A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection
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|ClinicalTrials.gov Identifier: NCT02356562|
Recruitment Status : Completed
First Posted : February 5, 2015
Results First Posted : November 24, 2017
Last Update Posted : December 20, 2017
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts.
Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure.
Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Infection||Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir Drug: Sofosbuvir Drug: Ribavirin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With or Without Sofosbuvir (SOF) and Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection|
|Actual Study Start Date :||February 3, 2015|
|Actual Primary Completion Date :||October 28, 2016|
|Actual Study Completion Date :||July 7, 2017|
Experimental: 3-DAA with or without SOF and RBV
3-DAA (ombitasvir/paritaprevir/ritonavir once daily [QD] and dasabuvir twice daily [BID]) with and without sofosbuvir (SOF) QD and with or without ribavirin (RBV) BID for 12 or 24 weeks
Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir
Other Name: Sovaldi
Other Name: RBV
- Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment [ Time Frame: 12 weeks after the last dose of active 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.
- Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment [ Time Frame: 12 weeks after the last dose of active drug ]SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug
- Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to week 24 ]On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.
- Percentage of Participants With Post-Treatment Relapse [ Time Frame: Within 12 weeks after the last actual dose of active study drug ]Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356562
|Study Director:||Eric Cohen, MD||AbbVie|