CHICAGO — A fixed-dose combination of ledipasvir and sofosbuvir for treatment-experienced patients with genotype 1 hepatitis C resulted in a sustained virologic response for almost all patients enrolled in the phase 3 ION-2 study.
The addition of ribavirin to the treatment, or extending the treatment from 12 weeks to 24 weeks, did not significantly increase the SVR12 rates.
“Patients infected with genotype 1 HCV who have failed prior therapy lack an interferon- and ribavirin-free treatment option that is simple, safe and effective,” Paul Y. Kwo, MD, professor of medicine and director of liver transplantation at Indiana University, and HCV Next Editorial Board member, said during a presentation here at Digestive Disease Week 2014.
The study included patients who had previously failed interferon-based therapy, including regimens that contained an NS3/4A protease inhibitor. The 440 patients were randomly assigned to four treatment arms: Ledipasvir (Gilead) and sofosbuvir (Sovaldi, Gilead) with or without ribavirin for 12 weeks, or ledipasvir and sofosbuvir with or without ribavirin for 24 weeks.
Among the patients who received treatment for 12 weeks, 94% of those treated with ledipasvir/sofosbuvir had an SVR12, as did 96% of those who also received ribavirin. Among patients treated for 24 weeks, both groups saw an SVR12 rate of 99%. The SVR12 rates ranged from 93% to 100% according to the type of treatment previously used, including interferon and ribavirin or interferon, ribavirin and a protease inhibitor.
In patients with cirrhosis, the SVR12 rates among those treated for 12 weeks were 86% for the ledipasvir/sofosbuvir arm and 82% for ledipasvir/sofosbuvir/ribavirin. But with 24 weeks of treatment, the SVR12 rates climbed to 100%, with and without ribavirin.
Among patients who received 12 weeks of treatment, 11 relapsed: Seven in the ledipasvir/sofosbuvir arm and four in the ledipasvir/sofosbuvir/ribavirin arm. No patients had a sofosbuvir-associated S282T resistance variant at baseline, but all 11 patients with relapse had detectable NS5A resistance variants at the time of virologic failure. In addition, seven of the patients who relapsed had cirrhosis.
“Ribavirin did not enhance SVR rates, alter viral kinetics or prevent relapse,” Kwo said. “The addition of ribavirin also contributed to a higher incidence of adverse events and laboratory abnormalities.” – by Emily Shafer
For more information:
Kwo P. Abstract #236. Presented at: Digestive Disease Week 2014; May 3-6; Chicago.
Disclosure: The researchers report numerous financial disclosures.