Sofosbuvir, velpatasvir, and voxilaprevir (SOF/VEL/VOX) is an effective and safe rescue therapy for patients with chronic hepatitis C virus (HCV) infection who did not respond to direct-acting antiviral (DAA) treatment despite the presence of resistance-associated substitutions, according to a prospective multicenter study published in the Journal of Hepatology.
Approximately 5% of patients with chronic HCV treated with DAAs do not achieve sustained virologic response (SVR). Although there is little data on its use in clinical practice, the currently approved treatment regimen for a prior lack of response to DAA is a combination of SOF/VEL/VOX. Thus, researchers evaluated the efficacy and safety of the fixed-dose combination of SOF/VEL/VOX for 12 weeks in 137 patients with chronic HCV of any genotype and with different degrees of liver fibrosis who had previously not responded to oral DAA therapy in a real-world setting. They found that 35% of patients had liver cirrhosis and most were infected with HCV genotype 1 or 3.
The most common prior DAA combinations were sofosbuvir plus an NS5A inhibitor or ombitasvir/paritaprevir/ritonavir plus dasabuvir, and 136 patients (99%) achieved undetectable HCV RNA at the end of treatment. Overall, SVR12 was 95% in the 135 patients who reached this point. The SVR12 was lower in patients with cirrhosis (89%, P =.05) and patients with HCV genotype 3 infection (80%, P <.001). In fact, patients with genotype 3 infection and cirrhosis had the lowest SVR12 rate (69%). The presence of resistance-associated substitutions did not appear to have an impact on SVR12 and adverse effects were mild and nonspecific.
“In conclusion, the real-world data obtained here support the notion that SOF/VEL/VOX
for 12 weeks is a safe, effective regimen for retreatment of HCV patients previously failing DAA therapy,” stated the investigators.
Llaneras J, Riveiro-Barciela M, Lens S, et al. Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs [published online June 8, 2019]. J Hepatol. doi:10.1016/j.jhep.2019.06.002