New Shorter Treatment For Hepatitis C On Horizon

As readers of my blog know, I was diagnosed with Hepatitis C several years ago. I waited until the ‘new’ three drug treatment regimen was given the green light by the FDA.

That regimen included Interferon-Pegasys weekly self- injections, Ribovirin and the ‘new’ drug, Telaprivir. The Telaprivir was used for the first twelve weeks of the 48 week treatment program and the cost of it was $ 48,000+ for twelve weeks worth of the drug, or as my doctor said…a brand new Toyota Corolla a month.

The side effects of these drugs were very debilitating and can cause people to lose quite a bit of time off from work.

Most people don’t know that there are over three million Americans known to be infected with the disease. Another thing a lot of people don’t know is that veterans have the disease at a much higher rate than the civilian population, about 17-20 percent as opposed to around 1 percent in the general population.

According to Fox News, there is a new treatment regimen on the horizon without all the debilitating side effects of the aforementioned drugs:

In the race to find a faster cure for hepatitis C, Bristol-Myers Squibb Co said it will test its experimental antiviral drug combination with Gilead Sciences Inc’s blockbuster drug Sovaldi, hoping to cut treatment time to four weeks.

Bristol-Myers disclosed plans for the exploratory 30-patient trial testing its three-drug combination with Sovaldi in an interview with Reuters. Eric Hughes, the leader of Bristol’s global hepatitis program, said the details were due to be posted on the clinicaltrials.gov website next week.

Sovaldi’s $84,000 price tag for a 12-week treatment has spurred outrage among insurers, state health officials and lawmakers who fear the cost of treating millions of Americans with the progressive liver disease will top $250 billion. Insurers are pushing Gilead’s rivals to offer lower prices when their hepatitis C medicines reach the market.

Using the drug for a shorter course of treatment could, in theory, lower the cost, even when combined with Bristol’s therapies. Rivals Merck & Co and AbbVie are also racing to develop next-generation hepatitis C treatments that cure most people of the virus in a shorter time frame.

Good news indeed, especially if they can really get the treatment down to a month instead of the current 24 to 48 weeks of treatment.

“The position and concept of pharma is not ingredient costs or duration of treatment cost. Pharma is looking at it as cost per cure,” said John Whang, co-president of Reimbursement Intelligence, which works with pharmaceutical companies and payers to help determine prices for medicines.

The cost could come down, he said, “but it’s not going to be proportionate to the degree that the duration of treatment shortens.”

The new generation of oral drugs being developed by several companies has raised hepatitis C cure rates to well above 90 percent from about 75 percent without the need for interferon or ribavirin, which caused miserable side effects that led many patients to delay or drop treatment. The drugs in clinical trials have already cut treatment time to 12 weeks from 24 to 48 weeks.

“We got rid of the tolerability problem. We got rid of the efficacy problem. Now there is a tremendous drive to get down to shorter treatment durations,” Bristol-Myers’ Hughes said in a telephone interview.

So according to big pharma, it’s basically…how badly do you want to be cured of the disease and how much how much is it worth to you?

I received my treatment through the VA, so my treatment cost me about $ 27 bucks a month for the co-pay. I’m thankful for that because I couldn’t have afforded it otherwise, especially after having to miss a lot of work because of the side effects of the ‘old’ treatment regimen.

All in all, good news for people who are infected with the disease. I would also recommend that people get tested to make sure you don’t have it, especially ” baby boomers”, as there has been shown a higher incidence of infection in this particular demographic.

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New Hepatitis C Drug On Horizon Plus Update

As I have posted before, I have Hepatitis C, a disease that effects the liver. Then in August, I had a little thing with my heart where I passed out and ended up in the hospital. I touched on it here and explained what happened here. Since my last posting where I explained about the newest drug, I have been prescribed another drug for pain to replace the Gabapentin. It wasn’t working except for the side effects, they worked just great. Dizziness and pain behind the eyes, bilateral kidney pain, somnolence. So now they gave me another drug called Tramadol, which is a narcotic analgesic.  It has some side effects too, but at least it’s working to stop the constant pain. Of course I have to watch out I don’t become dependent on it.

Over two million Americans have Hep C, 75 percent of which are baby boomers. I was lucky enough to have used one of the newest drugs that is FDA approved in conjunction with the other established Hepatitis C drugs, Interferon injections and Riboviran capsules. That drug was called Teleprevir and it worked great, except for the side effects I told about in one of the previous posts. Even after stopping the drug, you can look forward to another three weeks or so of the side effects, severe itching, tapped out Hemoglobin counts and extreme tiredness. And when I say severe itching, I mean the kind of itch that feels like it’s five layers deep under the skin and you can’t scratch enough to reach it. An anit-histamine plus a sleeping pill helps somewhat with this. And the rash eventually disappears.

But there might be some more good news out there for Hep C sufferers. It’s called the “Sponge” drug and is what’s called a RNA inhibitor. Here’s an article that explains a little how it works;

With an estimated 2 million baby boomers infected with hepatitis C, the disease has reached epidemic levels among Americans age 48 to 68.

Doctors can now cure about 70 percent of hepatitis C cases, but the drugs’ side effects can be severe. And many Americans are still left with a disease that can cause liver failure and cancer.

So doctors have been desperate for better treatment options.

One of the drugs in the pipeline, called miravirsen, may be able to stop the virus with little side effects, doctors from University Health Network in Toronto, Canada, reported Wednesday.

Their findings, published in The New England Journal of Medicine, are preliminary — the doctors gave the drug to just 27 patients for about a month. (Another 9 patients in the study were given a placebo.) But the study is still drawing attention because it offers proof-of-concept for a whole new class of drugs, called RNA interference drugs.

RNAi drugs work differently than traditional antivirals and antibiotics. And some scientists think they may have the potential to treat many illnesses, including the big killers, cancer and heart disease.

Traditional drugs are small chemicals that bind directly to the pathogen’s machinery. In contrast, RNAi drugs are little fragments of RNA (or DNA) that act like “sponges” inside the cell. They mop up other RNA molecules that a virus or cancer cell needs to survive.

The pharmaceutical industry has been working for decades to get RNAi drugs to work, says Dr. Judy Lieberman of Harvard Medical School, who wasn’t involved in the current study.

“At first there was wild enthusiasm – and billions of dollars,” she tells Shots. “Hundreds of companies became involved because these drugs could be a whole new class of therapeutics for all kinds of diseases.”

But enthusiasm and money waned over time, as companies realized it wasn’t going to be easy to get these drugs to work.

Pharmaceutical giants, like Roche and Novartis, pulled the plug on million-dollar programs back in 2010, the journal Naturereported. But a few companies stayed the course. And, recently, there have been hints of success.

In January, the Food and Drug Administration approved the first RNAi drug, Kynamro (brand name mipomersen sodium), to help people with an extreme type of high cholesterol.

Now the current study on miravirsen offers hope for hepatitis C. “It’s the first example of really strong clinical evidence” that the RNAi therapies are going to work in people, Lieberman says.

It’s too soon to say how effective miravirsen is compared to current hepatitis C treatments, says Dr. Harry Janssen, who led the study. The goal of the current trial was to figure out how much miravirsen is needed to stop the virus temporarily — not it’s overall effectiveness. That will require a bigger study.

Four of the nine patients who got the highest dose of miravirsen temporarily cleared the virus after five injections. “That compares very well to current treatments,” Janssen says.

But unlike many medications available now, the RNAi drug works on all types of hepatitis C, even those that are tough to treat. And the short-term side effects are minimal — a rash and pain at the injection site.

Still, Janssen and his team don’t know what the long-term effects could be and exactly how to combine miravirsen with other medications. And, he says, there are other hepatitis C drugs in the pipeline that are closer to getting approval.

“So I think our study is a big step forward for hepatitis C, but a bigger step forward for medicine in general,” he says. “It opens big avenues for using this concept [RNAi drugs] in humans.”

My last check up had good news. There is no discernible or detectable virus and the doctor said that he thinks that there is over a 90 percent chance that I will have gotten rid of the disease and it won’t come back. I’m keeping my fingers crossed.

#HepatitisC Update And A New Drug

If you recall a post I made back in August, I have Hepatitis C. I wrote about it here and explained the disease and how it can be caught. I also went over all the drugs I had to take and the associated side effects. One of the possible side effects is what’s called Atrial Fibrillation. That’s when your heart goes out of rhythm or you get an irregular heart beat.

That happened to me in the middle of August. It necessitated an emergency trip in an ambulance plus an overnight stay in the hospital. Since I blacked out and collapsed, of course, they had to give me a neck X-Ray and a C-Scan of my brain. In the emergency room, they gave me a shot of blood thinner plus another blood thinner called Cumiden in pill form, even though I had already run down the medicines I was taking which already thin the blood. They finally realized that I didn’t need blood thinners.

Later that day, they gave me an ECG with Ultrasound. The Heart Specialist came in and ordered a drug, at $1200 bucks a shot,  that was supposed to kickstart my heart back into rhythm, but after two doses of that, it was still not right. So they ordered another drug to knock me out, a nurse shaved my chest,( man, that sure itches when it grows back.), and they put a big electrode on my chest and one on my back. The reason they knocked me out was because they were going to shock my heart back into rhythm and I guess you’re not supposed to be awake for that.

So I got another drug to take twice a day for mild Pulmonary Hypertension called Metoprolol. It’s a tiny pill that I have to cut in half and take in the morning and at night. Another drug that possibly causes dizziness. (I’m already dizzy enough.)

In a previous update, I had talked about another new drug I had to take called Epoetin, a protein shot often given to patients on Dialysis. I had to take it because one of  the drugs for the Hepatitis C was clobbering my Hemoglobin count. It also necessitated two blood transfusions in a month. I no longer have to take the Epoetin because I no longer take the drug that was keeping my Hemoglobin counts so low.

My most recent lab tests show no discernible virus which is good. They have been like that since the first month of treatment. The doctors had said that I might possibly only have to do the 24 week treatment, but after reviewing all my tests and the Liver Biopsy they did last year, they decided since I had stage three Cirrhosis and had a lot of scarring that it would be better to go ahead and do the full 48 week treatment. That way, the chances of me having to go through all this again would decrease considerably.  The treatment I’m on has an 80 percent success rate.

In the mean time, I have developed real bad soreness in my left arm and neck and shoulder. My primary care doctor suggested it was a pinched nerve in my neck. So now I’ve been scheduled for what’s called an EMG. That’s where I guess they stick a bunch of needles into your muscle and measure the electrical current as you move a small amount during the test. Sounds like fun, eh?

In the meantime, I have been prescribed a new drug to take along with the plethora of drugs I already take. It’s called Gabapentin and I have to take it twice a day without fail. It’s one of those drugs that takes several days or weeks to become effective except of course, some of the side effects become readily apparent like dizziness and drowsiness. And like most new drugs these days, other side effects include mood swings and possible depression. The Gabapentin is supposed to help with the soreness in my arm.

I got to tell you…getting old aint for sissies.

As a Veteran,I have been receiving my treatments through the VA Hospital system and I just want to brag on those fine folks. I have always received the best treatment from them and the volunteers are very helpful.

I Got A New Drug…Hepatitis C Update

As you may know, I’ve been battling Hepatitis C. I had a check up today and things seem to be doing pretty good except for my blood count. During my four week and eight week check ups, the lab work showed no discernible virus. That’s good news. The bad news is that one of the drugs I have to take, does a trick on my hemoglobin. That’s the part of your blood that carries oxygen around your body. So my doctor cut down one of my daily medications to once a day instead of twice a day.

So in addition to the other drugs I take weekly and daily, I’ve got a new drug to take once a week. It’s called Procrit and is a sub-cutaneous protein shot. This one isn’t pre-loaded like my Pegasys shot, so I have to “be the doctor” and follow a particular procedure to draw up the shot.

The really good news is, if my twelve week check up is the same as my four and eight week checkups, I will only have to do the twenty-four week treatment option. So that means that I’m potentially almost halfway done. HooRah!

I’m going to be doing a post on my recent trip to the emergency room and subsequent day and a half stay in the hospital. I’m just waiting for all the bills to come in so I can total it all up. So far, it amounts to around fifteen grand.

I Have Hepatitis C…Thanks Uncle Sam!

The post title is kind of a two edged sword. It’s sarcastic because of the way I got the disease, but at the same time, it’s also a thanks to the military for stepping up to take care of us Veterans, especially because of the cost of treatment.

I have Hepatitis C, type 1 genome. It’s the most “popular” type of the disease and is also the hardest to get rid of. Approximately 4.5 million Americans are infected with or carry the Hepatitis C virus. That equates to about 2 percent of the population.

A medical survey of a representative group of Americans tested between 1988 and 1994 concluded that approximately 1.8% of the general population of the United States carried the antibody to hepatitis C in their bloodstream, which placed the the number of Americans with HCV at 3.9 million persons. More recent studies using newer assays have pushed the suspected rate of infection up to around 2.5%, indicating that around 4.5 million Americans are probably infected.

I’m a veteran and the numbers for Veterans are even more scary. Veterans have an incidence of Hepatitis C in the ten to twenty percent range. Why is that? First, most of these cases are Vietnam era Vets. I volunteered for service in the summer of 1976, right after Vietnam.

Anyone who went through basic training back then will remember  the march through the room where you received your vaccines to start your service. 150 new recruits pushed through a room in about five minutes, with medics on either side using what was called a “jet gun”, a method of giving vaccinations using high pressure forced air to inject the vaccine instead of needles. Below is a list of ways Hepatitis C can be passed;

Jet “Air Gun” Injections Blood Transfusions Blood Base Products/Vaccines
Exposed to Blood/body Fluid Reusable Needles,
Syringes & Vials Finger Pricks/Lancets
Medical Procedures Dental Procedures
Kidney/Blood Dialyses
Tissue/bone Transplant Tattoos In Service
Had a STD/STI or Multiple Partners in service
Used Tooth Brush Used Razors 2006 Prostate/Scope Exams 22,000 + vets … across the country are warned improperly sterilized equipment

Even though the jet guns are a needle less injection system, it has been found that improper application of the gun in giving a shot can draw a tremendous amount of blood. The high pressure air can actually cut the skin. The tech might wipe the end of the gun before giving the next shot and they might not. Back then, the Seventies, Hepatitis C was an unknown disease, much like AIDS.

 

If left untreated, Hepatitis C will cause Cirrhosis of the Liver and/or possibly Liver Cancer.   I was diagnosed two years ago with Hepatitis C, Type 1. At the time, the treatment prognosis wasn’t that good…maybe a 40 percent chance of effective treatment, depending on a person’s viral load. Here’s a link that explains viral load. I’m not sure what my V load is, somewhere in the 2 million range. At the time, my doctor and I decided to wait for the new treatment that was in the pipeline with the FDA. The new medicine added to the other treatments would extend the prognosis up to maybe 80 percent chance of success.

As part of my treatment, I received a biopsy of my liver. You lay on a table and are given an anesthetic so you don’t care that the doctor is getting ready to stick a horse needle between a couple of your ribs and guide it through muscle and other vital body parts to take a small piece of your liver for analysis. The biopsy said I had stage two Cirrhosis, but mt doctor said he believed I had more like stage three. That would be akin to a bottle of 80 proof a day habit for thirty years. I drank the occasional beer or mixed drink, but no more.

There are all kinds of links out there for people interested in finding out about Hepatitis C. Here’s a link to one search engine page and another.

Now we get to the “good” part where I describe the medications I have to take on a daily,( and weekly), basis. First off, is the weekly self-injection I give myself. It’s called Pegasys Alpha-2A. It is a subcutaneous 180 ml injection. I was warned that the side effects would be like having the flu for a couple of days every week. That’s why I take the injection on Friday nights right before bedtime. Surprisingly, I haven’t had that bad of a reaction to this medicine. I actually feel better for a day or two afterwards. This medicine is around $1300 bucks a month

The next medication is a twice daily dose of Ribovirin 200 mg capsules. I take three of these twice a day, once in the morning with my other daily medication, and again in the evening with dinner. Side effects are nausea, diarrhea, stomach upset, headache, dizziness, blurred vision, trouble sleeping, flu-like symptoms to name just a few. There’s also weight loss/gain, loss of hair, loss of taste and or hearing. From what little I could find out, this medicine costs about $1200 bucks a month.

This is the good one, the one I waited two years for. It’s called Teleprivir 375 tabs. My doctor explained to me that everytime he gave me a month’s prescription for this medicine, it was like he was handing me a brand new Toyota Corolla. Yes, you read that right, this medicine costs $ 12,000 bucks a month. I take two tablets three times a day. Side effects of this medication are nausea, vomiting, hemorrhoids, rectal itching/burning/discomfort, ( the butt hurt), and/or change in taste may occur. The problem with this medicine is you have to eat something with 20 fat grams each time you take it. (A Snicker’s bar has 17 fat grams. 😉 )

Hepatitis C has been in the news recently. Here and here are a couple of links to stories about it.

Well, that’s about it.