ongoing clinical trials
there are several ongoing phase III trials examining the efficacy of sofosbuvir combination therapy in patients with chronic hepatitis
randomized, open label, multinational trial in treatment-naive or treatment-experienced patients with chronic HCV genotype 3 infection and treatment-experienced patients with cirrhosis with chronic HVC genotype 2 infection comparing the efficacy of treatment with sofosbuvir plus ribavirin for 16 or 24 weeks with sofosbuvir plus peginterferon and ribavirin for 12 weeks
Open-label, multinatinational trial in patients who participated in prior sofosbuvir studies and failed to achieve a sustained virological response Trial compares sofosbuvir plus ribavirin for 12 or 24 weeks with sofosbuvir plus peginterferon and ribavirin for 12 weeks
Non comparative multicentre trial investigating the efficacy of sofosbuvir plus ribavirin in treatment-naive and treatmente-experienced Japanese patients with chronic HCV genotye 2 infection
open-label, multinational trial investigating sofosbuvir plus ribavirin for 12 or 24 week in treatment-naive patient with chronic HCV genotype 1,2,3 or 4 infection and treatment-experienced patients with chronic HCV 2 or 3 infection who are co-infected with HIV-1
several phase II sofosbuvir trials are also ongoing including a trial in patients with chronic renal insufficiency and trials investigating various regimens of sofosbuvir plus GS-5816 with or without ribavirin. in addition, an expanded access programme has been initiated for patients with aggressive, post-transplant,recurrent HCV infection for whom there are no other treatment options patient can receive sofosbuvir plus ribavirin with or without peginterferon-
3 current status
Sofosbuvir received its first global approval for the treatment of chronic hepatitis C