Early EPO Use Increased SVR Rates and Reduced Discontinuation Rate !
EASL April 23-26 2009 Copenhagen Denmark
Reported by Jules Levin
These findings are important because most studies to date have reported NOT finding that EPO improved SVR rates, but this was always implausiable to me so I always doubted the previous findings, I was convinced that EPO provided benefit and improved SVR rates. The EPO finding may need further study in a randomized prospective study but the association found here that early EPO use within the first 8 weeks of starting Peg/RBV appears to be the key. I don't think any previous studies examined the question this way, which underscores how common it see that we see poorly conducted studies in HCV: HALT-C and EPO studies. The problem now is that my understanding is that the FDA placed a Black Box on EPO saying it was restricted in HCV use and we know there are concerns about toxicities associated with EPO use. So what will Schering do with regards to to their approval application for boceprevir to the FDA, they will I think request the FDA to allow EPO use but how will the FDA respond? In addition, I don't know if EPO is being used in Vertex's phase 3 studies but it wasn't used in their phase 2 studies so this is another intetesting aspect of this story. In the SPRINT-1 boceprevir phase 2 results reported at EASL anemia was higher among study patients receiving boceprevir+peg/RBV than patients receiving peg/RBV alone 34% vs 54%, and EPO use was higher among the boceprevir group than those receiving only peg/RBV (7% vs 15%). In the Vertex telaprevir study in treatment-experienced reported at this EASL anemia rate was reported as 8% in the peg/RBV group, 8% in the telaprevir/peg group without ribavirin, and 26% in the telaprevir 12 week/peg/rbv 24 week group, and 27% in the telaprevir 24 week/peg/RBV 48 week group. So the anemia rates I think need to be better characterized in its association with both boceprevir and telaprevir. Jules Levin
