Disappointing Results for Gilead’s 8-Week Triple-Drug Hepatitis C Treatment

[Hep Editors]

Eight weeks Gilead Sciences’ experimental triple-drug hepatitis C virus (HCV) regimen sofosbuvir/velpatasvir/voxilaprevir failed to work as well as 12 weeks of Epclusa (sofosbuvir/velpatasvir) in a recent trial, Reuters Health reports. However, the former regimen did yield comparable results to the latter regimen for those with genotype 3 of hep C and compensated cirrhosis, the milder form of the severe liver disease.

Publishing their findings in the journal Gastroenterology, researchers analyzed results from two Phase III, open-label trials that randomized participants who were first-timers to HCV treatment to receive the three-drug combination for eight weeks or Epclusa for 12 weeks.

For more...
https://www.hepmag.com/article/disappointing-results-gileads-8week-tripledrug-hepatitis-c-treatment

[Mugwump]

This information confirms what we have seen here on this web site that a reduced 8 week treatment for GT1a with Harvoni is up to 4% less effective. And the newer treatment is no more effective at the shortest duration. So the reduction of treatment durations from 12 weeks to 8 weeks by the insurance companies to save a few dollars is almost criminal and should be stopped immediately. The practice of insurance companies making clinical decisions about treatment durations is at best asinine at worst malicious money grubbing stupidity that will wind up costing millions over the long term.

It seems that the human metabolism on average requires 12 weeks of the circulation of these particular DAAs to ensure the best level of HCV elimination. I would hope that this information leads Gilead to remove the 8 week option from their products, thus eliminating the option for insurance companies and government health care systems.

This situation came about because of the greed of Gilead. If they still insist upon holding the health care systems at ransom and not dealing fairly with everyone then perhaps there might soon be public pressure put upon them to lower their over the top drug pricing.

This is the only hope we currently have of eliminating HCV once and for all the way we did with polio and there is no reason stopping this from occurring if enough pressure is put upon these greedy jerks! Here is a question and a thought.

Why cannot a government simply buy out drug patents in the public interest instead of having to invalidate them or have others steal them in desperation?

This particular patent refers to the use of the specific chemical structure created by HCV's viral mechanisms to inject an attached drug directly into an hepatocyte. China and India have already repudiated this patent as invalid so within a few years I am certain they will eliminate HCV, long before the US and Canada do.

[Jetty]

I was just told that my virus is back after an 8 week harvoni treatment.  I had been approved for the 12 week treatment with one insurance company but then had to switch on the first of the year so the new company would only do 8.  Can you point me in the direction of other studies that show 8 weeks is not the complete treatment.
Thank you

[Mugwump]

I was just told that my virus is back after an 8 week harvoni treatment.  I had been approved for the 12 week treatment with one insurance company but then had to switch on the first of the year so the new company would only do 8.  Can you point me in the direction of other studies that show 8 weeks is not the complete treatment.
Thank you

Harvoni treatment is not as effective with certain resistant strains of the virus. The reason why Gilead changed the formula and created a new pan genotype drug was also to create a more effective treatment for those with resistant strains of HCV. I would suggest learning which genotype you have and if it is an NS5A resistant strain of the variant, if you do not know these things already or if your doctor did not do or recommend resistance testing.

Resistance testing is a different procedure and is complementary to complete genotype re-testing for those who are unfortunate enough to have a DAA treatment failure. Only in this way can one be certain that the treatment failed due solely to shortening of the duration by the insurance pencil necks.

The drug trials that were originally done to get approval for Harvoni showed that it was effective but not with as high cure rates with the shortest 8 week treatment for those with any liver damage. These original studies seem to be the only information available and it was done by Gilead.

However their recommendations were that 8 week treatment should only be considered for those with no signs of liver damage and a viral load at time of treatment under 3 million. But as we know HCV can and does do damage that is very hard to quantify and the viral load can be all over the place during the course of infection, so beyond a shadow of a doubt having insurance companies cut back a specialists recommendation regarding treatment duration is criminal in my books.     

But it could very well be if you were not tested for resistance then you may require re-treatment with a different DAA.

All the best being cured as soon as possible.

Eric