Table 1.
Clinical Characteristics of 200 Patients for Whom Intravenous (IV) Zanamivir Was Requested via an Emergency Investigational New Drug (EIND) Program, April 2009–April 2011
| Parameter | Value |
|---|---|
| EIND requests, by interval | |
| April–July 2009 | 0 |
| August 2009–July 2010 | 99 (49.5) |
| August 2010–April 2011 | 101 (50.5) |
| Age, y | |
| Median (range) | 47 (0.5–91) |
| Mean | 47 |
| 0–4 | 15 (7.5) |
| 5–9 | 9 (4.5) |
| 10–17 | 15 (7.5) |
| 18–49 | 96 (48) |
| 50–64 | 54 (27) |
| ≥65 | 11 (5.5) |
| Sex | |
| Male | 95 (47.5) |
| Female | 105 (52.5) |
| Pregnant | 14 (7) |
| Race/ethnicity | Not reported |
| Baseline comorbidity | |
| Cancer | 36 (18) |
| Chronic lung disease | 26 (13) |
| Obesity | 17 (8.5) |
| Diabetes | 9 (4.5) |
| Chronic renal failure | 8 (4) |
| Heart disease | 7 (3.5) |
| HIV/AIDS | 2 (1) |
| Cirrhosis | 1 (0.5) |
| Immunosuppressiona (not cancer, not HIV/AIDS) | 17 (8.5) |
| Not reported | 97 (48.5) |
| Baseline influenza virus detected | |
| Influenza A virus | 177 (88.5) |
| Any | |
| A(H1N1)pdm09 | |
| Confirmed | 98 (49) |
| Suspected | 18 (9) |
| Subtype H3N2, confirmed | 1 (0.5) |
| Subtype not reported | 60 (30) |
| Influenza B virus | 12 (6) |
| Virus type not reported | 11 (5.5) |
| Baseline virologic resistance data | |
| Not reported | 149 (74.5) |
| H275Y oseltamivir resistance | |
| Confirmedb | 18 (9) |
| Immunosuppressed patientsc | 11 (5.5) |
| Suspectedb | 33 (16.5) |
| Immunosuppressed patientsd | 12 (6) |
| Antivirals used prior to or at time of EIND request | 157 (78.5) |
| Oseltamivir | 152 (76) |
| Peramivire | 20 (10) |
| Inhaled zanamivirf | 8 (4) |
| Amantadineg | 3 (1.5) |
| Rimantadineh | 3 (1.5) |
| Ribavirinh | 3 (1.5) |
| Not reported | 43 (21.5) |
| Complications reported at time of EIND request | |
| Pneumoniai | 73 (36.5) |
| Lobar infiltrate | 57 (28.5) |
| Bilateral infiltrate | 16 (8) |
| Acute renal failure | 50 (25) |
| Shock and/or multiorgan failure | 25 (12.5) |
| Bacterial infectioni | 19 (9.5) |
| Supportive care reported at time of EIND request | |
| Intubation/invasive mechanical ventilation | 134 (67) |
| Dialysis | 38 (19) |
| Extracorporeal membrane oxygenation | 27 (13.5) |
| Oscillating ventilator | 16 (8) |
| IV zanamivir treatment duration | |
| Not reported | 160 (80) |
| ≤5 d | 22 (11) |
| >5 d | 18 (9) |
| Outcome/follow-up data | |
| Not reported | 153 (76.5) |
| Died | 21 (10.5) |
| Survived | 26 (13) |
| Clinical improvement | 18 (9) |
| No clinical improvement | 8 (4) |
Data are no. (%) of patients, unless otherwise indicated.
Abbreviation: HIV, human immunodeficiency virus.
Renal transplantation (n = 6), lung transplantation (n = 3), congenital immunodeficiency (n = 4), chronic use of steroids (n = 2), and rheumatoid arthritis with chronic use of tumor necrosis factor blocker (n = 2).
All had received oseltamivir.
Cancer (n = 8), renal transplantation (n = 1), lung transplantation (n = 1), and congenital immunodeficiency (n = 1).
Cancer (n = 8), renal transplantation (n = 2), chronic use of steroids (n = 1), and rheumatoid arthritis with chronic use of tumor necrosis factor blocker (n = 1).
Eighteen also previously received oseltamivir, and 2 received IV peramivir only.
Five also received oseltamivir, and 3 patients received inhaled zanamivir only.
One also received oseltamivir, 1 also received IV peramivir, and 1 received oral amantadine only.
All also received oseltamivir.
Few EIND narratives reported microbiologic data.