Skip to content

Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults

An Exploratory Study to Evaluate Immune Restoration Following Removal of Viral Antigen in Treatment-Naïve and Treatment-Experienced Adults With Genotype (GT) 1a Chronic Hepatitis C Virus (HCV) Infection Administered Ombitasvir/ ABT-450/Ritonavir With Dasabuvir and Ribavirin (RBV) for 12 Weeks

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02476617
Enrollment
25
Registered
2015-06-19
Start date
2015-06-30
Completion date
2016-12-31
Last updated
2017-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1a

Keywords

Treatment naive, Interferon free, HCV, Chronic Hepatitis C, Hepatitis C Genotype 1a, Hepatitis C, pegylated-interferon (pegIFN)/ribavirin (RBV) experienced

Brief summary

A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.

Detailed description

A study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with RBV treatment leading to sustained virologic response 12 weeks post-dosing (SVR12) on the changes from baseline in IFN-stimulated gene (ISG) expression in peripheral blood mononucleated cells (PBMCs) in HCV GT 1a-infected adult participants.

Interventions

ombitasvir/ABT-450/ritonavir tablets

dasabuvir tablets

DRUGribavirin

ribavirin tablets

Sponsors

AbbVie
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Screening laboratory result indicating hepatitis C viral (HCV) genotype (GT) 1a infection. 2. Chronic HCV infection. 3. Participants must be non-cirrhotic. 4. Participants must be treatment-naïve or have documentation that they were adherent to prior pegIFN/RBV combination therapy and meet the criteria of prior pegylated-interferon (pegIFN)/ribavirin (RBV) treatment failure. 5. Participants must meet specific human leukocyte antigen (HLA) allele requirements.

Exclusion criteria

1. Women who are pregnant or breastfeeding. 2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay. 3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment. 4. Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than pegIFN or RBV (including previous exposure to paritaprevir, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration. 5. History of solid organ transplant. 6. Screening laboratory analysis that shows abnormal results.

Design outcomes

Primary

MeasureTime frameDescription
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12Week 0 to Post-Treatment Week 12The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as 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. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.

Participant flow

Pre-assignment details

The intent-to-treat (ITT) population consisted of all enrolled participants who received at least one dose of study drug.

Participants by arm

ArmCount
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV
Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
25
Total25

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event1
Overall StudyLost to Follow-up1

Baseline characteristics

CharacteristicOmbitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV
Age, Continuous44.8 years
STANDARD_DEVIATION 12.61
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
19 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
24 / 25
serious
Total, serious adverse events
2 / 25

Outcome results

Primary

Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12

The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as 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. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.

Time frame: Week 0 to Post-Treatment Week 12

Population: All participants who achieved SVR12 and had both baseline and post-baseline value at Post-Treatment Week 12 were included in this analyses..

ArmMeasureGroupValue (MEAN)Dispersion
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12MX2-0.101 Fold changeStandard Deviation 0.6188
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12CXCL10-0.464 Fold changeStandard Deviation 0.6143
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12ISG15-0.148 Fold changeStandard Deviation 0.7458
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12CXCL11-0.611 Fold changeStandard Deviation 0.309
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12MX1-0.399 Fold changeStandard Deviation 0.3013
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFI27-0.462 Fold changeStandard Deviation 0.4624
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12OAS2-0.168 Fold changeStandard Deviation 0.5168
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12DDX60-0.016 Fold changeStandard Deviation 0.5696
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFIT3-0.543 Fold changeStandard Deviation 0.335
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFI44-0.467 Fold changeStandard Deviation 0.2569
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12STAT1-0.301 Fold changeStandard Deviation 0.343
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12CXCL9-0.552 Fold changeStandard Deviation 0.2816
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFIT1-0.440 Fold changeStandard Deviation 0.4441
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12HERC5-0.358 Fold changeStandard Deviation 0.2827
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IRF7-0.171 Fold changeStandard Deviation 0.4273
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12OAS10.284 Fold changeStandard Deviation 1.4668
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12PLSCR1-0.255 Fold changeStandard Deviation 0.3688
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IRF9-0.205 Fold changeStandard Deviation 0.2809
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFIH1-0.321 Fold changeStandard Deviation 0.3213
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12TRIM140.022 Fold changeStandard Deviation 0.5282
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IRF1-0.130 Fold changeStandard Deviation 0.6497
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IRF30.044 Fold changeStandard Deviation 0.6307
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12STAT2-0.051 Fold changeStandard Deviation 0.5762
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFNG0.516 Fold changeStandard Deviation 1.4653
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFNL1-0.361 Fold changeStandard Deviation 0.3753
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFNL2-0.199 Fold changeStandard Deviation 0.7031
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFNL3-0.205 Fold changeStandard Deviation 0.4306
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFNL4-0.228 Fold changeStandard Deviation 0.7298
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFNGR1-0.046 Fold changeStandard Deviation 0.3008
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12ADAR-0.212 Fold changeStandard Deviation 0.2314
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12ALG10-0.083 Fold changeStandard Deviation 0.7491
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12BCHE-0.101 Fold changeStandard Deviation 0.5739
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12CCL20.200 Fold changeStandard Deviation 1.5071
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12CCL40.638 Fold changeStandard Deviation 1.7396
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12CD1630.556 Fold changeStandard Deviation 2.7478
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12CXCL51.085 Fold changeStandard Deviation 2.7539
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12CXCR30.308 Fold changeStandard Deviation 0.5236
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12DDIT40.029 Fold changeStandard Deviation 1.2134
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12DDX580.388 Fold changeStandard Deviation 1.2231
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12DPP40.869 Fold changeStandard Deviation 1.573
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12EIF2AK2-0.317 Fold changeStandard Deviation 0.2521
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12GBP1-0.288 Fold changeStandard Deviation 0.4421
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12GCKR0.009 Fold changeStandard Deviation 0.5267
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12GUCY1B30.350 Fold changeStandard Deviation 0.7909
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12HELZ2-0.232 Fold changeStandard Deviation 0.5124
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12HERC6-0.074 Fold changeStandard Deviation 0.3294
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFI35-0.023 Fold changeStandard Deviation 0.6428
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFI44L-0.554 Fold changeStandard Deviation 0.4068
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFI6-0.464 Fold changeStandard Deviation 0.301
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFIT2-0.365 Fold changeStandard Deviation 0.4118
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFIT5-0.291 Fold changeStandard Deviation 0.2085
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFITM1-0.066 Fold changeStandard Deviation 0.3696
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFITM20.158 Fold changeStandard Deviation 0.7905
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFITM3-0.423 Fold changeStandard Deviation 0.3313
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFNA-0.202 Fold changeStandard Deviation 0.5037
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IFNB-0.167 Fold changeStandard Deviation 0.4427
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IL100.202 Fold changeStandard Deviation 0.8216
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IL18-0.078 Fold changeStandard Deviation 0.2695
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12IRF20.311 Fold changeStandard Deviation 1.0487
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12ISG200.156 Fold changeStandard Deviation 1.0071
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12MAP3K14-0.072 Fold changeStandard Deviation 0.2983
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12MOV10-0.185 Fold changeStandard Deviation 0.4048
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12MS4A4A-0.005 Fold changeStandard Deviation 0.7458
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12MYST1-0.057 Fold changeStandard Deviation 0.2404
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12NOS2A0.249 Fold changeStandard Deviation 0.8288
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12NT5C30.017 Fold changeStandard Deviation 0.3577
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12OASL-0.233 Fold changeStandard Deviation 0.6984
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12PPP3CB0.011 Fold changeStandard Deviation 0.1956
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12RNASEL0.395 Fold changeStandard Deviation 0.9973
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12RSAD2-0.406 Fold changeStandard Deviation 0.3202
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12SLC27A20.022 Fold changeStandard Deviation 0.9149
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12SOCS11.313 Fold changeStandard Deviation 3.5778
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12SOCS30.025 Fold changeStandard Deviation 1.1773
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBVChange in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12USP18-0.288 Fold changeStandard Deviation 0.3092

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026