Community‐based real‐world treatment outcomes of sofosbuvir/ledipasvir in Asians with chronic hepatitis C virus genotype 6 in the United States

Journal of Viral Hepatitis - Tập 24 Số 1 - Trang 17-21 - 2017
Robert J. Wong1, Mai Thanh Thi Nguyen2, Huy N. Trinh3, Andrew Huynh2, M. T. Ly2, Huy Nguyen3, Khanh K. Nguyen3, J.C. Yang3, Ruel T. Garcia3, Brian S. Levitt3, Eduardo Silveira3, Robert G. Gish4,5
1Division of Gastroenterology and Hepatology Alameda Health System – Highland Hospital Oakland CA USA
2Silicon Valley Research Institute, San Jose, CA, USA
3San Jose Gastroenterology, San Jose, CA, USA
4Division of Gastroenterology and Hepatology, Stanford Health Care, Stanford, CA, USA
5National Viral Hepatitis Roundtable, San Francisco, CA, USA

Tóm tắt

Summary

Sofosbuvir/ledipasvir (SOF/LDV) is the first all‐oral ribavirin‐free treatment approved for chronic hepatitis C virus (HCV) genotype 6, offering a safe and highly efficacious treatment option. Large studies evaluating real‐world outcomes of this regimen are lacking. We aim to evaluate real‐world treatment outcomes for HCV genotype 6. A retrospective cohort study evaluated 65 adults (age ≥18) with chronic HCV genotype 6 treated with SOF/LDV without ribavirin at a community gastroenterology clinic in the United States from November 2014 to May 2016. Rates of undetectable virus at week 4 on treatment, at end of treatment (EOT) and SVR12 were stratified by the presence of cirrhosis and prior treatment (treatment naïve vs treatment experienced). Among 65 patients with chronic HCV genotype 6 treated with SOF/LDV (52.3% male, mean age 66.3 years [SD 9.7], 41.5% cirrhosis and 15.4% treatment experienced), 97.3% had undetectable virus at week 4 on treatment, 96.9% had undetectable virus at EOT and 95.3% achieved SVR12. SVR12 was 100% in females vs 91.2% in males, P=.096, and 92.3% in patients with cirrhosis vs 97.4% in those without cirrhosis, P=.347. Resistance testing of treatment failures was attempted but unsuccessful due to lack of conforming primers to define the possible resistance mutations. Among the largest U.S. community‐based real‐world cohort of Asian chronic HCV genotype 6 patients treated with all‐oral SOF/LDV without ribavirin, SVR12 was similar to SVR12 reported in clinical trials, confirming the safety and effectiveness of this regimen and validating current HCV genotype 6 treatment guideline recommendations.

Từ khóa


Tài liệu tham khảo

10.1002/hep.27259

10.1016/j.jhep.2014.07.027

10.1002/hep.26218

10.1053/j.gastro.2014.11.039

10.1002/hep.26986

10.1001/jama.2014.7085

10.1001/jamainternmed.2015.6011

10.1002/hep.27736

10.1002/hep.23889

10.1016/j.jhep.2011.12.020

10.1056/NEJMoa1214853

AASLD‐IDSA.Recommendations for testing m and treating hepatitis C.2016.www.hcvguidelines.org. Accessed June 10 2016.

10.1053/j.gastro.2015.07.063

10.7326/M15-0785