Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) is safe and effective for those with hepatitis C virus (HCV) and advanced liver disease, Infectious Disease Advisor reports.
Publishing their findings in the Journal of Viral Hepatitis, researchers conducted a study of Harvoni with or without ribavirin among 200 people with HCV and advanced liver disease who participated in the Turkish Early Access Program.
Twenty-four weeks of treatment with Harvoni was recommended. The participants were followed for a median of 22 months.
Eighty-four percent of the participants had genotype 1b of HCV. Twenty-four percent had received a liver transplant prior to starting Harvoni.
Eighty-six percent of the study cohort achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). The cure rate did not differ significantly based on the severity of liver disease according to the Child-Pugh scoring system.
Treatment was generally well tolerated.
One participant was newly diagnosed with hepatocellular carcinoma (HCC, the most common form of liver cancer) during follow-up. Of the 35 people who had a history of liver cancer, 17 developed a recurrence during follow-up. Curing HCV was associated with a lower likelihood of liver cancer recurrence.
Between the start of treatment and the 12-week posttreatment mark, ALT enzymes typically declined and liver disease severity according to the MELD scoring system typically improved among participants.
To read the Infectious Disease Advisor article, click here.
To read the study abstract, click here.