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Bristol-Gilead Hep C Drug EASL Data Leaks
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CORRECTION: The analysts reporting online is wrong regarding the BMS' NS5A+ GS7977 with or without ribavirin study. The presentation at EASL will report on the 24 week study, so the analysts report from the leaked abstract that the 12-week data is End Of Treatment is not correct. The 97% reported in the online leaked abstract is after 12 weeks on treatment that is of 24 weeks duration. There is a lagging cohort of this study that looks at 12 weeks total therapy, but this part of the study started later so results will be reported later.
Updated with a corrected research report from Jefferies, noting that the end-of-treatment response to daclatasvir and GS-7977 was actually 97%, not 93%.
BOSTON (TheStreet) -- An early peek at data from a closely watched mid-stage study combining hepatitis C drugs from Bristol-Myers Squibb and Gilead Sciences has leaked in advance of the European Association for the Study of the Liver (EASL) annual meeting.
Ninety-seven percent of genotype 1 hepatitis C patients treated with Bristol's daclatasvir and Gilead's GS-7977 has undetectable viral levels after 12 weeks of treatment. For genotype 2/3 patients, the 12-week response rate was 90%, according to a research note published Monday by Jefferies analyst Thomas Wei.
Wei called the end-of-treatment response to daclatasvir-GS-7977 "encouraging" and "positive."
These data from Bristol and Gilead were supposedly embargoed by EASL and were therefore not made available to the public when research abstracts for the EASL meeting were posted online on April 4.
In an email to clients Monday, Jefferies said the Bristol-Gilead abstract was "briefly posted" on EASL's web site over the weekend before being taken down.
Officials with EASL have not responded to questions regarding the leak of the research abstract.
Interim results from a phase II study combining Bristol's NS5a inhibitor daclatasvir (BMS-52) with Gilead's GS-7977 in genotypes 1, 2, and 3 is the most highly anticipated data presentation at the EASL meeting this year. The study is important because it will be one of the first glimpses at the Hep C-killing potency of these two classes of direct-acting antivirals combined into a single, all-oral therapy.
Early cure rates from the dacalatasvir-GS-7977 study -- defined as the percent of patients with undetectable viral loads four weeks after cessation of treatment -- will be presented at the EASL meeting, which takes place April 18-22.
--Written by Adam Feuerstein in Boston.
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