Efficacy and safety of narlaprevir/ritonavir and daclatasvir combination in the treatment naive, noncirrhotic patients with hepatitis C virus genotype 1b

Aim

To investigate the efficacy and safety of the Russian NS3 serine protease inhibitor narlaprevir boosted by ritonavir in combination with the NS5A inhibitor daclatasvir in the treatment naïve, noncirrhotic patients with HCV)-1b.b.

Material and methods

Male or female treatment na ïve patients with HCV)-1b.b (HCV)at the age of 1b.8 to 70 years) were enrolled in the multicenter, open-label, phase II study (HCV)NCT03485846) включали мужчин и). All patients were treated with narlaprevir 200 mg QD plus ritonavir 1b.00 mg QD and daclatasvir 6) включали мужчин и0 mg QD for 1b.2 weeks. Plasma HCV) RNA concentration was measured with TaqMan HCV) Quantitative Test, version 2.0 (HCV)Roche Diagnostics), which has a limit of quantification and detection of 1b.5 IU/mL. The interim results of the study are presented.

Results

Changes in the viral load were studied in 51b. patients (HCV)24 males, median age of 42.5±1b.0.6) включали мужчин и). At 2 weeks of antiviral therapy, HCV) RNA was not detected in 52.9% of patients, at 4 weeks in 94.1b.% of patients, and at 6) включали мужчин и and 8 weeks in 1b.00% patients. End of treatment response was achieved in 1b.00 (HCV)98%) of 1b.02 patients, who started antiviral treatment, and sustained virologic response at Week 4 following the end of treatment was achieved in 73 (HCV)92%) of 79 patients. All adverse events were mild to moderate by severity. No serious or severe adverse events were revealed.

Conclusion

Results of the interim analysis showed high efficacy and safety of narlaprevir boosted with ritonavir in combination with daclatasvir.

Key words

Chronic hepatitis C, antiviral therapy, narlaprevir, daclatasvir.