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Olysio/Sovaldi found effective in treating HCV patients with cirrhosis

Combination treatment with Olysio and Sovaldi was more effective in treating patients with hepatitis C-related Child’s Class A cirrhosis vs. treatment with pegylated interferon, ribavirin and Sovaldi, according to study data published in Gastroenterology.

In an open-label study, researchers, including Brian L. Pearlman, MD, FACP, medical director of the Center for Hepatitis C, Atlanta Medical Center, Ga., analyzed data of 82 patients with chronic HCV genotype 1a and Child’s grade A cirrhosis from two clinics at a single medical center in Atlanta between December 2013 and January 2014. Fifty patients were previous null responders to treatment with pegylated interferon (PEG-IFN) and ribavirin and 32 were treatment-naive. Fifty-eight patients were randomly assigned to receive a combination of 150 mg of Olysio (simeprevir, Janssen) and 400 mg of Sovaldi (sofosbuvir, Gilead Sciences) daily and 24 patients received 1.5 µg/kg PEG-IFN alfa-2b (Merck) weekly plus 1,000 to 1,2000-mg ribavirin daily (based whether body weight < or ≥ 75 kg) and 400 mg of sofosbuvir daily, for 12 weeks.

Overall, 93% of patients treated with simeprevir and sofosbuvir achieved sustained virologic response at week 12 compared with 75% of patients given the PEG-IFN regimen (P = .02). In addition, patients who received PEG-IFN had a higher viral relapse compared with those treated with simeprevir (P = .009). Three previous null responders in the simeprevir group experienced virologic relapse, and three patients in the PEG-IFN group, one treatment-naive and two null responders, relapsed.

The simeprevir and sofosbuvir regimen was well-tolerated with no discontinuations due to adverse events or deaths. Common adverse events in the simeprevir-treated patients included rash, fatigue, headache, nausea and pruritus without rash, according to the research. Adverse events in the PEG-IFN group included fatigue, headache, flu-like illness, nausea, insomnia and fever. Two patients in this group discontinued due to severe fatigue and severe fatigue with grade 2 anemia.

“In a population of genotype 1a-infected patients with compensated cirrhosis, both treatment naive and prior null responders to peginterferon/ribavirin, the all oral regimen of simeprevir/sofosbuvir demonstrated significantly better [SVR12] rates, a lesser rate of virologic relapse and was better tolerated in terms of patient-reported outcomes and adverse events than a peginterferon-containing regimen, including ribavirin and sofosbuvir, when both were administered for 12 weeks,” the researchers concluded. – by Melinda Stevens

Disclosure: Pearlman reports financial relationships with AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead Sciences, Johnson & Johnson, and Merck. Please see the full study for a list of all other authors’ relevant financial disclosures.