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Olysio/Sovaldi yields SVR in HCV genotype 1 patients with cirrhosis

In a new study, researchers found that Olysio combined with Sovaldi with or without ribavirin yielded a sustained virologic response in patients with hepatitis C virus genotype 1 infection with liver cirrhosis, according to published findings in Hepatology.

“In this study, we report our multicenter experience using [simeprevir and sofosbuvir] with or without [ribavirin] for treatment of HCV [genotype 1] patients with compensated and decompensated [liver cirrhosis],” the researchers wrote.

Researchers assigned 119 patients with compensated cirrhosis and evaluated for liver transplant a regimen of 150 mg of Olysio (simeprevir, Janssen Therapeutics) and 400 mg of Sovaldi (sofosbuvir, Gilead Sciences) with or without ribavirin (RBV) for 12 weeks. No dose adjustments were allowed and select patients were administered weight-based RBV, with the initial dose of RBV being based on the estimated glomerular filtration rate (eGFR) and dose was adjusted depending on hemoglobin levels, according to the researchers. Of the patients, 61% were male, 87% were Caucasian, 69% had HCV genotype subtype 1a, 30% had Child- Turcotte-Pugh-B liver cirrhosis and 82% were treatment experienced. With the exception of three patients, all completed treatment and no patients were lost to follow-up.

Over a median follow-up of 38 weeks, 78% of patients achieved sustained virologic response at 12 weeks (n = 92/118).

Analyses showed that pretreatment MELD score was a predictor of SVR12 (P = .018). In a majority of patients, SVR12 stabilized or improved MELD score.

“Baseline viral load, previous treatment status, RBV use, or [genotype 1] subtype did not impact SVR 12,” the researchers wrote.

Twenty-six patients (22%) had at least one adverse event, of which were mild in severity, requiring only “supportive and symptomatic treatment without interruption of treatment,” according to the researchers. Headache was the most common adverse event and was observed in 9 patients. Anemia was observed in 6 patients, all of who received RBV. The patients with anemia underwent RBV dose reduction, and growth factor support was used in 2 patients. Grade 3 to 4 hyperbilirubinemia developed in 3% of patients (n = 4).

“Though viral clearance was associated with short-term improvement in MELD score, long-term impact of SVR12 is still to be determined,” the researchers concluded. “Our data support the FDA recommendation to extend duration of therapy of [simeprevir and sofosbuvir] to 24 weeks in patients with cirrhosis. The use of this regimen may be limited by the cost and availability of other effective all-oral treatment regimens.” – by Melinda Stevens

Disclosures: Aqel reports no relevant financial disclosures. Please see the study for a full list of all other authors’ relevant financial disclosures.