In more promising news for Gilead Sciences’ hepatitis C virus (HCV) therapy sofosbuvir, a Phase III trial of the drug in combination with ribavirin cured 90 percent of those study participants with genotypes 1, 4, 5 and 6, MedPage Today reports. The results from the NEUTRINO trial, which contributed to Gilead’s recent application for regulatory approval of sofosbuvir, were presented at the International Congress of the European Association for the Study of the Liver (EASL) in Amsterdam. The investigators also published their results in the New England Journal of Medicine.
The single-arm, open-label study gave the nucleotide analogue inhibitor sofosbuvir along with ribavirin for 12 weeks to 327 previously untreated participants who mainly had genotype 1 of hep C, but some of whom had genotypes 4, 5 and 6. Ninety percent of the group achieved a sustained virologic response (SVR, considered a cure) 12 weeks after completing therapy. This compares with a 60 percent historical cure rate for such a group, underscoring the significant improvement sofosbuvir would likely make on treatment success rates if improved.
Genotype did not significantly affect the likelihood of a cure: Of the 291 participants with genotype 1, 89 percent were cured, compared with 96 percent of the 28 patients with genotype 4. In addition, all six people with genotype 6 and the one participant with genotype 5 was also cured.
To read the MedPage Today story, click here.
To read the New England Journal of Medicine study, click here.
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