COVID therapeutics approved for Persons with End-stage Renal Disease

 

To: ESRD Facility Administrators and Medical Directors, SNF Nursing Directors and Medical Directors   From: CDPHE Medical Epidemiology & Infection Prevention Program   August 14, 2023 Dear Health Care Providers, Thank you for your continued partnership in supporting Coloradans affected by COVID-19 by ensuring ongoing access to COVID-19 therapeutics. We have important news to share that may be relevant to your patients.  As you may recall, remdesivir (Veklury®) is an antiviral medication indicated for treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are:  • Hospitalized, or  • Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.  On July 14, 2023, Gilead announced that the FDA approved a supplemental new drug application (sNDA) for the use of remdesivir (Veklury®) in patients with COVID-19 and renal impairment of any stage, including patients on dialysis, without dose adjustment.  Patients with renal impairment are considered high risk for severe COVID-19. The NIH treatment guidelines recommend (in order of preference) Paxlovid or remdesivir for nonhospitalized patients who are at high risk of progressing to severe COVID-19, which includes those with chronic kidney disease (CKD) and people receiving dialysis. Paxlovid is not currently recommended for patients with severe renal impairment (eGFR <30 mL/min), making remdesivir the only currently approved and NIH preferred option for outpatient treatment of COVID-19 in patients with severe renal impairment. (Renally dosed Paxlovid is available for eGFR ≥30 to <60 mL/min).  For outpatient treatment, remdesivir should be initiated within 7 days of symptom onset and is given by an IV infusion once daily for three days (Prescribing Information). It is available commercially and information about ordering and distribution can be found here. Information can be found here on NIH recommendations for inpatient remdesivir use. Thank you for your continued support and partnership. If you have questions about COVID-19 therapeutics, email med_epi@state.co.us or cdphe_infectionprevention@state.co.us.  Additional resources:  NIH Treatment Guidelines: Remdesivir (includes Considerations in Patients With Renal Insufficiency, which has been updated)