The NS5A and NS5B inhibitors ledipasvir/sofosbuvir reduced the incidence of compensated and decompensated cirrhosis, hepatocellular carcinoma and liver transplant in patients with hepatitis C virus compared with sofosbuvir with pegylated interferon plus ribavirin, according to data presented at AASLD/EASL Special Conference on Hepatitis C.
Researchers in the United Kingdom analyzed long-term outcomes of ledipasvir/sofosbuvir (LDV/SOF) in genotype 1 patients (n=10,000) with HCV who were treatment naive or had treatment-experienced protease inhibitor failure (TEPI). Nineteen percent of patients initiated treatment at compensated cirrhosis stage and had lifetime follow-up. Treatment-naive patients without cirrhosis received LDV/SOF for 8 weeks, and patients with compensated cirrhosis received 12 weeks of therapy. Outcomes were compared with patients who received SOF with pegylated interferon 2a and ribavirin (PR), SOF with RBV (for 24 weeks) and simeprevir (SMV) with PR. Among TEPI patients, LDV/SOF for 12 weeks was compared with SOF with PR and no treatment.
SVR in noncirrhotic and cirrhotic patients occurred in 94% of genotype 1 treatment-naive patients, while 95% of noncirrhotic and 86% of cirrhotic genotype 1 TEPI patients met SVR.
LDV/SOF reduced compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma and liver transplant in genotype 1 patients by 43% compared with SMV with PR, 17% compared with SOF with PR, and 60% compared with SOF with RBV. LDV/SOF reduced liver complications in TEPI patients by 47% compared with SOF with PR and by 81% compared with no treatment.
“LDV/SOF is highly effective and has the potential to further reduce the long-term burden of HCV compared to interferon-based DAA treatment, including in protease inhibitor failure patients where there is a clear unmet need for other treatment options,” the researchers concluded.
For more information: Guerra I. Abstract #12. Presented at: AASLD/EASL Special Conference on Hepatitis C; Sept. 12-13, 2014; New York.
Disclosure: This study was sponsored by Gilead Sciences.