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Asunaprevir

Phase 3

Hepatitis C | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Aug 11, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials2
Total Enrollment266
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01995266Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude DualPHASE3 COMPLETED 218 — — Feb 28, 2014Jul 31, 2015Aug 11, 202038 China, South Korea +1
NCT01886599Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney DiseasePHASE1 COMPLETED 48 — — Nov 1, 2012Feb 1, 2013Nov 11, 20133 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24)
24 Weeks after treatment discontinuation (Follow-up Week 24)

SVR was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) \< lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 24.

AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7
11 time points on Day 7

Area under the concentration-time curve in one dosing interval \[AUC(TAU)\] will be calculated from the blood drug concentration versus time curve

Secondary Endpoints
Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 12 (SVR12)
12 Weeks after treatment discontinuation (Follow-up Week 12)
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Death, and AEs Leading to Discontinuation
7 days after treatment discontinuation
Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24
24 Weeks after treatment discontinuation (Follow-up Week 24)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Asunaprevir + DaclatasvirEXPERIMENTALAsunaprevir 100mg soft capsule by mouth twice daily for 24 weeks and Daclatasvir 60mg tablet by mouth once daily for 24 weeks
Arm A: Subjects with normal renal functionEXPERIMENTALAsunaprevir 100 mg tablet by mouth twice daily for 7 days
Arm B: Subjects with end stage renal diseaseEXPERIMENTALAsunaprevir 100 mg tablet by mouth twice daily for 7 days
Arm C: Subjects with mild renal impairmentEXPERIMENTALAsunaprevir 100 mg tablet by mouth twice daily for 7 days
Arm D: Subjects with moderate renal impairmentEXPERIMENTALAsunaprevir 100 mg tablet by mouth twice daily for 7 days
Arm E: Subjects with severe renal impairmentEXPERIMENTALAsunaprevir 100 mg tablet by mouth twice daily for 7 days
Interventions
NameTypeDescription
AsunaprevirDRUG -
DaclatasvirDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites38

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Males and females, ≥ 18 years of age * Subjects chronically infected with HCV Genotype (GT)-1b only as documented by positive HCV RNA and anti-HCV antibody at screening and e...

Countries:ChinaSouth KoreaTaiwanUnited States
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Competitive Landscape -Hepatitis C 11 trials
CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir
Abbott LaboratoriesABT2 — Undisclosed
AbbVie, Inc.ABBV1 — Undisclosed
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