Paul E. Sax, MD
Apr 19, 2013
Hi. This is Dr. Paul Sax from Brigham and Women's Hospital and Harvard Medical School. Infectious disease and HIV specialists, hepatologists, and other clinicians who take care of patients with hepatitis C received some very exciting news recently: New drug applications for simeprevir and sofosbuvir, 2 investigational hepatitis C drugs, were submitted to the FDA.
The submissions were for at least genotype 1 hepatitis C, for use in combination with interferon and ribavirin. Notably, the sofosbuvir treatment course looks like it's going to be shorter, at 12-16 weeks. In addition, sofosbuvir is seeking approval for genotypes 1 and 3 in the submission in combination with ribavirin -- an interferon-free option.
This is very exciting. Both of these drugs are given once daily and look to have a much better toxicity profile than our existing hepatitis C protease inhibitors. But there are additional reasons why this information is very exciting, in particular for HIV care providers.
First, as you know, approximately 15%-20% of the HIV population in the United States is coinfected, and in some regions it's much higher. Second, treatment with our current standard of care, which is interferon-ribavirin plus telaprevir or boceprevir, has been challenging because of toxicity and drug-drug interaction issues. So there was a lot of room for improvement.
Third, we saw some very exciting data at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) combining these 2 drugs, simeprevir and sofosbuvir. Granted, that was in hepatitis C monoinfected patients, but the combination looked like it had outstanding results even without the use of interferon.
There is an emerging consensus in the field that using regimens that have direct activity against hepatitis C will make the HIV coinfection component of the population much less relevant in the future. A lot of other things, too, may be less relevant, such as IL-28B status, race, and prior treatment failure. All of these are harbingers for good things and progress in the hepatitis C treatment front.
I think we need to stay tuned for new data in this exciting area with the European liver meetings coming up later this month. Also, keep in mind for your patients who have HIV/hepatitis C coinfection that, if they're stable and if they don't have evidence of advanced liver disease, one could very easily make the argument that waiting for newer drugs such as simeprevir and sofosbuvir to be approved makes a lot of sense.
Thanks very much. There is more information on this topic on my blog, HIV and ID Observations. I hope you have a very nice spring, and I hope it's warmer than it is here in Boston, where it is still freezing.
Lawitz E, Ghalib R, Rodriguez-Torres M, et al. Suppression of viral load through 4 weeks post-treatment results of a once-daily regimen of simeprevir + sofosbuvir with or without ribavirin in hepatitis c virus GT 1 null responders. Program and abstracts of the 20th Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta, Georgia. Abstract 155LB.
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