EASL 2014: Final Data from the Phase 2 COSMOS Study of Janssen’s Once-Daily Simeprevir in Combination with Sofosbuvir Presented at the International Liver Congress™ 2014 of the European Association for the Study of the Liver (EASL)
Final Phase 2 Data from the Interferon-free COSMOS Study
Cohort 2
Genotype 1 treatment-naïve and prior null-responder HCV patients
"Final results from cohort 2 of the Phase 2 COSMOS study demonstrated that 93 percent of patients with genotype 1 HCV and advanced liver fibrosis (METAVIR scores F3 and F4) who were treated with simeprevir and sofosbuvir for 12 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). The addition of ribavirin did not improve SVR rates and consistent responses for both treatment arms were seen across HCV genotype subgroups after 12 weeks."
"I've been reading that people who failed with interferon and ribavirin before don't achieve the results of someone who has never gone through treatment. "
Not true.
"All patients with HCV genotype 1b achieved SVR12, regardless of treatment regimen or duration."
Genotype 1b HCV
Simeprevir/Sofosbuvir (%) = 100%
Simeprevir/Sofosbuvir + Ribavirin (%) = 100%
"Rapid virologic response (RVR, defined as undetectable HCV RNA at Week 4 of treatment) was not found to be predictive of achieving SVR. In patients receiving simeprevir and sofosbuvir alone for 12 weeks, 93 percent achieved SVR, while 57 percent achieved RVR. "
Side Effects
"The most common adverse events reported during the study were fatigue, headache, nausea, anemia, pruritus, dizziness, rash and photosensitivity. One patient discontinued treatment due to adverse events."
Hector
I agree with your doctor, interferon just didn't work with him. It's great your doctor is willing to go off label. His odds are very good that this time he will be cured. I would suggest he takes all his meds the full time and try to avoid any dose reductions for best results. Good luck to you both.