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Clin Gastroenterol Hepatol. 2018 Jun;16(6):927-935. doi: 10.1016/j.cgh.2018.03.003. Epub 2018 Mar 11.

No Difference in Effectiveness of 8 vs 12 Weeks of Ledipasvir and Sofosbuvir for Treatment of Hepatitis C in Black Patients.

Author information

1
Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts. Electronic address: julia_marcus@harvardpilgrim.org.
2
Kaiser Permanente Division of Research, Oakland, California.
3
Kaiser Permanente Northern California, Regional Pharmacy, Oakland, California.
4
Kaiser Permanente South San Francisco Medical Center, South San Francisco, California.
5
Kaiser Permanente Northern California, Medical Group Support Services, Oakland, California.
6
Kaiser Permanente Oakland Medical Center, Oakland, California.
7
Kaiser Permanente San Rafael Medical Center, San Rafael, California.
8
Kaiser Permanente Sacramento Medical Center, Sacramento, California.
9
Kaiser Permanente Santa Clara Medical Center, Santa Clara, California.
10
Kaiser Permanente Antioch Medical Center, Antioch, California; Kaiser Permanente Walnut Creek Medical Center, Walnut Creek, California.

Abstract

BACKGROUND & AIMS:

Treatment with the combination of ledipasvir and sofosbuvir for 12 weeks has been approved by the Food and Drug Administration for patients with genotype 1 hepatitis C virus (HCV) infection; some patients can be treated with an 8-week course. Guidelines recommend a 12-week treatment course for black patients, but studies have not compared the effectiveness of 8 vs 12 weeks in black patients who are otherwise eligible for an 8-week treatment regimen.

METHODS:

We conducted an observational study of Kaiser Permanente Northern California 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 from October 2014 through December 2016. We used χ2 analyses to compare sustained virologic response 12 weeks after the end of treatment (SVR12) among patients treated for 8 vs 12 weeks, and adjusted Poisson models to identify factors associated with receipt of 12 weeks of therapy among patients eligible for 8 weeks.

RESULTS:

Of 2653 patients eligible for 8 weeks of treatment with ledipasvir and sofosbuvir, 1958 (73.8%) received 8 weeks of treatment and 695 (26.2%) received 12 weeks; the proportions of patients with SVR12 were 96.3% and 96.3%, respectively (P = .94). Among 435 black patients eligible for the 8-week treatment regimen, there was no difference in the proportions who achieved an SVR12 following 8 vs 12 weeks' treatment (95.6% vs 95.8%; P = .90). Male sex, higher transient elastography or FIB-4 scores, higher INR and level of bilirubin, lower level of albumin, obesity, diabetes, and ≥15 alcohol drinks consumed/week were independently associated with receiving 12 weeks of treatment among patients eligible for the 8-week treatment regimen, but were not associated with reduced SVR12 after 8 weeks of treatment.

CONCLUSION:

In an observational study of patients who received ledipasvir and sofosbuvir treatment for HCV genotype 1 infection, we found that contrary to guidelines, 8-week and 12-week treatment regimens do not result in statistically significant differences in SVR12 in black patients. Patient characteristics were associated with receipt of 12-week regimens among patients eligible for 8 weeks, but were not associated with reduced SVR12 after 8 weeks. Shorter treatment courses might therefore be more widely used without compromising treatment effectiveness.

KEYWORDS:

Direct-acting Antiviral Agents; Effectiveness; Race; Sustained Virologic Response

PMID:
29535057
PMCID:
PMC5962408
DOI:
10.1016/j.cgh.2018.03.003
[Indexed for MEDLINE]
Free PMC Article

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