Simeprevir and Sofosbuvir Submitted to FDA — Clock Ticking on Boceprevir, Telaprevir, Even Interferon

This spring, two drug companies have submitted New Drug Applications to the FDA for drugs to treat chronic hepatitis C infection. Both simeprevir (an NS3/4A protease inhibitor; Janssen Research and Development) and sofosbuvir (a nucleotide analogue; Gilead Sciences) have looked promising in clinical trials to date. In his blog HIV and ID Observations, Dr. Paul Sax notes that, barring unforeseen occurrences that hold up these approvals, better HCV treatment options may be available in less than a year.

Published in Journal Watch HIV/AIDS Clinical Care April 12, 2013

Simeprevir and Sofosbuvir Submitted to FDA — Clock Ticking on Boceprevir, Telaprevir, Even Interferon

Paul Sax • April 10th, 2013

Categories: Health Care, Infectious Diseases, Patient Care, Research
 

Two weeks, two companies, two press releases, two future HCV drugs that begin with “S”: 

March 28, 2013: Janssen Research & Development announced that it has submitted a New Drug Application to the FDA seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic HCV in adult patients. 

April 8, 2013: Gilead Sciences announced that it has submitted a New Drug Application to the FDA for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic HCV infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with ribavirin and pegylated interferon for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

For several years now, all clinicians who see patients with hepatitis C have been promising them better treatments “soon”, with admittedly little precision about exactly what this “soon” actually means.

But with these filings, we have a pretty good idea. It will be less than a year — maybe much less. Why is that?

The FDA has roughly 10 months to review these applications. (The exact timing is somewhere on the FDA web site, see if you can find it.)These two drugs have looked pretty great in clinical studies to date. 

The bar to leap over to be substantially better than current standard -of-care treatment for HCV isn’t exactly high — a fact that could get at least one drug, if not both, priority review and even more rapid approval. 

One of my patients has joked that I’ve been saying “in a few years” for availability of better HCV treatment options for at least “a few years” now — so my time is up.

Of course, stuff could happen that holds up the approvals. A toxicity could arise that hasn’t been reported previously, or a tricky drug-drug interaction could crop up. Or the sun could explode.

But if these things don’t happen, then for patients with HCV genotypes 2 and 3, a non-interferon option looks like it’s right around the corner — sofosbuvir and ribavirin. For those with genotypes 1 and 4, a shortened, more effective, and all-round improved interferon-based regimen will arrive at the same time — pegylated interferon/ribavirin plus either simeprevir or sofosbuvir.

And even better, how about an off-label combination of these two new drugs as in this clinical study – in which case the interferon can be dropped entirely, right?

Let the choir sing out when that happens, and enjoy a hearty celebratory brunch at the famous Cambridge deli pictured above in honor of the new regimen.

Paul E. Sax, MD is the Editor-in-Chief, Journal Watch HIV/AIDS Clinical Care, Clinical Director of the Division of Infectious Diseases at Brigham and Women's Hospital, and Professor of Medicine at Harvard Medical School.

Learn more about HIV and ID Observations.