Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02023099 | Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection | PHASE3 | COMPLETED | 363 | — | — | Dec 1, 2013 | Oct 1, 2015 | Jun 6, 2018 | - | — |
| NCT01854528 | A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults | PHASE3 | COMPLETED | 148 | — | — | Jun 1, 2013 | Jul 1, 2015 | Jun 6, 2018 | - | — |
| NCT01833533 | A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection | PHASE3 | COMPLETED | 305 | — | — | Mar 1, 2013 | Sep 1, 2014 | Jul 12, 2021 | - | — |
| NCT01854697 | A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before | PHASE3 | COMPLETED | 311 | — | — | Mar 1, 2013 | Jul 1, 2015 | Jun 6, 2018 | - | — |
| NCT01767116 | A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection | PHASE3 | COMPLETED | 419 | — | — | Dec 1, 2012 | Aug 1, 2014 | Jul 12, 2021 | - | — |
| NCT01715415 | A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults | PHASE3 | COMPLETED | 395 | — | — | Nov 1, 2012 | Oct 1, 2014 | Aug 2, 2021 | - | — |
| NCT01716585 | A Study to Evaluate Chronic Hepatitis C Infection | PHASE3 | COMPLETED | 636 | — | — | Nov 1, 2012 | Oct 1, 2014 | Jul 12, 2021 | - | — |
| NCT01704755 | A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis | PHASE3 | COMPLETED | 381 | — | — | Oct 1, 2012 | Sep 1, 2014 | Jul 12, 2021 | - | — |
| NCT01674725 | A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C | PHASE3 | COMPLETED | 187 | — | — | Aug 1, 2012 | Oct 1, 2014 | Jul 12, 2021 | - | — |
| NCT01911845 | An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine | PHASE2 | COMPLETED | 38 | — | — | Apr 1, 2013 | Sep 1, 2014 | May 30, 2018 | - | — |
| NCT01672983 | A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection | PHASE2 | COMPLETED | 110 | — | — | Jul 1, 2012 | May 1, 2014 | May 30, 2018 | - | — |
| NCT01306617 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection | PHASE2 | COMPLETED | 50 | — | — | Feb 1, 2011 | Oct 1, 2012 | Jan 8, 2015 | 11 | United States |
The percentage noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline (HCV RNA ≥ 100,000 IU/mL) in the DB active treatment group with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of active study drug (SVR12). Among noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline, superiority of Arm A to a clinically relevant threshold based on historical SVR rate with telaprevir plus pegylated interferon alpha/ribavirin (pegIFN/RBV) in treatment-naïve, non-cirrhotic patients with high viral load; the lower bound of 95% confidence interval (LCB) had to exceed 63% to achieve superiority. The 95% confidence interval was calculated using the normal approximation to the binomial distribution.
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV.
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN).
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.
The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (\< 15 IU/mL).
| Arm | Type | Description |
|---|---|---|
| Substudy 1, Arm A: DB 2-DAA | EXPERIMENTAL | Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents \[2-DAA\]) once daily (QD) for 12 weeks in participants without cirrhosis |
| Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA | PLACEBO_COMPARATOR | DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis |
| Substudy 2, Arm C: OL 2-DAA | EXPERIMENTAL | OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis |
| 3-DAA/RBV | EXPERIMENTAL | 3-DAA (ABT-450/r/ABT-267 \[150 mg/ 100 mg/ 25 mg once daily\] and ABT-333 \[250 mg twice daily\]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| TPV/RBV | ACTIVE_COMPARATOR | TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously \[SC\] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information. |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | EXPERIMENTAL | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | EXPERIMENTAL | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks |
| Arm A: 3-DAA + RBV in GT1a | EXPERIMENTAL | ABT-450/r/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based RBV for 12 weeks (3 direct-acting antivirals \[DAAs\] with RBV in GT1a) |
| Arm B: TPV/PR in GT1a | ACTIVE_COMPARATOR | Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegIFN 180 µg/week and weight-based RBV (PR) for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a) |
| Arm C: 3-DAA + RBV in GT1b | EXPERIMENTAL | ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b) |
| Arm D: 3-DAA in GT1b | EXPERIMENTAL | ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b) |
| Arm E: TPV/PR in GT1b | ACTIVE_COMPARATOR | Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b) |
| Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | EXPERIMENTAL | Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks | EXPERIMENTAL | ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks |
| ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks | EXPERIMENTAL | ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks |
| ABT-450/r/ABT-267 and ABT-333 | EXPERIMENTAL | ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks |
| Arm 1 | EXPERIMENTAL | Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. |
| Arm 2 | EXPERIMENTAL | Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. |
| Arm 3 | EXPERIMENTAL | Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks. |
| Arm 4 | EXPERIMENTAL | Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks. |
| Arm 5 | EXPERIMENTAL | Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. |
| Arm 6 | EXPERIMENTAL | Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. |
| ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve | EXPERIMENTAL | ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants. |
| ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïve | EXPERIMENTAL | ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants. |
| ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-responders | EXPERIMENTAL | ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV. |
| Name | Type | Description |
|---|---|---|
| ABT-450/r/ABT-267 | DRUG | Tablet; ABT-450 coformulated with ritonavir and ABT-267 |
| Placebo | DRUG | Tablet |
| ABT-450/r/ABT-267, ABT-333 | DRUG | Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet |
| Ribavirin | DRUG | Tablet |
| Pegylated Interferon a-2a (PegINF) | DRUG | Pre-filled syringe |
| Telaprevir | DRUG | Film-coated tablet |
| Placebo for Ribavirin | DRUG | Capsule |
| Pegylated Interferon alpha 2-a (PegIFN) | DRUG | Pre-filled syringe |
| Placebo for ABT-450/r/ABT-267 | DRUG | Tablet |
| Placebo for ABT-333 | DRUG | Tablet |
| Ribavirin (RBV) | DRUG | Capsule |
| ABT-333 | DRUG | Tablet |
| ABT-450/ritonavir, ABT-267 | DRUG | ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet) |
| ABT-450 | DRUG | tablets |
| ritonavir | DRUG | capsules |
Inclusion Criteria: * Chronic HCV-infection prior to study enrollment * Screening laboratory result indicating HCV subgenotype 1b infection * Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening * Voluntarily sign an informed consent * Females must be practicing specific forms of...