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. 2016 Jan 29;60(2):1106–1113. doi: 10.1128/AAC.02606-15

TABLE 6.

RAVs in NS3 and NS5A in patients who experienced virologic failure in M12-536 and GIFT-Ii

Study arma, VF type, time point RAVs at each time point
NS3
 NS5A
Baseline Time of VF PTW24 PTW48 Baseline Time of VF PTW24 PTW48
M12-536
    2, relapse, PTW2b,d Nonef D168V Noneg None L28M + R30Q L28M + R30Q + Y93H L28M + R30Q + Y93H L28M + R30Q, Y93H/Y
GIFT-I
    A, breakthrough, W6b,d Noneh Y56H + D168V Noneg None Y93Hh Y93H Y93H Y93H
    A, relapse, PTW2c,e Noneh Y56H + D168V Noneg None Y93H/Y Y93H Y93H Y93H
    A, relapse, PTW4b,d Noneh D168V D168D/Vg None Noneh Y93H Y93H Y93H
    A, relapse, PTW2c,e Noneh D168D/V Noneg Noneg Y93H Y93H Y93H Y93H
    A, relapse, PTW12c,e Noneh D168V Noneg None Y93H/Y, P58Sh P58S + Y93H P58S + Y93H P58S + Y93H
    A, relapse, PTW8c,e Noneh D168Vg Noneg None Y93H/Y R30Q + Y93H R30Q + Y93H R30Q + Y93H
    A, relapse, PTW24c,e Noneh D168V D168V D168V A92A/M/T/V, Y93H/Y Y93H Y93H Y93H
    B, breakthrough, W12b,e Noneh Y56H + D168V Y56F/H/L/Y, D168D/Vg None Y93H P58S + Y93H P58P/S, Y93H Y93H
    B, relapse, PTW2b,d Noneh Y56H + D168A D168A/Dg None L28M + R30Q, Y93H/Y L28M + R30Q + Y93H L28M + R30Q + Y93H L28M + R30Q + Y93H
    C, relapse, PTW8b,e Noneh D168D/V Noneg None L31M, Y93H/Y L31M + Y93H L31M + Y93H L31M + Y93H
    C, breakthrough, W10b,e Noneh Y56H/Y, D168A D168D/H/L/V D168D/V Y93H L31V + Y93H L31V + Y93H L31V + Y93H
    C, relapse, PTW8b,e Noneh D168V D168D/V NA A92A/E, Y93Hh L31F + A92E L31F + A92E NA
a

Study M12-536, arm 2 (null and partial responders), received paritaprevir//r (150/100 mg) and ombitasvir (25 mg) QD for 12 weeks; study GIFT-I, arms A and B (noncirrhotics) and arm C (cirrhotics), received paritaprevir/r (150/100 mg) and ombitasvir (25 mg) QD for 12 weeks.

b

Treatment experienced with an IFN-containing regimen with or without RBV.

c

Treatment naïve.

d

IL28B genotype CT.

e

IL28B genotype CC.

f

Resistance-associated variants were not detected.

g

Results by clonal sequencing.

h

Results by deep sequencing.

i

NA, sample not available; PTW, posttreatment week; W, week; VF, virologic failure; +, linked variants; /, mixture of variants.