The retrospective study included a cohort of patients from six countries across Europe who were diagnosed with HCV and received daclatasvir during the Named Patient Program.
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The retrospective study included a cohort of patients from six countries across Europe who were diagnosed with HCV and received daclatasvir during the Named Patient Program. The study pool included 249 participants with a median age of 56 years, of which 75% were infected with HCV genotype 1, 78% were male, and 65% had previous treatment experience. A total of 59% of the subject pool had decompensated cirrhosis and 40% had a liver transplant prior to receiving daclatasvir. The vast majority (242 patients) received daclatasvir and sofosbuvir.
Over the course of the study, the patients, “either reached 12 weeks post treatment or died during or after treatment or were lost to follow up during treatment,” the team wrote in the journal BMC Infectious Diseases.
The primary aim of the study was to investigate the effectiveness of daclatasvir in combination with sofosbuvir or simeprevir—and to evaluate sustained virologic response 12 weeks after treatment (SVR12). Only one patient received daclatasvir with simeprevir, so the researchers modified their objective to measure the effectiveness of daclatasvir and sofosbuvir. Secondary objectives included summarizing the demographic and clinical characteristics of the participants and assessing effectiveness through SVR four weeks after treatment (SVR4).
A total of 234 patients completed treatment. SVR4 and SVR12 rates varied between patients from different countries (ranging from 82% to 100%). The six patients who did not achieve SVR12 had decompensated cirrhosis and none had received ribavirin. The researchers said that the results were consistent with their expectations, in that patients who either did not have cirrhosis or who had stable cirrhosis were easier to treat.
One of the study’s strengths lies in the fact that the collected data came from clinical practice. In addition, patients who had previously been difficult to treat were included in the patient pool. The researchers add that their data “come from a number of European countries and estimates have been appropriately averaged over different health care systems.” However, there was a small number of patients from each of the countries. Nonetheless, the findings were consistent with discoveries drawn from other studies.
While this study supports the use of sofosbuvir in combination with daclatasvir as a treatment for HCV, it also raises some questions.
The researchers concluded that investigation is still needed to determine “whether fewer than 24 weeks erodes effectiveness in these patients — and by how much; whether this treatment is as effective in HCV genotype 3 patients with decompensated cirrhosis; and whether the combination of daclatasvir and sofosbuvir is more effective than other treatment combinations for patients with decompensated cirrhosis.”
