In the May 2013 edition of Lancet Infectious Diseases, a group of researchers, including Robert Hindes, MD, published the results of a trial testing the effectiveness safety of the uridine nucleotide analogue sofosbuvir in patients with hepatitis C.
Current approaches to treating hepatitis C rely on protease inhibitors combined with pegylated interferon and ribavirin, and these regimens have improved the overall response of patients with chronic hepatitis C. However, many protease inhibitors have significant toxicities, and a large number of patients are not cured because of inadequate efficacy or because patients were unable to complete treatment because of drug side effects.
Unlike protease inhibitors, sofosbuvir works by inhibiting the RNA-dependent NS5B polymerase inhibitor of the HCV virus. Its lower incidence of toxicity and superior efficacy make it a better for most patients.
As VP clinical development for Pharmasset, Robert Hindes, MD, was responsible for monitoring a study in which patients received either a combination of sofosbuvir with peginterferon and ribavirin, or peginterferon/ribavirin alone, to 122 patients diagnosed with hepatitis C. After 12 weeks, participants continued with peginterferon and ribavirin for another 12 to 36 weeks.
Only eight patients stopped using the medication due to side effects, three of whom had been part of the placebo group. At the end of the trial, 90 to 95 percent of the sofosbuvir group had achieved a sustained viral response (SVR), compared to 58 percent of the perylated interferon/ribavirin group. A second cohort of patients received sofosbuvir in combination with peginterferon and ribavirin for 12 weeks only; 92 percent achieved SVR at the end of the trial period.
The researchers concluded that sufficient evidence exists to pursue phase 2 and phase 3 trials of sofosbuvir in combination with peginterferon and ribavirin as a treatment for hepatitis C infection.
Current approaches to treating hepatitis C rely on protease inhibitors combined with pegylated interferon and ribavirin, and these regimens have improved the overall response of patients with chronic hepatitis C. However, many protease inhibitors have significant toxicities, and a large number of patients are not cured because of inadequate efficacy or because patients were unable to complete treatment because of drug side effects.
Unlike protease inhibitors, sofosbuvir works by inhibiting the RNA-dependent NS5B polymerase inhibitor of the HCV virus. Its lower incidence of toxicity and superior efficacy make it a better for most patients.
As VP clinical development for Pharmasset, Robert Hindes, MD, was responsible for monitoring a study in which patients received either a combination of sofosbuvir with peginterferon and ribavirin, or peginterferon/ribavirin alone, to 122 patients diagnosed with hepatitis C. After 12 weeks, participants continued with peginterferon and ribavirin for another 12 to 36 weeks.
Only eight patients stopped using the medication due to side effects, three of whom had been part of the placebo group. At the end of the trial, 90 to 95 percent of the sofosbuvir group had achieved a sustained viral response (SVR), compared to 58 percent of the perylated interferon/ribavirin group. A second cohort of patients received sofosbuvir in combination with peginterferon and ribavirin for 12 weeks only; 92 percent achieved SVR at the end of the trial period.
The researchers concluded that sufficient evidence exists to pursue phase 2 and phase 3 trials of sofosbuvir in combination with peginterferon and ribavirin as a treatment for hepatitis C infection.