Daclatasvir and Sofosbuvir
Daclatasvir and Sofosbuvir Clinical Trials
Thomas J. Henry is currently investigating reports of serious adverse effects linked to clinical trials for Gilead’s experimental hepatitis C combination treatment containing Sofosbuvir and Daclatasvir. Gilead acquired Sofosbuvir (SD-7977) in its 2012 purchase of Pharmasset. Since acquiring the drug, Gilead has tested Sofosbuvir in a number of Hep C drug combination trials as the company attempts to produce an efficient, all oral hepatitis C treatment.
Though this new treatment has seen higher success rates than current treatments, clinical trial data suggests that some trial participants may have suffered from serious side effects including stroke and kidney failure.
ABOUT GILEAD AND SOFOSBUVIR
According to Gilead, Sofosbuvir is a nucleotide NS5B inhibitor that is being researched as a possible treatment for chronic HCV infections.
Sofosbuvir is currently in Phase III clinical trials and has been submitted to both U.S. and European regulatory agencies for approval.
Most of the trials consisted of combination treatments in which Sofosbuvir was tested in conjunction with the following drugs:
- Pegylated interferon
SOFOSBUVIR AND DACLATASVIR COMBINATION TRIALS
While the combination of Sofosbuvir and Daclatasvir has been hailed as a miracle treatment for chronic hepatitis C virus infection, the experimental treatment is not without risks.
These risks were acknowledged by CATIE after the findings of the AI444040 were released for the 2012 American Association for the Study of Liver Disease Meeting.
According the CATIE release, patients suffered from serious adverse events including:
- Lung Pain
- Intestinal Inflammation
- Kidney Failure