High HCV Sustained Virologic Response Rates With Elbasvir/Grazoprevir in Real-World Setting
Real-world effectiveness of elbasvir/grazoprevir for HCV GT1 or GT4 is similar in the US Veterans Affairs-treated population as compared with those reported in clinical trials.
For patients with hepatitis C virus (HCV) infection, treatment with elbasvir/grazoprevir results in high rates of sustained virologic response (SVR) regardless of sex, race/ethnicity, cirrhosis, renal impairment, or HIV status, according to results published in the Journal of Viral Hepatitis.
The study included patients being treated in the US Department of Veterans Affairs health system with positive HCV RNA who initiated elbasvir/grazoprevir treatment between February to August 2016 (n=2436). The researchers calculated 95% CIs for binomial proportions for SVR overall and by demographic subgroups.
Sustained virologic response was defined as HCV RNA below the limit of quantification performed at least 12 weeks after the end of treatment. If HCV RNA data at ≥12 weeks was not available for a participants, the researchers defined SVR based on HCV RNA testing from week 4 to week 12 after the end of treatment.
Participant demographics were 96.5% male; 57.5% black; mean age, 63.5; and 95.4% infected with HCV genotype (GT)-1. Comorbidities included diabetes (53.2%), depression (57.2%), and HIV (3.0%). A total of 33.2% of participants had cirrhosis.
In total, 95.6% (n=2328) of participants achieved SVR. By subgroup, the SVR rates were: 95.5% for men (2245/2350); 96.5% for women (83/86); 93.4% for GT1a; 96.6% for GT1b; 96.9% for GT4; 95.9% for blacks (1342/1400); 96.3% for treatment-experienced (310/322); 95.6% for cirrhosis (732/766); 96.3% for stage VI/V chronic kidney disease (392/407); and 98.6% for patents coinfected with HIV (73/74).
"Our findings show that the real-world effectiveness of [elbasvir/grazoprevir] among HCV-infected GT1 or GT4 patients in the VA population is comparable to efficacy rates reported in clinical trials," the researchers wrote.
The research reported here was supported in part by funding by Merck & Co., Inc., Kenilworth, NJ. Please refer to original reference for comprehensive list of disclosures.
Kramer JR, Puenpatom A, Erickson K, et al. Real-world effectiveness of elbasvir/grazoprevir in HCV-infected patients in the US Veteran Affairs healthcare system [published online May 31, 2018]. J Viral Hepat. doi:10.1111/jvh.12937