[Updated for release of top-line data from SAPHIRE-2.]
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. Full details of the 6 trials comprising the initial NDA/MAA will be presented at the EASL conference in Apr 2014.
All 9 of these global phase-3 trials include the 3-DAA combination of the protease inhibitor, ABT-450 (licensed by ABBV from ENTA; boosted by low-dose ritonavir); the NS5A inhibitor, ABT-267; and the non-nucleoside polymerase inhibitor, ABT-333. Some of these trials also include ribavirin in one more trial arms.
(ABBV/ENTA are testing the 2-DAA regimen of ABT-450 + 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—treatment-naïve GT1a/GT1b w/o cirrhosis; ABT-450 + ABT-267 + ABT-333 + ribavirin for 12w vs. identical regimen delayed by 12 weeks of placebo use; 631 patients (68% GT1a, 32% GT1b); top-line results (SVR12=96%) were released on 11/18/13 and discussed in #msg-94169219: http://www.clinicaltrials.gov/ct2/show/NCT01716585
SAPPHIRE-2—treatment-experienced GT1a/GT1b w/o cirrhosis; ABT-450 + ABT-267 + ABT-333 + ribavirin for 12w vs. identical regimen delayed by 12 weeks of placebo use; 394 patients (58% GT1a, 42% Gt1b); top-line results (SVR12=96%) were released on 12/10/13 and discussed in #msg-94817670 and #msg-94839006: http://www.clinicaltrials.gov/ct2/show/NCT01715415
PEARL-2—treatment-experienced GT1b w/o cirrhosis; ABT-450 + ABT-267 + ABT-333 ± ribavirin for 12w; 210 patients; purpose is to determine if ribavirin is needed is this patient subgroup; expected completion Mar 2014: http://www.clinicaltrials.gov/ct2/show/NCT01674725
PEARL-3—treatment-naïve GT1b w/o cirrhosis; ABT-450 + ABT-267 + ABT-333 ±ribavirin for 12w; 400 patients; purpose is to determine if ribavirin is needed is this patient subgroup; expected completion Dec 2013: http://www.clinicaltrials.gov/ct2/show/NCT01767116
PEARL-4—treatment-naïve GT1a w/o cirrhosis; ABT-450 + ABT-267 + ABT-333 ±ribavirin for 12w; 300 patients; purpose is to determine if ribavirin is needed is this patient subgroup; expected completion Dec 2013: http://www.clinicaltrials.gov/ct2/show/NCT01833533
TURQUOISE-2—DAA-naïve GT1a/GT1b with cirrhosis; ABT-450 + ABT-267 + ABT333 + ribavirin for 12w vs. identical regimen for 24w; 380 patients; purpose is to determine length of treatment for this patient group; 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/GT1b with HIV co-infection; ABT-450 + ABT-267 + ABT333 + ribavirin for 12w vs. identical regimen for 24w; 300 patients; purpose is to determine length of treatment for this patient group; 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/GT1b; ABT-450 + 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/GT1b; ABT-450 + 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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