Gilead's VOSEVI HCV Regimen for Re-Treatment Receives Health Canada Approval

Gilead Receives Health Canada Approval for the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment
August 17, 2017

Deb Schmitz
Please note: VOSEVI is available to eligible patients in Canada but is not yet covered by BC PharmaCare (or any provincial plans). VOSEVI is included in Gilead’s Momentum Patient Support Program

View all information, here..

VOSEVI is the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment, and Completes Gilead’s Portfolio of Sofosbuvir-Based HCV Direct-Acting Antiviral Treatments

MISSISSAUGA, ON, Aug. 17, 2017 /CNW/ – Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance for VOSEVI™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a pan-genotypic single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1, 2, 3 or 4 previously treated with sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies that evaluated 12 weeks of VOSEVI in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.

“HCV treatment has been transformed by effective direct-acting antiviral regimens, allowing health care providers the opportunity to cure many patients. However, for those patients who have failed with prior therapy, there remains an unmet clinical need for an effective and well-tolerated option,” said Dr. Stephen Shafran, Professor of Medicine, Division of Infectious Diseases, University of Alberta. “VOSEVI Phase 3 clinical studies have resulted in high cure rates among patients who were not previously cured with several widely-prescribed DAA regimens, providing physicians with an important new therapeutic option that could offer hope for their hardest-to-cure patients.”

VOSEVI is the latest single-tablet regimen in Gilead’s portfolio of sofosbuvir-based DAA treatments that offer people living with HCV a short course of therapy to cure their HCV infection, with the convenience associated with once-daily single-tablet regimens. Since 2013, Gilead has brought to market four HCV treatments, including three single-tablet regimens. To date, more than an estimated 1.5 million patients worldwide have been prescribed sofosbuvir-based regimens.

“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” said Kennet Brysting, General Manager, Gilead Canada. “The approval of VOSEVI in Canada completes our HCV portfolio and this will enable the company to commit to collaborative partnerships that will help drive progress towards the goal of eliminating HCV in Canada by 2030.”

The approval of VOSEVI is supported by Phase 3 data from the POLARIS-1 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3, 4, 5 or 6 infection with or without compensated cirrhosis who had failed prior treatment with an NS5A inhibitor-containing regimen, as well as Phase 3 data from the POLARIS-4 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3 or 4 infection with or without compensated cirrhosis who had failed prior treatment with a DAA-containing regimen that did not include an NS5A inhibitor. In these populations across the two studies, 431 of the 445 patients treated with VOSEVI (97%) achieved the primary endpoint of SVR12, defined as maintaining undetectable viral load 12 weeks after completing therapy.

The most common adverse events (≥10 per cent of patients) among patients who received VOSEVI were headache, fatigue, diarrhea and nausea. The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2 per cent for subjects who received VOSEVI for 12 weeks.

“As Canada moves forward with its World Health Organization commitment to eliminate hepatitis C by 2030, it is important for all patients to have the opportunity to access a cure, regardless if they are new to treatment, or they have failed a previous therapy,” said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and Hepatologist at Toronto General Hospital. “Treatment should be an option for everyone, including to those still seeking a cure. The CLF is pleased to see that additional effective therapies are available, and are becoming more accessible to all patients, regardless of where someone lives, or their ability to pay.”

Patient Support Program
To assist eligible HCV patients in Canada with access to VOSEVI, Gilead Canada has added VOSEVI to the Gilead Momentum Support Program™, which provides information to patients and healthcare providers to help facilitate patient access to medication. For more information regarding the Momentum Support Program in Canada, please call 1-855-447-7977.

Important Safety Information
The VOSEVI Product Monograph has a SERIOUS WARNINGS AND PRECAUTIONS BOX REGARDING THE RISKS OF HEPATITIS B VIRUS (HBV) REACTIVATION IN HCV/HBV CO-INFECTED PATIENTS. For further details, please see the Canadian Product Monograph at www.gilead.ca.

Contraindications
VOSEVI is contraindicated with the following drugs products: dabigatran etexilate, phenobarbital, phenytoin, rifampin, rosuvastatin. VOSEVI is also contraindicated with the herbal product, St. John’s wort.

Warnings and Precautions
Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with VOSEVI due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.

Drug Interactions
Coadministration of VOSEVI is not recommended with carbamazepine, oxcarbazepine, rifabutin, rifapentine, atazanavir, lopinavir, efavirenz, and cyclosporine due to changes (decreased or increased) in concentrations of sofosbuvir, velpatasvir and/or voxilaprevir, and/or the other agent.

For additional important safety information for VOSEVI, including the complete warnings and precautions, adverse reactions and drug-drug interactions, please see the Canadian Product Monograph at www.gilead.ca.

About Gilead Sciences
Gilead Sciences, Inc. (Gilead) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario, in 2006.

Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing VOSEVI for the treatment of adults with chronic HCV infection. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Canadian Product Monograph for VOSEVI, including the SERIOUS WARNINGS and PRECAUTIONS,
is available at www.gilead.ca.

VOSEVI is a trademark of Gilead Sciences, Inc., or its related companies.