An 8-week regimen of ledipasvir/sofosbuvir may be as effective as 12 weeks, according to a new study focusing on treatment for black patients.
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 infected with hepatitis C, 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 8 weeks. However, prior studies did not compare the effectiveness of 8 and 12 weeks of the medication in black patients otherwise eligible for the 8-week regimen. We compared the effectiveness of 8-week and 12-week regimens among patients eligible to receive 8 weeks of ledipasvir/sofosbuvir,” lead author Julia Marcus, PhD, MPH, assistant professor of population medicine at Harvard Medical School, told Medical Economics.
The researchers published the results in Clinical Gastroenterology and Hepatology in March.
Marcus and colleagues conducted an observational study at Kaiser Permanente Northern California, a large integrated healthcare system, among members with HCV genotype 1 infection who were eligible for 8 weeks of treatment with ledipasvir and sofosbuvir (treatment-naïve, no cirrhosis, no HIV infection, level of HCV RNA <6 million IU/mL) and were treated for 8 or 12 weeks.
Of 2,653 patients eligible for 8 weeks of treatment with the combination, 1,958 (73.8 percent) received 8 weeks of treatment and 695 (26.2 percent) received 12 weeks; both groups achieved 96.3 percent sustained virologic response at 12 weeks.
The researchers found that ledipasvir/sofosbuvir for 8 and 12 weeks was more than 95 percent effective in most subgroups of patients who were eligible for 8 weeks of treatment. Among 435 black patients eligible for 8 weeks, there was no difference in treatment response between those treated for 8 and 12 weeks. “Black race was not associated with treatment failure regardless of treatment duration,” said Marcus. “We also found that 8-week regimens were underused, with 26 percent of those eligible for 8 weeks receiving 12 weeks of therapy.”
Receipt of 12 weeks varied across medical centers, but there was no relationship between these prescribing practices and the overall treatment effectiveness at each medical center. “Together, these findings imply that shorter courses should be strongly considered for all patients, including black patients who meet other eligibility criteria for 8 weeks of treatment,” said Marcus. “More widespread use of shorter courses could result in more patients being treated without reducing treatment effectiveness.”
There were several clinical characteristics that were associated with receiving 12 weeks of therapy, such as greater liver fibrosis and obesity, but none was associated with reduced effectiveness of 8-week courses. This means that 8-week courses could be more widely used in patients who meet eligibility criteria, she said.
“Our study suggests that clinicians should consider using 8-week courses of ledipasvir/sofosbuvir in black patients who are otherwise eligible for shorter courses of therapy. The results provide key evidence that shorter durations of ledipasvir/sofosbuvir are underused, and should be considered for all subgroups, including black patients, who are otherwise eligible for 8 weeks of treatment,” said Marcus.