Ledipasvir/Sofosbuvir ± Ribavirin Effective, Safe in HCV With Advanced Liver Disease

A combination treatment of ledipasvir/sofosbuvir with or without ribavirin was an effective and tolerable treatment in patients with chronic hepatitis C and advanced liver disease before and after liver transplantation.

Ledipasvir and sofosbuvir with or without ribavirin is an effective and tolerable treatment in patients with hepatitis C virus (HCV)-infection with advanced liver disease, according to a multicenter study published in the Journal of Viral Hepatitis.1

Although HCV cure rates with direct-acting antivirals (DAAs) quickly exceed 90%,2-9 data regarding the risk for hepatocellular carcinoma (HCC) in HCV-infected patients with cirrhosis treated with DAA therapy is controversial.10-20 Therefore, researchers evaluated the efficacy and tolerability of ledipasvir and sofosbuvir with or without ribavirin combination treatment in 200 patients with chronic hepatitis C with advanced liver disease to determine the association of ledipasvir and sofosbuvir treatment with a new occurrence and/or recurrence of HCC during and after antiviral treatment.1

The recommended treatment duration was 24 weeks with a median follow-up period of 22 months. Eighty-four percent of patients were infected with genotype 1b, and 24% had received a liver transplantation before treatment.

The researchers found that the sustained virologic response at 12 weeks (SVR12) was 86.0%, and that the SVR12 was similar in patients with Child-Pugh class A, B, and C disease and transplant recipients. In addition, ledipasvir and sofosbuvir treatment was generally well tolerated; only one patient developed newly diagnosed HCC. Seventeen of 35 patients who had a history of previous HCC developed HCC recurrence during treatment or by a median follow-up of 6 months after treatment. HCC recurrence was less common in patients who received curative treatment for HCC compared with those who received noncurative treatment (P =.007).

“In conclusion, a combination treatment of [ledipasvir and sofosbuvir] with or without [ribavirin] was an effective and tolerable treatment in [chronic hepatitis C] patients with advanced liver disease before and after [liver transplantation]” stated the study authors.1 They added that, “HCV eradication is associated with improvements in liver function and a reduction in the risk of developing newly diagnosed HCC.”

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