Rapivab has a demonstrated safety profile in pediatric patients1
The safety and effectiveness of Rapivab for the treatment of influenza has been established in pediatric patients aged 2 years and older.
The primary endpoint was safety as measured by adverse events, laboratory analysis, vital signs, and physical exams.
- Safety was assessed in 110 pediatric patients ages 2 to 17 years with acute uncomplicated influenza who received a single dose of Rapivab (n = 88) within 48 hours of symptom onset or 5 days of treatment with oseltamivir (n = 22)
- Safety profile of Rapivab in pediatric patients was generally similar to that observed in adults
- Specific adverse reactions reported in pediatric subjects treated with Rapivab (occurring in >2% of subjects) and not reported in adults included vomiting (3% vs 9% for oseltamivir), fever (2% vs 0% for oseltamivir), and tympanic membrane erythema (2% vs 0% for oseltamivir)a
a The only clinically significant laboratory abnormality occurring in ≥2% of pediatric subjects treated with Rapivab was proteinuria by dipstick analysis (3% vs 0% for oseltamivir).
Safety Trial Design
The safety and effectiveness in pediatric patients was established in a randomized, active-controlled study in subjects with acute uncomplicated influenza who reported onset of symptoms within 48 hours. Patients were randomized to receive Rapivab (n = 88) 600 mg (13-17 years of age) and Rapivab 12 mg/kg up to a maximum dose of 600 mg (2-12 years of age), or oral oseltamivir twice a day for 5 days (n = 22). All enrolled subjects were allowed to take fever-reducing medications. Eligible patients had a fever ≥37.8°C (oral) with at least one respiratory symptom (cough or rhinitis) or a positive influenza rapid antigen test.1
Median time to resolution of flu symptoms and fever in pediatric patients aged 2 years and older who received a single dose of Rapivab1,b
Clinical Study Design
Study design in pediatric patient population1
A randomized, multicenter, open-label, active-controlled trial was performed to evaluate the safety, pharmacokinetics and efficacy of a single intravenous dose of Rapivab administered for a minimum of 15 minutes in subjects 2 to 17 years of age (n = 88) with acute uncomplicated influenza who had fever greater than or equal to 37.8°C (oral) with at least one respiratory symptom (cough or rhinitis) or a positive influenza rapid antigen test. Study treatment was started within 48 hours of onset of symptoms. Subjects were randomized to receive Rapivab 600 mg (13 to 17 years of age), Rapivab 12 mg/kg up to a maximum dose of 600 mg (2 to 12 years of age), or oral oseltamivir BID for 5 days. In addition, all enrolled subjects were allowed to take fever-reducing medications.
The overall efficacy population, consisting of subjects with confirmed influenza and administered study drug, totaled 84 subjects. Among the 69 subjects treated with Rapivab, the median age was 7.9 years; 55% were male; 58% were infected with influenza A virus, 36% were infected with influenza B virus, and 6% were co-infected with influenza A and B viruses.
The primary endpoint was the safety of peramivir compared to oseltamivir as measured by adverse events, laboratory analysis, vital signs and physical exams. Secondary endpoints included efficacy outcomes such as time to resolution of influenza symptoms and time to resolution of fever; however, the trial was not powered to detect statistically significant differences in these secondary endpoints. Subjects receiving Rapivab experienced a median time to alleviation of their combined influenza symptoms of 79 hours (interquartile range: 34-122 hours). The median time to recovery to normal temperature (less than 37°C) was 40 hours (interquartile range:19-68 hours).1