Interferon Interlude

WEDNESDAY, June 22, 2011 (HealthDay News) — The recently approved drug Incivek, combined with two standard drugs, is highly effective at treating hepatitis C, a notoriously difficult-to-manage liver disease, two new studies show.
The drug works not only in patients just starting treatment, but in those who failed earlier treatment, the research found.
The hepatitis C virus can lurk in the body for years, causing liver damage, cirrhosis and even liver failure.
"This is a significant advance in the treatment of hepatitis C," said Dr. David Bernstein, chief of the division of gastroenterology, hepatology and nutrition at North Shore University Hospital in Manhasset, N.Y., who was not involved in either study.
"We know that if we can get rid of the hepatitis C, we can prevent the progression of [liver] disease," he said. "This means we can prevent the progression of cirrhosis, we can prevent the development of cancer and also prevent the need for liver transplantation in a large number of people."
Incivek (telaprevir) was approved by the U.S. Food and Drug Administration in May and is the second drug in a class of drugs called protease inhibitors to be approved to fight hepatitis C. The other drug, called Victrelis (boceprevir), was also approved in May.
The standard treatment for hepatitis C has been a combination of two drugs, pegylated-interferon and ribavirin, which are given for a year. If protease inhibitors such as Incivek are added to the mix, the "viral cure" rate improves and the treatment time is reduced to six months, researchers found.
Both reports were published in the June 23 online edition of the New England Journal of Medicine.
In one study, a Phase 3 trial known as ADVANCE, patients were randomly assigned to either a placebo or the treatment in a double-blind study, which means that neither the patients nor the researchers know who's getting the drug and who's getting a sham treatment. This type of study is considered the gold standard for clinical research.
In the ADVANCE trial, 1,088 patients with hepatitis C who had never been treated for the condition were randomly assigned to standard therapy for 48 weeks, or telaprevir combined with standard therapy for eight or for 12 weeks, followed by standard therapy alone for a total treatment time of either 24 or 48 weeks.
The researchers found that 79 percent of those receiving Incivek for the longest period (24 weeks) had a "sustained response," which basically means their hepatitis C was contained. Among those receiving standard care, 44 percent had a sustained response, the researchers noted.
"We have entered a new era of therapy for hepatitis C, which enables us to cure many more patients than we could before," said lead researcher Dr. Ira M. Jacobson, from Weill Cornell Medical College in New York City.
Incivek needs to be given along with pegylated-interferon and ribavirin, Jacobson said. The researchers learned early on that Incivek alone reduces the level of the virus, but later the virus can become resistant to the drug, he said.
For the second study, called the REALIZE trial, 663 patients with hepatitis C who had failed standard therapy were divided into three groups. One group received Incivek plus standard therapy, another group was started on pegylated-interferon and ribavirin and then had Incivek added. The third group received standard therapy alone.
Here, the researchers found up to an 88 percent sustained response in patients receiving Incivek, compared with a 24 percent sustained response in the standard treatment group.
"These drugs represent a real milestone in the treatment of this disease," said lead researcher Dr. Stefan Zeuzem, a professor of medicine at J.W. Goethe University Hospital in Frankfurt, Germany.
"There were very limited treatment options in the past, but now many patients have excellent chances to be cured, even if they already have advanced disease," he said.
Bernstein noted that in the past, these patients could only be treated with more of the standard therapy for a longer period and the "cure" rate was only 10 percent. "Now you can treat these patients for six months with cure rates approaching 90 percent," he said. "You are really offering hope to a large number of patients."
The side effects of the medications include skin rashes, anemia, fatigue, itching, nausea, diarrhea, vomiting and taste changes. Some side effects were serious enough to cause a few participants to drop out, according to the study.
Incivek, made by Vertex Pharmaceuticals Inc., is sold to wholesalers for $49,200 for a four-week course of treatment, said Vertex spokeswomen Nikki Levy.
While both Incivek and Victrelis are important breakthroughs in the treatment of hepatitis C, new drugs with even fewer side effects and perhaps shorter treatment times are in clinical trials, Bernstein said.
Hepatitis C affects almost 4 million Americans, most of whom don't know they're infected. Often there are no symptoms, but it is the leading cause of liver transplantation in the United States and is linked to as many as 12,000 deaths a year, the researchers say.

How I Got Hepatitis C

How I Got Hepatitis C

1981

I had been going to an aerobics class that had recently started in Fresno, keeping up with the 18-year-old leader to the beat of rock 'n roll, going there right after my teaching day in Madera.  About six months later, I noticed that my legs seemed unusually heavy when I lifted them during the routine, so I scheduled a visit to my doctor to find out what was wrong.  Following Dr. Kennedy's examination, he called Dr. Chambers, a cardiologist who had designed the new heart wing at St Agnes Hospital.  Dr. C.  wanted me to come right over for further tests.  After his examination, the doctor advised me not go home before having an angiogram the next morning.  I objected, since I felt fine and was teaching school, but he was so insistent that I reluctantly agreed and called Harry to let him in on the news and have him call the school to arrange for a substitute.

Dr. Chambers showed me the subsequent x-ray, pointing out the mere thread that was my left artery descending, as well as the narrowness of my right artery. He advised me to have a new procedure called an angioplasty before leaving the hospital, for I could easily have a heart attack, which under the circumstances could be fatal.  After consulting with Harry, I agreed to do it.  I've heard that angioplasties now are comparatively simple, but such wasn't the case in 1981.  The preparation

for the procedure took an hour, with tubes and wires all over my body.  A crowd of doctors gathered to observe, since I was only the 13th patient to have an angioplasty at the hospital, and my heart later was featured on the front page of the Fresno Bee.
I was mildly sedated but conscious, in order to cough on command, in case my heart began to lag. Just when the team of three doctors and their assistants was about to begin, a call came in about a patient having a heart attack, whereupon I was put on hold and all the doctors left. An hour later my team of doctors and most of the observers returned.

Well into the procedure, Dr. Chambers suddenly stepped back, and everything came to a halt. The doctors huddled in conversation and I could tell something was wrong, but in my woozy state wasn't the least bit worried. Dr. C finally bent over me to say that he had scraped the inner lining of the artery at a curve, and I had a choice: to wait an hour to see if it would heal or have open heart surgery immediately. A team of that specialty had been waiting as a precaution. Recalling my mother's experience with heart surgery and hearing about others, I chose to wait. By then my back was killing me because I had been lying there for so long, and I was close to panic because my legs were strapped down. A nurse agreed to release them if I promised not to move. Meanwhile, no one had thought to tell Harry what was going on, and he was imagining the worst.

At the end of the hour the doctors returned and proceeded with the angioplasty.  Not sure how long that took, but after they stitched up the incision in my groin, where the tube to my heart had been inserted, everybody left except a nurse who remained to clean up at the sink.   My legs had been untied again but I was reminded to lie still. Just as I was drifting off to sleep, I felt warmth flooding over the operating area.  I looked down and saw a stream of  blood gushing up six inches high.  I managed a weak "Nuuurrse," which she heard above the pans banging and water running.  The woman dashed over to try and staunch the flow but was unsuccessful, so ran to summon help.  Dr. Chambers came rushing in but didn't have any better luck, so he shouted for a ladder.  Standing up a step or two for better leverage, he applied pressure on the incision for thirty minutes, to make sure the gusher was stopped before he and another doctor closed the artery again. They apologized for the two pints of barely-thawed blood they said I needed right away, which chilled me to the point my teeth chattered, and I was trundled off to Recovery. Five hours had elapsed from when I came into the surgery to the time I left.

Several nurses stayed with me all night, to keep me from moving from my spread-eagle position. I longed to tent my legs, to relieve my aching spine, but If I moved a leg, someone put it back. The nurses chatted, keeping me awake, occasionally asking a question--whether to make sure I was alive or not, I didn't know.

At my next physical checkup, I was told I had something new called non-A, non-B hepatitis, but I needn't worry about it; however, I should go to the Red Cross station and get checked for AIDS, a new disease that had been appearing in San Francisco and was carried in blood. The doctor thought I probably needn't worry about AIDS,  since Fresno used local blood--and fortunate for me, he was right.  It wasn't until I moved to the Cayucos in 1994 that the medical establishment decided to call the new disease, hepatitis C--which seems only logical.   It's a virus that destroys the liver over time, and millions of people aren't even aware they have it.  It gained attention when doctors and nurses began showing up infected through their handling of blood.  Previously, Hep C mainly appeared in drug addicts and homosexuals. The only developed treatment is a drug called interferon and a later companion drug, ribavirin, to be taken for at least six months, which semi-cures two thirds of those taking it.  The medication causes flu-like symptoms and deep depression the whole time, plus many serious side effects, including suicide.  Lately another drug is showing promise and will be added to the other two, which they think will cure 75% of those taking it.
As for me, I feel fine; however, my blood tests have risen as high as six times normal for the liver.  That's when my doctor had me see a liver specialist from Stanford hospital, who used to visit here once month.  My friend, Pat, from Fresno, came here and took me back to Fresno with her to see a specialist there, to learn how to give the abdominal shots, to get ready for the interferon series.  Possibly because of the ongoing search for better drugs like the new one still in trial, or because of my age, the team of twelve specialists at Stanford have not chosen to accept me for the treatment, which means a blood draw every two weeks and seeing one of them once a month, weekly self-administered shots in the abdomen and twice daily pills.  All this works better for young people.  Every doctor I've seen: primary, cardiologist, liver specialist and two nurses for two of those doctors--including the liver guy, have advised me not to do it because it's too terrible.  I was willing to do it, though, since I know I will be all right.  I have the kit with hypodermic needles, the interferon and the ribavirin in the refrigerator waiting for someone to give me the go ahead.
Jackie