On February 27, 2013, FDA approved changes to the Victrelis (boceprevir) label to include results from a clinical trial entitled, "Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naïve Subjects: A Comparison of Erythropoietin Use Versus Ribavirin Dose Reduction for the Management of Anemia." In addition the Microbiology-Resistance section was updated with new information about the impact of specific amino acid substitutions on HCV replicon susceptibility to boceprevir.
Thanks,I posted another one on Feb 18.
http://hcvadvocate.blogspot.com/2013/02/fda-hepatitis-update-victrelis.html
Victrelis (Boceprevir) label changes
On February 27, 2013, FDA approved changes to the Victrelis (boceprevir) label to include results from a clinical trial entitled, "Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naïve Subjects: A Comparison of Erythropoietin Use Versus Ribavirin Dose Reduction for the Management of Anemia." In addition the Microbiology-Resistance section was updated with new information about the impact of specific amino acid substitutions on HCV replicon susceptibility to boceprevir.
Full details...
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm342014.htm
Thanks Bob, I`ve moved your Feb 18 post (about the Feb 13 label update) to this section... we`ve got them covered!