ALLY 3: Daclatasvir/sofosbuvir combination shows efficacy in HCV genotype 3

BOSTON — Combination therapy with daclatasvir and sofosbuvir was associated with an 12-week sustained virologic response rate of 90% in previously untreated patients, according to findings presented at the late-breakers session here.

David R. Nelson, MD, of the University of Florida in Gainesville, presented data from the ALLY 3 open-label, randomized study, which included 152 patients with HCV genotype 3 disease.

Eligible participants were treated with daclatasvir (Bristol-Myers Squibb) 60 mg and sofosbuvir (Sovaldi, Gilead Sciences) 400 mg once daily for 12 weeks. The follow-up duration was 24 weeks. SVR12 served as the primary outcome measure.

There were 101 patients in the treatment-naïve group and 51 in the treatment-experienced group.

“The only really important exclusion criteria was prior treatment with an NS5A inhibitor,” Nelson said.

Patients in the naïve group experienced an SVR12 of 90%, while those in the experienced group reached 86% SVR12.

By the end of treatment, 99% of patients in the previously untreated arm and 100% of those in the treatment-experienced arm had undetectable viral load.

“Cirrhosis had a significant impact on response,” he said. The overall SVR12 rate was 63% among patients with cirrhosis, compared with 96% for those without cirrhosis. SVR12 rates for patients with cirrhosis were 58% in the treatment-naïve arm and 69% for those who were treatment-experienced.

Of 16 patients who relapsed, 11 had cirrhosis.

“Half of the patients who relapsed had resistance-associated variants emerging,” Nelson added.

Safety profile data revealed no grade 3 or 4 adverse events.

Factors such as gender and age did not impact SVR12 outcomes, according to Nelson. There were no deaths or discontinuations due to adverse events. Headache, fatigue, nausea, diarrhea, insomnia, abdominal pain and arthralgia were the only events that occurred in 5% or more of the cohort. No viral breakthroughs were reported. – by Rob Volansky

For more information:

Nelson DR. LB-3. Presented at: The Liver Meeting; Nov. 7-11, 2014; Boston.

Disclosure: Nelson reports associations with Abbott, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Genentech, Idenix, Janssen, Merck and Vertex.