For patients infected with hepatitis C virus (HCV) and treated with ledipasvir and sofosbuvir with or without ribavirin, HCV RNA may still be detectable and quantifiable at end of treatment, although sustained virological response (SVR) rates are still high, according to results published in Liver International.
These results do not indicate a need to prolong treatment in patients with detectable and quantifiable HCV RNA.
The study included participants with HCV genotype 1 who were treated with ledipasvir/sofosbuvir with or without ribavirin for 8 to 24 weeks who had HCV RNA testing completed using either the Roche COBAS AmpliPrep/COBAS TaqMan or the Abbott RealTime HCV assay (n=471). The researchers defined HCV RNA as detectable if it was either above or below the lower limit of quantification for the respective assay.
Most participants were treated for 8 to 12 weeks (93%; n=440). A total of 98.5% (n=464) participants achieved SVR.
At end of treatment, HCV RNA was detectable in 7% of participants (n=33), with 3% (n=14) of participants having quantifiable viral load (median, 18 IU/mL; range, 12-62 IU/mL).
Participants were more likely to have detectable and quantifiable results if the Abbott RealTime HCV assay was used for testing compared with the Roche COBAS AmpliPrep/COBAS TaqMan (29% [n=25/87] vs 2% [n=8/384]; P <.0001).
Among participants who had detectable HCV RNA, 97% (n=32) achieved SVR, and all participants with quantifiable HCV RNA achieved SVR.
“Determination of HCV RNA at [end of treatment] of modern [direct-acting antiretroviral] regimens should be avoided altogether because the vast majority of patients with a detectable or even a quantifiable viral load will eventually clear the virus and will go on to achieve SVR,” the researchers wrote.
Disclosures: This research was partially funded by AbbVie Deutschland GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KGaA, Gilead Sciences GmbH, Janssen-Cilag GmbH, MSD Sharp & Dohme GmbH, and Roche Pharma AG. Please refer to original text for full list of authors’ disclosures.
Maasoumy B, Buggisch P, Mauss S, et al. Clinical significant of detectable and quantifiable HCV RNA at the end of treatment with ledipasvir/sofosbuvir in GT1 patients [published online July 18, 2018]. Liver Int. doi: 10.1111/liv.13932