Tag Archives: CIRRHOSIS

New Hepatitis C Drug Approved: Janssen’s Hepatitis C Drug Simeprevir Now Available

This past week, the FDA gave approval to Janssen’s new drug to treat hepatitis C. Simeprevir, commercially know as OLYSIO, is the first new hepatitis C drug since the release of telapravir (Incevik) and boceprevir (Victrelis) in 2011. Simeprevir is a  NS3/4A protease inhibitor, used in combination with interferon and ribavirin.

The release of simeprevir marks the beginning of a new wave of direct acting antiviral agents against the hepatitis C virus. Additional drugs are set for FDA approval, including the Gilead drug sofosbuvir in early December 2013.

Most of the new hepatitis C drugs will have a number of features in common. These include:

  • Very high cure rate, in the 80-90% range – lower in null and non-responders
  • Less side effects
  • Shorter duration of treatment
  • Less pills to take each day
  • Cirrhosis reduces response rates
  • Less drug-drug interactions
  • Genotype 1 subtype differences exist

Looking at the dosing of simeprevir, I have attached the official product insert that describes how the drug will be doses. Several points to consider:

  • This is an interferon/ribavirin based therapy
  • Patients with genotype 1 need additional screening for the NS3 Q80K polymorphism
  • Those with this variant have a decreased response rate to the therapy, and should be considered for an alternative therapy
  • The initial dosing is 12 weeks of simeprevir with interferon and ribavirin, followed by an additional 12 or 36 weeks of interferon and ribavirin combination therapy.
  • There are drug-drug interaction which have to be monitored closely
  • FDA approval is for genotype 1 patients only

While the release of simeprevir is welcomed, it has not provided the proverbial “home-run” we have been looking for in our quest to cure hepatitis C. In well selected patients, achieving a better than 80% cure rate is available. The concerns I have relate to the Q80K polymorphism noted above. This will be an additional step required in screening our patients. Additionally, in patients with prior non-response or null responders, as well as those with cirrhosis, these patients will still require a full 48 week of interferon and ribavirin. One of the goals of the next generation of hepatitis C therapies is reduced interferon exposure, or complete elimination. Simeprevir does not fully meet this goal.

In the days to come, I will post additional information on sofosbuvir. For now, these are the highlights to consider (refer to this FDA document for additional details):

  • Sofosbuvir will likely receive FDA approval for Genotype 1,2,3, and 4 patients with hepatitis C
  • Interferon-free treatment in genotype 2 and 3 for 12 weeks
  • Sofosbuvir combined with interferon and ribavirin in genotype 1 and 4 for 12 to 16 weeks

This treatment strategy is far different than the simeprevir treatment noted above.

Looking further, we will eventually have all interferon-free protocols. It is anticipated that as additional new drugs are approved, they will be combined (example sofosbuvir and simeprevir), allowing us to treat a wide range of patients, safely, and with a cure rate many of us may have never envisioned 20 years ago.

For a consultation to see if you are a candidate for these new drugs, contact Lexa at our office at 713-794-0700 and visit our webpage for additional information.

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Annual Liver Meetings -AASLD- in Washington, DC This Week

Annual Liver Meetings -AASLD- in Washington, DC This Week

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The annual Liver Meetings are taking place in Washington, DC, and I will report back on the breakthroughs, specifically those related to hepatitis C, cirrhosis, fatty liver, and liver cancer and transplant.

This far, discussion regarding the new hepatitis C therapies continue to report on the impact of new therapies on the cure rates we have been seeing in clinical studies. In addition to the new Gilead drug soon to be released, the FDA is favorably evaluating Simeprevir another soon to be approved hepatitis C drug.

Another popular topic yesterday and today has been non-alcoholic fatty liver disease (NAFLD and NASH). The take home message for both patients and physicians is that those individuals with obesity, diabetes, fatty liver, plus fibrosis on their biopsy have the greatest risk for serious complications.

I will update the blog as new developments are available.

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Second Opinion in Hepatitis: Videoconferencing Between Houston and the World

Each week, I receive dozens of e-mails from followers of our social media sites (Twitter, YouTube, FaceBook, Your Health First, and Liver Specialists of Texas) seeking assistance regarding some form of liver disease they are suffering from, or one of their relatives. I usually respond back with some direction they should head in, or ask if they are available to travel to Houston for a face-to-face evaluation.

As technology improves, the availability of videoconferencing has never been easier. Working with Houston based software developers, there is now the opportunity to participate in a second opinion program with experts in liver disease in our practice. Because there is such variability in everyone’s home or work connectivity to the internet, we plan on supplying you with the needed technology to connect.

The savings of not having to travel to Houston, hotel and food charges, lost wages, and time, makes this an economically sensible alternative.

Second opinions in all aspects of liver disease will be available, including abnormal liver tests, fatty liver disease, hepatitis C, hepatitis B, cirrhosis, liver cancer, alcohol related liver disease, liver transplant, hemochromatosis, and autoimmune disease of the liver. The cost for this service will be based on a minimum of a 30 minute consultation, allowing for additional time at 15 minute increments. Medical records, x-ray reports and films, biopsies, and past consultations will be reviewed.

Feedback on this program is important to us. Please let us know what you think.

For additional information, contact Dee at (713) 634-5103.

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Should Alcoholics Be Allowed to Receive Liver Transplants?

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Alcohol, Liver, Cirrhosis and Transplant: Dr. Galati Discusses

A segment that I recorded for this weeks Your Health First was with Dr. Howard Monsour. who’s the Chief of hepatology at Houston Methodist. In this two-part interview, we discussed various aspects of alcoholic liver disease, effects of acetaminophen on the liver, and the difference between men and women in their alcohol consumption.

As noted in prior posts, the issue of liver transplant in patients with alcoholism and alcoholic cirrhosis is controversial, but when carefully reviewed, their outcomes following transplant are equal or better than other diseases we transplant livers for.

Watch the video interview here.

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World Hepatitis Day: Missed Opportunities for Awareness?

Yesterday was World Hepatitis Day. This is a day where we can give special attention to the world wide problem of viral hepatitis, the people that it affects, and celebrate the new therapies and technology that are available.

Reviewing numerous websites and online publications, they all state the desire to alert the world, as well as those of us in the United States, to the perils of viral hepatitis. A press release from the American Liver Foundation stated the following:

Hopefully, July 28 will be a day when more Americans become familiar with how to prevent, get tested and treated for hepatitis.

Unfortunately, the best of sincere intentions has made barely a ripple in the global understanding of viral hepatitis. No major television news outlet in the United States, nor such papers such as the New York Times, mentioned World Hepatitis Day.

Considering there are 1.4 million cases of hepatitis A every year, 240 million people living with chronic hepatitis B, 150 million people chronically infected with hepatitis C, this remains a global health concern. Untreated hepatitis B and C leads to progressive liver failure, the eventual development of liver cancer, and the need for liver transplantation. Effective antiviral therapies are available, and the key is early diagnosis and intervention.

The hepatitis community needs to take a more aggressive strategic stance, along the lines of HIV and breast cancer awareness. I salute these two diseases, and their respective organizations, in that they have done a superior job in creating public awareness and a call to action.

I dream for the day that the publics understanding and awareness of viral hepatitis is at the level of HIV and breast cancer awareness. My goal day after day is to touch as many people as possible, spreading the word on viral hepatitis, both locally and on a worldwide basis.

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Liver Transplant Houston: Is There a Special Diet to Follow?

A common question I am asked daily is in regard to “what kind of diet do I need to be on while waiting for my liver transplant?”. There is a great deal of misunderstanding surrounding this, that it deserves a few simple comments.

The simple answer is that there is no special diet you have to follow if you have cirrhosis. The central area of concern is dietary sodium or salt. The goal is to have a reduced salt diet, in the neighborhood of 1,500-2,000 mg per day. This is a very restrictive diet compared to the standard American diet (aka SAD). The SAD may include well over 6,000 mg per day. Too much!

The simplest way to achieve such a restricted diet is to eliminate all processes foods, avoid all foods in a can, bag, or box. If it has more than 5 ingredients on the label, keep away.

Salt is the enemy to anyone with chronic liver disease and cirrhosis. The body’s handling of salt and sodium are malfunctioning, resulting in fluid retention, edema, and the development of ascites. In many circumstances, diuretics (water pills) need to be used to remove the excess salt and fluid from the body.

All of our patients need to consume fresh fruits and vegetables, lean fresh meat and fish, and foods found in their natural state. This may be an overwhelming challenge to those accustomed to eating out and or consuming large quantities of processed foods. It is impossible to meet this less than 2,000 mg salt intake by eating out.

I highlight numerous tips from
past entries that will help you with this mission. Read labels, stop eating out, and eat foods found in their natural state.

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Wilsons Disease Houston:Transplant Will Cure the Disease

While still on vacation this week, I received news from my murse that one of our patients who has Wilsons Disease received his liver transplant. It was quite a relief for the patient, his family, and all of us taking care of him that his transplant took place.

In this particular case, the neurologic effects of the Wilsons Disease where the predominant features. While he did have cirrhosis, and the associated problems related to portal hypertension, the neuro-cognative symptoms predominated. This resulted in a wide range of symptoms, ranging from depression, apathy, mood swings, and difficulty in completing complex tasks.

This is typical for copper overload, making the diagnosis and treatment difficult. In up to 15% of the cases, the neurological effects get worse once therapy is started.

Across America, the allocation of donor organs is based on the MELD score -discussed previously. Many time, those with Wilsons Disease have low scores, making timely transplants problematic. On rare occasions, MELD exceptions can be allowed, but in most cases, the wait can be long and frustrating for all.

My hope is that our latest transplant does well. It will take several months for his copper metabolism to correct, and his disease has now been cured with the transplant and the new liver.

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Liver Education Video: Hepatitis C and Liver Transplant in Houston Part 2

Over the next week or two, we plan to roll-out a series of comprehensive videos covering a wide-range of topics related to all facets of liver disease. This is geared for our patients, their families, our staff, and all those interested in liver disease.

We plan to keep them no longer than 5 minutes, to keep everyones attention, as well as to stay focused on one general topic at a time.

This is Part 2 of the series. Part 1 was produced last year. Come back often and let us all know what you think.

Part 1 Liver Disease Education

Part 2 Liver Disease Education

 

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Is there a Special Diet for Hepatitis C?

In this video, Dr. Galati explains the commonly asked question about “special diets for hepatitis C”, or for that matter, any form of liver disease.

 

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