Efficacy and Safety of Daclatasvir-Based Regimens in Patients With Cirrhosis

Physician giving patient pills, medication
Investigators of this real-world Italian study found that treatment with protease inhibitors (ie, asunaprevir/simeprevir) should be avoided in patients with advanced liver disease.

Antiviral therapy with daclatasvir-based regimens, with or without ribavirin, resulted in a high proportion of patients with cirrhosis achieving a sustained virologic response at 12-weeks posttreatment (SVR12), with a low incidence of adverse effects, according to a study published in Scientific Reports.1

Studies have demonstrated that the efficacy and safety of daclatasvir-based treatments in patients with cirrhosis are not significantly different from those obtained in people without cirrhosis.2-4 However, there are limited data on interferon-free regimens in patients with advanced liver disease and on the impact of hepatitis C virus (HCV) clearance on patients with decompensated cirrhosis and in patients needing liver transplantation.

Therefore, researchers in Italy evaluated the efficacy and safety of daclatasvir-based interferon-free regimens in 275 patients with HCV cirrhosis, assessed factors associated with failure of interferon-free daclatasvir-based antiviral therapy, and assessed therapeutic efficacy with changes in liver function tests during treatment and follow up.1

They found that 240 patients achieved SVR12 (87.3%). People who had undergone transplant or who were co-infected with HIV were equally distributed among those achieving SVR and those not achieving SVR. In addition, daclatasvir-based regimens resulted in a high SVR when combined with sofosbuvir in those needing transplant or those undergoing orthotopic liver transplant and in difficult-to-treat HCV genotypes. However, the SVR rate was significantly higher in patients who received daclatasvir in combination with sofosbuvir compared with those who received it in combination with the protease inhibitors simeprevir or asunaprevir (93.2% vs 63.0%, P <.0001).

Daclatasvir-based antiviral therapy was found to be well tolerated with mean albumin and bilirubin values significantly improving between baseline and follow-up week 12.

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The authors concluded that, “daclatasvir + sofosbuvir, with or without ribavirin, in patients with advanced cirrhosis in a real-world setting is very effective, also for more ‘difficult to cure’ HCV genotypes.”1


  1. Calvaruso V, Mazzarelli C, Milazzo L, et al. Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program. Sci Rep. 2019;9:585.
  2. Choongho L. Daclatasvir: potential role in hepatitis C. Drug Des Devel Ther. 2013;7:1223-1233.
  3. Nelson DR, Cooper JN, Lalezari JP, et al; ALLY-3 Study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61(4):1127-1135.
  4. Smolders EJ, de Kanter CT, van Hoek B, Arends JE, Drenth JP, Burger DM. Pharmacokinetics, efficacy, and safety of hepatitis C virus drugs in patients with liver and/or renal impairmentDrug Saf. 2016;39(7):589-611.