Those coinfected with hepatitis C virus (HCV) and HIV achieved real-world success rates with the HCV treatment Harvoni (ledipasvir/sofosbuvir) similar to those seen in a major clinical trial, Healio reports. Results from a study of 140 HIV/HCV-coinfected individuals treated with Harvoni, with or without ribavirin, were presented at Digestive Disease Week 2016 in San Diego.
The participants started treatment between October 2014 and March 2015 and took Harvoni for eight (5 percent), 12 (75 percent) or 24 (20 percent) weeks.
Fifty-nine percent of the participants received treatment from a community site, 73 percent were African American, 46 percent were hep C–treatment experienced and 35 percent had cirrhosis. One in five of them had a high viral load upon beginning treatment, greater than 6 million international units per milliliter.
All of those treated for eight weeks achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Ninety-eight percent of those treated for 12 weeks and 97 percent of those treated for 24 weeks were cured.
All of those with cirrhosis were cured, as were 98 percent of the treatment-experienced participants without cirrhosis and 100 percent of the treatment-naive participants without cirrhosis. All of those with genotype 1a were cured, as were 95 percent of those with genotype 1b who had an initial hep C viral load of less than 6 million IU/mL and 100 percent of those with genotype 1b with a viral load greater than that.
All of those taking a proton pump inhibitor were cured, as were 99 percent of those who were not.
Ninety-seven percent of the African-American participants were cured, as were 100 percent of the nonblack participants.
Having a platelet count of less than 100,000 and having genotype 1b were each associated with a lower likelihood of a cure. However, there were few people in the study with genotype 1b, and its apparent effect on the likelihood of a cure was small.
The researchers concluded that Harvoni’s real-world effectiveness was comparable to that seen in the Phase III ION-4 trial.
To read the Healio article, click here.