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Yak Max

Drug Trials Offer Hope but May Hold Hazards as Well

by yak max

My initial hepatitis C diagnosis came when treatment options were limited. My physician’s instructions were simple. “Avoid alcohol. We’ll watch your levels and get you on a transplant list if you develop cirrhosis or liver cancer.”

By 2000, medical science had progressed to a potential new therapy. My new physician (courtesy of a divorce and change of insurance) sent t me a hepatologist at a prestigious Chicago hospital. His practice was about to participate in a second round clinical trial for a combination therapy of pegylated interferon and ribavirin. The first round study, a traditional double-blind test, determined that the therapy worked. The second round sought to identify optimum dosage.

A round of tests, including a liver biopsy and extensive blood work, qualified me for the trial. The head physician on the trial explained the potential benefits and dangers of participating in the program. I made the decision to take part, understanding that I may not be getting the best dosage, but that I would be getting some level of the medication. I began a 10 month period of medication and testing.

Each patient in the trials received two bottles of ribavirin in tablet form at a time: one contained a certain minimal level of the medication; the second contained either a placebo or an additional level of medication. These were taken twice daily. A self-injected dose of interferon once a week completed the medication plan.

My early response to the medication resulted in an “initial responder” label as the viral levels in my blood dropped. My nurse practitioner in the program cautioned me against getting excited until we knew if I was a “sustained responder,” continuing to show no virus load over time.

As the trial progressed, I experienced increased irritability, to the point of irrational anger. Later, I became severely anemic and required iron supplements. Through all of it, my viral level remained undetectably low. Once I finished the medication, my body began a slow return to normal. For five years after the trial ended in 2001, I provided annual blood samples to the study. I remained clear and have to this day.

My advice to those considering participation in a drug trial: Listen attentively to the information and ask questions if you don’t understand something. Follow the protocol to the letter. Take detailed notes and report everything to your physician. You will aid medical science and may help yourself.

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