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TOPAZ-I (M14-423)

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.


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