Hep C Clinical Trials- The Daclatasvir Studies
Thomas J. Henry is actively investigating reports of injuries and serious adverse events linked to clinical trials for Bristol-Meyers Squibb’s experimental hepatitis C drug Daclatasvir (formerly BMS-790052).
After abandoning the development of BMS-986094 as a possible combination drug to be taken with Daclatasvir due to reports of heart failure and heart and kidney toxicity, BMS began looking for other possible combinations in an effort to develop the first all oral hepatitis C treatment. Clinical trial data suggests that some patients may have suffered injury as a result of these combination studies.
ABOUT THE DACLATASVIR COMBINATION TRIALS
- Daclatasvir is a NS5A inhibitor being developed by Bristol-Meyers Squibb in the hopes that it could potentially replace current hepatitis C treatments.
- In efforts to maximize anti-HCV activity, the drug is often combined with other hepatitis C treatments with the goal of boosting results.
- According to the Hepatitis C Trust, Daclatasvir has been tested in conjunction with the following drugs:
- Pegylated interferon
- Sofosbuvir (GS-7977)
DACLATASVIR AND SOFOSBUVIR COMBINATION TRIALS
- In 2012, the results of clinical trial AI444040 were presenting at the American Association for the Study of Liver Disease Meeting (AAASLD 2012).
- According to CATIE, Daclatasvir was tested in combination with Sofosbuvir both with and without ribavarin in a Phase 2 clinical trial.
- While the drug was praised for its high success rate in some of the most hard to treat cases of hepatitis C, it did not come entirely free of complications.
- A release by CATIE reports that a number of participants suffered adverse effects including:
- Lung Pain
- Kidney Failure
- Intestinal Inflammation