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
‘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:
- Need for more combinations from same and from different drug classes
- For reasons of tolerability
- For reasons of viral resistance to a combo partner:
there is a low resistance threshold with NS5A inhibitors and the protease inhibitors - For faster viral clearance and shorter treatment durations
- For better PK match
- For truly pan-genotypic activity:
not a given with NS5A combos - As a fall-back option in case of sofosbuvir issues down the road
- Need for stand-alone drugs
- For free partnering of drugs from different companies
- For individualized dosing / dose adjustment
- Need for shorter treatment duration
- 12-wks is good but 8 wks is better
- For better compliance
- Need for new drugs for special populations like:
- ‘new’ non-responders to first-round DAA therapy
- pre-liver transplant and decompensated cirrhotics
- post-liver transplantation patients
- HBV / HIV co-infected patients
- Patients with co-morbidities
- Patients unable to take certain DAAs because it would create drug interaction problems
- Immunosuppressed / transplant patients
- 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]
Or just too expensive…
I would be interested in your comments on areas of need not listed above.
References:
[1] http://www.bloomberg.com/news/2014-01-27/at-84-000-gilead-hepatitis-c-drug-sets-off-payer-revolt.html
[2] http://www.newsweek.com/insurers-worry-84000-hepatitis-c-drug-sovaldi-could-break-bank-252539
