Wiping out Hepatitis C

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CLEVELAND, Ohio (Ivanhoe Newswire) – 3.2 million Americans are living with hepatitis c. It was once considered a death sentence – but now, new therapies are offering a cure for many.

Roger Warmuth loves spending time with his dogs – Stella and Teak.

“They help me get through the tough times,” Warmuth told Ivanhoe.

He’s had some tough times to get through; 17 years ago he was diagnosed with hepatitis c – a virus that attacks the liver.

“It’s given me cirrhosis. My symptoms include muscle aches and bone aches,” Warmuth said.

Roger tried interferon therapy – it’s an intense treatment that causes severe side effects and only works in less than half of patients.

“After going through all of this painful process of treatment, the odds were basically against them that they would not respond,” Nizar Zein, MD, Chief of Hepatology and Medical Director of Liver Transplantation, Cleveland Clinic, told Ivanhoe.

Now, there are new therapies that literally wipe out the infection. A class of drugs known as DAA targets the virus itself – not the immune system. They are oral drugs – and are taken for three or six months. In clinical trials, as many as 90 percent of patients were cured of their virus.

“Going from a very toxic, highly ineffective therapy, to a highly tolerated, almost universally effective treatment,” Dr. Zein said.

Warmuth will start the new drug in the next month. He’s hoping it will wipe out his infection for good – so he can focus on enjoying all the “warm” moments with his pups.

The most recently approved drug in this class – sofosbuvir– was approved in December of 2013.

One downside: it’s very expensive – some quotes have put it at 84-thousand dollars for 12 weeks of treatment! Researchers and drug companies are working on ways to lower the price for patients. It can be used without interferon injections avoiding many side effects. The treatment is approved by some insurance nationwide.

BACKGROUND: 3.2 million Americans have hepatitis c. It’s an inflammation of the liver that spreads through contact with infected blood; 25 percent of chronically infected patients can develop cirrhosis and related complications. It can also spread through sex with an infected person and from mother to baby during childbirth. Most people do not have symptoms for years. Symptoms could feel like the flu. Jaundice, dark-colored urine, and pale bowel movements are also symptoms of hepatitis c. Medicines sometimes help, but side effects can be problematic. (Source: www.webmd.com)

CAUSES: Hepatitis c is caused by the hepatitis c virus. Liver damage from alcohol, poisonous mushrooms, or other poisons can cause hepatitis. An overdose of acetaminophen can also cause the illness. Exposure may occur after a needle stick or if someone who has hepatitis contacts a cut on the skin or contacts the eyes or mouth. Those at risk include street drug users, people on long term kidney dialysis, and those who have regular contact with blood at work, such as a health care worker. (Source: www.mayoclinic.com)

NEW TECHNOLOGY: A class of drugs known as DAA, or direct-acting antiviral agents, can now target the hepatitis c virus . The oral drugs are taken for three month and in clinical trials 90 percent of patients were cured of their virus. The first drug approved is called Sofosbuvir, which gained FDA approval in December 2013. It works by blocking the RNA used by the virus to replicate itself. The drug costs about $84,000 for 12 weeks of treatment, and is covered by some health insurances. This is the first drug that is safe and effective without the need for administration of interferons according to the FDA. The most common side effects are fatigue, headache, nausea, insomnia, and anemia. (Source: www.fda.gov, Dr. Nizar Zein)

Nizar Zein, M.D., Chief of Hepatology and Medical Director of Liver Transplantation at Cleveland Clinic, talks about a new potential cure for Hepatitis C.

Is Hepatitis C a death sentence?

Dr. Zein: Hepatitis C has been called many things, including names like a deadly virus, a death sentence, and so on. In fact, Hepatitis C has reached epidemic proportions, both in the US and more so in developing countries. Hepatitis C today is the leading indication for liver transplantation and the leading cause of liver cancer in the United States. So it is not only epidemic in terms of numbers, but , it is very costly, in terms of lives, in terms of treating many thousands of patients with end-stage liver disease, and liver cancer related to type C. It’s a very serious disease.

How has it been treated thus far?

Dr. Zein: We've had treatment for Hepatitis C that's evolved over many years. The first wave of therapy dates back to the early-to-mid 1990’s which included basically Interferon only, or later on Interferon and Ribavirin. There is a lot of excitement today and enthusiasm about reaching a point in which we can cure everybody with Hepatitis C, a universal cure, however this didn’t happen overnight. It evolved over 30 years essentially, in which for many, many years we have been treating patients with very costly medications associated with high rate of complications and side effects.

So does this new class of drugs represent a possible cure?

Dr. Zein: The major breakthrough happened in 2011 in which a new class of medications was introduced and we refer to it as DAA, or Directly Acting Antivirals. Two medications were approved by the FDA, Telaprevir and Boceprevir, that actually improved outcomes significantly, but also increased the side effects associated with Interferon. So they were to be given only with Interferon and Ribavirin and the side effects were even more than what we’re used to. So these two medications were critical in paving the way for the new wave of medication that have fewer side effects and are even more effective and can be used without Interferon. So, the second wave of these medications happened just recently.

And what are those called?

Dr. Zein: They were two medications approved by the FDA, one is called Simeprevir and the second one Sofosbuvir; and both improved efficacy to what we know before, at least in the case of one of the two medications. They can even be used without Interferon and with ribavirin only in some patients with easy-to-treat Hepatitis C or intolerant to Interferon which is something new, we never had before. Having said that, this is only a second phase of really the final phase in which now we are talking about all oral therapy in which Interferon is completely gone in that you take a number of pills for a short period of time only for 12 weeks perhaps, maybe 3 months, few pills a day, very little side effects, no toxicities, and efficacy or cure rate of Hepatitis C at least 90% or close to 100%. This is not theoretical; this actually already happened in clinical trials. We have now two new medications that we talk about cure rate in the 80’s probably and we will have even newer wave of medication within the next year or so. So, really it’s a story to be told of going from a very toxic, highly ineffective therapy to a highly tolerated almost universally effective treatment within the period of mid 1990s to now.

How did these drugs, new drugs work?

Dr. Zein: The main advantage of these medications is that they target a specific step in the Hepatitis C virus replication cycle. So, they are directly affecting the virus itself, not the person’s immune system like Interferon. So, to compare it to early therapies with Interferon, it had no direct effect on the virus, rather it boosts the immune system with the idea that by doing so, the immune system will eradicate the virus and that was true in small proportion of patients. Now, we are talking about drugs that will only target the virus without interfering with the infected person’s immune system. The reason I call them a class of medications is because they work at different steps of the cycle, so not all work on the same steps.

Is this giving Hepatitis C patients a chance?

Dr. Zein: Most people in the field believe that if you have Hepatitis C long enough you will get complications from it. But also, a number of studies have confirmed that if you eradicate the Hepatitis C virus, you can shut off the process of damage of the liver. In many cases, whatever damage had happened up to that point, it can start reversing backward, with the liver’s ability to regenerate itself once you remove the offending agent and in this case is Hepatitis C. It is a breath of fresh air. It is almost unimaginable to be talking about cure in 80% or 90% of the patients which we have already today and even better so in the coming few months or couple of years. Patients should be excited and feel confident that the odds are in their favor.

What are some of the obstacles for the future?

Dr. Zein: The issues have changed now. In the past, we were very busy trying to find an effective therapy for Hepatitis C. Now, effective therapy is here, and the side effects are less severe. So the main issue is going to be cost and identification of patients infected. We believe at least 50% of the Hepatitis C infected patients in the U.S. don’t know they are infected. There may need, in the future, to be a screening program to identify patients since the treatment is so effective and they will benefit from it. And this applies to many other places in the world. I think the harder question is: how do you make these drugs affordable and accessible to the 170 million infected patients around the world? And I think this is the same issue that we faced with the HIV epidemic years ago. With a number of creative ideas and thoughts that came from governments and from industry alike, they were able to come up with specific HIV regimens in which were not costly and are highly accessible in even Africa and Asia. At the present time, as effective as these treatments are, we are talking about a cost that could run up to $100,000 for three months of therapy. The cost is going to be the major obstacle.