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

Phase 2. Treatment Naïve (unfavorable baseline treatment characteristics). Ledipasvir-Sofosbuvir +/- 3 rd DAA in HCV Genotype 1 SYNERGY. Kohli A, et al. 21 st CROI. 2014:Abstract 27LB. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1 SYNERGY Trial : Features.

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

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  1. Phase 2 TreatmentNaïve (unfavorable baseline treatment characteristics) Ledipasvir-Sofosbuvir +/- 3rd DAA in HCV Genotype 1 SYNERGY KohliA, et al. 21st CROI. 2014:Abstract 27LB.

  2. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1SYNERGY Trial: Features Source: Kohli A, et al. 21st CROI. 2014:Abstract 27LB.

  3. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1SYNERGY 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. 21st CROI. 2014:Abstract 27LB.

  4. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1SYNERGY Trial: Participants Source: Kohli A, et al. 21st CROI. 2014:Abstract 27LB.

  5. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1SYNERGY Trial: Viral Kinetics 107 Sofosbuvir + Ledipasvir 106 Sofosbuvir + Ledipasvir + GS-9669 Sofosbuvir + Ledipasvir + GS-9451 105 Median HCV RNA Decline 104 103 *p<0.05 *p<0.05 *p<0.05 102 0 7 14 21 28 Time (days) Source: Kohli A, et al. 21st CROI. 2014:Abstract 27LB.

  6. Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1SYNERGY Trial: Features NIH SYNERGY: SVR 12 by Treatment Regimen 20/20 19/20 20/20 Source: Kohli A, et al. 21st CROI. 2014:Abstract 27LB.

  7. Phase 2 Treatment Naïve and Treatment Experienced Sofosbuvir + (Ledipasvir or GS-9669) +/- Ribavirin in GT-1ELECTRON Trial (Arms 12-17 & 22) Source: Gane EJ, et al. Gastroenterogy. 2014:146:736-43.

  8. Sofosbuvir + (Ledipasvir or GS-9669) +/- Ribavirin in GT1ELECTRON Trial (Arms 12-17 & 22): Features Source: Gane EJ, et al. Gastroenterogy. 2014:146:736-43.

  9. 0 6 12 18 24 Week Sofosbuvir + (Ledipasvir or GS-9669) +/- Ribavirin in GT1ELECTRON Trial Arms (12-17 & 22): Design n =25 SVR12 NoncirrhoticTreatment Naive LDV + SOF + RBV n = 25 SVR12 SOF + GS-9669 + RBV n = 25 LDV-SOF + RBV SVR12 n = 9 SVR12 NoncirrhoticNull responder LDV + SOF + RBV n = 10 SVR12 SOF + GS-9669 + RBV n = 10 SVR12 CirrhoticNull responder LDV-SOF n = 9 SVR12 LDV-SOF + RBV Abbreviations: LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Drug DosingSofosbuvir: 400 mg once daily; Ledipasvir: 90 mg once daily; GS-9669 = 500 mg once dailyLedipasvir-sofosbuvir (90/400 mg): fixed dose combination one pill once dailyRibavirin (weight-based and divided bid): 1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg Source: Gane EJ, et al. Gastroenterogy. 2014:146:736-43.

  10. Sofosbuvir + (Ledipasvir or GS-9669) +/- Ribavirin in GT1ELECTRON Trial (Arms 12-17 & 22): Results ELECTRON TRIAL, SVR 12 by Treatment Regimen 25/25 23/25 17/25 9/9 10/10 7/10 9/9 NoncirrhoticTreatment-Naive NoncirrhoticPrior Null Responder CirrhoticPrior Null Responder *All regimens 12 weeks except treatment-naïve LDV-SOF + Ribavirin= 6 week regimen Source: Gane EJ, et al. Gastroenterogy. 2014:146:736-43.

  11. Sofosbuvir + (Ledipasvir or GS-9669) +/- Ribavirin in GT1ELECTRON Trial (Arms 12-17 & 22): Conclusion Source: Gane EJ, et al. Gastroenterogy. 2014:146:736-43.

  12. 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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