SOFOSBUVIR (SOVALDI®)


















  • GT 1a with cirrhosis has lower response if NS5A polymorphism is present
HCV genotype 1 cure rates
Drug No cirrhosis or CP A CP B/C
Epclusa > 90% > 90%
Harvoni > 90% > 85%
Vosevi > 90% N/A
Sofosbuvir + daclatasvir > 90% B > 90%
C ∼ 50%

  • Patients with previous treatment failure and cirrhosis may have lower response rates
HCV genotype 2 cure rates
Drug No cirrhosis or CP A CP B/C
Epclusa > 90% > 90%
Vosevi > 90% N/A
Sofosbuvir + ribavirin > 90% > 80%

  • Previous treatment failure ∼ 60%; Treatment-naïve > 90%
HCV genotype 3 cure rates
Drug No cirrhosis or CP A CP B/C
Epclusa > 90% > 90%
Vosevi > 90% N/A
Sofosbuvir + daclatasvir > 90% ∼ 60%
Sofosbuvir + ribavirin > 85% See note

HCV genotype 4 cure rates
Drug No cirrhosis or CP A CP B/C
Epclusa > 90% > 90%
Harvoni > 90% N/A
Vosevi > 90% N/A

HCV genotype 5 cure rates
Drug No cirrhosis or CP A CP B/C
Epclusa > 90% N/A
Harvoni > 90% N/A
Vosevi > 90% N/A

HCV genotype 6 cure rates
Drug No cirrhosis or CP A CP B/C
Epclusa > 90% N/A
Harvoni > 90% N/A
Vosevi > 90% N/A



  • All data is from 12 week trials
Side Effect Placebo
(N=71)
Sofosbuvir + RBV
(N=650)
Fatigue 24% 38%
Headache 20% 24%
Nausea 18% 29%
Insomnia 4% 15%
Itching 8% 11%
Anemia 0% 10%
Rash 8% 8%
Loss of appetite 10% 6%
Flu-like illness 3% 3%
Fever 0% 4%
Diarrhea 6% 9%
Neutropenia 0% < 1%
Muscle ache 0% 6%
CK elevations
(10 X ULN)
- 2%
Lipase elevations
(3 X ULN)
- 2%


















  • Ribavirin dosing should be weight-based
  • Previous treatment with interferon-based regimen with or without ribavirin
Sofosbuvir treatment regimens in adults
HCV GT Patient population Regimen
1
  • Treatment-naïve without cirrhosis or Child-Pugh A
Sofosbuvir + PegIFN + RBV for 12 weeks
  • See Epclusa and Harvoni for another HCV GT 1 regimen with sofosbuvir
2
  • Treatment-naïve and treatment-experienced without cirrhosis or with Child-Pugh A
Sofosbuvir + RBV for 12 weeks
  • See Epclusa for other HCV GT 2 regimens with sofosbuvir
3
  • Treatment-naïve and treatment-experienced without cirrhosis or with Child-Pugh A
Sofosbuvir + RBV for 24 weeks
  • See Epclusa for another HCV GT 3 regimen with sofosbuvir
4
  • Treatment-naïve without cirrhosis or Child-Pugh A
Sofosbuvir + PegIFN + RBV for 12 weeks
  • See Vosevi for retreatment of GT 1, 2, 3, 4, 5, and 6