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Division of Research findings contribute to change to national hepatitis C treatment guideline

Black patients being treated for hepatitis C can take 8 weeks of certain direct-acting antiviral drugs rather than the previous recommendation of 12 weeks, according to new practice guidelines from the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases.

The guidelines cite research from the Kaiser Permanente Division of Research (DOR) for the change in advice. DOR investigators published a March 2018 study in Clinical Gastroenterology and Hepatology that concluded there was no difference in effectiveness of the combination therapy of ledipasvir and sofosbuvir whether they were taken for 8 or 12 weeks by black patients.

Michael Silverberg, PhD, MPH, investigator with Kaiser Permanente Northern California Division of Research

DOR investigator Michael Silverberg, PhD, MPH, senior author on the 2018 study, said it was “exciting” that the work had a direct influence on national practice guidelines, which had previously singled out black patients for a longer regimen of hepatitis C drugs based on prior research. “This is especially gratifying since the study was motivated by clinicians at Kaiser Permanente Northern California, who had long suspected that the prior race-specific guidance was outdated since they were based on older data.”

The shorter regimen has multiple benefits, including being easier to complete and less expensive, said Julia Marcus, PhD, MPH, who was a DOR investigator in 2018 and lead author on the study. Marcus, who is currently a researcher with Harvard Pilgrim Health Care Institute, commented on Twitter Nov. 8 that she was “thrilled” the medical groups had removed race-based treatment criteria from their hepatitis C guidelines. “Race-based medicine can result in misdiagnosis, undertreatment, and overtreatment of black patients,” she wrote.

Julia Marcus, PhD, MPH, former Division of Research investigator, now assistant professor of population medicine at Harvard Medical School. Photo courtesy Harvard Medical School.

Marcus added that the health system also benefits from a shorter drug regimen that is just as effective. “For every HCV patient treated for 8 instead of 12 weeks, the health care system saves $31,500 on the meds alone, increasing the overall number of patients who can be treated,” Marcus wrote in a series of tweets.

Marcus further explained the work in a question-and-answer article on the Harvard Medical School Department of Population Medicine website.

The original DOR study was funded by a Delivery Science Research grant from The Permanente Medical Group and involved close collaboration with DOR scientists and members of the Kaiser Permanente Northern California HCV task force, which included Silverberg and Marcus, along with Leo B. Hurley, MPH, Scott Chamberland, PharmD, Jamila H. Champsi, MD, Laura C. Gittleman, RN, MBA, Daniel G. Korn, MD, Jennifer B. Lai, MSc, PharmD, Jennifer O. Lam, PhD, MPH, Mary Patricia Pauly, MD, Charles P. Quesenberry, Jr., PhD, Joanna Ready, MD, Varun Saxena, MD, Suk Seo, MD, and David J. Witt, MD.

 

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