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Hepatol Commun. 2018 Aug 06;2(8):884-892. doi: 10.1002/hep4.1206. eCollection 2018 Aug.

Liver Fibrosis Is Associated With Corrected QT Prolongation During Ledipasvir/Sofosbuvir Treatment for Patients With Chronic Hepatitis C.

Hepatology communications

Yuki Tahata, Ryotaro Sakamori, Ayako Urabe, Naoki Morishita, Ryoko Yamada, Takayuki Yakushijin, Naoki Hiramatsu, Yoshinori Doi, Akira Kaneko, Hideki Hagiwara, Yukinori Yamada, Taizo Hijioka, Masami Inada, Shinji Tamura, Yasuharu Imai, Kunimaro Furuta, Takahiro Kodama, Hayato Hikita, Tomohide Tatsumi, Tetsuo Takehara

Affiliations

  1. Department of Gastroenterology and Hepatology Osaka University Graduate School of Medicine Suita Japan.
  2. Otemae Hospital Osaka Japan.
  3. NTT West Osaka Hospital Osaka Japan.
  4. Kansai Rosai Hospital Amagasaki Japan.
  5. Kaizuka City Hospital Kaizuka Japan.
  6. National Hospital Organization Osaka Minami Medical Center Kawachinagano Japan.
  7. Toyonaka Municipal Hospital Toyonaka Japan.
  8. Minoh City Hospital Minoh Japan.
  9. Ikeda Municipal Hospital Ikeda Japan.

PMID: 30094400 PMCID: PMC6078212 DOI: 10.1002/hep4.1206

Abstract

Combination treatment of ledipasvir and sofosbuvir (LDV/SOF) is first-line treatment for patients with chronic hepatitis C genotype 1 in the United States, Europe, and Japan. However, the influence of LDV/SOF on the cardiovascular system is poorly characterized. A total of 470 chronic hepatitis C patients who started LDV/SOF treatment between September 2015 and February 2016 at nine hospitals in Japan were prospectively enrolled in this study. Corrected QT (QTc) prolongation was defined as a QTc interval ≥450 milliseconds. The sustained virologic response rate was 96.0% (451/470), and the discontinuance rate due to adverse effects was 0.9% (4/470). Among 395 patients whose electrocardiogram was evaluated over time and compared with baseline, the QTc interval was significantly prolonged during treatment and returned to baseline levels 12 weeks after the end of treatment. Twenty-four of 376 patients with baseline QTc intervals <450 milliseconds experienced on-treatment QTc prolongation. Higher aspartate aminotransferase-to-platelet ratio index scores (≥0.76; odds ratio, 4.375;

References

  1. N Engl J Med. 2014 Apr 17;370(16):1483-93 - PubMed
  2. Circulation. 1978 Jun;57(6):1074-7 - PubMed
  3. Am J Cardiol. 1985 Oct 1;56(10):585-7 - PubMed
  4. Clin Pharmacokinet. 2016 Nov;55(11):1337-1351 - PubMed
  5. J Hepatol. 2006 May;44(5):994-1002 - PubMed
  6. Oncology. 2017;92 Suppl 1:3-9 - PubMed
  7. Hepatol Res. 2016 Feb;46(2):129-65 - PubMed
  8. Lancet Infect Dis. 2015 Jun;15(6):645-53 - PubMed
  9. Eur Heart J. 2000 Aug;21(15):1216-31 - PubMed
  10. Am Heart J. 1985 Feb;109(2):399-411 - PubMed
  11. Cardiovasc Toxicol. 2015 Apr;15(2):197-202 - PubMed
  12. N Engl J Med. 2004 Mar 4;350(10):1013-22 - PubMed
  13. N Engl J Med. 2014 May 15;370(20):1889-98 - PubMed
  14. Hepatology. 2003 Aug;38(2):518-26 - PubMed
  15. J Hepatol. 2016 Jul;65(1):146-181 - PubMed
  16. Diabetes Care. 2014 May;37(5):1454-61 - PubMed
  17. Hepatology. 2015 Sep;62(3):932-54 - PubMed
  18. Circulation. 1991 Jun;83(6):1888-94 - PubMed
  19. Am Heart J. 1996 Jun;131(6):1184-91 - PubMed
  20. Hepatology. 1996 Aug;24(2):289-93 - PubMed
  21. Am J Med. 2003 Dec 15;115(9):689-94 - PubMed
  22. Circulation. 1991 Sep;84(3):1136-44 - PubMed
  23. N Engl J Med. 2014 May 15;370(20):1879-88 - PubMed
  24. Hepatology. 1998 Jan;27(1):28-34 - PubMed
  25. J Hepatol. 2005 Oct;43(4):637-44 - PubMed
  26. J Hepatol. 2015 Jul;63(1):237-64 - PubMed
  27. JAMA. 1986 Dec 5;256(21):2985-7 - PubMed

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