COMMENTARY

Hepatitis C: Let's Get 'Real'

Digestive Disease Week (DDW) 2016

William F. Balistreri, MD

Disclosures

June 24, 2016

In This Article

New Strategies

Combination of ABT-493 + ABT-530

The DAAs ABT-493 (an NS3/4A protease inhibitor) and ABT-530 (an NS5A inhibitor) demonstrate potent pangenotypic antiviral activity in vitro, with a high barrier to resistance and maintenance of activity against common resistance-associated variants. In clinical trials, ABT-493 + ABT-530 taken for 12 weeks was well tolerated and achieved SVR rates of 97%-100% in noncirrhotic patients with HCV genotype 1, 2, or 3 infection.

Studies presented at DDW 2016 extended these observations, reporting outcomes for other genotypes and following a shorter duration of therapy.

Poordad and colleagues[9] coadministered once-daily ABT-493 (300 mg) with ABT-530 (120 mg) for 8 weeks and reported that an SVR12 was achieved by 97% of genotype 1–infected patients and 98% of genotype 2–infected patients. There were no virologic failures regardless of the baseline viral load or prior treatment history.

HCV genotype 3 accounts for about 30% of all HCV infections worldwide and is now considered the genotype that is most difficult to cure.[10] In phase 2 studies, once-daily ABT-493 + ABT-530 for 12 weeks was well tolerated and achieved an SVR in 96% of treatment-naive, noncirrhotic genotype 3–infected patients, with no virologic failures. Muir and colleagues[10] documented high SVRs following the shorter treatment duration of 8 weeks in treatment-naive HCV genotype 3–infected patients without cirrhosis.

Gane and colleagues[11] evaluated the efficacy and safety of ABT-493 and ABT-530 coadministered for 12 weeks in noncirrhotic patients with HCV genotype 4, 5, or 6 infection. SVR4 was achieved by 100% of the patients.

In all of these studies, adverse events (AEs) were predominately mild in severity, with the most common being headache, diarrhea, and fatigue. No severe AEs or premature discontinuations due to AEs were reported. The combination of the next-generation DAAs, ABT-493, and ABT-530 was well tolerated and demonstrated high SVRs. These results establish the potent clinical pangenotypic activity of this ribavirin-free once-daily regimen.

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