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SVR12 demonstrated in 96% of treatment-naive HCV patients in early phase 3 trial results

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An all-oral, interferon-free, 12-week therapy achieved sustained virologic response in 96% of patients with chronic hepatitis C genotype 1, according to the first phase 3 study results released by drugmaker AbbVie.

The SAPPHIRE-I study analyzed 631 noncirrhotic, HCV genotype 1a and 1b treatment-naive patients in a global, multicenter, randomized, double blind, placebo-controlled trial to evaluate 12 weeks of therapy with twice-daily ABT-333 (250 mg) and ribavirin (weight-based), along with a fixed-dose combination of ABT-450 (150 mg) and ritonavir (100 mg) with ABT-267 (25 mg).

Of the 473 patients randomly assigned to the three direct-acting antiviral agents (3D), 455 (96%) achieved SVR12. Those with genotype 1b achieved SVR12 in 98% of cases (148 of 151), while patients with genotype 1a reached SVR12 in 95% of cases (307 of 322). Virologic breakthrough occurred in 1.7% of patients in the 3D arm, the release said.

After 12 weeks of treatment, placebo patients were switched to the 3D arm. Results were not yet available.

Therapy was discontinued because of adverse events in 0.6% of both the active and placebo arms. Adverse events included fatigue, headache and nausea, the release said.

“SAPPHIRE-I demonstrates that patients new to therapy with genotype 1 HCV achieved high rates of virologic response with AbbVie’s interferon-free, all-oral 3D regimen plus ribavirin, and the SVR rate is consistent with results from our phase 2 studies,” Scott Brun, MD, vice president of pharmaceutical development for AbbVie, said. “SAPPHIRE-I is the first of these [six] studies to report results and, based on the progress of our clinical program to date, we are on track for major regulatory submissions in the second quarter of 2014.”

Detailed results will be released in future scientific meetings and publications, the release said.

AbbVie also is in the midst of five related trials that include more than 2,300 HCV patients in two countries, according to the release.