
TOPAZ-I (M14-423)
An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)

Project Details
Start Date
2014
End Date
2021
Status
In Follow Up
Main Research Site
RIDU
The combination DAA regimen consisting of ombitasvir/paritaprevir/ritonavir plus dasabuvir (OBV/PTV/r + DSV) ± ribavirin (RBV) has demonstrated high sustained virologic response with 12 weeks post-treatment (SVR12) rates of >95% in phase 3 clinical trials with >2300 patients infected with HCV genotype 1, as well as in real-world evidence studies. Therefore, researchers are conducting 2 ongoing phase 3b trials (TOPAZ-I and TOPAZ-II) to assess the safety, efficacy, and long-term progression of liver disease and clinical outcomes for up to 5 years post-treatment in patients treated with OBV/PTV/r + DSV ± RBV. CIRG are taking part in the TOPAZ-I study.
In a report that assessed these outcomes at 3 years of post-treatment follow-up, researchers observed improvements in liver disease markers including fibrosis-4, METAVIR score, and Child-Pugh scores, as well as platelet counts. They also found that clinical outcomes related to long-term progression of liver disease such as liver decompensation were infrequent (<1%) and that hepatocellular carcinoma occurred in only 1.4% of cirrhotic patients.
MAIN FUNDING BODY