Efficacy of LDV/SOF for Retreatment of Chronic HCV in SOF-Experienced Patients
Adverse events, mostly mild to moderate in severity, were experienced 78% of participants, with headache and fatigue being the most common.
Among patients with hepatitis C who have been treated with sofosbuvir but not NS5A inhibitor, treatment with ledipasvir/sofosbuvir with or without ribavirin (LDV/SOF±RBV) resulted in a 12-week sustained virologic response rate in more than 88%, according to the results of 2 studies published in Liver International.
The results of the RESCUE study (ClinicalTrials.gov identifier: NCT02600351), which enrolled 82 adults with hepatitis C genotype 1 or 4 monoinfection, and the results of the AIDS Clinical Trials Group A54348 study (ClinicalTrials.gov identifier: NCT02605304), which evaluated 7 adults with hepatitis C genotype 1 and HIV coinfection, were reported. In the RESCUE trial, patients received 12 weeks of LDV/SOF ± RBV (participants who did and did not have cirrhosis), or 24 weeks of LDV/SOF alone (participants with cirrhosis). In A54348, patients were randomly assigned to receive 12 weeks of LDV/SOF+RBV or 24 weeks of LDV/SOF alone.
In the RESCUE study, 88% of participants attained overall sustained virologic response (SVR) at 12 weeks posttreatment. Among patients who did not have cirrhosis, 81% of the LDV/SOF alone group and 100% of the LDV/SOF+RBV group attained SVR. Among those with cirrhosis, 80% of those receiving 12 weeks of treatment with LDV/SOF+RBV and 96% of those receiving 24 weeks of treatment with LDV/SOF alone attained SVR. In the A54348 trial, 100% of participants reached SVR at 12 weeks.
No serious treatment-related adverse events were reported in either trial. Common adverse events included mild-to-moderate headache and fatigue.
The researchers concluded that “in SOF-experienced NS5A inhibitor-naive participants infected with [hepatitis C genotypes 1 or 4], high SVR12 rates were achieved with LDV/SOF±RBV retreatment for 12 or 24 weeks, including in [hepatitis C]/HIV co-infected individuals.”
Disclosure: The RESCUE study was funded by Gilead Sciences and the AIDS Clinical Trials Group A54348 was funded by the National Institutes of Health (NIH) and Gilead Sciences.
Tam E, Luetkemeyer AF, Mantry PS, et al; RESCUE and ACTG A5348 study investigators. Ledipasvir/sofosbuvir for treatment of hepatitis C virus in sofosbuvir-experienced, NS5A treatment-naïve patients: findings from two randomized trials [published online November 1, 2017]. Liver Int. doi: 10.1111/liv.13616