Difficult-to-treat HCV patients benefit from ledipasvir, sofosbuvir combo

CHICAGO — Treatment with sofosbuvir and ledipasvir is effective and safe for patients with hepatitis C who are typically considered difficult to treat, according to data from the ELECTRON-2 study presented here at Digestive Disease Week 2014.

This population of difficult-to-treat patients includes those with HCV genotype 3, decompensated patients with HCV genotype 1 and patients with HCV genotype 1 who have prior experience with sofosbuvir (Sovaldi, Gilead).

“This regimen has been studied in patients with HCV genotype 1, including those with compensated cirrhosis,” Catherine A. Stedman, MD, PhD, of Christchurch Hospital and the University of Otago in New Zealand, said during her presentation. “It is now being evaluated in difficult-to-treat patient populations that have poor tolerability or efficacy with currently approved antiviral regimens.”

The study included three groups of patients. Nineteen patients with HCV genotype 1 and prior sofosbuvir exposure received fixed-dose ledipasvir (Gilead) and sofosbuvir with ribavirin, and 20 patients with HCV genotype 1 decompensated cirrhosis class B received ledipasvir and sofosbuvir. A group of 51 patients with treatment-naïve HCV genotype 3 were randomly assigned to ledipasvir and sofosbuvir with and without ribavirin.

Among the 19 previously-treated patients, there was a 100% SVR12 rate after receiving ledipasvir/sofosbuvir with ribavirin. Among the patients with decompensated cirrhosis, seven patients relapsed, for an SVR12 rate of 65%. For patients with HCV genotype 3, treatment with ledipasvir and sofosbuvir alone resulted in an SVR12 rate of 64%. The addition of ribavirin to the regimen resulted in a 100% SVR12 rate for patients with HCV genotype 3.

Stedman said patients with HCV genotype 1 and decompensated cirrhosis class B currently have no treatment options. This combination, plus ribavirin, is being evaluated in these patients as well as patients with decompensated cirrhosis class B in the SOLAR-1 and SOLAR-2 trials.

“Ledipasvir/sofosbuvir regimens for 12 weeks are safe and effective interferon-free treatments for many diverse and difficult-to-treat patient populations,” Stedman said. – by Emily Shafer

For more information:

Gane E. Abstract #238. Presented at: Digestive Disease Week 2014; May 3-6; Chicago.

Disclosure: Stedman and colleagues report numerous disclosures.