Clinical drug trial could help shorten flu suffering

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Like so many Vancouverites, Dr. Melanie Mason got hit by the flu this past December, and it was brutal.

“I was out of commission for about five or six days, then it was another three or four before I was feeling back to normal,” the family doctor says in a phone interview. “I remember thinking, ‘How can something microscopic make me feel so bad?’

“The thing with the flu is that when you look at the time off work, the lost productivity, not being able to look after your kids, and stuff like that, for people who start off healthy you’re looking at two to three weeks,” she adds. “For people who have an underlying illness, you’re looking at six weeks. People underestimate the effects of the flu….People die from the flu.”

Aside from being medical director of the Seymour Health Centre, Mason is the principal investigator of the Vancouver branch of Manna Research, a national company that conducts clinical research trials. In that role, she’s heading the local portion of a global study underway into a new drug to treat the flu.

The medication is a broad-spectrum antiviral called favipiravir. It’s similar to the antiviral Tamiflu (oseltamivir phosphate), but that drug is in a different class, and it’s been shown to be ineffective in some cases.

“Part of the problem with Tamiflu is that we’re seeing resistance,” Mason explains. “One of the reasons we develop new drugs is because of that issue.”

The study into favipiravir is at phase three, meaning that it’s already been proven to be safe in previous trials in people who are healthy. The next phase will test it in those who have the flu. Signs of influenza include fatigue, muscle aches and pains, fever, cough, sore throat, runny nose, and headache. (Children may also experience nausea, vomiting, or diarrhea.)

“What sets the flu apart from having a cold is the severity of symptoms and the speed at which it comes on,” Mason says. “You can feel pretty good, then by the end of day you’re out; you’re pretty sick. It’s not just a sore throat and a sniffle.”

To be eligible to participate in the clinical trial, which is called the FAVOR study, people must be aged 18 to 80. Flu symptoms, including a fever of at least 38 degrees Celsius, must have started within 48 hours of signing up. (More information is available by calling Andrea or Sarah at Manna Research Vancouver at 604–336-8438.)

“All antivirals have to be started within 48 hours of starting symptoms, otherwise they’re not effective,” Mason says.

Research into the drug’s efficacy has been promising.

“The early studies looking at efficacy have shown that the time to resolution of symptoms is significantly shorter with favipiravir, and so people get better faster, they feel better faster, they get back to work faster,” Mason says.

The only side effect of concern so far has been a slight increase in levels of uric acid. High levels of this substance can lead to gout. That condition itself hasn’t been seen, and because participants’ blood is tested regularly, anyone showing adverse reactions would be pulled from the study, Mason says.

The trial is randomized, meaning that some participants will receive a placebo. The ratio of people receiving active medication versus placebo is three to one.

People taking part must go to the Seymour Health Centre five days in a row, plus two subsequent visits. They are compensated for their time and travel expenses.

Mason notes that the research is important not only to develop a medicine that could help people recover faster but also one that could help enormously if Vancouver ever experiences a pandemic.

“We have to have medications that are effective—that aren’t going to lead to resistance—so we are able to treat people in a pandemic, not only people at risk [of severe complications] such as the elderly and the young and those with chronic medical illnesses but in pandemics everybody gets sick, whether you’re old or young, well or healthy.”

According to FluWatch, the Public Health Agency of Canada’s surveillance system, the influenza A (H1N1) virus is the most common flu virus going around this season. People aged 20 to 64 years have been more affected by the flu than others this year. By the Straight’s deadline, 2,818 hospitalizations had been reported nationwide and 143 people had died. Locally, according to Vancouver Coastal Health, nearly a dozen hospitalizations had been linked to H1N1, mostly adults with chronic medical conditions in their 40s, 50s, and 60s.

Having the flu puts people at risk for other infections, including viral or bacterial pneumonia. Vancouver Coastal Health (VCH) recommends everyone get a flu shot. A nasal-spray influenza vaccine is available for eligible children aged two to 17 for free.

To prevent spreading the flu, VCH recommends frequent hand-washing, covering your cough with your arm, and staying home when you’re sick.

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