Tag Archives: Boceprevir

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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Starting New FDA Approved Hepatitis C Therapies: What Patients Need to Know

This week, we will be starting therapy using the new FDA approved protease inhibitors, Victrelis (boceprevir) and Incivek (telaprevir) in our patients with chronic hepatitis C.

Below is a brief podcast explaining some of the procedures required prior to initiating therapy with these new agents.

Listen to the podcast here: Hepatitis C Treatment Introduction

Call our office at 713-794-0700 if you have questions.

Liver Specialists of Texas
6624 Fannin, Suite 1990
Houston, TX 77030

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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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Boceprevir, New Hepatitis C Drug, in New England Journal of Medicine Today

Boceprevir, New Hepatitis C Drug, in New England Journal of Medicine Today

Meeeting in Berlin

At the European Association for the Study of Liver Disease, where I am currently at,  the major buzz in Berlin is hepatitis C, and the new therapies that everyone has been waiting on with great anticipation. In addition to the oral presentations and poster presentation taking place all week, today in the New England Journal of Medicine, two new articles, accompanied by an editorial, was released, presenting research data on Boceprevir, one of the two anti-viral agents poised to be released by the FDA very soon. The first Boceprevir  article deals with patients that are naive to therapy (never treated), while the second article on Boceprevir is concerned with previously treated patients.

The two New England Journal of Medicine articles are quite different. One of them focuses on patients that have previously been treated and analyze their response to a triple course of therapy including interferon, ribavirin, and Boceprevir. In the coming months, this triple therapy will be the new standard of care for patients with genotype 1 hepatitis C. For the non-medical person, reading the articles can be quite daunting. The key points are as follow: (1) patients that were previously treated and had a good response to interferon and ribavirin, but unfortunately relapsed after discontinuation of drug, had a very high response rate to triple therapy, in the order of 75%. (2) those that were previously treated but had less than a full response, still were able to see a significant rise in their viral response in the order of 30-50%. This is a significant increase from retreatment with medications they previously received. The dosing of the 3 drugs will be an issue that both physicians and patients, who will need to learn about the protocol designs. In the studies, there was a 4 week lead in with interferon and ribavirin alone, followed by the initiation of Boceprevir after the initial 4 week.

In the study looking at patient’s naïve to antiviral therapy, the triple therapy with Boceprevir had a sustained virologic response of approximately 68%. There were differences between the between the black and caucasian patients, and this difference will continue to be looked at. This study also had a 4 week lead in, administering interferon and ribavirin prior to the Boceprevir. In this particular study, the design was such that the patient’s who exhibited an early response to therapy, had a shortert total length of treatment.

In addition to these 2 articles that were released today, numerous presentations at the conference were discussed, focusing both on Boceprevir and Teloprevir, with a two protease inhibitors that will be FDA approved in the coming months. The above description of the 2 articles is superficial to say the least. There are many nuances to using these new drugs, and it will require both a good understanding of how these drugs work, and a certain level of patients and carefully monitoring as to how our patients will do. Each of the new protease inhibitors have their own side effect profile which physicians will need to become familiar with. There is the issue of resistance while taking these medicines, and this will be yet another area of detail we will all need to master. Lastly, there is the IL 28B gene pleomorphism, whose presents may confer a better overall response rate, and its lack of, may suggest that therapy should be discontinued sooner than later, due to less of a response. How all this new research and technology fits together is still being sorted out, which is why we have these meeting to share and learn from one another.

From patient’s perspective, the good news is that better therapies are available and more people than ever can be evaluated, treated, and cured of chronic hepatitis C. The pipeline for additional, very effective drugs to combat hepatitis C, or soon to follow as well.

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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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Boceprevir Improved Hepatitis C Response in Genotype 1 Patients-Dr. Paul Kwo Interview

Dr. Paul Kwo was on Your Health First with Dr. Joe Galati this past Sunday evening, discussing the latest results published this past week in the medical journal Lancet, which discussed the new finding with the drug Boceprevir. The response rates in chronic hepatitis C, genotype 1, are significantly improved compared to standard of care therapy currently available.

Listen to the interview here.

Paul Kwo HCV Interview

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