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Ledipasvir-Sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIAID SYNERGY: Genotype 1

Phase 2. Treatment Naïve (unfavorable baseline treatment characteristics). Ledipasvir-Sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIAID SYNERGY: Genotype 1. Kohli A, et al. Lancet. 2015:385:1107-13.

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Ledipasvir-Sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIAID SYNERGY: Genotype 1

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  1. Phase 2 TreatmentNaïve (unfavorable baseline treatment characteristics) Ledipasvir-Sofosbuvir +/- 3rd DAA in HCV Genotype 1 NIAID SYNERGY: Genotype 1 KohliA, et al. Lancet. 2015:385:1107-13.

  2. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1NIAID SYNERGY GT-1 Trial: Features Source: Kohli A, et al. Lancet. 2015:385:1107-13.

  3. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1NIAID SYNERGY GT-1 Trial: Features 0 6 12 18 24 Week Treatment NaïveAll stages fibrosis LDV-SOF n =20 SVR12 Treatment NaïveCirrhosis excluded LDV-SOF+ GS-9669 n = 20 SVR12 Treatment NaïveCirrhosis excluded LDV-SOF + GS-9451 n = 20 SVR12 Abbreviations: LDV-SOF= ledipasvir-sofosbuvir Drug DosingLedipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once dailyGS-9669: 500 mg once dailyGS-9451: 80 mg once daily Source: Kohli A, et al. Lancet. 2015:385:1107-13.

  4. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1NIAID SYNERGY GT-1 Trial: Participants Source: Kohli A, et al. Lancet. 2015:385:1107-13.

  5. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1NIAID SYNERGY GT-1 Trial: Viral Kinetics 7 Sofosbuvir + Ledipasvir 6 Sofosbuvir + Ledipasvir + GS-9669 Sofosbuvir + Ledipasvir + GS-9451 5 4 Log10 Median HCV RNA (IU/ml) 3 *p<0.05 *p<0.05 *p<0.05 2 0 7 14 21 28 Time (days) Source: Kohli A, et al. Lancet. 2015:385:1107-13.

  6. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1NIAID SYNERGY GT-1 Trial: Results NIH SYNERGY: SVR 12 by Treatment Regimen 20/20 19/20* 19/20^ *1 patient relapsed 2 weeks after completion of treatment^1 patient lost to follow-up after reaching SVR at 4 weeks Source: Kohli A, et al. Lancet. 2015:385:1107-13.

  7. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1NIAID SYNERGY GT-1 Trial: Interpretation Source: Kohli A, et al. Lancet. 2015:385:1107-13.

  8. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.

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