A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection
CompletedPhase 3Results postedLast updated 16 October 2017
What this trial tests
Phase 3 trial testing ombitasvir/paritaprevir/ritonavir and dasabuvir in Chronic Hepatitis C in 99 participants. Completed in 31 October 2016.
18 and older, any sex, with Chronic Hepatitis C or Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)Primary· 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. Participants with missing data after backwards imputation were imputed as nonresponders.
Group
Value
95% CI
3-DAA ± RBV for 12 or 24 Weeks
93.9
87.4 – 97.2
Percentage of Participants With Virologic Failure During TreatmentSecondary· up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment.
Group
Value
95% CI
3-DAA ± RBV for 12 or 24 Weeks
1.0
0.2 – 5.5
Percentage of Participants With Post-treatment RelapseSecondary· From the end of treatment through 12 weeks after the last dose of study drug
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.
Group
Value
95% CI
3-DAA ± RBV for 12 or 24 Weeks
2.2
0.6 – 7.7
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric DisordersSecondary· 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. Participants with missing data after backwards imputation were imputed as nonresponders.
Group
Value
95% CI
3-DAA ± RBV for 12 or 24 Weeks
95.8
86.0 – 98.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks for participants treated for 12 weeks and up to 28 weeks for participants treated for 24 weeks)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of ombitasvir/paritaprevir/ritonavir and dasabuvir
Trials testing the same drug.
NCT02609659 — Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatiti
· Phase 3
· completed
NCT02487199 — Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C
· Phase 3
· completed
NCT02442271 — A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who
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NCT02356562 — A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Ant
· Phase 2
· completed
NCT01782495 — A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients
· Phase 2
· completed
Other recruiting trials for Chronic Hepatitis C
Currently open trials in the same condition.
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· recruiting
NCT03993925 — Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 16 October 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02442284.