A Future Without Hepatitis C?

The Liver Meeting 2014: American Association for the Study of Liver Diseases (AASLD)

William F. Balistreri, MD


December 16, 2014

In This Article


With Sofosbuvir in Patients With Genotype 3

The efficacy and safety of an all-oral, once-daily regimen of DCV and SOF given for 12 weeks were evaluated in 152 patients chronically infected with HCV genotype 3.[16] Overall SVR12 rates were 91% and 86% in treatment-naive and treatment-experienced patients, respectively. The presence of cirrhosis had a significant negative impact, with only 63% achieving SVR. This combination was safe and well tolerated.

With Asunaprevir and BMS-791325 in Patients With Cirrhosis

This regimen was administered with or without RBV to treatment-naive and treatment-experienced patients with HCV genotype 1 infection and compensated cirrhosis in a phase 3, international clinical trial.[17] Patients were randomly assigned to receive a fixed-dose combination of DCV (30 mg), ASV (200 mg), and BMS-791325 (75 mg), with blinded RBV or placebo, twice daily, for 12 weeks. This all-oral treatment achieved high rates of SVR12 (87%-98%) in cirrhotic patients; virologic failure was observed in 6% of patients.

Assessing Real-World Outcomes

SMV and SOF were approved by the US Food and Drug Administration (FDA) more than a year ago. Given the success of SMV- or SOF-based regimens reported in clinical trials, Jensen and colleagues[18] aimed to assess real-world outcomes. They determined patient preferences using data obtained from the HCV TARGET consortium, which represents a broad spectrum of academic and community-based clinical practices.

Since January 2014, a total of 1107 patients have started antiviral treatment. Among genotype 1 patients, 60% were treated with off-label SOF/SMV with or without RBV, 28% with SOF/Peg-IFN/RBV, and 11% with SOF/RBV alone. More than 95% of patients with genotype 2 or 3 were treated with the SOF/RBV regimen. The SOF/SMV with or without RBV regimens were also most frequently used in patients with cirrhosis (50%) and in those who are post–liver transplantation (54%). The observed SVR rates were 85% for SOF/Peg-IFN/RBV and 90% for SOF/RBV. Off-label combinations were used in 68% of patients(53% were SOF/SMV with an SVR of 89%, and 15% were SOF/SMV/RBV with a SVR of 89%). Adverse events were primarily related to peg-IFN/RBV.

The investigators concluded that when these regimens are applied in the real world, the "cure rates" are similar to those seen in phase 2 and 3 studies. The high (at that time) rate of off-label use of oral SOF with SMV was particularly evident among patients with cirrhosis, in post–liver transplantation, and in elderly populations.


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