A combination of sofosbuvir/daclatasvir yielded sustained virological responses at 12 weeks after the last treatment in 95% of hepatitis C virus–infected patients with genotype 1.
“Real-life results of the sofosbuvir + ribavirin or sofosbuvir + simeprevir combination have been extensively reported, but there are few data regarding the sofosbuvir + daclatasvir combination in genotype 1–infected patients,” wrote Stanislas Pol, MD, of Hôpital Cochin, Institut Pasteur, Paris, and his colleagues.
To assess the effectiveness of the combination, researchers reviewed data from 768 patients with HCV genotype 1 who began treatments of 400 mg/day sofosbuvir and 60 mg/day daclatasvir prior to Oct. 1, 2014 (J Hepatol. 2016. doi: 10.1016/j.jhep.2016.08.021). Patients were treated for 12 or 24 weeks, and the primary endpoint was sustained virological response 12 weeks after the last treatment (SVR12).
A total of 92% of patients treated for 12 weeks and 99% of patients treated for 24 weeks with the combination met the primary endpoint of SVR12, for an average of 95% overall. Treatment duration and the presence or absence of ribavirin had no significant impact on the treatment responses in noncirrhotic patients. However, the SVR12 rate was significantly higher among cirrhotic patients in the 24-week treatment group than in the 12-week group (95% vs. 88%).
One patient died from cerebral hemorrhage 6 weeks after beginning treatment, and the death was considered possibly related to the combination treatment; two deaths from septic shock and two deaths from end-stage liver disease were not considered treatment related. Other serious adverse events were reported in 10% of patients independent of treatment duration or use of ribavirin. The six serious adverse events possibly related to treatment included three cardiac disorders. The most common adverse events included insomnia, headache, and asthenia, reported in at least 10% of patients.
Only decompensated cirrhosis and a prothrombin time greater than 70% were independently associated with serious adverse events.
The study was limited by several factors, including its observational nature and relatively low number of patients treated with ribavirin in the 12-week group, the researchers noted. However, the results suggest that “in real life, the sofosbuvir + daclatasvir combination in difficult-to-treat patients with HCV genotype 1 infection was associated with a high rate of SVR12,” they said.
Inserm-ANRS supported the study. The researchers disclosed funding from government organizations and pharmaceutical companies including MSD, Janssen, Gilead, AbbVie, BMS, and Roche.