Spotlight Series on Hepatitis C


New HCV Option Effective, Safe, Well-Tolerated -- and Use Will Likely Be Driven by Payors

December 22, 2014

As expected, the FDA approved the next treatment option for HCV on Friday -- "Viekira Pak", a (sometimes complete) regimen consisting of ritonavir-booted parataprevir and ombitasvir given as a two pills once a day, plus one pill of of dasabuvir given twice daily. It is indicated for treatment of HCV genotype 1.

For those of you mechanistically inclined, parataprevir is a protease inhibitor, ombitasvir an NS5A inhibitor, and dasabuvir the first approved non-nucleoside polymerase inhibitor. Ritonavir is there for PK boosting.

Cure rates have been outstanding -- 90% and higher -- and severe adverse events rare. All good news so far.

So what's the issue? The full prescribing information is here, but this is the key table:

prescribing information

Obviously, many patients will require concomitant administration of ribavirin, which makes this a considerably more complex regimen than the sofosbuvir/ledipasvir combination pill that has been available since October. Two other disadvantages include more drug-drug interactions (ID/HIV doctors are certainly familiar with ritonavir), and the potential for broader antiviral resistance if the treatment fails.

Whether these make a difference or not in clinical practice is a key unknown. But you can bet good Hanukkah gelt that payors are highly motivated to find out. Here's some proof.

Hey, Happy 20th Birthday to this classic:

Paul Sax is Clinical Director of Infectious Diseases at Brigham and Women's Hospital. His blog HIV and ID Observations is part of Journal Watch, where he is Editor-in-Chief of Journal Watch AIDS Clinical Care.

This article was provided by NEJM Journal Watch. NEJM Journal Watch is a publication of the Massachusetts Medical Society.


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