Long-term safety and efficacy results in hepatitis C virus genotype 1–infected patients receiving ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin in the TOPAZ-I and TOPAZ-II trials
Journal of Viral Hepatitis Feb 22, 2020
Poordad F, Castro RSE, Asatryan A, et al. - The phase 3 clinical trials including > 2,300 HCV genotype 1–infected patients and real-world evidence studies have demonstrated the effectiveness of the 3-direct-acting antiviral agent regimen consisting of ombitasvir/paritaprevir/ritonavir plus dasabuvir (OBV/PTV/r + DSV) ± ribavirin (RBV) for achieving high sustained virologic response rates (~95%). TOPAZ-I and TOPAZ-II, the ongoing phase 3b trials, are performed with the aim to assess safety, efficacy and long-term progression of liver disease and clinical outcomes for up to 5 years posttreatment in patients managed with OBV/PTV/r + DSV ± RBV. Regardless of the presence or absence of cirrhosis, high rates of sustained virologic response (SVR) are attained. In this report, researchers inscribed the long-term progression of liver disease and the incidence of clinical outcomes up to 3 years of posttreatment follow-up in patients with chronic HCV GT1 infection who underwent treatment with (OBV/PTV/r + DSV) ± RBV in the TOPAZ-I and TOPAZ-II studies. Liver disease markers including FIB-4, METAVIR and Child-Pugh scores as well as platelet counts improved in patients. Long-term progression of liver disease, such as liver decompensation, was infrequent (< 1%). Among cirrhotic patients, 1.4% developed hepatocellular carcinoma.
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