><br></p></li></ul><p><br></p> | | | |
| Billing Information | 184 | | Billing Information | <ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;font-family:"source sans pro", sans-serif;font-size:15px;background-color:#ffffff;"><li><p>ā<a href="https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies" target="_blank">CMS reimbursement information for monoclonal antibodies</a><br></p></li><li><p><a href="https://www.cms.gov/files/document/hpms-memo-oral-antiviral-guidance.pdf" target="_blank">CMS reimbursement information for oral antivirals</a><br></p></li></ul><p><br></p> | | | |