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Unlicensed drugs bring positive results for patients PDF Print E-mail
Written by Laureen McMahon, B.C. Catholic   
VANCOUVER  - For the first time since the B.C. Centre for Excellence in HIV/AIDS opened at St. Paul’s Hospital in 1992, even end-stage patients are beating the odds.

St. Paul’s, the city’s major downtown hospital founded more than 100 years ago by the Sisters of Providence, is one of six health care facilities in the archdiocese of Vancouver operated under the umbrella of the Catholic-based Providence Health Care.

Dr. Julio MontanerB.C. Centre for Excellence director Dr. Julio Montaner calls the latest developments in HIV/AIDS drugs “a quantum leap” with five of his critically ill patients achieving positive results.

Ten years after his HIV diagnosis and after years of taking a complicated drug cocktail mixture to keep him alive, 52-year old Vancouver artist Tiko Kerr was losing the battle. Drugs were no longer controlling his severe nerve damage, fast-falling weight and fatigue. In fact, Kerr was dying.

But, just six months after treatment with a controversial new therapy which combines two unlicensed AIDS drugs, TMC114 and TMC125, Kerr’s viral load is virtually undetectable.

St. Paul’s has been known for its work on AIDS since the early 1980s, when young men began to appear in the city’s emergency departments with unexplained respiratory symptoms. Unable to determine what was happening and why the mysterious illness was spreading, hospitals responded by closing their emergency rooms when they feared such patients might transmit the disease to others. Located in the heart of Vancouver’s downtown west end with its large homosexual population, St. Paul’s became known as a hospital that was willing to open its doors to those suffering from what is now recognized as AIDS. It later became the home of the B.C. Centre for Excellence in HIV/AIDS.

Montaner spent most of the last year lobbying Health Canada to allow him to begin using the drugs on what is termed a “special case” basis.

He argued that his patients “had nothing to lose, were well aware of their risks in taking unapproved medications but wanted to take them anyway.”

For the first time in 20 years, Kerr’s white blood cell count has dramatically increased, enabling him to fight the deadly infections which plague AIDS patients.

Today, instead of being bedridden, he can be found at the Vancouver Rowing Club in Stanley  Park, training three times a week for his favourite sport.

Montaner says he learned about this next generation of drugs when Tibotec, an Ireland-based pharmaceutical manufacturer, released research findings in 2005. Early tests showed the new medications’ potent HIV inhibitors are effective even with longtime AIDS patients like Kerr.

At that point, Montaner approached Health Canada for permission to begin using the new drugs.

Although a severely ill patient died before Montaner received permission to begin the new drug therapy, he says he expects Kerr and the others can look forward to a new, greatly improved quality of life.

“Assuming all things are equal, I would anticipate these people are on their way to achieving a long-term response,” he said.

He added that the new drugs are proving to be well tolerated with no one reporting serious side-effects. This favourably compares to previous drug “cocktail” therapies which often caused diarrhea, nausea and extreme fatigue.

Tibotec spokeswoman Karen Manson said that a much larger double-blind clinical study of the two drugs has been launched with hundreds of patients in North and South America and Europe.

And, although it still has not granted official approval, Health Canada has responded to news of Montaner’s success by approving TMC114 and 125 for patients across this country through expanded access clinical trials.

Unfortunately, said Montaner, he doesn’t believe an actual cure for HIV/AIDS will be found soon because, “We need a more basic understanding of how the virus interacts with cells to see if we can shut off viral reproduction on a permanent basis. That would be the next step ... and, at this point, while I hate to say it, that’s science fiction.”
 
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