I forgot what it was like to sleep through the night. I woke up at 1:00 am in the middle of a dream about treatment. Every hiccup, every headache, every stomach ache, patch of itchy skin, pimple, became the beginning of imagined liver failure and a portent of death. I had no idea what to do. I knew I couldn’t wait until January to talk to someone. The nurse practitioner had emphasized the need to make a timely decision and I felt myself that every day that elapsed was another day of irreparable damage to my liver.
So I called Robert and once again he came to my rescue. He had extensive professional connections with a Florida medical school and hospital, and the dean of the medical school was an old friend. Moreover, he dimly recalled that its Liver Center had a renowned hepatologist on staff. Robert called the dean, the dean’s secretary called me, and in a few hours I had an appointment with the director and founder of the hospital’s Center for Liver Diseases, author of the standard textbook on the subject, and one of the world’s foremost experts on hepatitis. Amazingly, he agreed to see me the next week, and Karl and I flew down for the appointment in early October.
I loved the doctor. He was no-nonsense, compassionate, knowledgeable, guessed what all my questions were without me even asking and then answered them clearly and concisely, told me that although I had cirrhosis I was well compensated, which meant that my liver was still functioning, advised that I wasn’t about to keel over and die any time soon, and gave me a thorough examination. He had previously reviewed my records and blood work, and felt that I was a good candidate for an interferon-free clinical trial. He told me exactly which experimental drugs would give me the best chance of recovery, the new Gilead drug Sofosbuvir, the Bristol Myers combination of Daclatasvir and Asunaprevir, and an Abbott three drug cocktail. He recommended that I hold off on interferon treatment until after he attended the Liver Meeting in Boston in November, at which time he would find out more about which drugs looked most promising. He told me to call him for an update in a month.
Now that I had some information, I spent hours on the computer trying to track down the sites where any of the recommended drugs were being tested. I started with the official government website, and made many phone calls to clinics and hospitals that appeared to be working in areas of interest to me. I found that most of the trials I called were no longer accepting new candidates, even though the website said they were recruiting. I was always several steps behind, and I did not know how to get ahead of the curve. (Talk about mixed metaphors.) I joined several online groups of hepatitis sufferers that discussed various trials, but I was hesitant to ask questions and nobody seemed to be taking an aggressive approach, probably because they were tied to a geographical area due to family obligations, work and lack of money. On the other hand, I was willing and able to go just about anywhere to get treatment. Have hep C, will travel was my motto.
Gradually I started to understand how trials worked. Whenever a pharmaceutical company develops a new drug, it has to pass FDA scrutiny. To do this, it conducts experimental programs on limited numbers of people, starting with Phase 1 trials and going on to Phase 2 and 3. At each stage the government has to approve the study based on the drug’s efficacy and safety, and give a green light to the next stage of testing. The companies must report every result, good or bad, to the FDA. Sometimes companies work together to test a particular drug combination, but most often they test their own drugs in combination or alone. For a hot target disease like hepatitis C, pharmaceutical companies frequently buy smaller companies just to acquire one particular formulation. For instance, in 2012 Gilead spent over $11 billion to purchase Pharmasset, maker of Sofosbuvir, and Bristol Myers bought Inhibitex for $2.5 billion to obtain a now discontinued experimental drug.