Patients suffering from the effects of hepatitis C could have another shot at a cure thanks to two new drugs recently approved by the Food and Drug Administration.
The approval came from clinical work involving Incivek and Victrelis, two drugs that block an enzyme that helps the virus reproduce. Health officials - and one local patient - are calling the new medicines the first breakthrough in treatment of the disease in 20 years.
"I'm excited there is something new and hope for myself and others who suffer from it," said Krum resident Michael Hood. "I was told 11 years ago I would never see 50."
Hood, who will turn 50 in December, participated in clinical trials at UT Southwestern Medical Center in Dallas. Hood, who has been fighting the disease since 2001, is among the 3 million to 4 million Americans who suffer from hepatitis C.
Hepatitis C is an infectious disease that is spread through the blood, including by using contaminated hypodermic needles or having sex with an infected person. Hood theorized that his exposure to the disease came during his hospital treatment after a motorcycle accident many years ago.
Incivek is approved for patients who have some liver damage from hepatitis C who either have not been treated, or were not cured by other drugs.
Vertex Pharmaceuticals Inc., which makes Incivek, said in a news release that many hepatitis sufferers in the United States do not know they are infected. Hepatitis C can cause liver damage, cirrhosis and liver failure and can increase the risk of cancer.
"It's the silent killer. People get it; they don't realize they have it until it's in a stage that it can't be slowed down," Hood said. "It can affect anyone. It's a blood-borne disease a lot of people suffer from and do not know; no matter your age or sex, you can get it."
This is his second clinical treatment. The first gave Hood the impression he had beat the disease in October. By December, he found out it was not gone. Hood managed to get on with UT Southwestern clinical trials in which patients were treated with a combination of Incivek and standard therapies for a number of weeks.
UT Southwestern and its Center for Liver Diseases has been involved in clinical trials for a long time, spokesman Dewayne Cox said.
"This wasn't a one-off clinical trial on those two drugs," he said. "We have some internationally recognized liver disease experts here."
In clinical trials, patients were treated with a combination of Incivek and standard therapies for 12 weeks. They continued on the standard treatments for another 36 weeks, but many of them were cured within 24 weeks. Vertex said about 79 percent of previously untreated patients were cured after treatment with Incivek. The drug was also much more effective in patients who had relapsed, had some response but not a cure, or had no response to other drugs.
The most common side effects of Incivek are fatigue, itching, nausea, diarrhea, vomiting, taste changes, and anal or rectal problems. More serious side effects include rash, anemia, low red blood cell count, and birth defects in pregnant women. The standard treatments - including the IV drug pegylated interferon and the pill ribavirin - can cause flu-like symptoms that can last for months, but less than half of patients are cured.
Hood said the promising new drugs are the best news for people like him in years.
"I think there is definitely prosperity to come with it. I don't see how people who have known about it have given up," Hood said, noting that some people stop taking standard treatments after being hit with the side effects. "It depends on if you want to live or die, and I am not ready to go yet."
The Associated Press contributed to this report.
BJ LEWIS can be reached at 940-566-6875. His e-mail address is firstname.lastname@example.org .