HCV Advocate Press Release
Two Phase 3 Studies Results of Sofosbuvir for Hepatitis C Released
Editor-in-Chief, HCV Advocate
On February 4, 2013 Gilead Sciences released results from two Phase 3 studies of sofosbuvir in combination with ribavirin for treatment of genotypes 1 through 6 patients.
The first study—FISSION—treated HCV genotypes 2 and 3 treatment naïve patients for a treatment duration of 12 weeks with sofosbuvir (once-a-day – QD) plus ribavirin (three times a day-TID) and compared the study drug combination to pegylated interferon plus ribavirin (standard of care or SOC) for an treatment duration of 24 weeks. In the study 20% of the patients had compensated cirrhosis and 72% were HCV genotype 3. There were 256 patients in the sofosbuvir group vs. 243 patients in the SOC group.
Top line SVR12 results by genotype in the sofosbuvir vs. SOC groups:
• Genotype 2 – 97% (sofosbuvir) vs 78% (SOC)
• Genotype 3 –56% (sofosbuvir) vs. 63% (SOC)
In those people who had cirrhosis, 47% achieved an SVR12 in the sofosbuvir groups compared to 38% in the SOC group.
The side effects reported were lower in the sofosbuvir group (3 patients) compared to those receiving SOC (26 patients). The most common side effects in the sofosbuvir group that occurred in greater than or equal to 10% of patients was fatigue, headache, nausea, insomnia and dizziness.
Comments: The study results above met primary endpoint of the study – non-inferiority. Gilead states that they will submit the data to the Food and Drug Administration for marketing approval. Even though non-inferiority doesn’t sound as exciting as what we have seen in the past, it is important to remember that the treatment duration is only 12 weeks and it is an interferon-free therapy—this is a big advancement in the treatment of HCV genotype 2 and 3.
The second study released was –NEUTRINO—treated 327 HCV genotype 1, 4, 5, and 6 treatment naïve patients with the triple combination of sofosbuvir (QD) plus pegylated interferon (once-a-week) and ribavirin (TID) for a treatment duration of 12 weeks. Seventeen percent of the patients had compensated cirrhosis. The SVR12 results were 89% for genotype 1and 97% for genotypes 4,5,6 patients (n=35). Five patients in the sofosbuvir group discontinued treatment due to side effects.
Comments: There was limited data released about this trial although the SVR12 results are impressive. Once more information is released we will have a better picture of the effectiveness and safety profile of this trial, although the preliminary results are very encouraging.
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