In a retrospective study, a combination treatment regimen of Olysio and Sovaldi led to high sustained virologic response rates among patients with hepatitis C virus infection post-liver transplant and with advanced liver disease.
“This study reports on the tolerability and outcomes of treatment with sofosbuvir and [simeprevir] and includes the largest single-center experience to date,” Ryan M. Ford, MD, of Emory Healthcare, Atlanta, GA, and colleagues wrote. “[We] found very high sustained virologic response rates in genotype 1 patients who have many traditional poor markers for viral response, including prior treatment, cirrhosis and liver transplant recipients.”
Ryan M. Ford
Researchers analyzed “real world” treatment of 170 patients from the Emory University Center for Viral Hepatitis with chronic HCV genotype 1 using a combination regimen of Olysio (simeprevir, Janssen Therapeutics) and Sovaldi (sofosbuvir, Gilead Sciences) with or without ribavirin for 12 weeks.
Of the entire cohort, 67% were men, 35% were African American and most had HCV genotype 1a. In patients who did not undergo liver transplant (LT), 77% had cirrhosis. Sixteen-percent of LT recipients experienced recurrent cirrhosis post-LT.
On an intention-to-treat (ITT) analysis, patients with chronic HCV genotype 1 achieved an overall SVR of 78% at 12 weeks after completion of therapy compared with 86% of patients by per protocol analysis. Of these patients, 84% were non-LT patients and 89% were post-LT recipients.
Undetectable viral load at 8 weeks was a positive predictor of SVR for the entire protocol cohort (P = .02). Of this cohort, 80% achieved a rapid virologic response (undetectable load at 4 weeks). However, this was not a significant, consistent finding in other studies, according to the researchers.
“HCV [viral load] at week 8 was a significant positive predictor of SVR12 on both univariate and multivariable and is a unique finding in our study,” the researchers wrote.
Both univariate and multivariable analysis showed hepatocellular carcinoma to be a negative predictor of SVR12 among all patients and confirmed in the ITT analysis (P = .015).
The most common adverse events of treatment included nausea, diarrhea, headache and fatigue.
The researchers concluded: “Although the FDA approval of [Harvoni] has surpassed previous expectations of antiviral therapy, the combination of [simeprevir] and [sofosbuvir] is still a worthwhile consideration.” – by Melinda Stevens
Disclosure: The researchers report no relevant financial disclosures.