Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ombitasvir/paritaprevir/ritonavir, dasabuvir · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| ombitasvir/paritaprevir/ritonavir, dasabuvir | DRUG | tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet |
| sofosbuvir (SOF) | DRUG | tablet |
| ribavirin (RBV) | DRUG | tablet |
Inclusion Criteria: 1. Male or female at least 18 years of age at time of screening 2. Chronic Hepatitis C virus (HCV) infection prior to study enrollment 3. Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only 4. Absence of cirrhosis and advanc...
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.