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Triple therapy decreased SVR12 in mildly decompensated patients
Patients with a Child-Turcotte-Pugh scores greater than 6 who underwent protease inhibitor triple therapy experienced decreases in sustained virologic response at 12 weeks, according to data in a new study.
Researchers conducted a multicenter study of 160 adults with genotype 1 hepatitis C virus (HCV) infection with cirrhosis; 69% were treated with pegylated interferon ribavirin (PEG-IFN/RBV) plus telaprevir, and 31% were treated with PEG-IFN/RBV plus boceprevir. Researchers compared patients with Child-Turcotte-Pugh (CTP) values of 5 with those with values of 6 or greater.
All participants were treated with 180 mcg PEG-IFN alfa-2a weekly or 1.5 mcg/kg PEG-IFN alfa-2b per week with 1,000 mg RBV (<75 kg) or 1,200 mg (≥75 kg) daily, plus telaprevir (750 mg three times daily or 1,125 mg twice daily) or boceprevir (800 mg three times daily) for 48 weeks. Telaprevir was given with PEG-IFN/RBV for 12 weeks, and boceprevir was administered with PEG-IFN/RBV for 44 weeks.
Norah Terrault
The overall sustained virologic response rate for 12 weeks (SVR12) was 45%, including 54% of patients with compensated cirrhosis vs. 35% of those with mildly decompensated cirrhosis (P=.02). Compared with those with CTP scores of 5, patients with CTP of 6 or greater had more PEG-IFN dose reductions, eltrombopag use, transfusions and hospitalizations because of adverse events (all P<.05).
The overall relapse rate was 20%. Forty-two percent of patients discontinued treatment early due to an adverse event. Five patients who were treated for a median of 223 days and stopped therapy early because of an adverse event later achieved SVR12.
“These results point to the importance of obtaining ‘real world’ outcomes on the risk vs. benefit of recently approved treatments to better inform clinical decisions and of the high need for safer and more effective therapies in patients with decompensated cirrhosis,” researchers said.
Disclosure: Researcher Norah A. Terrault, MD, reports receiving research support from Gilead Sciences, Genentech/Roche, Vertex, Novartis, Eisai and AbbVie and has served as consultant for Bristol-Myers Squibb. Researcher Mary P. Pauly, MD, reports clinical research support from Roche and Merck.