Xofluza efficacy confirmed in household transmission

Clinical study on household contact published in NEJM

1.9% of Xofluza group developed flu, effective in pediatric group as well

A next-generation flu drug Xofluxa’s effect of preventing flu virus transmission among the patient’s household member has been confirmed.

 

The latest edition of New England Journal of Medicine (NEJM) published on July 8 reported the clinical findings of Xofluza (baloxavir marboxil) and its flu preventive effect.

 

The study evaluated the flu drug’s positive post-exposure prophylaxis efficacy on household contacts by administrating Xofluza.

 

The outcomes of post-exposure prophylactic efficacy of the drug were confirmed based on household contacts of confirmed flu patients during the 2018–2019 flu season.

 

After identifying the index patients confirmed with influenza of their households from November 2018 through March 2019, the researchers conducted a positive rapid flu diagnostic test on the patients and administered either Xofluza or neuraminidase inhibitor as an antiviral treatment.

 

Based on the clinical trial participants consisting of 545 influenza patients and 752 household contacts, the study screened them twice-daily for axillary temperature until day 10 since the initial influenza diagnostic test and had at least 12-year-old participants self-monitor their influenza symptoms.

 

95.6 percent of the participants were tested positive for influenza A, 73.6 percent were younger than 12, and 52.7 percent were administered Xofluza.

 

Major adverse reactions in patients over age 12, such as cough and sore throat, headache, nasal discharge or congestion, feverishness or chills, muscle or joint pain, and fatigue were noted.

 

In the age group under 12, different levels of severity was scored by identifying symptoms like cough and nasal discharge or congestion.

 

Participants developing moderate to severe level of flu-like symptoms like fever were instructed to visit respective clinical institutes and provide their samples with nasopharyngeal swabs.

 

The obtained sample was processed with reverse-transcriptase-polymerase-chain-reaction (RT-PCR) analysis to confirm influenza virus, virus type and subtype.

 

The study’s primary efficacy endpoint was the laboratory-confirmed clinical flu, and the secondary endpoint were a ratio of RT-PCR-confirmed viral infection regardless of fever of flu-like symptoms against RT-PCR-confirmed patients with body temperature of at least 37 degrees Celsius or demonstrating at least one moderate or severe symptom.

 

Analyzing Xofluza group of 374 participants and placebo group of 375 participants, the ratio of patients developing clinically-confirmed influenza was lower in Xofluza group against the placebo group.

 

The outcome was noticeably contrasting between 1.9 percent in the Xofluza group and 13.6 percent in the placebo group.

 

The efficacy was also apparent in subgroup analysis in unvaccinated, high-risk and pediatric groups.

 

In the Xofluza group, regardless of symptoms, the influenza risk was measured 57 percent lower.

 

Moreover, the risk of adverse reaction in both groups of Xofluza and placebo did not show significant difference at 22.2 percent and 20.5 percent, respectively.

 

Xofluza is a next-generation influenza drug Roche released after commercializing Tamiflu two decades ago.

 

The new endonuclease-inhibiting flu drug is highly anticipated by the market as it can treat influenza by one-dose oral administration (Tamiflu administered for five days).