by Dr. Joe Galati on 11/29/2013
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.
Source - http://blog.texasliver.com/#sthash.ju2JBHrL.dpuf
Related:
OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C
HCV Drug Olysio (simeprevir) - The New Kid On The Block
OLYSIO Website
Prescribing Information
Patient Information
Important Safety Information
Simeprevir and Sofosbuvir-The Next Wave of Hepatitis C Treatment
No comments:
Post a Comment