Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ombitasvir/Paritaprevir/Ritonavir · 3 trials · 3 indications
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
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.
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. Participants with missing data were imputed as failures.
| Arm | Type | Description |
|---|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | EXPERIMENTAL | Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks |
| Arm A | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV. |
| Arm B | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV. |
| Arm C | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV. |
| Arm D | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced. |
| Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV | EXPERIMENTAL | Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks |
| Name | Type | Description |
|---|---|---|
| ombitasvir/paritaprevir/ritonavir | DRUG | Tablet |
| dasabuvir | DRUG | Tablet |
| ribavirin | DRUG | tablets |
| Ribavirin (RBV) | DRUG | Tablet |
Inclusion Criteria: 1. Chronic HCV infection at Screening. 2. Screening laboratory result indicating HCV genotype 1b infection. 3. Treatment-naïve and non-cirrhotic. Exclusion Criteria: 1. HCV genotype or subtype other than GT1b. 2. Positive test result for Hepatitis B surface antigen (HbsAg) or ...
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.