Faldaprevir to Treat Patients with Hepatitis C

Chicago—Patients with genotype 1 hepatitis C who received faldaprevir plus pegylated interferon and ribavirin had an increase in sustained virologic response (SVR) after 12 and 24 weeks of treatment compared with a group that took pegylated interferon and ribavirin alone, according to a pooled analysis of 2 phase 3 trials.

Results were presented at DDW during a poster session titled Faldaprevir Plus Pegylated Interferon α-2a and Ribavirin in Treatment-Naïve Patients with Chronic Hepatitis C Genotype-1 Infection: A Pooled Analysis of Two Randomized, Double-Blind, Placebo-Controlled, Phase III Trials (STARTVerso1 and 2).

Faldaprevir, an oral protease inhibitor, is an investigational agent. Boehringer Ingelheim Pharmaceuticals, Inc., the manufacturer of faldaprevir, has submitted a new drug application with the FDA for the drug’s approval. The company expects an FDA approval decision by the fourth quarter of this year.

An estimated 3.2 million people in the United States have hepatitis C, according to the Centers for Disease Control and Prevention, although most people are unaware they have the disease and do not feel sick. Approximately 75% to 85% of people with hepatitis C develop a chronic infection.

This analysis examined STARTVerso^™ 1 and 2, which were multicenter, randomized, double-blind, placebo-controlled studies that included patients from North America, Europe, Japan, South Korea, and Taiwan.

Of the patients included in the studies, 264 received placebo plus pegylated interferon and ribavirin, 521 received 120 mg of faldaprevir plus pegylated interferon and ribavirin, and 524 received 240 mg of faldaprevir plus pegylated interferon and ribavirin. The groups were well-balanced: 56% were male, 71% were white, 40% lived in Europe, 40% lived in North America, and the mean age was 49 years.

The proportion of patients with SVR after 12 weeks was 73% in the 120 mg faldaprevir group, 72% in the 240 mg faldaprevir group, and 50% in the placebo group. Patients who received faldaprevir had a significant increase in SVR rates compared with placebo (P<.0001 for both comparisons).

Furthermore, 84% of patients who received faldaprevir had early treatment success, which the authors defined as a below limit of quantification at week 4 and a below limit of detection at week 8. Among patients in the faldaprevir group who achieved early treatment success, 83% had SVR after 12 weeks.

More patients in the faldaprevir groups had a treatment response compared with the placebo group. Most cases of virologic failure resulted from on-treatment breakthroughs or post-treatment relapses.

The authors also noted that faldaprevir plasma trough levels were not correlated with SVR rates after 12 weeks.

Within the groups, there were similar incidences of adverse events, serious adverse events, adverse events leading to discontinuation, and anemia. The proportion of patients who had adverse events leading to discontinuation was 4% in the placebo group, 5% in the 120 mg faldaprevir group, and 8% in the 240 mg faldaprevir group.

Serious adverse events were found in 6% of patients in the placebo group, 7% of patients in the 120 mg faldaprevir group, and 8% of patients in the 240 mg faldaprevir group. Moderate adverse events were found in 59%, 58%, and 63% of patients, respectively. The most common moderate adverse events were anemia, gastrointestinal disorders, and rash.