VIENNA — Patients treated with regimens containing Sovaldi and daclatasvir achieved encouraging 4-week sustained virologic response rates, according to data presented during the Late Breakers session at the 2015 International Liver Congress.
Stanislas Pol, MD, of the Department of Hepatology at Cochin Hopital, the French Institute of Health and Medical Research, the Pasteur Institute and René Descartes University, treated 317 HCV genotype 1 mono-infected patients with 400 mg (sofosbuvir, Gilead)and 60 mg daclatasvir (Bristol-Myers Squibb) without ribavirin and 92 patients with the sofosbuvir/daclatasvir regimen plus 1 g to 1.2 g of ribavirin. The study included 12- and 24-week treatment groups.
“We aimed to evaluate real-life results of the sofosbuvir/daclatasvir combination,” Pol said.
The cohort included 319 patients with cirrhosis and 307 patients who previously underwent treatment.
Among patients treated without ribavirin, 12-week sustained virologic response (SVR12) rates were 84.9% in patients treated for 12 weeks and 93.4% in those treated for 24 weeks.
“If you consider the sofosbuvir and daclatasvir regimen, there is clearly benefit to extending the treatment duration from 12 to 24 weeks,” Pol said.
SVR4 results were indicative of the efficacy of the 24-week regimen in patients who did not receive ribavirin, according to Pol. He noted that treatment-experienced patients and those with cirrhosis treated for 24 weeks experienced about a 10% increase in SVR4 rates compared with those treated for 12 weeks.
In the ribavirin arm, SVR12 rates were close to 100% in both the 12- and 24-week arms.
“Twelve weeks is sufficient to achieve a high SVR rate in this group,” Pol said.
The researchers observed 22 treatment failures, which Pol described as a “low number.”
“The sofosbuvir and daclatasvir combination was associated with a high rate of SVR4 in difficult to treat patients infected by genotype 1 HCV,” Pol said. “Cirrhosis was strongly associated with treatment failure. All patients with failure had cirrhosis.”
Pol recommended that 12 weeks of the sofosbuvir/daclatasvir regimen was sufficient for patients without cirrhosis. While 24 weeks of treatment with ribavirin may be optimal in treatment-experienced patients or those with cirrhosis, he noted that 12 weeks may be more attractive due to economic considerations. – by Rob Volanksy
For More Information:
Pol S. Abstract L03. Presented at: International Liver Congress; April 22-26, 2015; Vienna.
Disclosure: The study was supported by MSD, Janssen, Gilead, BMS, Roche, Abbvie and conducted in collaboration with AFEF. Pol reports associations with a number of device and pharmaceutical companies. Please see the full study for a list of all other authors’ relevant financial disclosures.