Ledipasvir-sofosbuvir combination achieves 90% cure rate for HCV patients without cirrhosis

April 17, 2014

An 8-week regimen of ledipasvir-sofosbuvir was highly effective (>90% cure) in non-cirrhotic HCV patients with genotype infection, and adding ribavirin or extending treatment to 12 weeks did not significantly improve the results, according to a study published in the New England Journal of Medicine.

Dr Kowdley

An 8-week regimen of ledipasvir-sofosbuvir was highly effective (>90% cure) in non-cirrhotic HCV patients with genotype infection, and adding ribavirin or extending treatment to 12 weeks did not significantly improve the results, according to a study published in the New England Journal of Medicine.

“A shorter duration of treatment may be less expensive, increase adherence, and achieve the same response rate, and elimination of ribavirin from the regimen will make it even safer and require less monitoring,” said lead study author Kris Kowdley, MD, of Virginia Mason Medical Center in Seattle.

A non-inferiority design was used to randomize patients 1:1:1 in the phase 3 open-label study. Dr Kowdley and colleagues randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir–sofosbuvir) for 8 weeks, ledipasvir–sofosbuvir plus ribavirin for 8 weeks, or ledipasvir–sofosbuvir for 12 weeks. The primary end point was sustained virologic response at 12 weeks after the end of therapy. The study found that 94% of patients with HCV genotype 1 and no cirrhosis were able to treat the virus after just 8 weeks of sofosbuvir (Sovaldi) and ledipasvir with a single once-daily pill.

According to Dr Kowdley, the study was conducted to determine whether treatment for HCV could be shortened using this highly effective combination and whether ribavirin could be eliminated under this regimen for patients without cirrhosis.

“Cost of medications is, and should be, a concern for all involved, and every effort should be made to keep these as low as possible,” Dr Kowdley said, commenting on the recent controversy surrounding the cost of HCV drugs. “However, we must recognize that drug development in HCV is expensive. We must also balance the direct cost with the cost of ‘failed treatment’ and with the indirect costs associated with monitoring and management of side effects with less effective and more toxic regimens. Therefore, what appears to be a ‘costly’ drug may not be so costly, if almost all patients can be cured with minimal side effects and monitoring when compared to older, ‘less costly’ drugs.”