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OBV/PTV/r

Phase 2

Chronic Hepatitis C Virus Infection | Small molecule | Infectious Disease |AbbVie Inc.|Last Updated: Jul 12, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

OBV/PTV/r · 1 trial · 1 indication

Phase 2 1
NCT02292719A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus InfectionChronic Hepatitis C Virus Infection
COMPLETED70 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
Chronic Hepatitis C Virus InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
12 weeks after the last actual dose of study drug

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.

Secondary Endpoints

Percentage of Participants With On-treatment Virologic Failure
Up to Week 12
Percentage of Participants With Post-treatment Relapse
Up to 12 weeks after the last actual dose of active study drug
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A (genotype [GT]3, noncirrhotic)EXPERIMENTALOmbitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
Arm B (GT3, noncirrhotic)EXPERIMENTALOBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily \[BID\]) for 12 weeks.
Arm C (GT2, noncirrhotic)EXPERIMENTALOBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
Arm D (GT2, noncirrhotic)EXPERIMENTALOBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
Arm E (GT3, cirrhotic)EXPERIMENTALOBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
Arm F (GT3, noncirrhotic)EXPERIMENTALOBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.

Interventions

NameTypeDescription
OBV/PTV/rDRUGTablet
SofosbuvirDRUGTablet
Ribavirin (RBV)DRUGTablet
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Chronic HCV infection prior to study enrollment. 2. Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype). 3. Absence OR presence of cirrhosis. 4. If cirrhotic, need to have compensated cirrhosis an...

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Frequently asked questions about OBV/PTV/r

What is OBV/PTV/r used for?

OBV/PTV/r is an investigational small molecule being studied for the treatment of chronic Hepatitis C virus infection. It is a combination regimen being evaluated in adults with this condition. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes OBV/PTV/r?

OBV/PTV/r is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for chronic Hepatitis C virus infection.

What phase is OBV/PTV/r in?

OBV/PTV/r is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. The drug is being studied for the treatment of chronic Hepatitis C virus infection in adults, and its clinical trial program is ongoing.

What clinical trials is OBV/PTV/r in?

OBV/PTV/r has been studied in one completed Phase 2 clinical trial, registered as NCT02292719. This trial evaluated the safety and efficacy of ombitasvir/ABT-450/ritonavir with sofosbuvir, with or without ribavirin, in 70 adults with chronic Hepatitis C virus infection. The trial was controlled and randomized.

How does OBV/PTV/r work?

OBV/PTV/r is a combination of direct-acting antiviral agents that target the Hepatitis C virus. The regimen includes ombitasvir, an NS5A inhibitor, and ABT-450, a protease inhibitor, boosted with ritonavir to enhance drug levels. This combination works by interfering with viral replication.

Is OBV/PTV/r the same as ombitasvir/ABT-450/ritonavir?

Yes, OBV/PTV/r is the same as ombitasvir/ABT-450/ritonavir. The abbreviation OBV/PTV/r stands for ombitasvir, paritaprevir (ABT-450), and ritonavir. In clinical trials, this combination has been studied with sofosbuvir, with or without ribavirin, for chronic Hepatitis C virus infection.