Tag Archives: hepatitis C
AASLD Liver Meeting 2015

AASLD Liver Meeting 2015

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For the next several days, liver disease experts from around the world will be in San Francisco learning and sharing the latest developments in liver disease at the annual Liver Meeting.

Today, the one-day postgraduate course covered common clinical conditions, including non-alcoholic fatty liver disease, hepatitis C, liver cancer/hepatocellular carcinoma, and complications of cirrhosis, including volume overload/ascites, malnutrition, and hepatic encephalopathy.

More updates will be posted through the meeting.

Dr. Joe Galati

Liver Meeting 2015

 

 

 

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Latest News on Hepatitis C Cures

For tonight’s broadcast of Your Health First, Dr. Rashid Khan joins me to discuss the latest news on fatty liver disease, and the new therapies for hepatitis C, which results in a cure rate of over 95% of the cases. You can listed to the audio from the three segments here.

 

Dr. Rashid Khan and Dr. Joe Galati Discuss Liver Disease: Part 1 by Your Health First Radio on Mixcloud

Dr. Rashid Khan and Dr. Galati Discuss Fatty Liver Disease: Your Health First Part II by Your Health First Radio on Mixcloud

Hepatitis C: Dr. Rashid Khan and Dr. Joe Galati Discuss-Your Health First Interview Part III by Your Health First Radio on Mixcloud

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New Hepatitis C Cure FDA Approved: Daclatasvir for Genotype 3 Patients

This past week, the FDA gave approval to Bristol-Myers Squibb and their first drug in the hepatitis C market. Daclatasvir was given FDA approval for patients with the genotype 3 variety of chronic hepatitis C. Daclatasvir, commercially available as Daklinza, is approved to be taken with previously approved sofosbuvir (Sovaldi)-manufactured by Gilead-in this two-drug combination. Of note, Ribavirin nor interferon are required in the combination.

Published cure rates, also know as sustained virologic response (SVR) range from 86-90%. If you are non-cirrhotic, and naive to therapy, one can expect a 96% SVR. Unfortunately, prior treatment failures with past combinations, plus the presence of cirrhosis, carries a poor response rate of 63% in this most difficult group of patients.

For more information on hepatitis C and current therapies available, visit our website at Liver Specialists of Texas .

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Harvoni: Points to Consider

Harvoni, the newly FDA approved drug for chronic hepatitis C, is indicated for genotype 1 patients only. All others, at this time, are not approved. Additional new drugs are in the process of receiving FDA approval for the other genotypes.

While there is no official indication for treating post-liver transplant patients, many experienced physicians will evaluate post liver transplant patients with recurrent hepatitis C.

For patients interested in being treated, it is important that your old records from prior treatments are available. We would need to be aware of your prior response to treatment.

In conversations with patients the past couple of weeks, they are amazed that there is no use of interferon and ribavirin, which was always a concern because of the numerous serious side effects. With Harvoni, side effects include fatigue, headache, nausea, diarrhea, and insomnia. Most of these occur between 3-14% of the times.

Overall, this remains an exciting time for everyone with HCV, realizing that a cute is within reach.

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New Hepatitis C Drug Harvoni FDA Approved: Information for Patients

More information on the new Gilead drug Harvoni for patients with hepatitis C.

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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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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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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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Hepatitis C and HIV Co-Infection: Research Study Houston

We are please to announce that Liver Specialists of Texas and our research division, Research Specialists of Texas, will be conducting a clinical research study treating co-infected patients with hepatitis C and HIV infection.

The study will be using a combination of NS5A and NS3/4 protease inhibitors. This is an interferon-free protocol.

If you are interested in participating, contact Paula Juarez at 713-634-5110. If enrolled in this study, all study related testing, medications, labs, and visits are provided free of charge for your participation.

Prior to enrollment and participation, all patients must meet all of the specific entry criteria, which will be reviewed once your medical records are reviewed.

Screening will be starting now, and be completed by September 1, 2013.

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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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