Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
Bay Area Reporter - November 12, 2009
Matthew S. Bajko, m.bajko@ebar.com
Anyone who is HIV-positive and experiencing flu-like symptoms, such as a fever of 100 degrees Fahrenheit or higher, headaches, or fatigue in combination with cough, sore throat, congestion, or muscle aches, can call a hotline to determine if they meet the criteria for the study.
Quest Clinical Studies, the Conant Medical Group, and Emeryville-based Adamas Pharmaceuticals are partnering together for the new clinical trial. Those accepted into the study will then be treated at home with either the current standard flu therapy or the investigational drug.
The TCAD therapy includes Adamas' investigational proprietary fixed-dose combination of amantadine and ribavirin, to be administered adjunctively with a neuraminidase inhibitor such as oseltamivir phosphate. Preclinical data indicate that the in vitro combination of the drugs, each with their own mechanism of action, acts synergistically to provide a much higher level of antiviral activity than single or double drug combinations, according to study officials.
"These aren't new drugs; it is really a new way of using drugs we already have. What we would like to know is if the cocktail is more successful than individual medicines," said Quest's Dr. Jay Lalezari. "As we have seen with HIV, on some level using a cocktail is more potent and potentially retains more active resistance against various flu strains."
All related treatment costs, including lab fees and prescriptions, will be provided at no charge to study participants. Those who qualify for the study will also be compensated for their time and travel for follow-up visits.
"Drug-resistant seasonal influenza is an urgent public health matter, and is one of the leading causes of mortality and morbidity," stated Gregory Went, Ph.D., chief executive officer and chairman of Adamas. "We are grateful to patients who participate in this study and help us learn more about this disease."
The Flu Hotline at 1-888-5-HIV-FLU set up between Quest and Conant went live on October 14. But with the seasonal flu not expected to hit the Bay Area until late December or January, so far not many people have used the phone number to seek treatment.
That very well may change, particularly since supplies of the seasonal flu vaccine have already run out in the Bay Area. Due to the concerns over vaccinating people for the more severe HINI strain of influenza, commonly called swine flu, less doses of the seasonal flu vaccine were made this year.
"There hasn't been lot of vaccine available in San Francisco. Most of the HIV-positive patients have not been able to vaccinate," said Lalezari, adding that even the staff working on the new study has been unable to be vaccinated against the seasonal flu.
Health officials have long advised HIV-positive people to get vaccinated for the seasonal flu each year. Each year 6,000 Californians die due to influenza, though people with HIV are no more susceptible to the flu than other people with suppressed immune systems.
The same is the case with the swine flu, which to date has largely been more of an issue for pregnant women and healthy young adults and teenagers, according to health officials. Though there have been some reported cases of HIV-positive people dying from the swine flu, the numbers have not been cause for concern to health officials.
As the vaccines for the swine flu become available - now expected to arrive in San Francisco some time in December - HIV-positive people are being advised to get vaccinated but are not being prioritized to receive the first batch of vaccine.
"In HIV-positive people it is not so much death but prolonged illness is the real concern," said Lalezari during a forum November 10 about the flu held for people who are HIV-positive.
In addition to having people living with HIV get flu vaccinations, Dr. Marcus Conant also advised such patients to make sure they are up to date on their vaccinations against pneumonia.
"If you have not had the Pneumovax in the last five years you should get it," Conant told the 40 people at the forum. "It will reduce your risk of pneumonia. HIV-positive patients should usually get it every five years."
At the forum Project Inform's Alan McCord said the agency is only receiving two calls a week from people worried about this year's flu season. In an interview prior to the forum, Lalezari said he has also seen little evidence of HIV-positive people being more concerned about the flu this year.
"I don't seen any agitation or hysteria," he said. "I think people are handling it well."
Lalezari said he hopes anyone who does become sick this year with the flu calls the study hotline to receive treatment.
"I don't have a particular agenda around this. I just want to make sure everyone with HIV in San Francisco knows if they feel sick with the flu there is someone they can call," he said. "The current antiretroviral drugs are not as effective as we would like them to be in getting people well and back on their feet as quickly as possible. The hope is by using a combination of drugs we will be able to have more potent and rapid virologic and clinical benefit in patients."
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