Major Clinical Trials

As mentioned on our genotype specific treatments page you and your doctor need to decide in the best drug regimen to treat your specific genotype. That decision is informed by clinical trials which have looked at what works best.

There are many studies that are relevant and could be included. We have tried to select the most relevant ones. The Abstract links point to data published on the National Library of Medicine. The Overview links have detailed expert coverage. The company links point to the relevant press releases.  If you have suggestions of trials that should be included here to provide a broad and even handed coverage please send us an email with the link.

Sofosbuvir/Ledipasvir - the ION trials

ION-1 ION-2 ION-3

Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24725239
Overview: http://www.nejm.org/doi/full/10.1056/NEJMoa1402454#t=articleDiscussion
Company: http://www.gilead.com/news/press-releases/2013/12/gilead-announces-svr12-rates-from-three-phase-3-studies-evaluating-a-oncedaily-fixeddose-combination-of-sofosbuvir-and-ledipasvir-for-genotype-1-hepatitis-c-patients

ION-4

Company: http://www.gilead.com/news/press-releases/2015/2/gilead-announces-svr12-rates-from-phase-3-study-evaluating-harvoni-for-the-treatment-of-chronic-hepatitis-c-in-patients-coinfected-with-hiv

Sofosbuvir/Ledipasvir +/- Ribavirin - the ELECTRON2 trial

Company: http://www.gilead.com/news/press-releases/2014/4/gilead-announces-phase-2-results-for-two-investigational-alloral-sofosbuvirbased-regimens-for-the-treatment-of-chronic-hepatitis-c

Sofosbuvir/Daclatasvir - the ALLY trials

ALLY-1 ALLY-2 ALLY-3

Abstract: http://www.ncbi.nlm.nih.gov/pubmed/25614962
Overview: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4409820/
Company ALLY-1: http://news.bms.com/press-release/ally-1-trial-results-show-investigational-daclatasvir-based-regimen-cures-94-post-live
Company ALLY-2: http://news.bms.com/press-release/ally-trial-demonstrates-97-hepatitis-c-cure-rates-among-patients-coinfected-hiv-after-
Company ALLY-3: http://news.bms.com/press-release/rd-news/ally-trial-demonstrates-high-cure-rates-investigational-daclatasvir-and-sofosb

Sofosbuvir/Ribavirin

Overview: http://www.nejm.org/doi/full/10.1056/NEJMoa1316145#t=articleDiscussion
Overview: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3992065/

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.

On the 25th April 2015 at the International Liver Conference a paper was presented: http://www.eurekalert.org/pub_releases/2015-04/eaft-sce042415.php which suggests that adding Ribavirin to Sofosbuvir and Daclatasvir may well turn out to be beneficial.