Austin Regional Clinic studying anti-flu drug in high-risk patients

Austin Regional Clinic has been studying a new drug to fight the flu.

The drug from Japanese company Shionogi Inc. is known as S-033188 to the Food and Drug Administration or baloxavir marboxil outside of the study. It would be an alternative to Tamiflu.

Baloxavir marboxil already has been studied in otherwise healthy people with the flu, and showed promise for its rapid reduction of symptoms. This new phase is testing the anti-viral medication in people who are considered high risk.

This 2011 Centers for Disease Control and Prevention shows the H3N2 strain of the flu, which has only been 10 percent to 15 percent responsive to the flu vaccine. Centers for Disease Control and Prevention

This flu season has been the worst since the swine flu outbreak of 2009. Already 37 people have died from the flu in Travis County. In the U.S. 63 children have died from the flu, though none in Central Texas.

ARC was added as a site for the study after researchers were having trouble getting enough people who qualified,says Dr. Anurekha Chadha, a rheumatologist at ARC.

To qualify, you have to have flu symptoms less than 48 hours. You also have to have asthma or another chronic lung disease; an endocrine disorder such as diabetes; a compromised immune system; HIV; neurological or neurodevelopmental disorders such as epilepsy, stroke or cerebral palsy; heart disease beyond high blood pressure; blood disorders such as sickle cell anemia; a metabolic disorder; have a body mass index greater than 40; or are American Indian or Alaskan Native; older than 65 years old; live in a long-term care facility or are within two weeks postpartum and not nursing.

The drug is a small molecule inhibitor and works slightly differently than Tamiflu, Chadha says. The hope is that this drug will provide a choice for viruses that don’t respond to Tamiflu, which came out in 1999. Not all patients respond to Tamiflu, she says, and Tamiflu also been known to cause gastrointestinal problems. With only one choice, doctors worry that it will stop responding to the flu or that the virus will mutate, Chadha says.

Dr. Anurekha Chadha is a rheumatologist with Austin Regional Clinic.

“When I saw this protocol, it was like, ‘Wow, finally another choice,’” she says. “You want to have an entire bag of choices to apply to patients.”

This study is important, she says, because patients who are at high risk tend to get sicker.

To enroll in the study, patients also have to be willing to be seen at ARC’s Wilson Park location and meet the qualifications. “What’s challenging is finding the right patient to enroll,” she says. So far ARC has been able to enroll at least one patient, she says.

Patients who enroll are given either the new drug or Tamiflu. There is a potential with this study for getting a placebo. Participants take this drug for five days once a day, instead of twice a day. Then they are studied from Day 6 through Day 22 with examinations, ECGs of the heart, blood tests, nasal swabs, throat swabs and filling out questionnaires. “It is allowing them access to care above the standard of care in treating their flu,” she says.

More flu-fighting medications, including biologics, are in early stages of study, Chadha says.

Find out more about the flu study

austinregionalclinic.com/services/clinical-research/flu-study

clinicaltrials.gov


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