Quintiles Employee Tess Brennan lived with atypical symptoms from a medical condition for more than 20 years trying to understand why she constantly felt tired and was experiencing bone pain and tenderness around her stomach.
After seeing a variety of general practitioners and specialists, Tess was given diagnoses including fibromyalgia, rheumatoid arthritis, psoriatic arthritis and was repeatedly tested for lupus, sjogrens syndrome, and other auto-immune disorders.
2012 test results revealed that Tess had elevated liver enzymes. While her liver tests had always been normal, additional testing finally provided a conclusive diagnosis: Tess was infected with the Hepatitis C virus.
She was shocked by the diagnosis, but at least now she could form a plan of action after more than two decades symptoms. By process of elimination, Tess’ doctors concluded that she’d contracted the Hepatitis C virus through two blood transfusion she received as a baby. Unknown to Tess and her entire family she’d had the disease practically all of her life.
Joining a Clinical Trial
As an employee of Quintiles, with 20 years of research experience, Tess immediately thought of enrolling in a clinical trial. As luck would have it she met the medical criteria and was enrolled into a clinical trial at Duke University Hospital.
“As soon as I signed the informed consent form, I asked if the trial was being conducted by a contract research organization (CRO),” Tess says. “They said ‘Yes, it’s being administered by Quintiles.’”
Tess just had to laugh, learning that not only would her chosen profession play a role in what she hoped would be a complete cure of her Hepatitis C, but it would be her employer, Quintiles, and her clinical colleagues that were overseeing the trial.
Tess was enrolled into a Phase II open-label trial with four treatment arms (meaning there were four different treatments available and she would be randomly selected to receive one of the four). She was randomized to receive three drugs used in combination to fight Hepatitis C and was instructed to take these medications twice daily for eight consecutive weeks.
Tess was told that her viral load was at 10.6 million at the start of the study. She and her husband Peter hoped that her viral load would be reduced by one-half midway through the study. Then, during her second week of taking study medication the Duke research staff came into the examining room smiling. Tess was excited and was hoping to hear some good news. Tess was a little confused when the medical staff at Duke told her that her viral load was at 47.
47? As in 47 million? Or 4.7 million? Under 5 million would have been greatly appreciated so soon into the trial. “No, not 4.7 million or even 47,000,” the study staff told her. “Your viral load is at 47 … as in one less than 48.”
This was a life changing moment for Tess. She had gone from a viral load of more than 10 million to less than 100, during the first week of treatment. Her week-two tests showed a viral load of zero, she was considered “non-detecatable” which means no virus can be found. For the remaining six weeks Tess was taking the investigational drugs, her viral load was tested and she remained at zero; however she was not yet considered cured because patients with Hepatitis C can relapse.
For Tess to be considered cured of the Hepatitis C virus, she had to complete her eight weeks of taking medication and remain virus free six months afterwards, thus demonstrating that the drug really worked in killing the virus and that there was no relapse.
Tess and her family celebrated a major milestone in July 2014 when test results remained consistent and indicated that she was still “non-detecable. She is now officially considered “Hep-Cured.”
With 20 years of research experience, Tess says, “I know all the ins and outs of clinical trials, but what I didn’t know was what it was like to be an actual study patient. I’ve celebrated the close of a trial because it means that a drug is getting closer to approval, but I never thought about that patient waiting desperately to get in to a trial, waiting for a cure, but I’ve lived it. I now understand.
”When we do our work well, we are impacting patients. When our customers are successful, we collectively bring treatments to people who need them.”
CAPTION: Tess Brennan shares the patient perspective at the Biopharmaceutical Innovation forum, alongside Astellas US President Jim Robinson and Governors Corbett (PA), McCrory (NC), and Pence (IN), and senior R&D executives from Lilly and Merck.