Originator Clinical Trials of Direct Acting Antivirals

The website hcv-trials.com maintains a regularly updated list of all the major HCV clinical trials, with the significant exception of those performed on generics, perhaps related to its funding.

NATAP (National Aids Treatment Advocacy Project) maintains an excellent HCV resource at www.natap.org/hcv.htm that is substantially more complete, and includes reporting from the AASLD, CROI and EASL conferences.

Generic Clinical Trials of Direct Acting Antivirals

REDEMPTION-1 final results.

PYRAMID-1 Sofosbuvir + Ravidasvir results.

Margin of Error

Research into these new medications and the best drug combinations is ongoing. Many studies suffer from n < 100 which means mathematically we can only say the results something like xx% not xx.x% (which is what they tend to quote). See this Wikipedia analysis on margin of error.

Sample Size (n) Margin of Error
 96  +/- 10%
 384  +/- 5%
 600  +/- 4%
 1067  +/- 3%
 2401  +/- 2%

 

What this means is that for a sample size of 96, if we had a 90% SVR (typically quoted as 90.0%) that could be represent a real result anywhere between 80% and 100% and we will only know the result with greater accuracy when we have more people (more n). So when you read 96.6% and then think "that sounds better than 94.4%" make sure you consider the (n)umber of people in the study.

We know that each medications will exhibit a log kill and can observe that with HIV (also an RNA virus) that is one medication is good, two is better, and three can be better again. See ART and HAART.

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