When Scott Pelley of “60 Minutes” asked HHS Secretary Katheleen Sebelius about political punditry critical of the public health response to novel H1N1, she pointedly said, “I tend to like to get my health advice from doctors and scientists.”
She’ll be getting some of her advice about treating flu from UNC. Charlie van der Horst and Christopher Hurt, from our much heralded Center for Infectious Diseases, are each leading the first studies of medications for IV treatment of influenza.
ID at UNC is known around the globe for groundbreaking work in HIV/AIDS and other scourges. They’ve identified who’s most at risk for HIV and potential ways to prevent infection. But this is the first inpatient flu study.
“We’ve never had IV drugs (for flu) before. Ever,” says van der Horst, who ran his first clinical trial in 1983 at UNC. “Each year in the U.S. 35,000 people die from flu … We’ve had nothing to offer these people,” vdHorst says. “We’ve routinely had patients die.”
Novel H1N1 put a scare in the medical community because, Hurt and vdHorst say, it resembled “Spanish” flu that killed tens of millions of people around the world from 1918 to 1920. Both bugs started in spring and made a come-back in the fall. If you get the flu now, you can bet it’s H1N1, vdHorst says.
Late-20th century medicine gave us the anti-flu drugs Tamiflu, Relenza (zanamivir) and peramivir. Tamiflu is taken orally; Relenza is aerosolized. They prevent the flu or shorten its duration. So it made sense to provide them in IV form, which provides a more accurate, assurable dosage that goes directly to the bloodstream in people who are hospitalized and beyond the help of chicken soup.
Hurt is studying peramivir, a medication that had not been tested until recently. It’s only available in IV form, and the criteria for receiving the drug in the study are pretty tight; prior treatment with Tamiflu eliminates a lot of people.
But viruses mutate for a living, and novel H1N1 has beefed up its resume by showing some resistance to peramivir’s close kin, Tamiflu, in an isolated instance. One of the usual seasonal flu viruses from last year had widespread resistance to Tamiflu. Both medications operate by blocking the same protein to keep the virus from spreading.
So far, novel H1N1 hasn’t shown widespread resistance to zanamivir, the drug vdH is studying. And to get into that trial a patient has to be sick enough to be hospitalized for five days and, basically, have the flu. It’s open to pregnant women, people on ventilators, people who have received other flu meds, etc.
As for the protection against pundits, some are more innoculated than others. VdHorst waves them off. “Vaccine and medication development in the US is based on pure science, not science fiction,” he says.
** Blog update: Dr. Hurt was informed yesterday (Nov. 17, 09) that he was the first to enroll a patient in the BioCryst (peramivir) study. Way to go! We hope the patient is doing well.
6 Comments
November 12, 2009 at 4:24 pm
[...] not science fiction: two flu drugs studied at UNC By Lisa [Originally posted on the UNC Health Care blog and penned by Clinton [...]
November 13, 2009 at 2:47 pm
Right on re: science! In fact, it is equally important to minimize politics too.
I have read that peramivir has saved many lives, even when given to patients who were literally “on their death bed”. What I do not understand is why peramivir is not being stockpiled at hospitals so the relatively few patients who need it can get it ASAP (currently the MD has to justify using it, then order it from the CDC [or maybe its HHS], then receive it via over night shipping). That extra paperwork and time lag could mean the life of many, many extremely sick patients.
Robbie
November 13, 2009 at 2:51 pm
Dr. Hurt: since peramivir has been shown to work, and the CDC allowed its use in cases where either Tamiflu or Relenza are not effective, what do you think makes peramivir DIFFERENT? Is it that peramivir is administered via IV, or is the drug just different enough that it attacks the flu bug where the others do not?
Thanks in advance. Robbie
November 18, 2009 at 4:51 pm
From Dr. Chris Hurt:
Hi Robbie – It’s a good question. All three drugs work in the same way on the same component of influenza (namely, its neuraminidase, an enzyme that allows a newly made influenza virus particle to escape from the host cell to go off and infect another cell). None is more powerful or less powerful than another, so to speak. So the most important difference is that it’s intravenous, whereas the other two are not. (Tamiflu is taken by mouth, and Relenza is inhaled).
I would also caution about your statement that “peramivir has been shown to work.” This is true in the sense that we have information about the drug’s activity in the “test tube” and we have safety and tolerability data from phase II clinical trials – but the whole reason we’re participating in this phase III study is to demonstrate that peramivir works in the way that it’s intended. CDC and FDA have permitted emergency use of peramivir in select cases where the potential benefits of an unproven medication outweigh its potential harms – specifically, in cases where the patient is expected to do poorly or die from the infection.
November 19, 2009 at 1:39 pm
We also know that under the Emergency IND granted in June, 32 patients aged 3 months to 80 years, including two pregnant women and one that just gave birth, were given peramivir as rescue therapy while they were on ventilators. 29 of them lived. I’d say “peramivir has been shown to work.” is a fair statement in the real world, and the Phase III trial is designed to get the drug approved by the FDA.
November 20, 2009 at 6:14 pm
Michael;
The report from the real world today that Tamiflu-resistant flu has likely passed from person to person at Duke doesn’t prove that the drugs don’t work (as noted above, Tamiflu and peramivir have the same mechanism), but it proves that it doesn’t always work, and clinical trials help us understand drugs better.
http://www.usatoday.com/news/health/2009-11-20-drug-resistant-swineflu_N.htm