Written by David Bernstein Tuesday, 12 January 2010 12:53
What does 2010 have in store for people with hepatitis C? For the patient, it will likely be a year to wait and observe what happens with many of the new medications being evaluated in clinical trials. From the provider side, 2010 will be an exciting year. There are several new medications being introduced into clinical trials and some of the more advanced new medications are likely to complete their pre-approval evaluation this year.
While there is lots of chatter regarding new medications for hepatitis C, it is important to understand that the new medications are in addition to the current therapies. They are not replacement therapies. This means that the current standard treatment of interferon and ribavirin will not disappear. Future treatment regimens will be comprised of at least three drugs, interferon, ribavirin, plus a third or perhaps a fourth new agent. While the current interferons that are currently approved for therapy are pegylated interferon alfa 2a or 2b, newer interferons and new delivery systems of already approved interferons are being introduced as well into the research arena.
Most of the new clinical trials are evaluating previously untreated patients with genotype 1. Unfortunately, there are limited studies being planned for previous non-responders to pegylated interferon or for relapsers to the same regimen despite the vast number of patients who fall in to these categories. The good news is these patient populations have been studied with a treatment regimen of three drugs including interferon, ribavirin and a protease inhibitor with excellent outcomes. There are also limited data available for the use of any of these new compounds in genotypes other than type 1.
When can the public expect that these new medications will become available? While we are not able to assure when the next agent will be approved by the FDA, two different protease inhibitors seem poised to be approved for the treatment of hepatitis C in the latter half of 2011. Both of these agents are oral agents which will be used in combination with pegylated interferon and ribavirin; and the sustained viral response rates with the triple therapy is significantly better than with dual therapy, although the side effect profile with the three drugs is greater. Therefore, the use of these products requires significant experience by the physicians and their staffs. These agents also offer hope for the non-responder and relapse patient, and hopefully, their approval will offer the chance of a sustained viral response to many patients with hepatitis C.
In addition to these new agents, the team at Duke has identified a genetic polymorphism near the IL28B gene which can predict response to therapy with standard pegylated interferon and ribavirin. If this proves to be a real finding and a commercial assay can be developed, it may become available for routine testing which would allow physicians to predict response to therapy prior to initiating treatment. This would differentiate those patients requiring the new triple therapies versus those who will do well with standard dual therapy.
So what are patients to do in the interim? My suggestion is to continue current evaluations and discussions of what therapies are available now and what may be best for the individual patient in the future. For some, watchful waiting may be appropriate, while in others, initiation of treatment at this time may be the best treatment course. Either way, a little education will go a long way in best understanding and treating hepatitis C.
(Disclaimer: The views and opinions represented are those of the author and meant for informative purposes only. For your specific questions, consult your physician.)