A single dose of the the neuraminidase inhibitor (NAI) peramivir can safely and effectively relieve influenza symptoms such as fever and viral shedding when administered within 48 hours of the onset of symptoms, according to the results of clinical trials.
The treatment was evaluated with phase 2 and phase 3 clinical trials, the American Society for Microbiology reported.
"Based on clinical data, peramivir is the first neuraminidase inhibitor (NAI) that has shown to be safe and effective as a single-dose therapy for patients with acute, uncomplicated influenza. According to a retrospective combined analysis of two clinical studies, a single dose of peramivir, administered intramuscularly (IM), alleviated flu symptoms, including fever, significantly faster than the studies' placebo arms," said presenting author Rich Whitley of the University of Alabama at Birmingham.
The two placebo-controlled studies included 427 adults who were given a single dose of peramivir as an injection within 48 hours of the onset of flu-like symptoms. The study participants recorded their temperatures and the severity of their flu symptoms using a four-point scale for 14 days. Compared to the patients that received the placebo, peramivir was found to reduce the median time to alleviation of symptoms by 22 hours and time to resolution of fever by 24 hours.
Influenza is responsible for 200,000 hospitalizations and 36,000 deaths in the U.S. annually. Vaccines can be used for prevention, but the virus often changes strains, making virus development difficult.
Peramivir has been approved in Japan and Korea since 2010 and has been administered to about one million Japanese patients. More than 2,700 subjects have been treated with the drug in 27 clinical trials. If approved by the FDA, the drug could be used as a single-dose treatment for influenza in the U.S.
The findings were presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), an infectious diseases meeting of the American Society for Microbiology (ASM).
