Baloxavir Marboxil Shows Reduction in Influenza Transmission

Key Takeaways

Baloxavir marboxil reduced influenza transmission in a phase 3 study, meeting its primary endpoint of virological transmission reduction by day 5.
The study involved randomizing symptomatic individuals to receive either baloxavir marboxil or placebo, with specific dosing based on age and weight.
Baloxavir marboxil, approved in 2018, has demonstrated safety and efficacy in reducing symptoms and illness duration in uncomplicated influenza cases.
The study's results were presented at the Options XII for the Control of Influenza 2024 Congress, emphasizing its potential role in pandemic preparedness.

Baloxavir marboxil (Xofluza; Roche) demonstrated a reduction in the transmission of influenza viruses in the phase 3 CENTERSTONE (NCT03969212) study. Investigators reported that the study met its primary end point, demonstrating that a single, oral dose reduced the transmission of influenza by those infected to others in their household.¹

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“Building on [baloxavir marboxil’s] established efficacy in treating and preventing influenza after exposure, this new evidence of transmission reduction represents an important advance that could help improve health outcomes at an individual and community level,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, said in a news release. “We look forward to discussing these data with regulatory authorities and public health organizations for influenza pandemic preparedness to bring these benefits to patients.”¹

In the study, investigators randomized treatment to individuals who were otherwise healthy with influenza symptoms within 48 hours of screening; individuals either received baloxavir marboxil or placebo. Households were enrolled within 24 hours if at least 1 household contact did not receive a flu vaccination within 6 months of screening and if all household contacts were negative for the infection, according to the study information.²

Baloxavir marboxil was given as a single oral dose, with those younger than 12 years receiving 2 mg/kg if weighing less than 20 kg, or 40 mg if weighing 20 kg or more. Those aged 12 or older received either 40 mg or 80 mg, depending on their weight. The primary end point included virological transmission by day 5, and secondary end points included symptomatic transmission by day 5 and by day 9, virological transmission at the household level by day 5 and by day 9, virological transmission by day 9, and percentage of individuals with adverse events (AEs).²

The study was the first global phase 3 trial that showed reduction benefits with the antiviral for treatment of a respiratory viral illness, adding to the already established benefits of the drug. The results were presented at the Options XII for the Control of Influenza 2024 Congress from September 29, 2024, to October 2, 2024, in Brisbane, Australia.¹

About The Trial

Trial Name: Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

ClinicalTrials.gov: NCT03969212

Sponsor: Hoffmann-La Roche

Completion Date: May 2024

In 2018, baloxavir marboxil was approved for the treatment of uncomplicated influenzas for patients 12 and older who have been symptomatic for no more than 48 hours, according to the FDA.³ The drug, according to Debra Bimkrant MD, director of the Division of Antiviral Products in the Center for Drug Evaluation and Research at the FDA, can lessen symptoms and shorten the time where patients feel sick.³ Further, the safety and efficacy were well established, demonstrating the ability to alleviate symptoms in a shorter time compared with patients who received the placebo. The most common AEs were diarrhea and bronchitis, according to the news release.³

The FDA had granted baloxavir marboxil priority review before the 2018 approval for the same indication.³

REFERENCES

1. Positive phase 3 results show Xofluza significantly reduces the transmission of influenza viruses. News release. Roche. September 19, 2024. Accessed September 30, 2024. https://www.roche.com/media/releases/med-cor-2024-09-19

2. Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households. ClinicalTrials.gov identification: NCT03969212. Updated May 23, 2024. Accessed September 30, 2024. https://clinicaltrials.gov/study/NCT03969212

3. FDA approves new drug to treat influenza. News release. FDA. October 24, 2018. Accessed October 7, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treat-influenza