This week a friend of mine named Michael, a member of the Facebook group Hepatitis C Treatment w/o Borders, posted the sentence below with a photo of their end of treatment test results, which showed the virus was undetected two weeks after the end of treatment with generic Harvoni from India. He wrote:
Ultimately we all are guinea pigs ....and statistics. Allow me to throw my piece of paper on the pile - 2 weeks since EOT - RNA results - Virus Undetected: Generic Harvoni. Thanks Greg Jefferys and James Freeman for helping me to do this.
This post caused me to think again about the fact that we, the people using these Direct Acting Antivirals (DAAs), are indeed guinea pigs. We are being used to confirm how effective these drugs are and what their side effects are.
To a degree the situation with the release of the DAAs is quite unique. Because there were (and are) so many people with Hepatitis C and because Hepatitis C is such a deadly disease and because the previous existing treatment of Interferon + Ribavirin had such a low cure rate with so many terrible side effects, because of all these factors these new drugs, the Direct Acting Antivirals, were given approval very quickly by the medical regulatory authorities around the world.
The reason for the fast tracking of approval DAAs was that there were hundreds of millions of people with Hep C and, as mentioned, the existing treatment was so ineffective and so dangerous, there was nothing to lose by allowing the wide spread use of DAAs without extensive trials.
So the FDA in the United States and other regulatory authorities granted approval for Sofosbuvir and Daclatasvir and other DAAs based on relatively small samples of trial results.
And so we, the people who have now completed their treatment using DAAs were guinea pigs.
My comment/reply to Michael’s post that I referred to above was this:
“Yes we are all guinea pigs and there were side effects that I had not expected, that were not in the literature, but none of the side effects was as bad as having advanced, chronic Hepatitis C.”
Click here to read the rest of Greg’s blog, "On Being a Cured Guinea Pig."