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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02442271 | A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil | PHASE3 | COMPLETED | 222 | — | — | Apr 27, 2015 | Sep 26, 2016 | Aug 1, 2017 | - | — |
| NCT02219503 | A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis | PHASE3 | COMPLETED | 60 | — | — | Sep 1, 2014 | Sep 1, 2015 | Jul 12, 2021 | - | — |
| NCT02486406 | A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects | PHASE2 | COMPLETED | 64 | — | — | Oct 28, 2015 | Nov 19, 2020 | Oct 5, 2021 | 21 | United States, Belgium +3 |
| NCT02356562 | 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 | PHASE2 | COMPLETED | 29 | — | — | Feb 3, 2015 | Jul 7, 2017 | Dec 20, 2017 | - | — |
| NCT01782495 | A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients | PHASE2 | COMPLETED | 129 | — | — | Feb 25, 2013 | Jul 13, 2017 | Nov 7, 2017 | - | — |
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 were counted as failures.
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug. The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ombitasvir present was measured up to 24 hours after dosing.
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of paritaprevir present was measured up to 24 hours after dosing.
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of dasabuvir present was measured up to 12 hours after dosing. For two subjects in the 15-29 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. For one subject in the 30-44 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation.
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ritonavir present was measured up to 24 hours after dosing.
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) \< lower limit of quantification (LLOQ) 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.
| Arm | Type | Description |
|---|---|---|
| 3-DAA ± RBV | EXPERIMENTAL | 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks. |
| Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir | EXPERIMENTAL | Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks |
| Adult tablet, 12-17 yr, Part 1 | EXPERIMENTAL | Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. |
| Adult tablet, 12-17 yr, Part 2 | EXPERIMENTAL | Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label. |
| Mini tablet, 9-11 yr, Part 1 | EXPERIMENTAL | Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label. |
| Mini tablet, 3-8 yr, Part 1 | EXPERIMENTAL | Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label. |
| 3-DAA with or without SOF and RBV | EXPERIMENTAL | 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 |
| Arm A | EXPERIMENTAL | Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| Arm B | EXPERIMENTAL | Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| Arm C | EXPERIMENTAL | Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. |
| Arm D | EXPERIMENTAL | Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| Arm E | EXPERIMENTAL | Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| Arm F | EXPERIMENTAL | Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| Arm G | EXPERIMENTAL | Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. |
| Arm H | EXPERIMENTAL | Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| Arm I | EXPERIMENTAL | Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. |
| Arm J | EXPERIMENTAL | Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| Arm K | EXPERIMENTAL | Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| ombitasvir/paritaprevir/ritonavir and dasabuvir | DRUG | Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet |
| ribavirin | DRUG | Tablet |
| Ombitasvir/Paritaprevir/Ritonavir | DRUG | Tablet; paritaprevir co-formulated with ritonavir and ombitasvir |
| Dasabuvir | DRUG | Tablet |
| Ombitasvir mini tablet | DRUG | Film-coated tablet for oral use |
| Paritaprevir mini tablet | DRUG | Film-coated tablet for oral use |
| Ritonavir mini tablet | DRUG | Film-coated tablet for oral use |
| Dasabuvir mini tablet | DRUG | Film-coated tablet for oral use |
| Ribavirin solution | DRUG | Oral solution |
| Sofosbuvir | DRUG | tablet |
Inclusion Criteria: * Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control * Males must be surgically sterile or agree to practice acceptable forms of birth control * Chronic hepatitis C virus (HCV) infection at screening * Fibr...