Use and Safety of Paxlovid Among Patients with Moderate or Severe Hepatic or Renal Impairment

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Paxlovid
• Study drug International non-proprietary name (INN) or common name:
  NIRMATRELVIR

  RITONAVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AE) Protease inhibitors

  (J05AE30) nirmatrelvir and ritonavir
• Medical condition to be studied:
  Jaundice

  Vomiting

  Nausea

  Diarrhoea

  Abdominal pain

  Dysgeusia

  Headache

  Anaphylactic reaction
• Additional medical condition(s):
  Hepatic transaminase elevations, clinical hepatitis

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adult and elderly population (>18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Renal impaired

Study design details

• Main study objective:
  Assess the safety of Paxlovid among 1) individuals with moderate or severe hepatic impairment and 2) individuals with moderate or severe renal impairment; compared to users of molnupiravir or to unexposed.
• Outcomes:
  Hepatic transaminase elevations, clinical hepatitis, or jaundice, severe vomiting, nausea, diarrhoea, or abdominal pain, dysgeusia, headache, or hypertension, anaphylactic reactions.
• Data analysis plan:
  The study will have a cohort design, the design is retrospective, and the data were collected prospectively. Focusing on the target populations, the descriptive component will include tabulations of age, sex, comorbidities, selected concurrent medications, COVID-19 vaccination status, history of COVID-19, current COVID-19 status and setting of Paxlovid use (among Paxlovid users). Comparative analyses will be based on the estimation of risk/prevalence, risk/prevalence ratios, and risk/prevalence differences. Comparative analyses will control for measured confounding within each data source. Aggregated results from each data source will be combined using meta-analytic techniques as numbers allow. If a study population is too small, analyses will be only descriptive, pooling of results from various data sources will be undertaken only if at least 3 independent data points are available.

Documents

Study report

EUPAS50123-50126