Despite Guidelines, Shorter HCV Treatment Proven Effective for Black Patients

Julia Marcus, PhD, MPH

A new study confirms that 8 weeks of ledipasvir/sofosbuvir (Harvoni) treatment of hepatitis C virus (HCV) genotype 1 (GT1) infection without cirrhosis is as effective as 12 weeks in patients of different races and ethnicity, and challenges guidelines that recommend the shorter regimen for non-black patients.

Julia Marcus, PhD, MPH, Assistant Professor, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, and colleagues contrast their findings to a guideline which they charge is based on “limited evidence and could exacerbate observed racial/ethnic disparities in HCV treatment initiation.”

Marcus told MD Magazine that it was important for her group to specifically compare 8 and 12 weeks of ledipasvir/sofosbuvir (LDV/SOF) by race,"because current treatment guidelines recommend 12-week courses for black patients, even if they meet clinical eligibility criteria for an 8-week regimen.

The clinical guidelines from the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society for America (IDSA) were recently updated to include the race criterion, recommending the 8-week course of LDV/SOF for patients with HCV genotype 1a or 1b who are treatment-na&#1111;ve and without cirrhosis "who are non-black, HIV-uninfected, and whose HCV RNA level is <6 million IU/mL.”

The basis for the race criterion is questionable, Marcus said.

"These guidelines were based on studies suggesting that treatment may be less effective for black patients treated for 8 weeks, but 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,” Marcus said.

To examine the validity of the racial distinction in the recommendation, Marcus and colleagues conducted an observational study of approximately 2600 eligible patients with HCV GT1 in the Kaiser Permanente Northern California health system who were eligible for 8 weeks of treatment with LDV/SOF and received either 8 or 12 weeks of treatment from October 2014 through December 2016. This period is prior to the addition of the race criterion in the AASLD/IDSA treatment guidelines. Over half (57.9%) of patients were white and 17.3% were black.

Treatment effectiveness was determined by sustained virologic response (SVR) at least 12 weeks after the end of treatment. The SVR12 corresponded to an HCV RNA of less than 20 IU/ml, and treatment failure by HCV RNA more than 20 IU/ml.

"Among patients eligible to receive an 8-week regimen, we found no difference in treatment response between black patients treated for 8 and 12 weeks," Marcus told MD Magazine. "We also found that 8-week regimens were underused overall, with 1 in 4 patients who were eligible for the 8-week regimen treated with 12 weeks of therapy."

Finding that shorter durations of SDV/SOF are underutilized, Marcus encourages practitioners to consider the 8-week treatment for all subgroups, including black patients who are otherwise eligible.

"These medications are expensive for both patients and the healthcare system, so the use of shorter courses could result in more patients being treated and cured," Marcus said.

The study, "No Difference in Effectiveness of 8 vs 12 Weeks of Ledipasvir and Sofosbuvir for Treatment of Hepatitis C in Black Patients," was published online in Clinical Gastroenterology and Hepatology last month.