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Patients with the hepatitis C virus (HCV) could benefit from a new therapeutic treatment that has achieved positive results from a Phase III clinical trial.
The trial found that a 48-week course of treatment with thymalfasin in combination with pegylated interferon alpha-2a (peg-IFN-2a) and ribavirin (RBV) resulted in a sustained virological response (SVR) among a secondary population of 182 patients.
However, the results in the primary analysis population of 552 patients did not achieve statistical significance relating to SVR.
Friedhelm Blobel, president of SciClone Pharmaceuticals, which carried out the trial, said: “We are disappointed that the study did not reach its primary efficacy endpoint in the ITT population.
“Nevertheless, the data seen in the completer population suggest a potential benefit of using thymalfasin in patients who completed the full course of treatment.”
The company’s chief medical officer, Israel Rios, added: “These data suggest that the immunomodulatory activity of thymalfasin may play an important role in maintaining the viral response in patients who completed the full prescribed 48 weeks of treatment.
“Although the safety analyses are still ongoing, thymalfasin appeared to be well tolerated. During the course of the trial the side effects reported were those usually associated with the use of interferon and ribavirin.”
Copyright Press Association 2008