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Dr. granted FDA approval to use sofosbuvir/daclatasvir for HCV transpl...
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Dr. granted FDA approval to use sofosbuvir/daclatasvir for HCV transplant patient


Troy — A new drug regimen for liver transplant patients — tried for the first time ever at the University of Michigan Hospital — could bring hope to millions of hepatitis C suffers and the man who received the initial treatment has made it his mission to educate the public about the disease.
Robert Gholston Jr., a 59-year-old General Motors Co. durability test driver from Troy, contracted the hepatitis C virus from a blood transfusion he received after he was hit by a car at age 9. By 2011, it had destroyed his liver, and he received a transplant at U-M Hospital. But within six months, the virus was back — and aggressively attacked his liver.
Dr. Robert Fontana, professor of internal medicine and medical director of liver transplantation at U-M Health System, obtained emergency approval from the federal Food and Drug Administration to give Gholston a treatment that combined two oral antiviral medications, sofosbuvir and daclatasvir.
“Dr. Fontana said, ‘It hasn’t been tested, and if you take this, you’ll be the only one of 7 billion people taking this,’ ” Gholston recalled. “I thought, ‘If I’m the one supposed to test this medication, then so be it.’ ”
According to Fontana, the new therapy works faster and is effective in a greater percentage of patients than the standard treatment for people with genotype 1 hepatitis C, the strain infecting Gholston. It’s the most common strain of the virus, infecting about 70 percent of sufferers, and the most difficult to treat. The new drugs also have proven effective in people with other cases of the disease, Fontana said.
The new treatment provides an alternative for patients, like Gholston, who can’t tolerate the current standard of care. At present, patients with genotype 1 hepatitis C typically receive a weekly interferon injection, and ribavirin, boceprevir and telaprevir, pills that must be taken three times daily with food for six to 12 months. It’s a complicated regimen with lots of side effects. Patients often feel like they have a low-grade flu, and even if they do everything they’re supposed to, many patients won’t be cured or the virus will come back.
By comparison, Gholston took two oral tablets daily for six months, with no side effects.
“Clearly, we’re on the brink of a revolution in therapy,” Fontana told The Detroit News, noting the therapy is not yet available to the public and is awaiting FDA approval. “Probably 50 to 65 percent (are) clear (of the virus) in six to 12 months with standard drugs. With the new drugs, 80 to 90 percent (are) clear in three to six months.
“We’re all hoping they’ll be approved (by the FDA) in the next six months.”
Hepatitis C has emerged as a quiet killer among baby boomers. Those who are affected often show no symptoms at all for 10, 20 or 30 years. If left untreated, the virus causes cirrhosis, liver cancer, or liver failure, which Gholston experienced. According to the Centers for Disease Control and Prevention, chronic liver disease, often hepatitis C-related, is a leading cause of death among African- Americans age 45-64. The CDC says black Americans “have a substantially higher rate of chronic hepatitis C infection than Caucasians and other ethnic groups.”
An estimated 4 million to 5 million people are infected with the virus, and many don’t know it. Scientists didn’t know how to test for it until 1992. It was only then that Gholston, a consistent blood donor, got a letter from the Red Cross advising him to visit his doctor, and he learned he had the disease.
The CDC estimates if all baby boomers were to be screened at one time, nearly 1 million additional cases of hepatitis C infection would be diagnosed. Recently, the number of annual deaths in the U.S. attributed to the virus exceeded those due to HIV infection.
Gholston’s life was saved three times: when he was 9, when he received a liver transplantin 2011, and when the new drug treatment wiped out his hepatitis C.
An ordained minister and chaplain for United Auto Workers Local 653, he’s dedicated his life to giving those blessings back. A father of eight, with eight grandchildren, he also started taking better care of his health. He walks up to five miles a day and participates in 5K runs.
Gholston has struck up a relationship with the young son of the man who gave him his liver — Adam James Tuthill of Battle Creek, who died suddenly of an aneurism (aneurysm) at age 26. Eyan Tuthill, 7, now lives with his great-grandparents in Hastings. Through the Gift of Life organ donation program, Gholston started a correspondence with the family shortly after his transplant in January 2011.
Gholston and some of his children traveled to Hastings to meet Eyan and his great-grandparents after Christmas last year. Since then, he’s started a savings account in Eyan’s name.
“I took him Christmas shopping — I told him Santa sent me because his Dad wasn’t here,” Gholston said. “He said, ‘I know who you are, you’re my father’s best friend.’ It was more exciting for me than it was for him.”
Gholston has become an advocate of testing for the virus, and for organ donation, especially among African-Americans. He does public speaking for the Gift of Life program, and has trained Secretary of State workers on the importance of encouraging people to sign up as organ donors when they renew their driver’s license.
“God didn’t give me this just to sit around around,” Gholston said. “It was all God’s plan; you can’t just write that. Somebody’s got to be in charge of that.”
Eyan’s great-grandmother, Lawanda Converse, said Gholston has been a blessing in their lives. Eyan is a “replica” of his dad, and “Robert makes him feel really good,” she said.
“It has been so wonderful to meet him — it feels good to see the results of an organ donation like that,” Converse said. “I just feel that my grandson would have been so pleased. That’s the kind of person he was — he would have wanted that.

From The Detroit News: http://www.detroitnews.com/article/20130916/LIFESTYLE03/309160016#ixzz2f5rKnNNt

Tags: Sofosbuvir, Daclatasvir, FDA, Hepatitis C, transplant
5 Comments Post a Comment
great story
        thanx!!   that could help a friend, who is running out of options
I too have a friend that just had liver transplant and he could certainly benefit from access to this drug combination.
Wonderful news, thanks for posting.
This is great news! I too, am a post liver transplant  patient. Hepititas C  was busy destroying my liver for over 20 years, finally resulting in a transplant. My sister was my donor in 2010. Shortly after the transplant the Hepatitis C attacked my new donor liver. It became cirrhotic very quickly.  I was in very fournate to get into a Geilead trial that used Sofoosbuvir along with Ribavirin. I just received the great news that I am undetectable after 12 weeks post treatment. My trial was limited world wide to 42 people. This is a miracle that I can attest to personally. I watched my health go down hill twice, once with my liver and then again in my donor liver. It was almost to much to bear. To get a liver and in my case a living donor liver (my sister) and experience it go bad in such a short period of time was almost to much for one to witness.
This is a great drug, and a great combo combined with Daclatasvir. Hopefully they can soon treat before transplants to assure the new donor liver will not be attacked after transplant. Your friend sounds like a wonderful human being and I wish him and his family the very best.
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