High Cure Rates Reported With Hepatitis C Combination Regimen

Ribavirin-free treatment succeeds in phase 2 studies

After eight weeks of treatment, 97% to 98% of genotype 1 to 3 (GT1–3) chronic hepatitis C virus (HCV)-infected patients without cirrhosis treated with an investigational, once-daily, ribavirin (RBV)-free, pan-genotypic regimen of ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor (AbbVie), achieved a sustained virological response at 12 weeks post-treatment (SVR12). The results for GT1 (33/34), GT2 (53/54), and treatment-naïve GT3 (28/29) patients were based on an intention-to-treat (ITT) analysis. In addition, 100% (34/34) of GT4–6 chronic HCV-infected patients without cirrhosis achieved SVR12 after 12 weeks of treatment. The new data––from the SURVEYOR-1 and SURVEYOR-2 studies––will be presented at the International Liver Congress 2016 in Barcelona, Spain.

In a separate late-breaking report from the SURVEYOR-2 study, 100% of GT3 chronic HCV-infected patients with compensated cirrhosis (Child-Pugh A) new to therapy achieved SVR12 after 12 weeks of treatment both with and without RBV (24/24 in each arm). No patients discontinued treatment because of adverse events.

SURVEYOR-1 is an ongoing phase 2, two-part study designed to evaluate the safety and efficacy of treatment with ABT-493 and ABT-530, with and without RBV, for eight to 12 weeks in cirrhotic and noncirrhotic adult GT1 patients, and in noncirrhotic adult patients with GT4, 5, or 6 chronic HCV infection who were new to therapy or did not respond to previous treatment with pegylated interferon (pegIFN)/RBV (null responders).

SURVEYOR-2 is an ongoing phase 2, four-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with or without RBV, in adult patients with GT2, 3, 4, 5, or 6 chronic HCV infection who were new to therapy or had failed previous treatment with pegIFN/RBV.

The primary endpoint of both studies is the percentage of subjects achieving SVR12.

A pooled safety analysis was conducted in 531 patients across both SURVEYOR studies. Twenty-six percent had GT1 infection; 24% had GT2 infection; 43% had GT3 infection; and 6% had GT4, 5, or 6 infection. Patients across genotypes received ABT-493/ABT-530 at five doses: 300/120 mg (n = 258); 300/120 mg with RBV (n = 27); 200/120 mg (n = 121); 200/120 mg with RBV (n = 56); and 200/40 mg (n = 69).

The most commonly reported adverse events were fatigue (18%), headache (17%), nausea (13%), and diarrhea (10%). Three patients across all study arms (two of whom received RBV) discontinued the study drugs early because of adverse events.

Source: AbbVie; April 16, 2016.