Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ombitasvir/ABT-450/Ritonavir · 5 trials · 9 indications
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.
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.
SVR12, defined as HCV RNA \< lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.
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.
HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.
| Arm | Type | Description |
|---|---|---|
| Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily \[QD\]) + dasabuvir (250 mg twice daily \[BID\]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID) |
| 3-DAA ± RBV for 12 or 24 weeks | 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, dosed as per label based on genotype and presence of cirrhosis. |
| Group 1: GT1B | EXPERIMENTAL | ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants |
| Group 2: GT1 Non-B | EXPERIMENTAL | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants |
| Group 3: GT4 | EXPERIMENTAL | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants |
| 3-DAA (Direct Acting Antivirals) with or without RBV | EXPERIMENTAL | 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks |
| Arm A: Ribavirin Full Dose for Last 10 Weeks | EXPERIMENTAL | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. |
| Arm B: Ribavirin Full Dose for 12 Weeks | EXPERIMENTAL | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. |
| Arm C: Ribavirin Low-dose for 12 Weeks | EXPERIMENTAL | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| ombitasvir/paritaprevir/ritonavir | DRUG | ombitasvir/ABT-450/ritonavir tablets |
| dasabuvir | DRUG | dasabuvir tablets |
| ribavirin | DRUG | ribavirin tablets |
| ombitasvir/paritaprevir/ritonavir and dasabuvir | DRUG | Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet |
| Ombitasvir/ABT-450/Ritonavir | DRUG | Ombitasvir/ABT-450/ritonavir combination tablets |
| Ribavirin (RBV) | DRUG | Ribavirin tablets |
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 th...
Ombitasvir/ABT-450/Ritonavir is used for the treatment of chronic hepatitis C virus (HCV) infection, including genotype 1 and genotype 4 infections. It is being studied in adults with chronic hepatitis C, with or without cirrhosis, and in treatment-naive patients. The drug is a small molecule combination therapy developed by AbbVie Inc.
Ombitasvir/ABT-450/Ritonavir is a combination of direct-acting antiviral agents that target the hepatitis C virus. Ombitasvir inhibits the NS5A protein, ABT-450 (paritaprevir) inhibits the NS3/4A protease, and ritonavir boosts the levels of ABT-450. Together, they block viral replication in patients with chronic HCV infection.
Ombitasvir/ABT-450/Ritonavir is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical trials to evaluate the safety and efficacy of this combination therapy in adults with chronic hepatitis C virus infection.
Ombitasvir/ABT-450/Ritonavir is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. AbbVie has completed multiple Phase 3 trials evaluating the combination in patients with chronic hepatitis C virus infection, including those with genotype 1 and genotype 4.
Ombitasvir/ABT-450/Ritonavir has been studied in several completed clinical trials. NCT02219477 evaluated it with dasabuvir and ribavirin in genotype 1 and genotype 4 patients with decompensated cirrhosis. NCT02442284 studied it in US veterans with genotype 1. NCT02582632 evaluated it in treatment-naive genotype 1b patients. NCT02493855 was a Phase 2 trial in genotype 1a patients.
Ombitasvir/ABT-450/Ritonavir is a combination product that includes ABT-450, which is also known as paritaprevir. The full regimen contains ombitasvir, paritaprevir, and ritonavir. In clinical trials, this combination is often studied together with dasabuvir and sometimes ribavirin for the treatment of chronic hepatitis C.