Tag Archives: sofosbuvir

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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New Gilead Drug Sovaldi FDA Approved: Improved Cure Rate Available

Yet another new drug to treat hepatitis C has been approved. The FDA announced the approval of sofosbuvir, commercially known as Sovaldi. Sovaldi is manufactured by Gilead.

More details on this new therapy will be added this weekend, so stay tuned. For an office evaluation and opinion if you are a candidate for these new hepatitis C therapies, call our office at 713-794-0700, and fill out this on-line form.

Look at our latest video on these new hepatitis C treatment. It will be update this weekend.


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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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New Hepatitis C Therapy Sofosbuvir to be Released in December 2013

For those following the release of the new medicines for hepatitis C, Gilead is one step closer to FDA approval.

Yesterday, the FDA released further positive feedback that sofosbuvir will receive positive approval in mid-December 2013. This will be the start of yet another new era in the successful treatment of patients with chronic hepatitis C. Based on available research data, sofosbuvir will be associated with a 90% sustained virology response (no detectable virus) in patients naive to any form of HCV therapy.

One major topic of discussion, especially among patients, is whether or not it will be the first interferon-free protocol? The answer is part yes, and part no.

Genotype 2 and 3 patients with hepatitis C will take the combination of sofosbuvir and ribavirin for 12 weeks, while genotype 1 patients, the most common in North America, will have to take a triple combination of PEG-interferon,sofosbuvir and ribavirin for 12 weeks.

While most of us are still waiting for all interferon therapies, 12 weeks of interferon is a vast improvement over the previous 48 weeks of interferon in genotype 1 cases. It is expected that the 12 weeks of interferon will be very well tolerated, considering most symptoms related to interferon develop around 12 weeks.

Our practice is gearing up for patients once approval is announced. Visit us on our website for updated information as well as this blog. Sign up for our newsletter for up-to-date information on the FDA approval.

This new FDA approval of sofasbuvir will not address patients previously treated and failed treatment, those with advanced cirrhosis, transplant patients, those with liver cancer, or co-infected with HIV. Despite a lack of formal FDA approval for these specific patients, I anticipate we will be seriously discussing treatment in this very special group of patients.

To make an appointment, contact Lexa in our office at 713-794-0700; make sure old records are available.

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Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 in Patients With Unfavorable Treatment Characteristics: New Treatments in Houston Soon

There continues to be good news for those with hepatitis C genotype 1. Gilead is on the verge of FDA approval for their new hepatitis C drug, sofosbuvir, combined with ribavirin, in HCV patients with genotype 1 HCV. The study, available here for review, further shows how effective this combination is in eradicating the HCV virus.

For those of us who have been involved in hepatitis C therapy for the past 20 years, these new agents are a wonderful and welcomed addition to the already excellent therapies we have.

Stay tuned for further developments, and their eventual FDA approval.

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