Eight weeks of direct-acting antiviral (DAA) treatment was found to be just as effective as 12 weeks of treatment for patients—particularly black patients—with hepatitis C virus (HCV), according to a study by researchers at Kaiser Permanente Northern California Division of Research, Oakland, CA.
The finding suggests that an 8-week course of treatment could be used more widely in clinical practice, resulting in more patients having access to treatment without reducing its effectiveness, researchers noted in a recent article published in Clinical Gastroenterology and Hepatology.
“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, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.
Current 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 in black patients. The guidelines are based on prior studies indicating that 8 weeks of DAA therapy resulted in less effective treatment outcomes in black patients with genotype 1 HCV.
Comparable SVR rates
In this new study, which recruited participants from the Kaiser Permanente Northern California system, researchers compared the effectiveness of 8- and 12-week treatment regimens in 2,653 patients with HCV genotype 1 infection who were eligible for 8 weeks of ledipasvir/sofosbuvir treatment. To be eligible for the study, patients had to be treatment-naive, without cirrhosis or HIV infection, and have a viral load of less than 6 million IU/mL.
Of these patients, 1,958 (73.8%) received 8 weeks of treatment and 695 (26.2%) received 12 weeks. In both treatment arms, patients had an equivalent cure rate: 96.3% achieved sustained virologic response at 12 weeks (SVR12).
Among 435 black patients who were eligible for 8 weeks of ledipasvir/sofosbuvir treatment, SVR12 rates were comparable: 95.6% for patients on the 8-week course and 95.8% for those receiving the 12-week course.
“We found that treatment was equally effective for black patients who were treated for 8 and 12 weeks,” said senior author Michael J. Silverberg, PhD, MPH, Kaiser Permanente Division of Research.
More use of shorter treatment
“The 8-week regimen was also generally underused for all patients, with 26% of those eligible for 8 weeks receiving 12 weeks of therapy,” Dr. Silverberg added.
This finding suggests that among eligible HCV patients, more of them may be able to take advantage of the shorter, less costly 8-week treatment regimen.
“We have known for some time that a shorter treatment duration is effective, but these data highlight that we could offer this option to more patients,” said co-author David J. Witt, MD, Kaiser Permanente San Rafael Medical Center. “Given the high cost of these medications, more widespread use of shorter courses could result in more patients receiving treatment without compromising treatment effectiveness.”
Funding for this study was provided by the Kaiser Permanente Delivery Science Research Program and the National Institute of Allergy and Infectious Diseases.