The results of this study (UNITY-1) and another (UNITY-2) evaluating a 12-week oral combination of daclatasvir (an NS5A inhibitor), asunaprevir (an NS3 protease inhibitor), and beclabuvir (a nonnucleoside NS5B inhibitor) in patients with chronic hepatitis C virus (genotype 1) infection have been published in the same issue of JAMA. Both included treatment-naïve and treatment-experienced patients, and evaluated a 12-week duration of treatment. UNITY-1 included patients without cirrhosis, whereas UNITY-2 included those with compensated cirrhosis and evaluated the additional role of ribavirin.
Both studies reported high rates of sustained virological response 12 weeks post-treatment (SVR12); the lowest were seen in patients with genotype 1a infection who were treatment experienced (and who did not receive additional ribavirin in UNITY-2). As with other oral regimens, treatment with the triple drug combination was well tolerated, with few serious adverse events attributed to the antiviral regimens and few adverse events leading to treatment discontinuation (0.7%-1.9%).
The authors of a related editorial note that these studies “add to the armamentarium of all-oral IFN-free regimens that have revolutionized management of hepatitis C, not only for patients who are treatment naive with no significant liver disease but also for those who are treatment experienced and those with cirrhosis.” They note that the observed high SVR12 rates among the different patient groups are clinically important given that viral eradication has been shown to delay or decrease chance of decompensation of liver disease and also hepatocellular carcinoma.
They go on to discuss the challenges that remain, including access to and affordability of these therapies, improvement in quality of life, and cost-effectiveness.