Merck Says Zepatier Yields High HCV Cure Rates in US Veterans Study

Veterans had undetectable HCV RNA 12 weeks after treatment with the DAA.

Merck & Co.’s hepatitis C drug combining elbasvir and grazoprevir (Zepatier) achieved high cure rates among patients treated in the US Department of Veterans Affairs health system, the pharmaceutical giant announced on April 21.

The Kenilworth, NJ-based company said 95.6% of the 2436 veterans with chronic hepatitis C virus (HCV) whose records were studied achieved sustained virologic response (SVR). That result meant they had undetectable RNA at least 12 weeks after a once-a-day therapy with the direct-acting antiviral (DAA) medication.

“US veterans are 3 times more likely to have chronic hepatitis C compared to the general US population,’’ said Jennifer Kramer, an investigator at the Michael E. DeBakey VA Medical Center in Houston and an assistant professor of medicine at Baylor College of Medicine in a news release. “A high proportion suffer co-morbid conditions that can make treatment challenging. This study shows that chronic hepatitis C antiviral treatment can result in a high rate of sustained virologic response in US veterans.”

Military Times, which covers news relevant to service members, reported last year that an estimated 200,000 veterans have the liver-attacking HCV. Some 174,000 of them are enrolled in the VA health system. Globally, 350,000 to 500,000 patients die each year from HCV-related liver diseases, the World Health Organization estimates.

The patients in the study who had chronic HCV were identified from the VA Corporate Data Warehouse, a national repository of the department’s electronic medical records. The veterans had been treated with Zepatier from February 1 to August 1, 2016. They began the therapy at at least 18 years of age, had positive HCV RNA, and had undergone at least 1 inpatient or outpatient visit within a year before starting the medication.

“Analysis of data from real-world medical settings can provide useful insights to supplement knowledge gained from randomized clinical trials,” said Susan Shiff, senior vice president at Merck’s center for observational and real-world evidence. “These data from a real-world VA setting add to the body of evidence on Zepatier and help deepen scientific understanding of the treatment of this complex disease affecting diverse, sometimes difficult to treat, patient populations.”

The VA announced in March 2016 that it was able to fund care for all veterans with HCV during that fiscal year regardless of the stage of the disease. The move followed increased funding from Congress along with reduced drug prices, the VA said. The department allocated $696 million for new HCV drugs in fiscal 2015, or 17% of its total pharmacy budget. It planned to spend approximately $1 billion in the 2016 fiscal year.

Merck said limitations to the study include the possibility that the VA population is not generalizable to the entire US population because of differing demographic make-up and/or risk factors. In addition, the analysis used prescription records to identify treatment completion, which may not reflect patients’ adherence to their regimens. Further, database analyses are prone to errors in coding and missing data, the company said.

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