Hepatology Xagena

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HCV genotype 3 patients: efficacy of an investigational oral combination based on ABT-493 and ABT-530

A hepatitis C ( HCV ) drug currently under investigation, ABT-493 and ABT-530, which is an all-oral once-daily antiviral treatment, helped HCV genotype 3 patients with heavily scarred livers and no previous treatment history to achieve a 100% sustained virologic response after receiving the treatment for 12 weeks ( SVR12 ).
Additional data from this study have shown that 97% of patients with the same HCV genotype, but without scarred livers, achieved SVR12 after eight weeks on the same treatment without Ribavirin ( RBV ).

As treatments for HCV have evolved, genotype 3 patients have become the most difficult subgroup of patients to cure. Although there have been recent advances in direct-acting antiviral therapies for HCV genotype 1, genotype 3 remains a challenge and is a highly prevalent strain of the infection globally, with a particularly high concentration of cases in Asia.

The current standard of care for HCV genotype 3 is the nucleotide polymerase inhibitor Sofosbuvir ( Sovaldi ) with weight-based RBV for 24 weeks.
This recommendation comes from the Valence study where high SVR rates were seen in those who had no previous HCV treatment history, without or with scarring of the liver, known as cirrhosis ( 93% and 92%, respectively ). However, treatment-experienced genotype 3 cirrhotic patients experienced a lower SVR rate of 60%.

In the international phase 2 clinical trial, two study arms enrolled 24 cirrhotic patients each, none who had previously been treated for HCV infection.
In the two patient groups taking the investigational combination treatment ABT-493 and ABT-530 with and without once-daily Ribavirin, all achieved SVR12 after 12 weeks on treatment. No patient discontinued the study or experienced virologic failure.

In another trial treatment arm that focused on non-cirrhotic patients, 29 genotype 3-infected patients were enrolled. SVR12 was achieved by 97% ( 28/29 ) of patients with no patient experiencing virologic failure.

The most common side effects were the same across both studies, including headache, and fatigue. ( Xagena )

Source: The International Liver Congress, 2016