Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) is safe and effective for people with kidney transplants undergoing treatment for hepatitis C virus (HCV), Healio reports.
Publishing their findings in the Annals of Internal Medicine, researchers conducted a Phase II, open-label study of 114 people with genotype 1 or 4 of hep C who had received a transplanted kidney at least six months before entering the study. The participants, 69 percent of whom were being treated for HCV for the first time, were evenly randomized to receive 12 or 24 weeks of Harvoni.
All the participants achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure).
Thirteen participants (11 percent) experienced serious adverse health events, three of which were judged related to treatment, including fainting, pulmonary embolism (blockage of an artery in the lungs) and an increase in serum creatinine (an indication of reduced kidney function).
The most common reported adverse health events were headache (19 percent), weakness (14 percent) and fatigue (10 percent).
To read the Healio article, click here.