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J Hepatol. 2019 Jan;70(1):15-23. doi: 10.1016/j.jhep.2018.09.018. Epub 2018 Sep 26.

Real-world effectiveness of daclatasvir plus sofosbuvir and velpatasvir/sofosbuvir in hepatitis C genotype 2 and 3.

Author information

1
Department of Veterans Affairs, Population Health Services, Palo Alto Health Care System, Palo Alto, CA, USA.
2
Department of Veterans Affairs, Population Health Services, Palo Alto Health Care System, Palo Alto, CA, USA. Electronic address: Lisa.Backus@va.gov.

Abstract

BACKGROUND & AIM:

Understanding the real-world effectiveness of all-oral hepatitis C virus (HCV) regimens informs treatment decisions. We evaluated the effectiveness of daclatasvir + sofosbuvir ± ribavirin (DCV + SOF ± RBV) and velpatasvir/sofosbuvir (VEL/SOF) ± RBV in patients with genotype 2 and genotype 3 infection treated in routine practice.

METHODS:

This observational analysis was carried out in an intent-to-treat cohort of patients with HCV genotype 2 and genotype 3. Sustained virologic response (SVR) analysis was performed in 5,400 patients initiated on DCV + SOF ± RBV or VEL/SOF ± RBV at any Department of Veterans Affairs facility.

RESULTS:

For genotype 2, SVR rates did not differ between DCV + SOF (94.5%) and VEL/SOF (94.4%) or between DCV + SOF + RBV (88.1%) and VEL/SOF + RBV (89.5%). For genotype 3, SVR rates did not differ between DCV + SOF (90.8%) and VEL/SOF (92.0%) or between DCV + SOF + RBV (88.1%) and VEL/SOF + RBV (86.4%). In multivariate models of patients with genotype 2 and 3 infection, the treatment regimen was not a significant predictor of the odds of SVR. For genotype 3, significant predictors of reduced odds of SVR were prior HCV treatment-experience (odds ratio [OR] 0.51, 95% CI 0.36-0.72; p <0.001), FIB-4 >3.25 (OR 0.60; 95%CI 0.43-0.84; p = 0.002) and a history of decompensated liver disease (OR 0.68; 95%CI 0.47-0.98; p = 0.04). For patients with genotype 2 and 3, treated with VEL/SOF ± RBV, 89% and 85% received 12-weeks of treatment, respectively. For DCV + SOF ± RBV, 56% and 20% of patients with HCV genotype 2 received 12-weeks and 24-weeks of treatment, respectively; while 53% and 23% of patients with HCV genotype 3 received 12-weeks and 24-weeks, with most direct-acting antiviral experienced patients receiving 24-weeks.

CONCLUSIONS:

In patients infected with HCV genotype 2 and 3, DCV + SOF ± RBV and VEL/SOF ± RBV produced similar SVR rates within each genotype, and the regimen did not have a significant impact on the odds of SVR. For patients with genotype 3, prior treatment-experience and advanced liver disease were significant predictors of reduced odds of SVR regardless of regimen.

LAY SUMMARY:

In clinical practice, cure rates for hepatitis C virus (HCV) genotype 2 were 94% and cure rates for HCV genotype 3 were 90%. The chance of achieving cure was the same whether a person received daclatasvir plus sofosbuvir or velpatasvir/sofosbuvir. Ribavirin did not affect cure rates. The chance of a cure was lowest in people who had received HCV medication in the past.

KEYWORDS:

Daclatasvir; Hepatitis C; Sofosbuvir; Sustained virologic response; Velpatasvir

PMID:
30266283
DOI:
10.1016/j.jhep.2018.09.018

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