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Re: DewDiligence post# 204855

Monday, 10/03/2016 10:13:40 AM

Monday, October 03, 2016 10:13:40 AM

Post# of 252892
ABBV/ENTA, browsing the AASLD abstract book...

no material news about actual results, at least not for ph3, but a promise to have them at AASLD in November

Endurance-3 seems to be missing, perhaps a late-breaker?

P.S.: who in marketing invented those names - glecaprevir (ABT-493) / pibrentasvir (ABT-530)?



No 253 (GT 1)
ENDURANCE-1: Efficacy and Safety of 8- versus 12-week Treatment with ABT-493/ABT-530 in patients with Chronic HCV Genotype 1 Infection
p. 132 (SVR 12 to be presented at meeting)

No 73 (GT 2)
ENDURANCE-2: Safety and Efficacy of ABT-493/ABT-530 in Hepatitis C Virus Genotype 2-infected Patients without Cirrhosis, a Randomized, Double-Blind, Placebo-Controlled Study
p. 39 (SVR 12 to be presented at meeting)

No 114 (GT 4,5,6)
ENDURANCE-4: Efficacy and Safety of ABT-493/ABT- 530 Treatment in Patients with Chronic HCV Genotype 4, 5, or 6 Infection
p. 63 (SVR 12 to be presented at meeting)

No 113 (GT 3, mixed ph2/3)
SURVEYOR-II, Part 3: Efficacy and Safety of ABT-493/ABT-530 in Patients with Hepatitis C Virus Genotype 3 Infection with Prior Treatment Experience and/or Cirrhosis
p. 62 (SVR 12 to be presented at meeting)

No 849 (GT 1, failures)
Analysis of HCV Variants in the MAGELLAN-1 Part 1 Study: ABT-493 and ABT-530 Combination Therapy of Genotype 1-Infected Patients Who Had Failed Prior Direct Acting Antiviral-Containing Regimens
p. 417
RAVs in both NS3 and NS5a in 16 of 50 patients, "Of the 2 out of 50 (4%) patients who experienced virologic failure, 1 patient had baseline NS3 (Y56H and D168A/T) and NS5A (M28V and Q30L/R) RAVs, and the other patient had baseline RAVs in NS5A (L31M and H58D) only."

No 854 (with blood pressure drugs)
Drug-drug interactions between direct acting antivirals ABT-493 and ABT-530 with angiotensin II receptor blockers (losartan or valsartan)
p. 420 (losartan/valsartan exposure increased, ABT-493/ABT-530 exposure unaffected)

No 855
Hemodialysis does not affect the pharmacokinetics of ABT-493 or ABT-530
p. 421




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