VX-135/daclatasvir therapy yields positive SVR4 results in HCV patients

A study of Vertex Pharmaceuticals’ VX-135 in combination with daclatasvir resulted in 83% of patients achieving sustained virologic response at 4 weeks posttreatment, a company release said.

The open label, phase 2a trial included 12 treatment-naive patients with hepatitis C genotype 1 and without cirrhosis. Each was to receive 200 mg VX-135, a nucleotide analog polymerase inhibitor, in combination with 60 mg daclatasvir (Bristol-Myers Squibb), an NS5A replication complex inhibitor, for 12 weeks.

At 4 weeks of treatment, 58% of patients had undetectable HCV RNA. One patient discontinued treatment after the initial dose due to vomiting and nausea, but most adverse events were mild, the release said.

“We are encouraged by these initial phase 2a data for VX-135 in combination with another direct-acting antiviral medicine,” Robert Kauffman, MD, PhD, senior vice president and chief medical officer at Vertex, said in the release. “We believe that VX-135 has the potential to play an important future role in the treatment of hepatitis C, and we are currently evaluating these data with BMS to determine the next steps for this combination in people with hepatitis C, including people with genotypes 1 and 3.”

Another arm of the study treated 11 treatment-naive patients with hepatitis C genotype 1 and without cirrhosis using 100 mg VX-135 and 60 mg daclatasvir daily. Eight patients (73%) had undetectable HCV RNA after 4 weeks of therapy, and the same number demonstrated SVR4, the release said. While receiving the regimen, two patients experienced viral breakthrough; one patient relapsed during follow-up.

Vertex gained worldwide rights to the drug candidate from Alios BioPharma via an exclusive licensing agreement. It had been known as ALS-2200, according to the release.