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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.

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Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts. Electronic address:
Kaiser Permanente Division of Research, Oakland, California.
Kaiser Permanente Northern California, Regional Pharmacy, Oakland, California.
Kaiser Permanente South San Francisco Medical Center, South San Francisco, California.
Kaiser Permanente Northern California, Medical Group Support Services, Oakland, California.
Kaiser Permanente Oakland Medical Center, Oakland, California.
Kaiser Permanente San Rafael Medical Center, San Rafael, California.
Kaiser Permanente Sacramento Medical Center, Sacramento, California.
Kaiser Permanente Santa Clara Medical Center, Santa Clara, California.
Kaiser Permanente Antioch Medical Center, Antioch, California; Kaiser Permanente Walnut Creek Medical Center, Walnut Creek, California.



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.


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.


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.


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.


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

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