Twelve or 16 weeks of Gilead Sciences’ Sovaldi (sofosbuvir) and Pharco Pharmaceuticals’ investigational ravidasvir cured high rates of people with genotype 4 of hepatitis C virus (HCV) in a recent large trial, MedPage Today reports. The Phase III PYRAMID trial included 300 people with genotype 4 treated with Sovaldi and the NSFA inhibitor ravidasvir, with or without ribavirin, including those with cirrhosis.
Preliminary results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.
The participants were randomized into three groups: 150 treatment-naive people with and without cirrhosis; 80 non-cirrhotic people previously treated with interferon; and 70 cirrhotic people previously treated with interferon.
The treatment-experienced people with cirrhosis took Sovaldi and ravidasvir plus ribavirin and were randomly assigned to 12 or 16 weeks of treatment. The other participants took Sovaldi and ravidasvir, and some were randomly assigned to take ribavirin; they were all treated for 12 weeks.
Thus far 261 participants have completed treatment and 12 weeks of follow-up.
Of the non-cirrhotic participants, 100 percent of those who were treatment naive and did not take ribavirin achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), as did 98 percent of those who were treatment naive and did take ribavirin. Ninety-five percent of the non-cirrhotic treatment-experienced participants who did not take ribavirin were cured, as were 100 percent of the non-cirrhotic treatment-experienced participants who did take ribavirin.
Of the cirrhotic participants, 93 percent of those who were treatment naive and did not take ribavirin were cured, as did 92 percent of those taking ribavirin. Eighty-six percent of the treatment-experienced cirrhotic participants treated for 12 weeks were cured, as were 100 percent of those treated for 16 weeks.
To read the MedPage Today article, click here.
To read a press release on the study, click here.
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