Table 1:
Patient characteristics and adverse events.
| Molnupiravir | Nirmatrelvir/ritonavir | |
|---|---|---|
| Patient characteristics | N = 15 | N = 12 |
| Age (years), median (IQR) mean (Range) | 76 (49–96) | 76 (51–96) |
| Female sex, n (%) | 10 (66.7) | 3 (25) |
| Time from symptom onset to medication start (days), median (IQR) | 2 (0–5) | 1.9 (0–4) |
| Race/ethnicity, n (%) | ||
| White | 14 (93.3) | 10 (83.3) |
| Black | 0 (0) | 1 (8.3) |
| Hispanic | 0 (0) | 0 (0) |
| Asian | 1 (6.7) | 1 (8.3) |
| Other | 0 () | 0 (0) |
| Comorbidities, n (%) | ||
| Hypertension | 14 (93.3) | 12 (100) |
| Coronary artery disease | 8 (53.3) | 8 (66.7) |
| Diabetes mellitus | 9 (60) | 10 (83.3) |
| Cirrhosis | 0 (0) | 0 (0) |
| Medication use, n (%) | ||
| ACEi/ARB | 11 (73.3) | 12 (100) |
| Proton pump inhibitors | 10 (66.7) | 8 (66.7) |
| Diuretics | 11 (73.3) | 9 (75) |
| Immunosuppressantsa | 4 (26.7) | 1 (8.3) |
| CKD stage, n (%) | ||
| Stage 4 (eGFR 15–30 mL/min/1.73 m2) | 11 (73.3) | 11 (91.7) |
| Stage 5 (eGFR <15 mL/min/1.73 m2) | 1 (6.7) | 0 (0) |
| Stage 5D, receiving KRT | 3 (20) | 1 (8.3) |
| Baseline labs, median (IQR) | ||
| Serum albumin (g/dL) | 3.8 (2.4–4.5) | 4.2 (3.7–4.5) |
| Hemoglobin (g/dL) | 9.9 (7.4–12.6) | 11.9 (9.1–16.1) |
| Platelet count (1000/μL) | 255.5 (94–333) | 180.6 (120–252) |
| AST (U/L) | 19.4 (14–38) | 20 (15–24) |
| ALT (U/L) | 14.9 (5–39) | 17 (10–19) |
| COVID-19 vaccination status, n (%) | ||
| Primary series | 15 (100) | 12 (100) |
| At least 1 booster dose | 11 (73.3) | 10 (83.3) |
| COVID-19 symptoms at presentation, n (%) | ||
| Cough | 12 (80) | 6 (50) |
| Fever | 9 (60) | 1 (8.3) |
| Congestion | 4 (26.7) | 3 (25) |
| Shortness of breath | 2 (13.3) | 2 (16.7) |
| Gastrointestinal upset | 2 (13.3) | 2 (16.7) |
| Asymptomatic prior to initiating antiviral therapy | 0 (0) | 1 (8.3) |
| Concurrent treatment with monoclonal antibody | 2 (13.3) | 1 (8.3) |
| Adverse event summaryb, n (%) | ||
| Any AE | 3 (20) | 8 (66.7) |
| AE leading to treatment discontinuationc | 3 (20) | 2 (16.7) |
| Hospitalization within 4 weeks | 2 (13.3) | 2 (16.7) |
| Hospitalized for severe COVID-19 | 0 (0) | 0 (0) |
| Adverse events reported, n (%) | ||
| Gastrointestinal upset | 3 (20) | 2 (16.7) |
| Dysgeusia | 0 (0) | 3 (25) |
| Dry mouth | 0 (0) | 1 (8.3) |
| Fatigue | 0 (0) | 2 (16.7) |
| Dizziness | 0 (0) | 1 (8.3) |
| Dyspnea | 1 (6.7) | 2 (16.7) |
| Myalgia | 0 (0) | 1 (8.3) |
| Insomnia | 1 (6.7) | 0 (0) |
| Delirium | 1 (6.7) | 0 (0) |
| Gout | 0 (0) | 1 (8.3) |
| Worsening kidney functiond | 0 (0) | 1 (8.3) |
| Unresolved COVID-19 symptoms | 0 (0) | 3 (25) |
| Drug–drug interaction requiring medication adjustmente, n (%) | 0 (0) | 7 (58.3) |
Among the patients with kidney failure, the three treated with molnupiravir included two receiving hemodialysis and one receiving peritoneal dialysis. The one patient with kidney failure who was treated with nirmatrelvir/ritonavir was receiving hemodialysis.
aImmunosuppressant therapy used in molnupiravir-treated patients were prednisone and mycophenolate; nirmaltrelvir/ritonavir-treated patients were on daratumumab and dexamethasone.
Adverse events included any adverse events that occurred within 4 weeks of initiating oral antiviral therapy.
Molnupiravir (discontinued on Day 1 and 3 of the regimen due to gastrointestinal upset), an additional patient discontinued on Day 4 due to hospitalization for hallucinations (see text); nirmaltrevir/ritonavir (discontinued on Day 1 of the regimen due to gastrointestinal upset).
Worsening kidney function was defined by hospitalization for worsening kidney function or a rise in serum creatinine rising ≥1.5 times baseline anytime during treatment or within 4 weeks of treatment completion.
The drugs withheld due to drug–drug interaction were apixaban, oxycodone, atorvastatin, hydrocodone, tamsulosin and dexamethasone.
IQR, interquartile range; AST, aspartate aminotransferase; ALT, alanine transaminase; ACEi/ARB, angiotensin-converting enzyme inhibitor or angiotensin II receptor blockade; KRT, kidney replacement therapy.