Sofosbuvir / Velpatasvir Fact Sheet

Sofosbuvir / Velpatasvir Facts SheetThe 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

Sofosbuvir / Velpatasvir Facts

Genotypes Tested Against1 – 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.

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: 

  • Headache
  • Nausea
  • 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:

Patients
Treatment Regimen
Duration in Weeks
SVR12
ASTRAL-1: A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Naïve and Experienced Genotype 1, 2, 4, 5, 6 HCV Infected Patients with and without cirrhosis (Abstract LB-2 from AASLD’s Liver Meeting 2015)
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%
ASTRAL-2 and ASTRAL-3: Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
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)
ASTRAL-4: Sofosbuvir/Velpatasvir Fixed Dose Combination for the Treatment Of HCV in Patients with Decompensated Liver Disease
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:

Please email or visit the Hepatitis C Treatment Information Project for more information about Sofosbuvir / Velpatasvir or any other hep C treatment.