Sofosbuvir/Daclatasvir Combination Effective in Hepatitis C Treatment

Therapy shows promise in treatment of hepatitis C genotype-1 mono-infected patients.

The combination of sofosbuvir and daclatasvir showed promising results for the treatment of hepatitis C virus (HCV) during a recent clinical trial, which was the first to evaluate this drug combination in a real world setting.

The study, presented this week at The International Liver Congress 2015, included 409 HCV genotype-1 mono-infected patients who received a combination of sofosbuvir at 400 mg/d and daclatasvir at 60 mg/d without ribavirin (n=318) or with ribavirin (1-1.2 g/d, n=91). Of these patients, 318 had cirrhosis and 306 had prior treatment with peginterferon-ribavirin (n=134) or peginterferon-ribavirin with a first generation protease inhibitor (n=172).

The results showed the sustained virologic response rate at 4 weeks (SVR4) for sofosbuvir and daclatasvir was 81.6% after a 12-week treatment duration and 93.9% after a 24-week treatment duration. Meanwhile, the SVR4 rate for sofosbuvir and daclatasvir with ribavirin was 100% after a 12-week treatment course and 96.6% after a 24-week treatment course.

"The cohort study has found that the sofosbuvir/daclatasvir combination is associated with a high rate of SVR4 in difficult-to-treat patients infected by genotype-1 hepatitis C,” principal investigator Stanislas Pol said in a press release. “We also found that the combination with ribavirin increases the SVR rate in cirrhotic or experienced patients without the additive effect of the extension of the treatment from 12 to 24 weeks. We hope that this helps support further treatment options for difficult-to-treat patients."

Additionally, the 12-week combination of sofosbuvir and daclatasvir with ribavirin achieved a 100% SVR4 rate in cirrhotic patients without an extension of the treatment to 24 weeks with or without ribavirin (95.7% and 92.5%, respectively), which was also true in experienced patients.

All non-cirrhotic patients reached 100% SVR4 at 12 weeks, which indicates the 12-week combination of sofosbuvir and daclatasvir is a proven therapeutic option. Furthermore, the SVR12 rate was 100% for sofosbuvir and daclatasvir with ribavirin after 12 and 24 weeks.

Serious adverse events were reported in 9% of patients, with treatment discontinuation related to these adverse events reported in 3.1% of patients.

"This study shows very positive results for hepatitis C genotype-1 mono-infected patients,” Professor Tom Hemming Karlsen, of the European Association for the Study of the Liver, said in a press release. “This is one of the first real-life studies looking into sofosbuvir/daclatasvir combinations and has demonstrated that this is a good therapeutic option for these patients. It represents another treatment option to help patients beat hepatitis C.”