Gilead Sciences’ hepatitis C virus (HCV) treatment Harvoni (ledipasvir/sofosbuvir) appears to work as well in real-world practice as it did in clinical trials.
Publishing their findings in the Journal of Viral Hepatitis, researchers analyzed data from a retrospective cohort study of 1,597 people with genotype 1 of hep C who were treated with Harvoni for 12 weeks in a real-world setting; 76 of them also took ribavirin.
The study cohort was 60 years old on average (they ranged between 19 and 89 years old). Forty-three percent of them received care at an academic medical center and 30 percent had cirrhosis.
Ninety-four percent of the group achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Forty-four (2.9 percent) of the participants experienced viral relapse. Among those who took ribavirin with Harvoni, 97 percent were cured and none experienced viral relapse.
After adjusting the data for various factors, the researchers found that receiving HCV care at an academic center rather than elsewhere was associated with a 44 percent reduced likelihood of achieving a cure. Receiving a prescription for HCV treatment that ran contrary to U.S. Food and Drug Administration (FDA) labeling was associated with a 71 percent reduced likelihood of a cure.
To read the study abstract, click here.