The fixed-dose combination tablet of Gilead Sciences’ Sovaldi (sofosbuvir) and ledipasvir yields a host of liver-related benefits when compared with treating hepatitis C virus (HCV) with current medications, Healio reports. Presenting their findings at the American Association for the Study of Liver Diseases/European Association for the Study of the Liver Special Conference on Hepatitis C, researchers looked at the long-term outcomes of those treated with the combination pill of the nucleotide analog polymerase inhibitor Sovaldi and the NS5A inhibitor ledipasvir. They then compared the outcomes with current treatment paradigms.

Gilead applied for U.S. Food and Drug Administration approval of Sovaldi-ledipasvir in the spring. A decision is expected by October 10.

Ten thousand people with genotype 1 of hep C took Sovaldi-ledipasvir; they were either treatment naive or had failed a previous protease inhibitor regimen. Nineteen percent of them had compensated cirrhosis upon starting treatment. The treatment-naive participants who did not have cirrhosis took the combination pill for eight weeks, while those with compensated cirrhosis underwent 12 weeks of treatment.

Their outcomes were compared with participants who took Sovaldi plus pegylated interferon and ribavirin for 12 weeks, Sovaldi with ribavirin for 24 weeks and with Janssen’s NS3/4A inhibitor Olysio (simeprevir) plus interferon and ribavirin for 12 weeks. Those who had failed a previous protease inhibitor regimen took Sovaldi-ledipasvir for 12 weeks; their outcomes were compared with Sovaldi plus interferon and ribavirin and with no treatment.

Ninety-four percent of both the cirrhotic and noncirrhotic treatment-naive participants who took Sovaldi-ledipasvir achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Meanwhile, 95 percent of the noncirrhotic and 86 percent of the cirrhotic people who had failed a previous protease inhibitor regimen were cured.

Those who took the combination tablet treatment had a 43 percent reduced rate of compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (the most common form of liver cancer) and liver transplant when compared with those who took Olysio, as well as a 17 percent rate of these liver complications when compared with those who took Sovaldi plus interferon and ribavirin, and a 60 percent reduced rate when compared with those who took Sovaldi plus ribavirin. Among those participants who had failed a previous protease inhibitor regimen, Sovaldi-ledipasvir was associated with a 47 percent reduction in the rate of liver complications when compared with Sovaldi plus interferon and ribavirin and an 81 percent reduction when compared with no treatment.

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