Experimental Oral HCV Drugs Effective in Hard-to-Treat Patients

Patients with HCV genotype 3 without scarred livers achieved SVR after 8 weeks.

Hepatitis C virus (HCV) genotype 3 patients with cirrhosis and no prior treatment history were able to achieve 100% sustained virologic response (SVR) after receiving the experimental oral drugs ABT-493 and ABT-530 for 12 weeks.

Data presented at The International Liver Congress in Barcelona showed 97% of HCV genotype 3 patients without scarred livers achieved SVR after 8 weeks using the same treatment without ribavirin (RBV).

The current standard care is the nucleotide polymerase inhibitor sofosbuvir (Sovaldi) with weight-based RBV for 24 weeks. This came from the Valence study, which showed high SVR rates in patients with no prior HCV treatment, with or without cirrhosis (93% and 92%, respectively).

However, cirrhotic HCV genotype 3 patients experienced a lower SVR rate of 60%.

“We are pleased to see the efficacy of this two direct-acting antiviral investigational, pan-genotypic regimen has been validated for treatment-naïve Hepatitis C genotype 3 patients -- with 100% of cirrhotic patients treated for 12 weeks and 97% of non-cirrhotic patients treated for 8 weeks achieving sustained virologic response at 12 weeks post treatment,” said lead study author Paul Kwo. “Clinical trials are ongoing to evaluate the safety and efficacy of the investigational treatment, and we are now focusing on a larger cohort of HCV genotype 3 patients, including treatment-experienced patients.”

In the international phase 2 clinical trial, 2 study arms enrolled 24 cirrhotic patients each, who had no prior HCV treatment.

Each patient in the 2 groups who took the combinational treatment ABT-493 and ABT-530 with or without once daily RBV achieved SVR12 with no discontinuation of treatment.

Another trial treatment arm enrolled 29 non-cirrhotic HCV genotype 3 patients. None of the patients experienced virologic failure, with SVR12 achieved by 97% of patients.

Common side effects in both studies were headache and fatigue.

“These data mark another step forward in continued research efforts to address the unmet medical need among HCV patients,” said Frank Tacke, EASL Governing Board member. “We will be watching with close interest to see whether similar efficacy levels can be achieved for treatment-experienced genotype 3 HCV patients — a group known for being hard to cure.”