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Also known as Viekira Pak
Paritaprevir/ritonavir/ombitasvir · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Paritaprevir/ritonavir/ombitasvir (75mg/50mg/12.5mg) and dasabuvir (250mg) with or without ribavirin (1000-1200mg) daily taken orally for 8 weeks. |
| Cohort 2 | EXPERIMENTAL | Three tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 6 weeks |
| Cohort 3 | EXPERIMENTAL | Three tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 4 weeks |
| Name | Type | Description |
|---|---|---|
| Paritaprevir/ritonavir/ombitasvir | DRUG | - |
| Dasabuvir | DRUG | - |
| Ribavirin | DRUG | - |
| Glecaprevir/pibrentasvir | DRUG | - |
Inclusion Criteria: * Provision of written informed consent; * Male and female patients aged 18 years and over; * For Cohort One: willing to use two effective methods of contraception during the treatment period and 24 weeks post; * For Cohort Two and Three: If female and of childbearing potential,...
Paritaprevir/ritonavir/ombitasvir is a small molecule combination regimen being studied for the treatment of acute hepatitis C. It has been evaluated in a Phase 3 clinical trial in adults with recently acquired hepatitis C virus infection. The regimen is investigational and is not described as approved for this use.
Paritaprevir/ritonavir/ombitasvir is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating this combination regimen in acute hepatitis C.
Paritaprevir/ritonavir/ombitasvir is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are ongoing. The program remains investigational, and the available information does not indicate that the combination has received FDA approval for acute hepatitis C.
Paritaprevir/ritonavir/ombitasvir has been studied in the Phase 3 trial NCT02634008, titled Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P. That completed trial enrolled 83 adults with acute hepatitis C across Australia, New Zealand, and the United Kingdom and used a controlled design.
The Phase 3 study NCT02634008 was a controlled trial that enrolled 83 participants aged 18 years and older with acute hepatitis C. It was not randomized and not double blinded, and it did not select patients by biomarker. The trial was conducted in Australia, New Zealand, and the United Kingdom and has been completed.