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POLARIS-1 and POLARIS-4

Across a total of 445 DAA-experienced chronic HCV patients in both trials, VOSEVI® achieved cure in 96–98% of cases.1 High cure rates of over 90% were demonstrated across HCV genotypes.1

 

EASL defines cure as SVR, i.e. undetectable viral RNA after treatment completion.2

 

 

Polaris 1 and 4

SVR12, sustained virological response at 12 weeks after treatment (any genotype).

Learn more about genotypes

Design of POLARIS clinical studies

POLARIS-1 was a randomised, double-blind (patients were blinded until week 4) placebo controlled, multicentre trial evaluating 12-week treatment with VOSEVI® in 415 patients with HCV. All patients had to be previously treated with an NS5A inhibitor and have had a virologic failure after completing at least 4 weeks of treatment. Non-GT-1 patients were assigned to receive VOSEVI®, and randomisation was stratified according to cirrhosis status. Patients received either a fixed dose of VOSEVI® or a matching placebo once daily. The primary endpoints were percentage of participants with SVR at 12 weeks and percentage of participants who permanently discontinued due to AEs.1

 

POLARIS-4 was an open-label, randomised, multicentre study in 333 patients with HCV, receiving either VOSEVI® or EPCLUSA® once daily for 12 weeks. All patients had to have been previously treated with any DAA regimen that did not include an NS5A inhibitor. Those with non-GT-1–3 HCV or unknown genotypes were put into the VOSEVI® group. Randomisation was stratified by cirrhotic status and genotype. Primary endpoints were percentage of those who permanently discontinued due to AEs and those who achieved SVR at 12 weeks.1

 

Across both trials, patients were assessed for HCV RNA levels at Weeks 2, 4, 8 and 12 during treatment, and again at 4 and 12 weeks after treatment completion.1

Elimination Ambition

Suitable interventions can support the ambition to leave no patient behind on the path to HCV elimination3

To certain patients, elimination may mean freedom from extra burden. To others, elimination means freedom from reinfection.

 

EPCLUSA® (sofosbuvir and velpatasvir) delivers high cure (94%, n=97/103) even though real-world settings can vary.4 And with VOSEVI®, you can offer patients a treatment specifically licensed after DAA failure.1,5 

 

EPCLUSA® and VOSEVI® offer a simplified route to HCV elimination.

 

 

EPCLUSA® (sofosbuvir and velpatasvir 400 mg/100 mg tablets) 
 
Prescribing Information
 
 
EPCLUSA® is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older.

VOSEVI® in the real world

Friends in a coffee shop

A study using a veterans registry of over 500 patients experienced with DAA treatment found that VOSEVI® was able to cure over 90% of cases in a real-world setting.6

 

VOSEVI®’s cross-genotype efficacy can support the ambition to leave no patient behind on the on the path to HCV elimination.6

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Dosing

Abbreviations:

DAA = direct-acting antiviral; EASL = European Association for the Study of the Liver; GT = genotype; HCV = hepatitis C virus; NS5A = nonstructural protein 5A; RNA = ribonucleic acid; SVR = sustained virologic response.

References:

  1. Bourlière M et al. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017;376:2134–2146.
  2. European Association for the Study of the Liver (EASL). J Hepatol. 2020;73:1170–1218.
  3. World Health Organization. Global Health Sector Strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections for the period 2022–2030. Available at: https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/strategies/global-health-sector-strategies. Accessed July 2024.
  4. Grebely J et al. Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial. Lancet Gastroenterol Hepatol. 2018;3:153–161.
  5. VOSEVI Summary of Product Characteristics.
  6. Belperio P et al. Real-world effectiveness of sofosbuvir/velpatasvir/voxilaprevir in 573 direct-acting antiviral experienced hepatitis C patients. J Viral Hepat. 2019;26:980–990.

UK-VSV-0090

Date of preparation July 2024