BOSTON – All but 1 of 51 patients who failed sofosbuvir-containing treatment regimens for hepatitis C achieved a sustained virologic response for 12 weeks after retreatment with ledipasvir and sofosbuvir plus ribavirin.
The study was supposed to include only patients with genotype 1 hepatitis C virus (HCV), but the one patient who failed retreatment turned out to have genotype 3a and had been enrolled in error, Dr. David L. Wyles said at the annual meeting of the American Association for the Study of Liver Diseases.
Among the 50 patients with genotype 1, retreatment achieved a sustained virologic response for 12 weeks (SVR12) in 100%, reported Dr. Wyles of the University of California, San Diego, and his associates.
The patients had failed to achieve SVR12 after prior treatment in clinical trials using sofosbuvir plus pegylated interferon and ribavirin (25 patients), sofosbuvir with or without ribavirin (21 patients), or sofosbuvir and placebo (5 patients).
The cohort had a mean age of 54 years, 31 patients were male (61%), 8 were African American (16%), and the mean body mass index was 30 kg/m2. Fifteen patients had cirrhosis (29%).
Genetic resistance analyses conducted before retreatment showed that no patients had the sofosbuvir-associated variant S282T, but two patients had the NS5B treatment-emergent variant L159F, and each of them achieved SVR12 after retreatment.
Adverse events were reported by 41 patients (80%) and serious adverse events by 2 patients (4%), including bipolar disorder, chest pain, anemia, and cholecystitis. The most common adverse events included fatigue in 13 patients (25%), headache in 11 (22%), diarrhea in 7 (14%), rash in 6 (12%), and insomnia or nausea in 5 patients each (10% each). Most adverse events were mild or moderate in severity.
Gilead funded the study. Dr. Wyles is a consultant for Gilead, AbbVie, and Bristol-Myers Squibb.