Researchers at the Toronto Western Hospital (TWH) Liver Clinic have found that a simple drug regimen delivered over 12 weeks achieved sustained eradication of several genotypes of the hepatitis C virus (HCV) in 99 percent of the trial's patients.
The study, released today in the New England Journal of Medicine, showed that receiving a once daily drug combination of sofosbuvir-velpatasvir for a 12 week period was effective in both treatment-naïve and previously treated patients with HCV genotype 1, 2, 4, 5, or 6, including those with compensated cirrhosis (where scarring of the liver has occurred but patients have yet to experience symptoms as a result of it).
"This drug regimen changes the standard of care in treating patients with HCV – we can now cure almost everyone with a very simple treatment," says Dr. Jordan Feld, a hepatologist at the Francis Family Liver Clinic at TWH and the first author of the study. "It's incredibly gratifying to be part of research where we not only cure a disease but can also think about eliminating HCV in Canada."
Current approved treatments for chronic HCV are not equally effective in combating the virus' different genotypes. Testing to determine the genotype and subtype of the virus is required before treatment could be initiated. But the combination of sofosbuvir-velpatasvir has been shown to be applicable to all strains of HCV, effectively eliminating the need to test for the viral genotype – an obstacle that often delayed treatment.
The regimen was tested in an international, randomized, double-blind placebo-controlled phase three trial conducted at 81 sites in eight different countries. After 12 weeks, 99 percent of the 624 patients who had been treated with a daily tablet of sofosbuvir-velpatasvir experienced a sustained virologic response – the medical term for eradication or cure of HCV -- meaning that patients remained free of the virus three months after completing treatment. None of the 116 patients receiving a placebo experienced the same result.
"This is truly a one size fits all treatment that is very easy to administer and extremely well tolerated," says Feld. "Our challenge now is getting treatment to those who need it. Over half of people living with hepatitis C remain undiagnosed. Fortunately this regimen, along with other advances in therapy, will allow us to move treatment out of specialty clinics so that we can deliver care and ideally cure all infected Canadians."
Chronic HCV is known as a "silent" killer because symptoms often don't appear until the liver is severely damaged. Left undiagnosed, HCV can lead to cirrhosis which can progress to liver failure or liver cancer. HCV is primarily spread by blood-to-blood contact and is associated with intravenous drug use, contact with poorly sterilized medical equipment and blood transfusions before 1992.
Approximately 170 million people are infected with chronic HCV worldwide with an estimated 252,000 in Canada. HCV causes the greatest burden of disease, measured in years of life lost, than any infectious disease in Canada.
The research was funded by Gilead Sciences.
Source: University Health Network (UHN)