Recently published data showed that treatment outcomes did not differ between 8 weeks and 12 weeks of Harvoni among black patients with hepatitis C, contrary to guideline recommendations.
Julia L. Marcus
“Our results suggest that clinicians should strongly consider using 8-week courses of ledipasvir/sofosbuvir in all patients, including black patients, who meet other eligibility criteria for shorter courses of therapy,” Julia L. Marcus, PhD, MPH, from Harvard Medical School and Harvard Pilgrim Health Care Institute, Massachusetts, told HCV Next.
Currently, FDA labelling for Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) and clinical guidelines recommend 12 weeks of treatment for genotype 1 among treatment-naive patients and state that an 8-week course can be considered in those who also have no cirrhosis, are not coinfected with HIV, and have HCV RNA less than 6 million IU/mL.
Recent guideline revisions specify that black patients should receive treatment with 8-week regimens of ledipasvir/sofosbuvir. According to Marcus and colleagues, however, the addition of race as a criterion for treatment duration is based on limited evidence.
The researchers reviewed the outcomes of patients treated with ledipasvir/sofosbuvir between October 2014 and December 2016 within Kaiser Permanente Northern California. Of the 2,653 patients included in the study, 73.8% received 8 weeks of therapy, 26.2% received 12 weeks of therapy, 57.9% were white, and 17.3% were black. All patients were eligible for an 8-week course except for the recommended limitation for black patients.
Overall sustained virologic response was 96.3% for both 8 weeks and 12 weeks. Among black patients, SVR rates were not significantly different between 8 weeks and 12 weeks (95.6% vs. 95.8%). Similarly, the researchers observed no difference after adjusting for race and age.
“The benefits of shorter courses of treatment are reduced costs for both patients and health care systems, especially given the high cost of these medications,” Marcus said. “Treating more patients with shorter courses allows for a greater number of patients to be treated overall.” – by Talitha Bennett
Disclosure: Marcus reports she received research grant support from Merck. Please see the full study for the other authors’ relevant financial disclosures.