Saturday, September 23, 2017

Gilead Receives Approval in Canada for Expanded Indication of EPCLUSA® for Chronic Hepatitis C in Patients Co-Infected with HIV

Gilead Receives Approval in Canada for Expanded Indication of EPCLUSA® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV

– New Data for First Approved Pan-genotypic Once-Daily Single Tablet Regimen for
Chronic Hepatitis C Virus Infection –
MISSISSAUGA, ON, Sept. 21, 2017 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance (NOC) for updated labeling of EPCLUSA® (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV-1. Health Canada granted EPCLUSA an NOC in July 2016, for the treatment of adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin.

"HCV co-infection remains a major cause of morbidity in HIV-infected individuals. With this expanded indication, EPCLUSA provides co-infected patients with a much-needed one-pill-a-day regimen that works across all HCV genotypes and at all stages of disease. Being compatible with most widely-used antiretroviral regimens adds to its convenience," said Dr. Brian Conway, President and Medical Director, Vancouver Infectious Diseases Centre. "With EPCLUSA, physicians have an important new treatment option for their HCV/HIV co-infected patients."
The supplemental new drug submission was supported by data from the open-label, Phase 3 ASTRAL-5 study, which evaluated 12 weeks of treatment with EPCLUSA in 106 subjects with genotype 1-4 HCV infection who were co-infected with HIV and on stable antiretroviral therapy. In the study, 95 per cent (101/106) of patients achieved the primary endpoint of SVR12, defined as an undetectable viral load 12 weeks after completing therapy. The study also included patients with compensated cirrhosis.

The safety profile of EPCLUSA in HCV/HIV co-infected patients was similar to that observed in HCV mono-infected patients. The most common adverse events (in at least 10 per cent of subjects) were fatigue (22 per cent) and headache (10 per cent).

"Canada has committed to eliminating hepatitis C by 2030. To accomplish this goal, it is imperative that steps be taken to increase treatment rates in Canada, including treatment for people who are co-infected with hepatitis C and HIV," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and Hepatologist at Toronto General Hospital. "Hepatitis C progresses faster in individuals who are co-infected with HIV, often increasing and speeding up the onset of liver damage. Today, with pan-genotypic curative hepatitis C therapies approved for treatment in hepatitis C and HIV co-infected patients, it is an important time for patients to discuss treatment options with their health care providers."

"EPCLUSA has already helped further simplify HCV treatment among mono-infected patients, and we are pleased that HCV/HIV co-infected patients can benefit from this pan-genotypic single tablet regimen," said Kennet Brysting, General Manager, Gilead Canada. "This approval advances the commitment we've made to the HCV and HIV communities to deliver innovative new treatments that address their unmet medical needs."

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