Those treated for hepatitis C virus (HCV) with Viekira Pak (ombitasvir/paritaprevir/ritonavir; dasabuvir) may have a greater risk of progression to decompensated cirrhosis in the three months following treatment than those who receive Harvoni (ledipasvir/sofosbuvir).
Publishing their findings in Alimentary Pharmacology & Therapeutics, researchers followed participants of the ERCHIVES study for up to 12 weeks after they completed treatment for hep C. The study included 3,728 people who took Viekira Pak, 1,578 people who took Sovaldi (sofosbuvir) plus Olysio (simeprevir) and 440 people who took Harvoni.
Looking at the rate of diagnosis of decompensated cirrhosis per 1,000 cumulative years of follow-up among the participants, the researchers found that the rates were: 10.6 among those who took Viekira Pak; 32.4 among those who took Sovaldi plus Olysio; and 13 among those who took Harvoni. Among those who started treatment with cirrhosis, the respective rates were 36.9, 61.8 and 41.1. Among those who started treatment without cirrhosis, the respective rates were 2.7, 7.5 and 2.7.
The researchers found that having advanced fibrosis was associated with an increased risk of developing decompensated cirrhosis among all three groups. For every 0.5 unit of increase in an individual’s FIB-4 score (a measure of liver disease severity), developing decompensated cirrhosis was: 11 percent more likely among those who received Viekira Pak, 3 percent more likely among those who received Sovaldi and Olysio and 2 percent more likely among those who received Harvoni.
The proportion of those who developed reduced kidney function, specifically an eGFR test result below 30, was higher among those who received Viekira Pak compared with those who received the other two regimens. Starting treatment with cirrhosis did not appear to affect this rate.
The researchers concluded that the rate of the development of decompensated cirrhosis within 12 weeks of completing treatment was comparable between those receiving Viekira Pak and Sovaldi plus Olysio but that those two regimens were associated with a higher rate of decompensated cirrhosis compared with Harvoni. This risk was mostly seen among those who started treatment with cirrhosis.
To read the study abstract, click here.