SVR12 Is Equivalent to SVR24 in Assessing New HCV Regimens

Eradication of hepatitis C virus (HCV) is typically defined as an undetectable level of HCV RNA 24 weeks after completing treatment (i.e., sustained virologic response at week 24, or SVR24). The FDA recently determined that sustained virologic response at 12 weeks posttreatment (SVR12) is as valid as SVR24 as an efficacy endpoint due to its high rate of concordance with SVR24. However, this concordance has not been extensively studied since the advent of direct-acting antiviral–based regimens.

In a retrospective analysis of data from five phase III trials of sofosbuvir-containing regimens (with and without peginterferon) in 863 patients with HCV infection (genotypes, 1–6), investigators assessed the concordance between SVR at 4 weeks (SVR4) …