Real world observational study supports data on sustained hepatitis C virologic response rates.
Real-world study data show that patients with chronic hepatitis C virus (HCV) in the Department of Veterans Affairs (VA) health care system treated with elbasvir/grazoprevir (Zepatier) achieved high sustained virologic response rates.
Included in the retrospective database analysis were patients with chronic HCV treated with elbasvir/grazoprevir from February 1, 2016, to August 1, 2016, and who were identified from the VA Corporate Data Warehouse.
A total of 2436 patients were included in the analysis, with a mean age of 63.5 years. The investigators used ICD-9 and CPT codes recorded in the VA database to determine the prevalence of comorbidities. Comorbidities included cirrhosis, diabetes, depression, and HIV coinfection. More than half of the participants had a history of alcohol or drug abuse.
The study population consisted of 1988 previously untreated patients and 446 treatment-experienced patients. Of the treatment-experienced patients, 322 previously received an interferon-based regimen with or without an NS3/4A HCV protease inhibitor, and 126 received an interferon-free direct-acting antiviral regimen.
The primary outcome was sustained virologic response at 12 weeks (SVR12), according to a press release.
The results showed that 95.6% of veterans treated with elbasvir/grazoprevir achieved SVR12. For patients with no HCV RNA measurements at or after 12 weeks, the investigators used measurements available at least 4 and less than 12 weeks after the end of treatment.
“US veterans are 3 times more likely to have chronic hepatitis C compared to the general US population, and a high proportion suffer comorbid conditions that can make treatment challenging,” investigator Jennifer Kramer said in a press release. “This study shows that chronic hepatitis C antiviral treatment can result in a high rate of sustained virologic response in US veterans.”
Adverse event data were not collected as part of the real-world data analysis, according to the report.
“Analysis of data from real-world medical settings can provide useful insights to supplement knowledge gained from randomized clinical trials,” Susan Shiff, senior vice president, center for observational and real-world evidence at Merck, said in a release. “These data from a real-world VA setting add to the body of evidence on Zepatier (elbasvir/grazoprevir) and help deepen scientific understanding of the treatments of this complex disease affecting diverse, sometimes difficult to treat, patient populations.”
The findings will be presented at The International Liver Congress 2017 in Amsterdam.