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. 2017 Feb 24;142:83–122. doi: 10.1016/j.antiviral.2017.02.014

Table 11.

Efficacy of 90 mg ledipasvir + 400 mg sofosbuvir, QD for 12 weeks.

Cirrhosis Prior treatment SVR12 rate
Study and trial phase Ref.
GT-1 GT-3 GT-4 GT-5 GT-6
No cirrhosis
Naïve 94.7% (18/19) LONESTAR, phase 2 Lawitz et al., 2014b
Experienced 100% (8/8)
Naïve 1a:100% (11/11), 1b:100% (9/9) Phase 2a Kohli et al., 2015a
Naïve or experienced 92.9% (13/14) NIAID, phase 2a Kohli et al., 2015b
Naïve or experienced 76.2% (16/21) 95.7% (22/23) ELECTRON-2, phase 2 Gane et al., 2015
Experienced 100% (7/7) SPARE, phase 2a Osinusi et al., 2014
Experienced 91.2% (31/34) NIAID synergy, phase 2a Wilson et al., 2016
Naïve 95.2% (20/21) Phase 2 Abergel et al., 2016a
Experienced 84.6% (11/13)
Naïve 94.4% (17/18) Phase 2 (Abergel et al., 2016b)
Experienced 100% (14/14)
Naïve 100% (70/70) GS-US-337-0113, phase 3 Mizokami et al., 2015
Experienced 100% (60/60)
Naïve 100% (179/179) ION-1, phase 3 Afdhal et al., 2014a
Experienced 96.2% (50/52) ION-2, phase 3 Afdhal et al., 2014b
Experienced 94.3% (33/35)
Naïve 1a: 94.8% (163/172), 1b: 97.7% (43/44) ION-3, phase 3 Kowdley et al., 2014a
Naïve 1a: 94.6% (406/429), 1b: 98.3% (172/175) TRIO, real-world study Younossi et al., 2016
Naïve 1a:95.7% (1352/1413), 1b:95.2% (415/436) Real-world study
Ioannou et al., 2016
Experienced 1a:96.7% (472/488), 1b:95.6% (175/183)

Cirrhosis Experienced 90.9% (10/11) LONESTAR, phase 2 Lawitz et al., 2014b
Naïve 100% (1/1) Phase 2 Abergel et al., 2016a
Experienced 100% (9/9)
Naïve 100% (3/3) Phase 2 Abergel et al., 2016b
Experienced 83.3% (5/6)
Null response 70% (7/10) Phase 2 Gane et al., 2014a
Naïve or experienced 100% (7/7) NIAID, phase 2a Kohli et al., 2015b
Experienced 70% (7/10) ELECTRON-1, phase 2 Gane et al., 2013b
Naïve or experienced 25% (1/4) 100% (2/2) ELECTRON-2, phase 2 Gane et al., 2015
Naïve 96.9% (32/33) ION-1, phase 3 Afdhal et al., 2014a
PI + PegIFNα+RBV 85.7% (12/14) ION-2, phase 3 Afdhal et al., 2014b
PegIFNα+RBV 87.5% (7/8)
Naïve 100% (13/13) GS-US-337-0113, phase 3 Mizokami et al., 2015
Experienced 100% (28/28)
Naïve 1a:91.7% (483/527), 1b:93.6% (162/173) Real-world study Ioannou et al., 2016
Experienced 1a:90.7% (68/75), 1b:100% (38/38)
Experienced 76.9% (10/13) a 40% (2/5)a Real-world study Cheung et al., 2016
a

SVR24 rates were evaluated in the clinical study.

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