The below treatment fact sheet was designed to give you more information about sofosbuvir / velpatasvir and to encourage you to help us, PHCN, with our sofosbuvir / velpatasvir patient group input report for CADTH. The fact sheet was put together in hopes that you will help us advocate on behalf of those with hep C and their loved ones.
Sofosbuvir / velpatasvir, an exciting new hepatitis C treatment, is currently being reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH). Therefore, CADTH is seeking patient input about hep C, hep C treatments, and sofosbuvir / velpatasvir.
PHCN’s Sofosbuvir / Velpatasvir Surveys
- Take this survey if you are living with hep C/if you have had hep C.
Sofosbuvir / Velpatasvir Facts
Genotypes Tested Against: 1 – 6
Treatment Description: Sofosbuvir / velpatasvir is made up of two direct-acting antivirals, sofosbuvir and velpatasvir. Sofosbuvir (brand name Sovaldi) is a nucleotide NS5B polymerase inhibitor that “…targets the hep C virus to stop it from making copies of itself in the liver. Sofosbuvir attaches itself to the genetic information (RNA) to block the virus from multiplying.” (Gilead)
Velpatasvir is a pan-genotypic NS5A inhibitor that blocks a virus protein, NS5A, that the hep C virus needs for reproducing and various stages of infection.
- Sofosbuvir +
- Velpatasvir +/-
Approximate Sustained Viral Response (SVR)/”Cure Rate”: 94 – 100%
Daily Dose: 1 pill +/- ribavirin
Possible Length of Treatment: 8, 12, or 24 weeks
Common Side Effects Reported in Clinical Trials:
- Tiredness (fatigue)
Usage Warning: Do not take sofosbuvir in any combination while taking Amiodarone or with bradycardia.
Step in Drug Approval Pipeline: Step 4 – Common Drug Review by CADTH
Availability: Not approved for use in Canada
Sampling of Phase II/III Clinical Trials for Sofosbuvir / Velpatasvir:
Duration in Weeks
|Genotype (GT) 1, 2, 4, 5, 6 Hepatitis C with and without cirrhosis; 740 patients||Sofosbuvir / Velpatasvir (SOF/VEL)
||12||Overall: 99% (618/624)
GT1: 98% (323/328)
GT2: 100% (104/104)
GT4: 100% (116/116)
GT5: 97% (34/35)
GT6: 100% (41/41)
|Placebo||116 patients received placebo, experienced similar adverse effects, SVR12 0%|
|GT 2, 3 HCV; treatment naive and treatment experienced; including patients with compensated cirrhosis||GT2 14% with cirrhosis||SOF/VEL||12||99% (133/134)|
|Sofosbuvir + ribavirin (RBV)||94% (124/132)|
|GT3 30% with cirrhosis||SOF/VEL||12||95% (264/277)|
|Sofosbuvir + RBV||24||80% (221/275)|
|Genotypes 1-6 All with Child-Pugh class B (decompensated) cirrhosis||SOF/VEL||12||83% (75/90) Overall (GT1 88% GT2 100% GT3 50% GT4 100%)|
|SOF/VEL + RBV||94% (82/87) Overall (GT1 95% GT2 100% GT3 84% GT4 100%)|
|SOF/VEL||24||86% (77/90) Overall (GT1 91% GT2 75% GT3 50% GT4 100% GT6 100%)|
Additional Facts about Sofosbuvir / Velpatasvir can be Found in the Following Resources:
- New Drug Application to the US Food and Drug Administration
- Sofosbuvir / Velpatasvir Clinical Trial Results
- Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection published by The New England Journal of Medicine
- Sofosbuvir + velpatasvir—Very high rates of cure against major strains of hepatitis C by CATIE