Eight versus 12 week course of treatment studied

Boston, MA – A study by the Harvard Pilgrim Health Care Institute found that contrary to current hepatitis C treatment guidelines, an eight-week treatment regimen may be just as effective as 12 weeks in black patients. 

The new study of more than 2,600 patients in Kaiser Permanente’s Northern California region also showed that more people overall could take advantage of the shorter treatment duration, which has important implications for access given the medication’s high cost. The study, “No Difference in Effectiveness of 8 vs 12 Weeks of Ledipasvir and Sofosbuvir for Treatment of Hepatitis C in Black Patients,” appears in Clinical Gastroenterology and Hepatology, published online on March 12, 2018.

“Our findings do not support current hepatitis C treatment guidelines that recommend against the use of a shorter course of treatment in black patients,” said lead author Julia L. Marcus, PhD, MPH, Assistant Professor of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. 
Hepatitis C can now be cured with highly effective, direct-acting antiviral agents. The most common type of hepatitis C infection in the United States can be treated with a combination of ledipasvir and sofosbuvir for 12 weeks.

Current hepatitis C treatment guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America recommend a 12-week course of ledipasvir/sofosbuvir for black patients, even if they meet clinical eligibility criteria for a shorter 8-week regimen. These guidelines were based on studies suggesting that treatment may be less effective for black patients treated for eight weeks. However, prior studies did not compare the effectiveness of eight and 12 weeks of the medication in black patients otherwise eligible for the eight-week regimen. In the new study, researchers compared the effectiveness of  eight and 12-week regimens among patients eligible to receive eight weeks of ledipasvir/sofosbuvir within Kaiser Permanente Northern California, a large integrated healthcare system. 

The study found that the effectiveness of eight or 12-week regimens of ledipasvir/sofosbuvir was over 95% in most subgroups evaluated, including black patients. 

“We found that treatment was equally effective for black patients who were treated for eight and 12 weeks,” said senior author Michael J. Silverberg, PhD, MPH, of the Kaiser Permanente Division of Research. “The eight-week regimen was also generally underused for all patients, with 26 percent of those eligible for eight weeks receiving 12 weeks of therapy.” 

The study authors suggest that shorter courses of hepatitis C treatment should be considered for all patients, including black patients, who meet other eligibility criteria for eight-week regimens, and that the more widespread use of shorter courses can benefit patients, providers, and healthcare systems.

About Harvard Pilgrim Health Care Institute's Department of Population Medicine
The Harvard Pilgrim Health Care Institute's Department of Population Medicine is a unique collaboration between Harvard Pilgrim Health Care and Harvard Medical School.  Created in 1992, it is the only appointing medical school department in the United States based in a health plan.  The Institute focuses on improving health care delivery and population health through innovative research and teaching.


Harvard Pilgrim Health Care
Joan Fallon