Treatment with sofosbuvir/velpatavir for 12 weeks is safe and effective in patients with hepatitis C (HCV) recurrence after a liver transplant, according to results published in the Journal of Hepatology.
A multicenter, open-label study (ClinicalTrials.gov Identifier: NCT02781571) included participants infected with HCV genotype 1, 2, 3, and 4 (n=79). Inclusion criteria included having received a liver transplant or combined liver-kidney transplant at least 3 months prior to study entry with no clinical signs of rejection in the past 3 months. Patients without cirrhosis or with compensated cirrhosis were eligible for inclusion.
Each participant was treated with sofosbuvir 400 mg and velpatasvir 100 mg daily for 12 weeks.
The primary end points were sustained virologic response rates 12 weeks after treatment (SVR12) and discontinuations due to adverse events.
Overall, 96% of participants achieved SVR12. By genotype, the SVR12 rates were 95% for genotype 1, 100% for genotype 2, 97% for genotype 3, and 100% for genotype 4.
During treatment, 1 participant discontinued treatment due to hyperglycemia. No serious or severe adverse events were reported. No liver transplant rejection or death occurred during the study.
“These results are especially notable because they were achieved in a broad HCV genotype 1-4 infected liver transplant population,” the study investigators noted. “Characteristics associated with harder-to-cure patient populations, such as HCV genotype, the presence of cirrhosis, prior treatment experience, and pretreatment RASs [resistance-associated substitutions] had no clinically meaningful impact on SVR12 [sustained viral response at 12 weeks] rates.”
This study was funded by Gilead Sciences, Inc. Please refer to original reference for full list of disclosures.
Agarwal K, Castells L, Mullhaupt B, et al. Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients [published online June 7, 2018]. J Hepatol. doi:10.1016/j.jhep.2018.05.039