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Oral antivirals, ribavirin efficacious in patients with HCV genotype 1
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A combination of protease inhibitor ABT-450 plus ritonavir, ribavirin, nonnucleoside polymerase inhibitor ABT-333, and NS5A inhibitor ABT-267 effectively treated patients with hepatitis C virus who were prior-treatment nonresponders or previously had never been treated.
The study, a phase 2b open-label trial conducted between October 2011 and April 2012, comprised 571 patients aged 18 to 70 years with chronic HCV genotype 1 infection who did not have cirrhosis. Of these patients, 438 had never been treated and 133 were nonresponders. All patients received at least one dose of a study drug.
For 8, 12, or 24 weeks the patients were randomly assigned ABT-450 and ritonavir plus ABT-267 or ABT-333 in one of 14 treatment subgroups. Patients in 13 of the groups also received ribavirin. ABT-333 (400 mg twice daily) and ABT-267 (25 mg once daily) doses were consistent throughout. Patients weighing 75 kg or more received 1,200 mg ribavirin (600 mg twice daily); those weighing less than 75 kg received 1,000 mg ribavirin daily (400 mg and 600 mg). The ritonavir dose was 100 mg, but ABT-450 dose varied by subgroup: 200 mg, 150 mg, or 100 mg.
Patients were divided into two cohorts: nine subgroups of previously untreated patients and five subgroups of prior-treated patients.
The study’s primary efficacy endpoint was sustained virologic response (SVR; ie, an HCV RNA level <25 IU/mL) at 24 weeks posttreatment. Among patients who received three direct-acting antivirals and ribavirin, SVR at 24 weeks was 88% and 95% after 12 weeks. All subgroups displayed SVR ranging from 83% to 100%.
Eight patients discontinued therapy because of adverse events, including fatigue, headache, insomnia and nausea.
“These preliminary data suggest that a 12-week regimen of three direct-acting agents plus ribavirin is efficacious in patients without cirrhosis who either had not received treatment previously or had not had a response to prior therapy,” the researchers concluded.
Disclosure: See the study for a full list of relevant financial disclosures.