GILD's Sofosbuvir + ribavirin study in Japan will enroll GT2 only (no GT3).
The early results in LONESTAR for treatment-experienced patients were excellent. This is the GT1 subgroup GILD had to worry about ABBV poaching. So far so good for GILD in GT1.
The news from Japan creates many questions. Did GILD approach the Japanese regulators with a GT2/GT3 design? Did the Japanese regulators insightfully suggest GILD could do better in GT3? Or did GILD take it upon themselves to file solely in GT2? If so why didn't they do this in the U.S.?
GILD CC
Norbert continues to base GT3 review assumptions on the 60% SVR rate seen in the dated GT3 SOC of PegRiba. Remember we are seeing 90%+ SVR rates in all other genotypes. GILD continues to withhold the 12-week data on the Sofo/PegRiba combo. They are now testing Sofo/PegRiba for 24-weeks, a study that conveniently won't mature until after oral review. Just like the new 12-week study in treatment-experienced patients.
There was little talk on the merits of GS-5816. Surprisingly because this is GILD's follow-up NS5A and the answer to the GT3 problem. Just as radio silence has fallen over the interferon-based option mum is the word on Sofo/GS-5816. I guess they will be more open to talking about it after Sofo/Riba approval.
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