For patients with hepatitis C genotype 1 (HCV GT1) who experience virologic relapse after an antiviral regimen of simeprevir (SMV) and sofosbuvir (SOF), a regimen of ledipasvir/sofosbuvir (LDV/SOF) with or without ribavirin (RBV) is effective and well tolerated, according to results published in the Annals of Hepatology.
The study included participants treated with standardized clinical protocol of LDV/SOF with or without RBV at 3 transplant centers (n=45). Participants were treated for 12 or 24 weeks. The primary end point was the proportion of participants who achieved sustained virologic response 12 weeks after completing treatment (SVR 12).
Participants started LDV/SOF with or without RBV at a median of 22 weeks (range 7-55 weeks) after their last dose of SMV plus SOF treatment. Of 37 participants who received LDV/SOF for 24 weeks, 24 were also treated with RBV. Of 8 participants who received LDV/SOF for 12 weeks, 5 were also treated with RBV. After treatment, 96% (n=43) of participants achieved SVR 12.
The researchers did not find that baseline viral load, RBV use, or GT1 subtype affected the likelihood of achieving SVR 12.
There were minimal adverse events reported among participants who were not treated with RBV. Among participants who were treated with RBV, significant anemia that required RBV dose reduction or discontinuation developed in 45%.
“The use of RBV, whenever possible, should be considered in this cohort and may allow shorter treatment duration,” the researchers wrote. “Despite prior exposure to SOF twice, none of the patients developed SOF [resistance-associated variants] which potentially limit the use of SOF-containing regimens in the future.”
Aqel B, Leise M, Vargas HE, et al. Multicenter experience using ledipasvir/sofosbuvir ± RBV to treat HCV GT 1 relapsers after simeprevir and sofosbuvir treatment. Ann Hepatol. 2018;17(5):815-821.