BALTIMORE, Md. (Ivanhoe Newswire) - Hepatitis C is the most common bloodborne viral infection in the US, affecting more than 4-million people. The deadly disease can lead to cirrhosis of the liver and liver cancer. Now there is a new era of Hepatitis-C drugs that could cure the disease, without side effects.
For Linda Cornwall gardening is a creative release, but Linda never would have imagined the viral seed that had taken root inside of her. Despite having no risk factors, she was diagnosed with Hepatitis C.
"I was shocked to say the least," Linda Cornwall told Ivanhoe.
The standard treatment, injections of interferon, it's an immune stimulant that can lead to severe anemia and rash.
"The risk was worse than the disease," Linda Cornwall said.
Now a new class of interferon-free drugs, known as Direct Acting Anti-Virals could treat Hepatitis C without the side effects. Doctor Paul Thuluvath says the different D.A.A combinations are in phase 2 and phase 3 trials.
"Most likely it will end up with two drugs combined into one pill. So they'll take one pill a day for three months, we will cure 95 percent of hepatitis C," Doctor Paul J. Thuluvath, M.D., at Mercy Medical Center in Baltimore, MD, told Ivanhoe.
After taking part in one of the trials, Linda has good news.
"I just found out today I'm still undetectable. After three months off the medication. And I had no side effects; absolutely none.
The new drugs could be on the market by 2015. People with Hepatitis C can sometimes take decades to show symptoms, about 75 percent of those with the disease don't know they have it and most of them are baby boomers. New CDC guidelines recommended anyone born between 1945 and 1965 to get tested, even if you have no known risk factors.
BACKGROUND: Hepatitis C is an infection caused by a virus that attacks the liver and leads to inflammation. Most people infected with the hepatitis C virus (HCV) have no symptoms. In fact, most people don't know they have the hepatitis C infection until liver damage shows up, decades later, during routine medical tests. Every year, 3–4 million people are infected with the hepatitis C virus. About 150 million people are chronically infected and at risk of developing liver cirrhosis and/or liver cancer. More than 350,000 people die from hepatitis C-related liver diseases every year. (SOURCE: www.mayoclinic.com/health/hepatitis-c; www.who.int/mediacentre/factsheets)
TRANSMISSION: The hepatitis C virus is most commonly transmitted through exposure to infectious blood. It may also be transmitted through sex with an infected person or sharing personal items contaminated with infectious blood, but these are less common. Hepatitis C is not spread through breast milk, food or water or by casual contact such as hugging, kissing and sharing food or drinks with an infected person. (SOURCE: www.who.int/mediacentre/factsheets)
LATEST MEDICAL BREAKTHROUGH: Combination antiviral therapy with interferon and ribavirin has been the mainstay of hepatitis C treatment. Unfortunately, interferon is not widely available globally and it is not always well tolerated. The Holy Grail for hepatitis C researchers has been to discover new drugs that work better and that work without negative side effects. Dozens of drug companies and hundreds of research scientists have been working on this for more than a decade. Now, the approval of two hepatitis C virus (HCV) protease inhibitors by the U. S. Food and Drug Administration in --boceprevir and telaprevir--marked the start of a new chapter in hepatitis C treatment. However, the story of hepatitis C treatment will not end here. Several new drugs are being developed for all strains of HCV; many may be approved in the next few years, making new treatment regimens available for patients. (SOURCE:www.who.int/mediacentre/factsheets/fs164/en/; www.ft.com/cms; www.hepatitis.va.gov)
Paul Thuluvath, PhD, Professor of Medicine and Surgery at Georgetown and the University of Maryland and Medicaid Director of the Institute of Digestive Health at Mercy Medical Center, talks about new treatment options for Hepatitis C.
Can you talk about how much Hepatitis C is such a huge problem in the United States?
Dr. Thuluvath: Hepatitis C is a common disease and we see about four million people in this country, but majority of these people, about seventy to seventy five percent remain undiagnosed. That's a huge problem. Recently CDC recommended that everybody born in this country between nineteen forty five and sixty five are routinely screened for Hepatitis C. We believe that if you were to do that we may diagnose seventy to eighty percent of the population with Hepatitis C. We are seeing more people recently diagnosed with Hepatitis C, because the family practitioners have started routinely screening their patients. I think that is one thing we could do to improve the diagnosis and also that may help to manage this disease better.
Why do people born between nineteen forty five and nineteen sixty five need to get screened?
Dr. Thuluvath: I think this may be a population with a higher risk associated with viral Hepatitis. There were many factors involving this population, drug use was perhaps one of the major problems, and blood transfusions and other risk factors were probably more common in those days. We know from our own experience and experience from the epidemiology studies that this population carries a very high risk; and if you were to routinely screen that population we may find eighty percent of the population with Hepatitis C.
What are some of the treatments that have been available in the past?
Dr. Thuluvath: We started in the nineteen nineties with the interferon mono therapy. We were using standard interferon; that is we injected three times a week subcutaneously. The cure rate was about six to ten percent. Then we added another drug called Riboviron, that is a pill and they take it every day along with interferon. That increased the cure rate to thirty to forty percent. Then came pegylated interferon that is an interferon, which can be used once a week instead of three times along with Riboviron. We pushed it up a little further, maybe another five to ten percent. And two years ago, there was an important breakthrough, we added a protease inhibitor, the two drugs are approved now, telaprevir and boceprevir. With that the cure rate went for genotype I, that's the most common one in this country to around seventy five percent. It went from about ten percent to almost seventy five percent. However, the problem is all these treatments are based on interferon and it has a lot of side effects. Especially the protease inhibitors; patients find it very difficult to tolerate. The three drug combination many patients have side effects including anemia, significant rash, so patients don't tolerate this treatment very well although the cure rate is quite high. In this country seventy to eighty percent of the population has genotype I and that is the most difficult type to treat. Genotype II and III were relatively easy with the combination treatment with interferon and Riboviron. So Genotype I the cure rate has gone up but tolerability is not very good. That's why we are looking forward to treatment without interferon; we call it interferon free regiment that is going to be the future.
Now the push for the interferon free regiments, can you talk a little bit about that? What you're working on in this trial?
Dr. Thuluvath: There are many drugs in development, I think we have come a long way in the last three to five years, there has been tremendous progress. The future is going to be one or two pills for about three months. What drugs we don't know yet, but based on the early clinical trials that have been published it looks like it is possible for us to combine two drugs and get around ninety five percent cure rate for genotype I. That with very little side effects, I think that is the most important part. These combination treatments with these direct acting antiviral drugs many of the patients don't even feel any side effects. So the compliance is good, patients are going to come forward for treatment and we're going to cure most patients with Hepatitis C with this combination.
With this it's just a pill that you take?
Dr. Thuluvath: I think either one pill or two pills. Most likely it will end up these two drugs combine in to one pill. There are three types of drugs we probably will be seeing. One is a protease inhibitor that we have two drugs already approved. However, then the new generation of protease inhibitors will come with less side effects, with less drug, drug interaction and with better tolerability. So that is the protease inhibitors. Then there are other two drugs, one we call NS5A inhibitors and we already have some drugs in later stages of development. These drugs are well tolerated with very little side effects. One other drug is called daclexaval, it is by BMS and it is in Phase III now in trials and it is quite tolerable, very little side effects so far in the trials. Another group of drugs is called NS5B inhibitors and there are two classes in that. One is a nuclear side and has 5B inhibitor, the other one has no nuclear side, and these are proteinase inhibitors. The nuclear side MS5B inhibitors have been shown to be very potent. I think one of these drugs could be approved by the later part of this year. It is made by Giliat. That drug in combination or NS5B inhibitor in combination with MS5B inhibitor the cure rate is going to be close to ninety five percent. So these medicines could be on the market very soon and theoretically if the pharmaceutical companies work together it could be even faster.
Tuesday, December 10 2013 5:15 PM EST2013-12-10 22:15:07 GMT
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