Journal of the Formosan Medical Association (Aug 2022)

Ledipasvir/sofosbuvir for HCV genotype 1, 2, 4–6 infection: Real-world evidence from a nationwide registry in Taiwan

  • Ching-Chu Lo,
  • Chung-Feng Huang,
  • Pin-Nan Cheng,
  • Kuo-Chih Tseng,
  • Chi-Yi Chen,
  • Hsing-Tao Kuo,
  • Yi-Hsiang Huang,
  • Chi-Ming Tai,
  • Cheng-Yuan Peng,
  • Ming-Jong Bair,
  • Chien-Hung Chen,
  • Ming-Lun Yeh,
  • Chih-Lang Lin,
  • Chun-Yen Lin,
  • Pei-Lun Lee,
  • Lee-Won Chong,
  • Chao-Hung Hung,
  • Te Sheng Chang,
  • Jee-Fu Huang,
  • Chi-Chieh Yang,
  • Jui-Ting Hu,
  • Chih-Wen Lin,
  • Chun-Ting Chen,
  • Chia-Chi Wang,
  • Wei-Wen Su,
  • Tsai-Yuan Hsieh,
  • Chih-Lin Lin,
  • Wei-Lun Tsai,
  • Tzong-Hsi Lee,
  • Guei-Ying Chen,
  • Szu-Jen Wang,
  • Chun-Chao Chang,
  • Lein-Ray Mo,
  • Sheng-Shun Yang,
  • Wen-Chih Wu,
  • Chia-Sheng Huang,
  • Chou-Kwok Hsiung,
  • Chien-Neng Kao,
  • Pei-Chien Tsai,
  • Chen-Hua Liu,
  • Mei-Hsuan Lee,
  • Chun-Jen Liu,
  • Chia-Yen Dai,
  • Wan-Long Chuang,
  • Han-Chieh Lin,
  • Jia-Horng Kao,
  • Ming-Lung Yu

Journal volume & issue
Vol. 121, no. 8
pp. 1567 – 1578

Abstract

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Background/purpose: The Taiwan Association for the Study of the Liver (TASL) HCV Registry (TACR) is a nationwide registry of chronic hepatitis C patients in Taiwan. This study evaluated antiviral effectiveness of ledipasvir (LDV)/sofosbuvir (SOF) in patients in the TACR. Methods: Patients enrolled in TACR from 2017–2020 treated with LDV/SOF were eligible. The primary outcome was the proportion of patients with sustained virologic response 12 weeks after end of treatment (SVR12). Results: 5644 LDV/SOF ± ribavirin-treated patients were included (mean age: 61.4 years; 54.4% female). Dominant viral genotypes were GT1 (50.8%) and GT2 (39.3%). 1529 (27.1%) patients had liver cirrhosis, including 201 (3.6%) with liver decompensation; 686 (12.2%) had chronic kidney disease. SVR12 was achieved in 98.6% of the overall population and in 98.2% and 98.7% of patients with and without cirrhosis, respectively. SVR12 rates in patients with compensated cirrhosis treated with LDV/SOF without RBV were >98%, regardless of prior treatment experience. SVR12 was 98.6%, 98.4%, 100%, 100%, and 98.7% among those with GT1, GT2, GT4, GT5, and GT6 infections, respectively. Although patient numbers were relatively small, SVR12 rates of 100% were reported in patients infected with HCV GT2, GT5, and GT6 with decompensated cirrhosis and 98% in patients with severely compromised renal function. LDV/SOF adherence ≤60% (P < 0.001) was the most important factor associated with treatment failure. Incidence of adverse events was 15.8%, with fatigue being the most common. Conclusion: LDV/SOF is effective and well tolerated in routine clinical practice in Taiwan. Cure rates were high across patient populations.

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