Tag Archives: Liver Specialists of Texas

Alcoholic Liver Disease: What You Need to Know-The Basics

Our latest video covers the basic aspects of alcohol related liver disease, and the complications of excessive alcohol intake. In general, there are three areas of concern:

1. The development of alcoholic fatty liver disease

2. The development of acute alcoholic hepatitis

3. Alcoholic cirrhosis

The major point to understanding is that all alcoholic drinks (servings) have about the same amount of alcohol in them. Thus, 1-beer, 1-glass of wine, and 1-serving of spirit (i.e. vodka, rum, gin, etc) all have approximately 10-12 grams of alcohol in them. Alcohol is alcohol, regardless of the volume, color, or taste.

The other key point to remember, is that the amount of alcohol daily is different for men and women. For women, one serving/day is the limit; two for men. Period. Above this, you run the risk of complications.

View our latest video.

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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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Dr. Joe Galati and the Liver Specialists of Texas Staff: Supporting Local Charities

Our practice, Liver Specialists of Texas and staff, have been supporters of the First Colony Dream League. The Dream League roster is approximately 60 physically- and/or mentally- challenged players. In addition, the league has an “Angels in the Outfield” program, where approximately 150 teenage boys and girls from Ft. Bend area schools volunteer to assist Dream League players during the game, becoming a loyal buddy in the process.

On this particular Saturday morning in May, our staff came out to support the players and their families, and also provided educational material on liver disease, increasing public awareness.

This video is a brief summary of the day, and the BBQ cookout that followed.

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Lentils: A Super Food to Love

Lentils: A Super Food to Love

LentilsDay 20.

Hard to believe we are almost finished with the 31 Days of Wellness. Don’t fear, there are 334 days in the year left afterwards.

There is a very nice entry from the New York Times Recipe for Health section, that features an assortment of healthful recipes you should all bookmark and check in with from time to time. Today I chose the entry on Lentils.

If you have lentils, you have dinner. This high-fiber, protein-rich legume cooks in 20 to 40 minutes, depending on the dish, and requires no soaking. Lentils are the basis for many starters and salads, soups and stews, side dishes and Middle Eastern pastas. The distinctive flavor has been adapted to a variety of classic cuisines, from France to the Mediterranean, from India to Mexico and North America.

The usual supermarket offerings are brown lentils, but there are other varieties and they’re all worth looking out for. Chefs prefer the pricier small black “beluga” lentils (in their raw state they glisten like caviar, but the resemblance stops there) and the firm green Le Puy lentils from France, because when cooked both types stay intact and maintain a firmer texture. But the flavors of all three are similar enough to make them interchangeable in this week’s recipes.

Red lentils, available in Indian and Mediterranean markets, have a different taste, more akin to dried favas or split peas, and a very different texture when cooked, so do not attempt to substitute these for the brown, black or green varieties.

One fact worth noting: unlike other beans, lentils do not contain sulfur, the gas-producing element in legumes. And in addition to being an excellent source of soluble fiber and a good source of protein, manganese, iron, phosphorous, copper, vitamin B1 and potassium, lentils are an excellent source of molybdenum, a mineral important in the metabolism of fats, carbohydrates and iron. – Martha Rose Shulman

Like so many foods, the key message all of us are stressing is the need to experiment, and leave your comfort zone of what you are used to. Discuss it over with your family, and each week select one new vegetable to try. If you don’t like it, try another.

Send me your feedback, and share your experience. Keep trying.

Dr. Joe Galati

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Dr. Joe Galati Discusses Colonoscopy: Instructions for our Patients

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Dr. Galati and Liver Specialists of Texas: What We Do

We have produced a brief introductory video describing the staff and activities of Liver Specialists of Texas.  Let us know what you think. Your feedback is valued.

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Dr. Saira Khaderi Discusses Hepatology

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Boceprevir is FDA Approved:Now What?

Boceprevir is FDA Approved:Now What?

Now that Boceprevir is FDA approved, it seems that a big sigh of relief has been let out by both patients and physicians. Despite this great news and FDA success, the work now starts, evaluating and screening the thousands of patients that have been waiting for this day.

Here is my advice to all concerned patients:

  • I cannot stress the need to get your old records related to past HCV therapies. This will help assist us in how to best manage you on the three-drug combination.
  • Get the report from your most recent liver biopsy. The degree of damage, or lack of it, will be of great value when we discuss how to best treat you.
  • Have an up to date list of all your other medical condition, if this applies to you. Other conditions such as diabetes, heart disease, kidney disease, depression, or cancer will allow us to modify treatment as needed-taylored specifically to you.
  • Have the names and phone numbers of all your treating physicians and health care providers. Communication with them is vital.

This is an exciting time for all of us. Call us if you have questions and concerns. We will be updating the blog and website daily. Stay tuned to these new development.

Now What Do We Do?

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Telaprevir and FDA Approval: The Race is On for New Hepatitis C Drugs

Telaprevir and FDA Approval: The Race is On for New Hepatitis C Drugs

Liver Specislists of Texas-HCV Research

For those of us that are involved in the care of patients with chronic hepatitis C, the “never too soon” announcement that we will finally have new drugs to treat our hepatitis C patients with cannot come soon enough. There is a real possibility that one and possibly two new agents for hepatitis C will be granted approval by the FDA in the months to come. When that day will be is unknown to me, but I anticipate later this summer at the latest.

There is a frenzy of discussion in the press, as well as the blogosphere on the new drugs, namely Telaprevir, manufactured by Vertex, and Boceprevir, manufactured by Merck. I have had the opportunity to use both of these drugs in clinical studies over the past several years, and understand how they both work, and what patients can expect. Much to everyone’s surprise, patients will still need to take one of the pegylated interferons once weekly, and ribavirin twice daily. The new drugs are added to this backbone of therapy. Besides the expected interferon and ribavirin side effects, the protease inhibitors do add some additional problems, but for the most part, in experienced hands, they can be managed fine. Once these drugs are approved, I anticipate a mad-dash of patients, wanting to get their hands on these therapies.

My advise is to start requesting your old records now if you were previously treated. Knowing exactly how many weeks you were treated, what your response was, and what complications developed, will be important information prior to commencing any sort of new therapy, regardless of which protease inhibitor you are started on. It can take weeks to get these records, so start asking now.

There are hundreds of thousands of patients with hepatitis C that are either naive to therapy (never treated), or previously treated with a partial response (null responder, non-responder, or responder-relapser). All of these individuals should be considered for these new therapies, but you need to be sure you are being seen by a practice that can handle these patients. With the new protease inhibitor drugs, resistance can become an issue, and discontinuing the therapy in a timely fashion is important. The treatment protocols are different from prior therapies, with a lead-in phase with interferon. All of these steps requires careful monitoring and communication with the patient. An experienced staff of nurses will be needed. Prior to being evaluated for these new exciting drugs, you, as a consumer, need to ask these questions to see if your care provider has the necessary experience, as well as a dedicated team to support them once patients are started on therapy.

Besides the two contenders for FDA approval later this summer, the pipeline for additional drugs is incredibly long. We are conducting research studies on an additional 12 drugs, all of which look promising. Some of the protocols are free of the hated interferon. Imagine, HCV therapy without interferon? That day will be here, allbeit several more years. I am currently in Chicago with the HCV team from Abbott, who also has a number of exciting compounds we will start studying soon with our patients in Houston.

So, when will the new hepatitis C drugs be available? My best educated guess will be by Labor Day, but we may all be surprised sooner, based on the chatter in the press and FDA hallways.

I am eager to hear what you think? Comment on your prior experience with hepatitis C therapy.

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The MELD Score and Liver Transplant: An Update for Patients

The MELD Score and Liver Transplant: An Update for Patients

Liver Transplant

Patients awaiting transplant commonly have questions regarding there MELD score, and how this number is determined. As you can imagine, there is great anxiety in patients awaiting transplant. At almost every clinic visit, patients are asking for they’re updated score. In my own practice, at every visit we calculate the new score and discussed this result with them. The MELD score, which we have been using for the past several years, is calculated by taking the patient’s most recent bilirubin, creatinine, and INR, which is then entered into the computer and calculated. Theoretically, the MELD score can arrange in values between 5 and 40. It has generally been accepted that patients with a MELD score less than 15 have a better survival is not transplanted. Those with scores over 15 should be considered for transplant. The higher the MELD score, the more ill the patient is, with a greater likelihood of not surviving. In the greater Houston area, most of the transplant programs, including ours at the Methodist Hospital, are transplanting  patients with MELD score is greater than 25.

There are certain exceptions to the MELD score. Many of these are developed regionally. With patients who develop hepatocellular carcinoma, in most cases, they will receive a MELD exception of 22 points, even if they have a lower calculated score as described above. It’s been well established that patients with liver cancer should be transplanted quickly. This MELD exception allows this to take place. If after 3 months the patient is not transplanted, additional points are granted. Other MELD exceptions for pulmonary hypertension, refractory gastrointestinal bleeding, and refractory ascites are also allowed. These are given on a case by case basis after a regional review by other transplant centers. Not every exception is granted, and this could be another source of anxiety for patients and their family.

Looking at the bilirubin, creatinine, and INR, you could see that as the patient becomes more ill, their MELD score will reflect a higher value. It is very difficult to sit with the patient who has a low MELD score, who happens to feel very ill, and tells him that they must continue to get even more debilitated before a transplant is performed. While the current allocations system works for the vast majority of patients, there are always going to be those patients that have a MELD score that does not accurately represent how sick they are. For these patients, this is where most of the anxiety and concern is present. The best that we can do as physicians and other healthcare providers is to reassure them and worked very closely with them. I personally have been involved in liver transplantation for over 20 years, and the same issues we faced 20 years ago, despite a different allocations system, remained today.

To calculate your own MELD score, I have listed a link below. Of course, if you have any questions, feel free to contact me or post your comments on this blog for others to see and learn from. You can always reach me at Liver Specialists of Texas at 713-794-07 00.

Calculate your MELD score here

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