December 20th, 2014

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

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:


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:

4 Responses to “New HCV Option Effective, Safe, Well-Tolerated — And Use Will Likely Be Driven by Payors”

  1. Marvin Rabinowitz says:

    All this will do is create more work for my staff and me with another round of prior authorizations that will be denied.

  2. Keith bradbury says:

    I think the observations under estimate the many disadvantages of Ziekira + ribavirin versus Harvoni in terms of inconvenience, toxicity ( ribavirin), liver monitoring and longer duration of treatment for many patients.

    • Paul Sax says:

      under estimate the many disadvantages of Ziekira + ribavirin

      Keith, that was my point about emphasizing the ribavirin. It greatly adds to the complexity of the regimen, and will be required for most patients.


  3. Keith bradbury says:


    I understand.


HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Contributing Editor

NEJM Journal Watch
Infectious Diseases

Biography | Disclosures | Summaries

Learn more about HIV and ID Observations.