After Harvoni: What’s Still Left to Improve (Besides the Price Tag)?

SVR rates in recent DAA combination trials are really impressive.  Hardly a month goes by without yet another trial showing excellent efficacy in populations so far considered

...not so long ago...
…not so long ago…

‘difficult to treat’, like cirrhotics or post-liver transplant patients on immunosuppressive therapies.  This begs the question: is there still room for improvement?  Why are there still drugs in early stages of development?  Doesn’t Harvoni and Sovaldi + simeprevir (and some other combos) already have it all: efficacy, safety, tolerability and once-daily convenience?

We are clearly experiencing the end of the pegylated interferon plus ribavirin era, and that is a good thing.  But don’t assume that HCV drug development has now come to an end: There are plenty of reasons for companies to develop better HCV drugs. 

Spending on hepatitis C drugs alone is projected to rise seven-fold from $3 billion a year in 2011 to $21 billion in 2018, according to market research firm Decision Resources Group LLC
Ref. [1]

Here my – admittedly subjective – list of areas for future opportunities:

  1. Need for more combinations from same and from different drug classes
    1. For reasons of tolerability
    2. For reasons of viral resistance to a combo partner:
      there is a low resistance threshold with NS5A inhibitors and the protease inhibitors
    3. For faster viral clearance and shorter treatment durations
    4. For better PK match
    5. For truly pan-genotypic activity:
      not a given with NS5A combos
    6. As a fall-back option in case of sofosbuvir issues down the road
  2. Need for stand-alone drugs
    1. For free partnering of drugs from different companies
    2. For individualized dosing / dose adjustment
  3. Need for shorter treatment duration
    1. 12-wks is good but 8 wks is better
    2. For better compliance
  4. Need for new drugs for special populations like:
    1. ‘new’ non-responders to first-round DAA therapy
    2. pre-liver transplant and decompensated cirrhotics
    3. post-liver transplantation patients
    4. HBV / HIV co-infected patients
    5. Patients with co-morbidities
    6. Patients unable to take certain DAAs because it would create drug interaction problems
    7. Immunosuppressed / transplant patients
    8. GT3 patients

So, there is still room for new drugs for special situations and special patient

By law, insurers cannot deny access to new drugs if they represent a real improvement for patients, leaving drug companies with the upper hand in most price discussions.
Ref. [2] 

populations for whom neither Harvoni nor the Sovaldi/Olysio combination is not ideal.

Or just too expensive…

I would be interested in your comments on areas of need not listed above.





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