Baloxavir Marboxil Safe and Effective for High Risk Influenza Patients

October 06, 2018

Baloxavir was found to be superior to oseltamivir with respect to reducing the duration of virus replication and treatment of influenza B.

SAN FRANSISCO – Balboavir marboxil, an oral selective endonuclease inhibitor, was associated with a reduced risk of influenza complications and faster recovery in patients at higher risk compared to placebo high. In addition, baloxavir marboxil was found to be superior to oseltamivir in shortening the replication time of the virus and in resolving influenza B, according to a study presented at IDWeek 2018, held on 3 October 7, 2018, San Francisco, California.

Researchers participating in this international double-blind, randomized, placebo-controlled and oseltamivir international treatment study examined the safety and efficacy of baloxavir marboxil in patients at higher risk of osteoporosis. complications of influenza. Age of eligible participants >12 years old, had symptoms of influenza and fever for less than 48 hours, and at least one of the criteria for high risk criteria 1 of the Centers for Disease Control. Participants (N = 2184) were randomized to receive either an oral dose of baloxavir marboxil (40/80 mg for body weight less than or equal to 80 kg), a placebo or twice daily a dose of oseltamivir 75 mg for 5 days. The primary endpoint of the study was the time to improve flu-like symptoms in participants with confirmed influenza infection via reverse transcription polymerase chain reaction (RT-PCR); the secondary endpoints included complications related to influenza and prescriptions for antibiotics.

Fifty-three percent (n = 1,116) of the participants were confirmed by influenza RT-PCR (47.9% of the A / H3N2 strain, 6.9% of the A / H1N1 strain, 41.6% of the influenza B) and the most prevalent risk factors were over 65 years old. (27.4%) and with chronic lung disease or asthma (39.2%). The improvement in symptoms was significantly shorter in baloxavir marboxil than in placebo (median at 73.2 hours vs 102.3 hours). P<0.0001), as well as with respect to oseltamivir (81.0 h, P= 0.8347). The time to improvement in baloxabir marboxil symptoms in participants with influenza A / H3N2 was significantly shorter than those receiving placebo (median: 75.4 vs. 100.4; P= 0.0141), and significantly shorter in patients with influenza B than placebo or oseltamivir (74.6 hours vs 100.6 hours; P= 0.0138 and 101.6 hours; P= 0.0251, respectively). Influenza complications and routine antibiotic use were both significantly lower in baloxavir marboxil (2.8% and 3.4%, respectively) compared to placebo (10.4% and 7.5%, respectively). respectively); P<.0001 and P= 0.0112). There was no significant difference between the 3 groups with respect to the incidence of adverse events (25.1% to 29.7%) and serious adverse events ( 0.7% to 1.2%).

The researchers concluded that oral baloxavir marboxil "is a promising treatment option for [patients] with risk factors for flu complications ".

Disclosures: GlaxoSmithKlein helped with research.

Reference

Ison MG, Portsmouth South, Yoshida Y, Shishido T., Hayden F., Uehara T .: Phase 3 trial of baloxavir marboxil in patients at high risk of influenza (CAPSTONE-2 study). Presented at: IDWeek 2018; October 3 to 7, 2018; San Francisco, California.