ABBV will report phase-3 top-line HCV data from some of the trials listed in #msg-92959364 this year data via press release(s); no further details available, but the first PR will presumably include SAPHIRE-1 and SAPHIRE-2.
ABBV’s 3Q13-results PR this morning said the HCV-data PR(s) would begin in 4Q13 (i.e. the current quarter); however, on today’s CC, ABBV’s CEO said the PR(s) would come in “late 2013,” which I interpret to mean after AASLD.
[Updated for change in expected completion of SAPHIRE-1/2 to Nov 2013 (formerly Sep 2103). This change does not affect the timing of the planned NDA submission in 2Q14).]
ABBV/ENTA have 9 global phase-3 trials testing an all-oral regimen in HCV genotype-1a/1b : 6 trials that comprise the initial NDA/MAA submissions in 2Q14, and 3 trials for subsequent use. (MALACHITE-1 and MALACHITE-2 are essentially phase-4 trials that have been listed as phase-3.)
All 9 of these global phase-3 trials include the 3-DAA combination of the protease inhibitor, ABT-450/r (licensed by ABBV from ENTA); the NS5A inhibitor, ABT-267 (from ABBV’s pipeline); and the non- nucleoside polymerase inhibitor, ABT-333 (from ABBV’s pipeline). Some of these trials also include ribavirin in one or both trial arms.
SAPHIRE-1 and SAPHIRE-2 are essentially safety studies, as explained in #msg-91739317.
(ABBV/ENTA are testing the 2-DAA regimen of ABT-450/r + ABT-267 in a phase-3 trial for genotype-1b patients in Japan [#msg-91870291] and in various phase-2 trials globally.)
Six phase-3 trials comprising initial NDA/MAA submissions:
SAPPHIRE-1—(see #msg-91739317 for discussion)—treatment-naïve GT1a/1b w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w vs. identical regimen delayed by 12 weeks of placebo use; 600 patients; expected completion Nov 2013: http://www.clinicaltrials.gov/ct2/show/NCT01716585
SAPPHIRE-2—(see #msg-91739317 for discussion)—treatment-experienced GT1a/1b w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w vs. identical regimen delayed by 12 weeks of placebo use; 400 patients; expected completion Nov 2013: http://www.clinicaltrials.gov/ct2/show/NCT01715415
TURQUOISE-2—DAA-naïve GT1a/1b with cirrhosis; ABT-450/r + ABT-267 + ABT333 + ribavirin for 12w vs. identical regimen for 24w; 380 patients; expected completion Jan 2014: http://www.clinicaltrials.gov/ct2/show/NCT01704755
Three phase-3 trials not part of initial NDA/MAA submissions:
TURQUOISE-1—DAA-naïve GT1a/1b with HIV co-infection; ABT-450/r + ABT-267 + ABT333 + ribavirin for 12w vs. identical regimen for 24w; 300 patients; expected completion Dec 2014: http://clinicaltrials.gov/ct2/show/NCT01939197
MALACHITE-1—5-arm trial including 3 DAA arms and 2 control arms—treatment-naïve GT1a/1b; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w vs. Incivek + peg-IFN + ribavirin for 12w plus an additional 12w or 36w of peg-IFN/ribavirin on a response-guided basis; separate DAA and control arms for GT1a and GT1b; additional DAA arm for GT1b without ribavirin; 314 patients; expected completion Jul 2015: http://www.clinicaltrials.gov/ct2/show/NCT01854697 (Note: This is essentially a phase-4 trial.)
MALACHITE-2—treatment-experienced GT1a/1b; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w: vs. Incivek + peg-IFN + ribavirin for 12w plus an additional 12w or 36w of peg-IFN/ribavirin on a response-guided basis; 150 patients; expected completion Jul 2015: http://www.clinicaltrials.gov/ct2/show/NCT01854528 (Note: This is essentially a phase-4 trial.)
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