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

Autor:	Marcus JL; Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts. Electronic address: julia_marcus@harvardpilgrim.org., Hurley LB; Kaiser Permanente Division of Research, Oakland, California., Chamberland S; Kaiser Permanente Northern California, Regional Pharmacy, Oakland, California., Champsi JH; Kaiser Permanente South San Francisco Medical Center, South San Francisco, California., Gittleman LC; Kaiser Permanente Northern California, Medical Group Support Services, Oakland, California., Korn DG; Kaiser Permanente Oakland Medical Center, Oakland, California., Lai JB; Kaiser Permanente San Rafael Medical Center, San Rafael, California., Lam JO; Kaiser Permanente Division of Research, Oakland, California., Pauly MP; Kaiser Permanente Sacramento Medical Center, Sacramento, California., Quesenberry CP Jr; Kaiser Permanente Division of Research, Oakland, California., Ready J; Kaiser Permanente Santa Clara Medical Center, Santa Clara, California., Saxena V; Kaiser Permanente South San Francisco Medical Center, South San Francisco, California., Seo SI; Kaiser Permanente Antioch Medical Center, Antioch, California; Kaiser Permanente Walnut Creek Medical Center, Walnut Creek, California., Witt DJ; Kaiser Permanente San Rafael Medical Center, San Rafael, California., Silverberg MJ; Kaiser Permanente Division of Research, Oakland, California.
Jazyk:	angličtina
Zdroj:	Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association [Clin Gastroenterol Hepatol] 2018 Jun; Vol. 16 (6), pp. 927-935. Date of Electronic Publication: 2018 Mar 11.
DOI:	10.1016/j.cgh.2018.03.003
Abstrakt:	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 χ 2 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. (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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