Thursday, May 26, 2011

Vertex Incivek Patient Steve Goodwin On The FDA Approved Drug

In my last blog posts, I introduced the new drug INCIVEK by Vertex as a way to help people suffering from Hepatitis C. As I reported, Hepatitis C is a virus, particularly common among African Americans, and that causes inflammation of the liver.

Hepatitis C effects an estimated 270 million to 300 million people Worldwide, 30,000 people in Santa Clara County, 12,000 people in San Francisco City and County, and 2,400 new cases were reported in 2010.

For this blog post, and as promised, I interviewed the main advocate for the use of INCIVEK. His name is Steve Goodwin.

Steve Goodwin is a chief engineer and a one-person band, talking to anyone who will listen about INCIVEK. In the video, below, Goodwin eloquently explains how he came to find out about INCIVEK via the use of the website Clinical Trials, at clinicaltrials.gov, and how it's helped him to a more normal path of life.



Steve also wrote a paper of INCIVEK and how it's helped him, and all of this has been his doing because he's, frankly, happy to be alive. Here's what he wrote:

I am eternally grateful to Vertex Pharmaceuticals and the UCSF Medical Center, for providing me the opportunity to eradicate the virus that I likely had for over 35-years. I was part of a Phase 2b Study referred to as PROVE 3 in 2007. This study was designed for subjects with Genotype 1 Hepatitis C who had not achieved a Sustained Viral Response (SVR) with a prior course of interferon based therapy. I was most fortunate to be in the arm of the trial that has now been approved by the FDA. This included triple treatment of INCIVEK with the standard of care (SOC) for the first 12-weeks and then a continuation of pegylated interferon alpha 2a and ribavirin for the remaining 12-weeks. All said, my treatment was only 24-weeks compared to the previous SOC of 48-weeks.

Although I was asymptomatic for the approximate 35-years prior to obtaining the elusive cure, I knew that the viral infection was continuing to damage my liver in insidious ways that I was unaware of. I also educated myself on the disease and realized that I could not expect the disease to remain dormant forever. Recent studies have indicated that as an individual approaches the age of 60 and beyond, that the disease begins to progress at a much greater level, as compared to being young. The body’s ability to fight off the infection by replacing damaged liver cells is reduced with advancing age. I did not want to be part of those statistics and decided to do anything and everything I could to get the monkey off my back.

Regarding reported side effects, I would have to say that the worst thing for me was temporarily losing the ability to taste (hypogeusia) chocolate and coffee! As for the reports of rash, I had a slight increase in the sensation of itching (pruritus) but never broke out with any rash. I have inherited allergies and eczema, but found that I only needed to control myself from scratching. I found Gold Bond skin lotion as a great remedy for helping to reduce the itching and I wore white cotton socks over my hands while sleeping. I remembered the days when my daughters were babies! I tolerated the treatment quite well. I continued playing tennis, running the treadmill and traveled on vacation. So much of it has to do with attitude.

2007 was indeed a magical year for me. I was considered to be one of the most difficult groups of subjects to be treated: 1) treatment experienced – meaning that I had previously failed an interferon based treatment, and was a: 2) null responder - meaning that I had not achieved a 2-Log drop within the first 12-weeks of my previous treatment in 2003. I beat the odds and recognize that there are thousands of other people that remain infected today that did not achieve an SVR from a previous attempt at treatment.

Now does Steve's cheerleading benefit Vertex? Hell yes. But lost in that is the simple fact that the job of medicine to is save lives and help make our lives better. That's what happened for Steve Goodwin, and that's why he's so happy.



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