HARVONI® (ledipasvir + sofosbuvir)

















HCV cure rates for Harvoni ± ribavirin
Genotype No cirrhosis or Child-Pugh A Child-Pugh B/C
1 > 90% > 85%
4 > 90% N/A
5 > 90% N/A
6 > 90% N/A




  • Reference [1]
Side effect Harvoni® for 12 weeks
(N=539)
Harvoni® for 24 weeks
(N=326)
Fatigue 13% 18%
Headache 14% 17%
Nausea 7% 9%
Diarrhea 3% 7%
Insomnia 5% 6%
Bilirubin elevations
(> 1.5 X ULN)
< 1% 2%
Lipase elevations
(> 3 X ULN)
2% 3%

















  • Previous treatment with regimens containing PegIFN/RBV with or without an HCV NS3/4A protease inhibitor
  • Ribavirin dosing should be weight-based
Harvoni treatment regimens
HCV GT Patient population Regimen
1
  • Treatment-naïve without cirrhosis, baseline viral load < 6 million IU/ml
May consider Harvoni for 8 weeks
  • Treatment-naïve without cirrhosis or with Child-Pugh A
Harvoni for 12 weeks
  • Treatment-experienced without cirrhosis
Harvoni for 12 weeks
  • Treatment-experienced with Child-Pugh A
Harvoni for 24 weeks
Harvoni + ribavirin for 12 weeks can also be considered
  • Treatment-naïve and treatment-experienced with Child-Pugh B or C
Harvoni + ribavirin for 12 weeks
  • Treatment-naïve and treatment-experienced post-liver transplant without cirrhosis or with Child-Pugh A
Harvoni + ribavirin for 12 weeks
4
  • Treatment-naïve and treatment-experienced without cirrhosis or with Child-Pugh A
Harvoni for 12 weeks
  • Treatment-naïve and treatment-experienced post-liver transplant without cirrhosis or with Child-Pugh A
Harvoni + ribavirin for 12 weeks
5
  • Treatment-naïve and treatment-experienced without cirrhosis or with Child-Pugh A
Harvoni for 12 weeks
5
  • Treatment-naïve and treatment-experienced without cirrhosis or with Child-Pugh A
Harvoni for 12 weeks