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Olysio/Sovaldi combo yields high SVR in HCV with advanced cirrhosis

In a study published in the American Journal of Gastroenterology, a combination regimen of Olysio and Sovaldi showed high sustained virologic response rates in patients with hepatitis C virus infection genotype 1 with advanced cirrhosis.

“This report represents one of the first large experiences with the all oral antiviral regimen [simeprevir] and [sofosbuvir] in patients with HCV and cirrhosis,” the researchers wrote.

Researchers, including Mitchell L. Shiffman, MD, of the Liver Institute of Virginia and Bon Secours Health System, analyzed data of 120 consecutive patients with HCV genotype 1 and cirrhosis treated with Olysio (simeprevir, Janssen Therapeutics) and Sovaldi (sofosbuvir, Gilead Sciences) for 12 weeks at the Liver Institute of Virginia between December 2013 and April 2014. Of the patients, 63% were male, 48% were Caucasian, 44% were African American, 69% had HCV genotype 1A, 49% were treatment-naive, 96% did not have the interleukin-28B CC genotype, 33% had either Child class B or C cirrhosis and 25% had prior hepatic decompensation, according to the research.

Mitchell L. Shiffman

Overall, the SVR 12 weeks after stopping treatment by intention-to-treat analysis was 81% with a relapse rate of 14%. The SVR by per-protocol analysis was 87% with a relapse rate of 13%. At 2 weeks, 32% of patients had undetectable levels of HCV RNA. By 4 weeks, 87% had undetectable HCV RNA levels and by the end of treatment at 12 weeks, all patients became HCV RNA undetectable.

According to multifactor analysis, the only factor associated with SVR was Child class. SVR in patients with Child class A cirrhosis was 87%, 77% in class B patients and 67% in class C patients.

Four percent of patients did not return for follow-up after they had undetectable levels of HCV RNA (n = 5). In addition, six patients discontinued treatment before 12 weeks due to adverse events or other issues.

Severe adverse events were observed in 11% of patients, which included sepsis (n = 2), variceal bleeding (n = 2), hepatocellular carcinoma (n = 2) and hyperbilirubinemia (n = 8). One of the patients with sepsis died and two patients relapsed more than 12 weeks after stopping the treatment regimen.

The researchers concluded: “The present study has demonstrated that treating patients with advanced cirrhosis using simeprevir and sofosbuvir for 12 weeks is associated with an SVR of about 81 [to] 87%. In contrast, the SVR rate reported for patients with stable Child class A cirrhosis using various [interferon]-free all oral antiviral regimens generally exceeds 90 [to] 95%. We believe that other oral antiviral regimens given for the same duration would likely yield similar results. We speculate that higher SVR rates would likely only be achieved by extending the duration of therapy in patients with advanced cirrhosis.” – by Melinda Stevens

Disclosures: Shiffman reports advising for AbbVie, Achillion, Bristol-Myers Squibb, Boehringer-Ingelheim, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Novartis and Roche/Genentech; is a speaker for AbbVie, Bayer, Bristol-Myers Squibb, Gilead Sciences and Janssen; and receives grant support from AbbVie, Achillion, Beckman-Coulter, Bristol-Myers Squibb, Boehringer-Ingelheim, Conatus, Gilead Sciences, Hologic, Intercept, Lumena, Merck and Novartis. Please see the full study for a list of all other authors’ relevant financial disclosures.