A Phase 2 interventional study of OBV/PTV/r and Sofosbuvir in Chronic Hepatitis C Virus Infection, sponsored by AbbVie. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.
6,686 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 70 is below the median of 120 across 4,199 interventional studies indexed under Infections.
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Exclusion Criteria:
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
Drug: OBV/PTV/r · Drug: Sofosbuvir
OBV/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.
Drug: OBV/PTV/r · Drug: Sofosbuvir · Drug: Ribavirin (RBV)
OBV/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.
Drug: OBV/PTV/r · Drug: Sofosbuvir · Drug: Ribavirin (RBV)
OBV/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.
Drug: OBV/PTV/r · Drug: Sofosbuvir · Drug: Ribavirin (RBV)
OBV/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.
Drug: OBV/PTV/r · Drug: Sofosbuvir · Drug: Ribavirin (RBV)
OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Drug: OBV/PTV/r · Drug: Sofosbuvir
Tablet
Also known as: ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir (r) also known as Norvir, VIEKIRAX combination tablets, TECHNIVIE
Tablet
Also known as: Sovaldi
Tablet
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.
Time frame: Up to Week 12
Percentage of Participants With Post-treatment Relapse
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.
Time frame: Up to 12 weeks after the last actual dose of active study drug
| Milestone | Arm A (Genotype [GT]3, Noncirrhotic) | Arm B (GT3, Noncirrhotic) | Arm C (GT2, Noncirrhotic) | Arm D (GT2, Noncirrhotic) | Arm E (GT3, Cirrhotic) | Arm F (GT3, Noncirrhotic) |
|---|---|---|---|---|---|---|
| Started | 9 | 11 | 10 | 9 | 21 | 10 |
| Completed | 9 | 11 | 9 | 8 | 20 | 10 |
| Not completed | 0 | 0 | 1 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Subject enrolled in new study. | 0 | 0 | 1 | 0 | 0 | 0 |
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 participants | Arm A (Genotype [GT]3, Noncirrhotic) | Arm B (GT3, Noncirrhotic) | Arm C (GT2, Noncirrhotic) | Arm D (GT2, Noncirrhotic) | Arm E (GT3, Cirrhotic) | Arm F (GT3, Noncirrhotic) |
|---|---|---|---|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 100 (70.1 to 100) | 90.9 (62.3 to 98.4) | 90.0 (59.6 to 98.2) | 44.4 (18.9 to 73.3) | 100 (84.5 to 100) | 100 (72.2 to 100) |
On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.
| percentage of participants | Arm A (Genotype [GT]3, Noncirrhotic) | Arm B (GT3, Noncirrhotic) | Arm C (GT2, Noncirrhotic) | Arm D (GT2, Noncirrhotic) | Arm E (GT3, Cirrhotic) | Arm F (GT3, Noncirrhotic) |
|---|---|---|---|---|---|---|
| Percentage of Participants With On-treatment Virologic Failure | 0 (0.0 to 29.9) | 0 (0.0 to 25.9) | 0 (0.0 to 27.8) | 0 (0.0 to 29.9) | 0 (0.0 to 15.5) | 0 (0.0 to 27.8) |
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.
| percentage of participants | Arm A (Genotype [GT]3, Noncirrhotic) | Arm B (GT3, Noncirrhotic) | Arm C (GT2, Noncirrhotic) | Arm D (GT2, Noncirrhotic) | Arm E (GT3, Cirrhotic) | Arm F (GT3, Noncirrhotic) |
|---|---|---|---|---|---|---|
| Percentage of Participants With Post-treatment Relapse | 0 (0.0 to 29.9) | 0 (0.0 to 27.8) | 10.0 (1.8 to 40.4) | 55.6 (26.7 to 81.1) | 0 (0.0 to 15.5) | 0 (0.0 to 27.8) |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A (Genotype [GT]3, Noncirrhotic) | 0/9 (0%) | 0/9 (0%) | 8/9 (88.9%) |
| Arm B (GT3, Noncirrhotic) | 0/11 (0%) | 0/11 (0%) | 10/11 (90.9%) |
| Arm C (GT2, Noncirrhotic) | 0/10 (0%) | 1/10 (10%) | 10/10 (100%) |
| Arm D (GT2, Noncirrhotic) | 0/9 (0%) | 0/9 (0%) | 9/9 (100%) |
| Arm E (GT3, Cirrhotic) | 0/21 (0%) | 2/21 (9.5%) | 20/21 (95.2%) |
| Arm F (GT3, Noncirrhotic) | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Event | Arm A (Genotype [GT]3, Noncirrhotic) | Arm B (GT3, Noncirrhotic) | Arm C (GT2, Noncirrhotic) | Arm D (GT2, Noncirrhotic) | Arm E (GT3, Cirrhotic) | Arm F (GT3, Noncirrhotic) |
|---|---|---|---|---|---|---|
| PNEUMONIAInfections and infestations | 0/9 | 0/11 | 1/10 | 0/9 | 0/21 | 0/10 |
| ANAEMIABlood and lymphatic system disorders | 0/9 | 0/11 | 0/10 | 0/9 | 1/21 | 0/10 |
| RESPIRATORY TRACT INFECTION VIRALInfections and infestations | 0/9 | 0/11 | 0/10 | 0/9 | 1/21 | 0/10 |
| Event | Arm A (Genotype [GT]3, Noncirrhotic) | Arm B (GT3, Noncirrhotic) | Arm C (GT2, Noncirrhotic) | Arm D (GT2, Noncirrhotic) | Arm E (GT3, Cirrhotic) | Arm F (GT3, Noncirrhotic) |
|---|---|---|---|---|---|---|
| FATIGUEGeneral disorders | 3/9 | 3/11 | 3/10 | 6/9 | 10/21 | 4/10 |
| HEADACHENervous system disorders | 1/9 | 2/11 | 6/10 | 3/9 | 9/21 | 2/10 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 0/9 | 0/11 | 4/10 | 0/9 | 5/21 | 1/10 |
| CONSTIPATIONGastrointestinal disorders | 0/9 | 1/11 | 1/10 | 3/9 | 0/21 | 0/10 |
| DYSPEPSIAGastrointestinal disorders | 0/9 | 1/11 | 1/10 | 3/9 | 1/21 | 0/10 |
| PRURITUSSkin and subcutaneous tissue disorders | 1/9 | 2/11 | 0/10 | 2/9 | 7/21 | 1/10 |
| DIARRHOEAGastrointestinal disorders | 0/9 | 1/11 | 3/10 | 2/9 | 2/21 | 3/10 |
| NAUSEAGastrointestinal disorders | 0/9 | 1/11 | 3/10 | 0/9 | 6/21 | 3/10 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 0/9 | 3/11 | 0/10 | 1/9 | 0/21 | 0/10 |
| INSOMNIAPsychiatric disorders | 1/9 | 0/11 | 2/10 | 0/9 | 5/21 | 1/10 |
All subjects who received at least 1 dose of study drug were included in the intent-to-treat (ITT) population; the safety population is the same as the ITT population.
| Age, Continuous(years) | Arm A (Genotype [GT]3, Noncirrhotic) | Arm B (GT3, Noncirrhotic) | Arm C (GT2, Noncirrhotic) | Arm D (GT2, Noncirrhotic) | Arm E (GT3, Cirrhotic) | Arm F (GT3, Noncirrhotic) | Total |
|---|---|---|---|---|---|---|---|
| Mean | 52.1 ± 9.17 | 53.5 ± 8.26 | 56.6 ± 6.70 | 61.6 ± 5.90 | 53.8 ± 6.56 | 48.9 ± 7.52 | 54.2 ± 7.88 |
| Sex: Female, Male(Participants) | Arm A (Genotype [GT]3, Noncirrhotic) | Arm B (GT3, Noncirrhotic) | Arm C (GT2, Noncirrhotic) | Arm D (GT2, Noncirrhotic) | Arm E (GT3, Cirrhotic) | Arm F (GT3, Noncirrhotic) | Total |
|---|---|---|---|---|---|---|---|
| Female | 4 | 4 | 5 | 3 | 9 | 2 | 27 |
| Male | 5 | 7 | 5 | 6 | 12 | 8 | 43 |
| Race/Ethnicity, Customized(Participants) | Arm A (Genotype [GT]3, Noncirrhotic) | Arm B (GT3, Noncirrhotic) | Arm C (GT2, Noncirrhotic) | Arm D (GT2, Noncirrhotic) | Arm E (GT3, Cirrhotic) | Arm F (GT3, Noncirrhotic) | Total |
|---|---|---|---|---|---|---|---|
| White | 7 | 11 | 10 | 7 | 17 | 9 | 61 |
| Black or African American | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Asian | 1 | 0 | 0 | 2 | 1 | 1 | 5 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 2 | 0 | 2 |
| Native Hawaiian or other Pacific Islander | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
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