Cirrhosis patients benefit from new hepatitis C drug

The new combination hepatitis C drug ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) has been found to be highly effective in treating patients with cirrhosis who have not benefited from previous therapies.

In a phase 2 study by the manufacturer, which included 155 patients with compensated cirrhosis and the most common genotype 1 form of the liver virus, the new drug was found to achieve high cure rates. Study patients who were randomized to receive ledipasvir/sofosbuvir alone for 24 weeks had a cure rate of 97%, whereas those randomized to receive the combination drug and ribavirin for 12 weeks had a cure rate of 96%.

All cirrhosis patients included in the study had failed to benefit from previous treatment with pegylated interferon and ribavirin, as well as when a protease inhibitor was added to that regimen. Such standard older drugs are known for their potential to result in debilitating side effects. These medications also require treatment for a much longer period of about 1 year.

Ledipasvir/sofosbuvir is an oral medication taken once daily. Although interferon and ribavirin have to be taken with sofosbuvir (Sovaldi, Gilead Sciences), the combination drug makes this unnecessary.

FDA approved ledipasvir/sofosbuvir on October 10, 2014, for the treatment of chronic hepatitis C infection in adults. Data collected from 3 phase 3 studies served as the basis for its approval. For genotype 1 patients, with and without cirrhosis, the sustained cure rate was 100%. For genotype 3 patients with cirrhosis the cure rate was 88%.

The high cost of ledipasvir/sofosbuvir, estimated at $94,500 for 12 weeks of treatment, has been controversial in a time when healthcare costs are seen as needing to be better controlled, if not scaled back. These results, however, showing its effectiveness in treating and curing cirrhosis patients who have failed previous treatment options, help support the value of this new combination drug.

Gilead notes that the safety and efficacy of ledipasvir/sofosbuvir have not been established for this investigational use.