Combination therapy with direct-acting antiviral agents (DAAs) confers real clinical benefits in patients with chronic hepatitis C virus (HCV) infection, and these benefits appear to persist and become more apparent during long-term follow-up, according to the results of a study published in the Journal of Viral Hepatitis.
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; ClinicalTrials.gov Identifiers: NCT02219490 and NCT02167945, respectively) 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.
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.
The study authors concluded that, “The TOPAZ-I and -II clinical trials continue assessing the long-term outcomes in a prospective way, and the interim results from these studies presented here support the benefits of SVR12 on clinical outcomes and reinforce the need for HCV treatment at an early stage of the disease.”
Disclosure: This clinical trial was supported by AbbVie. Several study authors declared affiliations with the pharmaceutical industry. Please refer to the original reference for a full list of authors’ disclosures.
Poordad F, Castro RE, Asatryan A, et al. 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 [published online January 18, 2020]. J Viral Hepat. doi:10.1111/jvh.13261