Paxlovid Associated with Decreased Hospitalization Rate Among Adults with COVID-19 — United States, April–September 2022

Abstract

On November 22, 2022, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr).Nirmatrelvir-ritonavir (Paxlovid), an oral antiviral treatment, is authorized for adults with mild-to-moderate COVID-19 who are at increased risk for progression to severe illness. However, real-world evidence on the benefit of Paxlovid, according to vaccination status, age group, and underlying health conditions, is limited. To examine the benefit of Paxlovid in adults aged ≥18 years in the United States, a large electronic health record (EHR) data set (Cosmos † ) was analyzed to assess the association between receiving a prescription for Paxlovid and hospitalization with a COVID-19 diagnosis in the ensuing 30 days. A Cox proportional hazards model was used to estimate this association, adjusted for demographic characteristics, geographic location, vaccination, previous infection, and number of underlying health conditions. Among 699,848 adults aged ≥18 years eligible for Paxlovid during April-August 2022, 28.4% received a Paxlovid prescription within 5 days of COVID-19 diagnosis. Being prescribed Paxlovid was associated with a lower hospitalization rate among the overall study population (adjusted hazard ratio [aHR] = 0.49), among those who had received ≥3 mRNA COVID-19 vaccines (aHR = 0.50), and across age groups (18-49 years: aHR = 0.59; 50-64 years: aHR = 0.40; and ≥65 years: aHR = 0.53). Paxlovid should be prescribed to eligible adults to reduce the risk of COVID-19associated hospitalization.Paxlovid is an oral antiviral medication that received Emergency Use Authorization by the Food and Drug Administration on December 22, 2021 (1), for use in patients with mild-to-moderate COVID-19 at high risk for progression to severe illness. Eligibility for Paxlovid includes 1) receipt of a positive SARS-CoV-2 test result (including home antigen test), 2) symptoms consistent with mild-to-moderate COVID-19, 3) symptom onset within the past 5 days, 4) age ≥18 years (or age ≥12 years and weight ≥40 kg), 5) one or more risk factors for progression to severe COVID-19, 6) no known or suspected severe renal or hepatic impairment, 7) no history of clinically significant reactions (e.g., toxic epidermal necrolysis or Stevens-Johnson syndrome) to the active ingredients (nirmatrelvir or ritonavir) or other components of the product, and 8) no contraindicated medications. §

Characteristics and outcomes of US Veterans at least 65 years of age at high risk of severe SARS-CoV-2 infection with or without receipt of oral antiviral agents

“…The primary outcome was composite hospitalization or death at 28 days, which was reached in a very small proportion of patients in each group: 0.8% versus 0.8%. There are a few observational studies available evaluating either nirmatrelvir/ritonavir or molnupiravir compared to usual care, but these studies are also challenged by varying primary outcomes, low incidences of primary outcome events, or low numbers of individuals included at least 65 years or older 18 , 19 , 20 , 21 , 22 , 23 , 24 . The largest of these projects was from Shah and colleagues at the US Centers for Disease Control and Prevention 24 .…”

“…There are a few observational studies available evaluating either nirmatrelvir/ritonavir or molnupiravir compared to usual care, but these studies are also challenged by varying primary outcomes, low incidences of primary outcome events, or low numbers of individuals included at least 65 years or older 18 , 19 , 20 , 21 , 22 , 23 , 24 . The largest of these projects was from Shah and colleagues at the US Centers for Disease Control and Prevention 24 . Administrative database review limited to nirmatrelvir/ritonavir patients examining effect of treatment on subsequent need of hospitalization demonstrated a a 51% lower hospitalization rate within 30 days after diagnosis than those who were not prescribed nirmatrelvir/ritonavir.…”

Safety and Efficacy of Paxlovid Against Omicron Variants of Coronavirus Disease 2019 in Elderly Patients

“…In kidney transplant recipients infected with SARS-CoV-2, the Paxlovid treatment under a strict protocol was also relatively safe and effective [ 20 ]. Another retrospective analysis also demonstrated that Paxlovid could reduce the risk of COVID-19-associated hospitalization [ 21 ]. However, these studies were not powered to demonstrate the effect of Paxlovid on the elderly patients, although they were predominantly affected by omicron surge.…”

Benefits of near-universal vaccination and treatment access to manage COVID-19 burden in the United States

“…S13). Further, if the true risk reduction for hospitalization of treatment is 50%, lower than the originally reported 88%, as indicated in recent CDC reports (12), universal treatment is projected to reduce mortality by 78% and hospitalization by 56% on average across all three transmission scenarios and two immune durations. Similarly, using a risk reduction for hospitalization of 30% (as seen in molnupiravir trials ( 50)) universal treatment is projected to reduce mortality by 70% and hospitalization by 41% on average across all three scenarios and two immune durations (Fig.…”