All Clinical Trials
Filter by Category
- All Clinical Trials
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Resistance/Virological Failure
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
- Pharmacology
- Adverse Effects
- Adverse Effects
Common TitleAGATE-II Industry
Official Title Ombitasvir, Paritaprevir, and Ritonavir plus Ribavirin for Chronic Hepatitis C Virus Genotype 4 Infection in Egyptian Patients With or Without Compensated Cirrhosis (AGATE-II): a Multicentre, Phase 3, Partly Randomised Open-Label Trial.
Purpose / DescriptionThis phase 3, open-label, partly randomized trial enrolled treatment-naive or treatment-experienced adults with HCV genotype 4 infection, including 100 participants with cirrhosis and 60 without cirrhosis. The study was conducted at five academic and hepatology centers in Egypt. Participants without cirrhosis received 12 weeks ombitasvir-paritaprevir-ritonavir plus weight-based ribavirin. Patients with compensated cirrhosis were randomized to receive ombitasvir-paritaprevir-ritonavir for 12 weeks or 24 weeks. Overall, including both treatment-naive and treatment-experienced patients, more than 90% of patients achieved an SVR 12 (94% in those without cirrhosis; 97% in those with cirrhosis treated with 12 weeks; and 93% in those with cirrhosis treated with 24 weeks).
Phase Phase III
ClinicalTrials.gov NCT01685203
Treatments
Ombitasvir-Paritaprevir-Ritonavir![Ombitasvir-Paritaprevir-Ritonavir Technivie](//cdn.hepatitisc.uw.edu/css/images/drugs/19.png)
![Ombitasvir-Paritaprevir-Ritonavir Technivie](http://cdn.hepatitisc.uw.edu/css/images/drugs/19.png)
Ombitasvir-Paritaprevir-Ritonavir
Tradename:TechnivieOther Names:OBV-PTV-RTVClass:DiscontinuedFunding
IndustryAbbVie
References
- Waked I, Shiha G, Qaqish RB, et al. Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. Lancet Gastroenterol Hepatol. 2016;1:36-44.
Official Title Ombitasvir plus Paritaprevir plus Ritonavir with or without Ribavirin in Treatment-Naive and Treatment-Experienced Patients with Genotype 4 Chronic Hepatitis C Virus Infection (PEARL-I): a Randomised, Open-Label Trial
Purpose / DescriptionIn the phase 2b PEARL-I study, patients with chronic genotype 4 HCV infection, without cirrhosis, were treated with a 12-week course of ombitasvir plus paritaprevir plus ritonavir, with or without ribavirin. The study was a multicenter trial conducted in Europe, Turkey, and the United States. The enrollment included treatment-naive and treatment-experienced patients. The treatment-naive patients were randomized to receive a regimen with or without ribavirin, whereas all treatment-experienced patients received a regimen that included ribavirin. Note the regimen used in this trial did not include dasabuvir since it does not have activity against genotype 4 HCV. For the treatment-naive patients, 40 (91%) of 44 achieved an SVR12 with the regimen ombitasvir plus paritaprevir plus ritonavir; 42 (100%) of 42 of the treatment-naive patients achieved an SVR with ombitasvir plus paritaprevir plus ritonavir and ribavirin. Among the treatment-experienced patients, 49 (100%) of 49 patients achieved an SVR12 with ombitasvir plus paritaprevir plus ritonavir and ribavirin. This regimen was well-tolerated and there were few treatment discontinuations.
Phase Phase II
ClinicalTrials.gov NCT01685203
Treatments
Ombitasvir-Paritaprevir-Ritonavir![Ombitasvir-Paritaprevir-Ritonavir Technivie](//cdn.hepatitisc.uw.edu/css/images/drugs/19.png)
![Ombitasvir-Paritaprevir-Ritonavir Technivie](http://cdn.hepatitisc.uw.edu/css/images/drugs/19.png)
Ombitasvir-Paritaprevir-Ritonavir
Tradename:TechnivieOther Names:OBV-PTV-RTVClass:DiscontinuedFunding
IndustryAbbVie
References
- Hézode C, Asselah T, Reddy KR, et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015;385:2502-9.
Editor's Summary
A PDF version of this treatment drug's summary, including the clinical trial descriptions and references.
Ombitasvir-Paritaprevir-Ritonavir Slide Deck
Clinical Trial Image Decks
PEARL-I - August 9, 2017