# 598
With the current fatality rate among bird flu victims running in excess of 60%, and the only real treatment Tamiflu, researchers are looking to see if higher doses of the antiviral are both safe and more effective.
First the article, then some discussion.
Doctors test double Tamiflu dose to cut H5N1 deaths
HONG KONG, March 28 (Reuters) - Doctors in Asia and the United States will give double doses of Tamiflu to patients suffering bird flu and severe seasonal human flu from May in a trial aimed at cutting high death rates from avian flu.
People infected with the H5N1 bird flu virus are now prescribed the standard dose of Tamiflu, which is one capsule twice daily for five days.
But less than half the patients survive.
"In animal studies, higher doses of Tamiflu have resulted in higher cure rates for H5N1. The death rate from H5N1 is 60 percent, we want to see if we can solve this problem," said Tawee Chotpitayasunondh, senior medical officer at Thailand's Ministry of Public Health.
Indonesia, Thailand, Vietnam and the United States will participate in the Tamiflu clinical trial.
All bird flu victims will be included in the trial and each country will pick 100 patients suffering from severe human flu.
In both categories, half of the participants will be given the standard Tamiflu dosage, while the other half will be given double doses, or 150 mg orally, twice daily for 10 days.
Severe human flu cases would be included because some symptoms and complications were similar to H5N1, such as pneumonia.
"We'll find out if it is safe to give double dose," Tawee said.
"We will look at clinical signs such as whether the person is feeling better. We will take secretions from the throat and lungs and check for viral load. We will check to see the progression."
As is often the case with news articles, there is a bit more to the story than is presented here.
The `official' treatment course for Avian flu in humans is, as stated, 10-pills over 5 days. However, the actual treatments received by patients in places like Turkey, Vietnam, Egypt, and Indonesia have likely exceeded that dose, either in strength or duration. Doctors have known for some time that the 10-pill course is inadequate.
Unfortunately, we rarely get details on the actual treatments delivered. There have been reports, however, of 300mg/day being given to some patients, and of treatment lasting longer than 5 days.
What we haven't had is a clinical trial, where patients receive a standardized dose, and their progress is tracked. Hopefully this trial will answer some of the outstanding questions on this treatment.
If the details of this report are correct, the `double dose' treatment described is in actuality a quadrupling of the treatment course. Instead of 10 pills, they will test a 40-pill course of treatment. Two pills, twice daily, for 10 days.
This, by the way, corresponds more closely with the treatments that doctors I've spoken to privately have recommended.
If the animal studies are any indication, the higher dosage should result in a lower viral load. A study conducted in 2004 on mice showed that the therapeutic effects were dose dependant, with mice that received higher doses surviving at a higher rate than those who received the standard dose.
Long time readers of this blog will remember that I've written about the `fiction' of the 10-pill treatment course numerous times, and have suggested that 20, 30, or even 40 pills may be required.
The downside, of course, is that if we quadruple the number of pills required to treat a patient, we cut the number of treatment courses in our stockpile by 75%.
The United States currently has around 20 million courses in its Strategic Stockpile based on the 10-pill regimen. By the end of 2008, they hope to have enough to cover 25% of the nation, or 80 million courses.
But that assumes a 10-pill treatment course.
Should 40 pills be required, that stockpile would only cover about 6% of the nation by the end of next year, and our current stockpile would only treat about 2% of the nation.
A sobering reminder of just how limited our resources are should we face a pandemic.
