Non-cirrhotic, treatment-naïve patients with hepatitis C virus (HCV) who were treated with a combination of three investigational drugs achieved a more than 99% sustained virologic response (SVR) rate, findings from the PEARL-III study indicate.
The combination therapy was equally effective when administered with or without ribavirin, according to study researcher K. Rajender Reddy, MD, of the University of Pennsylvania in Philadelphia. He presented the findings at the 2014 Conference on Retroviruses and Opportunistic Infections.
The HCV treatment regimen, dubbed the “three-D,” consists of three novel direct-acting agents — ABT-450/r, an HCV protease inhibitor boosted with ritonavir 100 mg (Norvir); the NS5A inhibitor ABT-267; and the non-nucleoside NS5B inhibitor ABT-333.
Reddy and colleagues analyzed the drug combination’s safety and efficacy among 419 patients with HCV genotype 1b.
The study’s primary endpoint was non-inferiority of SVR 12 weeks after the end of treatment (SVR12) among patients assigned to the three-D regimen compared with a similar historical cohort previously treated with telaprevir (Incivek) and pegylated interferon-alfa plus ribavirin.
A secondary endpoint also assessed was non-inferiority of the three-D regimen without and without ribavirin.
At least 99% of patients in both study arms achieved SVR12 (99.5% with ribavirin and 99% without), the researchers found. This was substantially non-inferior to the 73% SVR12 achieved among patients on the telaprevir-based regimen.
Adding ribavirin to the three-D regimen did not provide any added clinical benefit. Researchers observed high-SVR rates across various types of patient characteristics, including male gender, black race and those with IL28B non-CC HCV genotypes.
There were no documented relapses that occurred within 12 weeks post-treatment. Additionally, no on-treatment virologic failures occurred in the treatment arm without ribavirin and only one virologic failure occurred in a patient assigned treatment with ribavirin.
The most common adverse events were headache, fatigue, pruritus, nausea and asthenia. Anemia was most common in patients assigned treatment plus ribavirin.
“Results from PEARL-III are encouraging, as they demonstrate [the three-D] regimen can achieve high rates of sustained virologic response, with and without ribavirin across several patient characteristics in those with genotype 1b chronic hepatitis C infection,” Peter Ferenci, MD, professor of gastroenterology and hepatology at the Medical University of Vienna said in a press release.