The clinical efficacy of direct-acting-antivirals (DAAs) has been demonstrated in various late-stage clinical trials and in real-life studies following their approval. The sustained viral response at 12-weeks post treatment completion (SVR12) for the routinely used DAA regimens exceeds 90% in the majority of patients. However, not much is known about the outcome of treatment from the patient’s perspective and the change in life quality after treatment.
Importantly, expanding access to expensive DAA treatments allows some non-cirrhotic patients with hepatitis C infections to receive treatment. These patients typically do not experience physical limitations in their daily activities due to the chronic infection and the level of medical necessity of treatment might therefore be questioned. However, a study presented at the European Association for the Study of the Liver (EASL) conference in Amsterdam surprisingly indicates that the patient-reported outcome (PRO) is equally positive in non-cirrhotic and cirrhotic individuals.
In the study conducted by the group of Prof. Younossi, 1,908 enrolled participants from the POLARIS-1, 2, 3, and 4 studies were included, of which 718 had compensated cirrhosis and 1,190 had no liver cirrhosis. Patients were divided into three arms and either received sofosbuvir with velpatasvir (S/V) (N=700), sofosbuvir with velpatasvir and voxilaprevir (S/V/V) (N=1,056), or a placebo (N=152).
The researchers used a PRO-scale ranging from 0 to 100 and the baseline PRO-scale for non-cirrhotic HCV patients was 70, while patients with compensated cirrhosis had a slightly lower apparent quality of life at a score of 63. After treatment, cirrhotic patients overall gained nine points on the PRO-scale, while non-cirrhotic patients gained seven points; patients who received a placebo had an unchanged PRO score. No significant difference in the PRO-scale improvement was observed between patients receiving S/V or S/V/V.
Positive changes in life quality were based on both physiological and psychological factors, but instances of improved emotional well-being and reduced anxiety dominated the analysis. Surprisingly, even non-cirrhotic patients significantly improved in physiological parameters, including vitality and overall physical activity, and these changes were comparable to those observed in cirrhotics. Hence, these results indicate that even patients not experiencing symptoms caused by hepatitis C show significant improvement in overall well-being, arguing for increased access to DAA treatment for this patient population.
However, not all data were promising for Gilead’s products in this study. From a clinical perspective, S/V, marketed by Gilead as Epclusa, and S/V/V, Gilead’s late-stage DAA pipeline combination, resulted in the same SVR12 rates of 94.3%. While strong overall efficacy was demonstrated, this lack of improvement in SVR12 rates between these two products might also translate into limited uptake of S/V/V after the expected launch in the US later this year.
Although these data imply treating and curing hepatitis C positively impacts the quality of life of non-cirrhotic patients, GlobalData anticipates that the restricted access to DAA treatments will only slowly change, and any broadening of treatment access will be mostly driven by reduced patient populations and lowered costs.