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Gilead’s controversial Hepatitis C drug Sofosbuvir (brand name Sovaldi) is back in the news again, this time not over its cost, but for successfully clearing Hepatitis C in patients with HIV.
Hepatitis C is a contagious liver disease which can last anywhere from several weeks to a lifetime. Infection with HCV is often undiagnosed, with an estimated 50 percent of infected individuals who do not know it. Hepatitis C can lead to chronic liver disease, cirrhosis, and less frequently liver caner.
“Because of poor tolerability to the previous standard of treatments for Hepatitis C, co-infection patients were considered difficult to treat,” said Mark Sulkowski, medical director of the Johns Hopkins Infectious Disease Centre for Viral Hepatitis.
Now, the data from a Phase III clinical trial have been incorporated into the US Food and Drug Administration’s (FDA) approval of the new drug called sofosbuvir.
“The treatment with a new all-oral regimen – sofosbuvir and ribavirin – is now considered on-label,” researchers reported.
For the trial, doctors administered sofosbuvir and ribavirin to a total of 223 HIV-1 patients chronically co-infected with Hepatitis C either for 12 weeks.
Twelve weeks after the treatment ended, researchers tested patients again for Hepatitis C infection to determine if the treatment was effective.
They found that 76 percent patients with genotype 1, 88 percent with genotype 2 and 67 percent with genotype 3 were cured.
“We have always termed this to be ‘sustained virologic response but we now know that means hepatitis C has been cured,” Sulkowski noted.
The trial study was published in the Journal of the American Medical Association.
Agencies/Canadajournal
