JPM on Gild at EASL:
Headline: Gilead Sciences : EASL: ION 2 Confirms RBV Not Needed; Next Gen Combo Supports Pangenotypic Activity - ALERT
Author(s): Geoff Meacham, Michael E Ulz, Anupam Rama, Carter L Gould
Abstract: We are attending the EASL meeting where phase 2 data for the fixed dose combination (FDC) of Sovaldi + ledipasvir were presented for the first time this morning. Consistent with previously released top line data, the FDC combination resulted in 90% SVR rates without the need for RBV in difficult to treat treatment-experienced GT1 patients. At EASL, there is a growing chorus on RBV related toxicity; data in many all-oral trials using RBV consistently show hematological toxicities and, in a lot of cases, lower SVR12 rates. In ION-2, 20% of the patients were cirrhotic with 41-46% being prior non-responders and 46-61% being prior protease inhibitor failures. Overall, we remain quite encouraged by the ION trials, which formed the basis of the FDC NDA filing (PDUFA date Oct 10, 2014). Additionally, data from a phase 2 trial of Sovaldi + GS-5816 demonstrated pangenotypic activity for this next generation once-daily regimen were SVR12 data were very impressive in GT1-6. Reiterate Overweight.
Phase 3 ION 2 results: The ION-2 study evaluated the FDC +/- RBV for 12 of 24 wks in GT1 treatment experienced patients (included 20% with cirrhosis). Treatment for 12 wks without RBV resulted in 93.6% SVR (SVR 96.4% w/ RBV) while 24 wks of treatment resulted in 99.1% SVR (SVR 99.1% w/ RBV). Overall, the ION-2 data confirm a high SVR with durations of 12 wks in experienced patients without the need for RBV in this tough population.
Phase 2 Sovaldi + GS+5816 results: Recall, GS-5816 is Gilead’s next generation, pan genotypic NS5A inhibitor, behind ledipasvir. Data in the abstract indicate that Sovaldi (400mg) + GS-5816 (25mg or 100mg) without RBV result in SVR4 of 96% in GT1-6. For the 100 mg dose of GS-5816, SVR12 rates were 100% in GT1, 100% in GT2, 93% in GT3, 86% in GT4.
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I have been buying GILD and will be adding if weakness persists.
