December 15, 2013

HCV Clinical Research: A Coordinator’s Perspective.


December 15, 2013

By Stacey Carmody, CCRP
Clinical Research Coordinator for Liver Diseases

The year was 2001. I was brand new to the world of clinical research, and to the world of liver disease. Clinical trials were still being done on a new approved drug called pegylated or “peg” interferon. It was considered “cutting edge” as the time. My very first clinical trial that I handled myself was with peg interferon plus the ribavirin pills, and the objective was to find out if a weight based dose of ribavirin was better than a fixed dose of 800mg daily.

Fast forward to the end of the decade, when a new drug called telaprevir was added to the regimen of peg and ribavirin. I was a coordinator for two telaprevir clinical trials before it was FDA approved. The pills were big, they came on cumbersome fold-out blister cards, and the study subjects had to take them with food, 3 times a day, 8 hours apart for 12 weeks, in addition to taking their peg interferon injection weekly for 24 or 48 weeks, and 5 or 6 ribavirin pills a day for 24 or 48 weeks.

Along the way, I learned a lot about hepatitis C and what it does, and what the treatment regimen does, and I learned about who is the face of hepatitis C, or HCV. There is no specific type of person who is infected. HCV spans all ages, all cultures, all faith traditions, all education levels, all socio-economic classes. The HCV patient looks like any of us.

The side effects from all three medicines were brutal for some, while others tolerated them a little easier. I saw everything from mild fatigue to a full body rash. The psychological effects such as depression or irritability were hard for some too. Once in awhile, someone would want to quit the treatment out of exasperation, or because of the stress it was causing their loved ones.

Study subjects generally would come to the clinic for visits several times a year. During this course, I’d get to know their personalities, their struggles, their personal lives- and some would confide in me about their worries and fears. I would root for them and hope to give them good news in the near future.

I’d say one of the worst parts of my job is giving the heartbreaking news of treatment failure or relapse. But then one of the best parts of the job is give the great news of virus clearance. Seeing the reaction is priceless.

The study staff at my site- made of nurses and doctors, got a education in teleprevir too as I shared the side effects I saw with them. They got to see a preview of things that would become commonplace once it got FDA approval and it became the standard. The drug did get approved, it was branded the name Incivek , with the blister cards giving way to more appealing packaging.

Fast forward to 2013. There are new HCV drugs on the market, and more yet to come. What was considered “cutting edge” a few years ago is no longer considered so. I have worked with some of the newer drugs too. HCV research is always changing and that keeps the field exciting.

The data from these clinical trials is compiled together in publications, posters, lectures and shared among the specialists in the field. It is an awesome thing to see the finished product presented at national and world meetings, and in some cases- see it talked about in the mainstream media. Thanks to the advent of the internet and social media, HCV patients have become very savvy at keeping up on the latest developments!

I have learned a lot in the 12 years I have worked in this field. It’s the kind of education you do not find in a university.

Seeing the results reminds me that I am part of something big, and that all of us are part of something bigger than ourselves. It is an amazing tapestry of researchers, healthcare providers, patients and others too numerous to name. These medicines couldn’t come to fruition without all of us.

And the medicines are getting more promising.

I am confident that one day I will be telling a future generation: “There used to be a disease called Hepatitis C...” I hope you’ll be saying this too.


  1. thank you so much- i am one of the 2x SOC relapsers- after "clearing" both times, it was devastating to go thru all that and have the hope dashed! I can no longer take inf or riba, as the sx caused some perma probs that i am just now starting to recover from. being solo, self employed (or not!) i hope hope hope that their is another option coming soon!

  2. And with all that said, the reality and everything you said is that it is a "BUISNESS" period. People, lives, health are meaningless. It's all about the profit. A drug and clinical trials are used to make money (a profit). That is the only goal to get a drug approved. I'm not hating. Not at all. Just telling it like it is.